ArchiveTo investigate the gram-positive coccus resistance in nationwide tietiary hospitals, understand the trend of antimicrobial resistance and provide scientific data for the rational use of antibiotis.
All the clinical isolates were collected from 18 hospitals and the minimal inhibitory concentrations (MICs) were tested using agar/broth dilution method recommended by Clinical and Laboratory Standards Institute (CLSI) in central laboratory.
A total of 2 311 pathogenic gram-positive coccus from 18 tertiary hospitals in 18 cities nationwide over the period from July 2023 to June 2024 were studied. Based on the MIC results, the prevalence of methicillin resistant Stapylococcus aureus (MRSA) and methicillin resistant Stapylococcus epidermidis (MRSE) were 30.6% and 76.3%, respectively. No vancomycin insensitivitive Staphylococcus was detected. Stapylococcus aureus were 100% susceptible to linezolid and teicoplanin. Antibiotic resistance rates of Enterococcus faecalis and Enterococcus faecium to ampicillin were 0.6% and 89.1%, respectively. 18 strains of vancomycin-resistant Enterococcus (VRE) were detected, all of which was Enterococcus faecium. The detection rate of VRE among Enterococcus faecium was 5.5%. The prevalence of penicillin non-susceptible Streptococcus pneumoniae (PNSSP) was 9.9% based on non-meningitis and parenteral administration criterion, while for cases of oral penicillin, the rate was 73.1%, showing similar to last time. The resistance rates of Streptococcus pneumoniae from children to cephalosporins, macrolides and clindamycin were slightly higher than those of adults and the elderly, while there were no statistic significant differences of resistance rates of Stapylococcus aureus, Stapylococcus epidermidis, Enterococcus faecalis, Enterococcus faecium and Streptococcus pneumoniae among various groups such as different departments, ages, or specimen sources (all P>0.05).
The detection rate of MRSA has continued to decline, while the detection rate of VRE has been on the rise. This situation requires continuous monitoring.
To investigate the gram-negative bacteria resistance in nationwide tietiary hospitals, understand the trend of antimicrobial resistance and provide scientific data for the rational use of antibiotis.
All the clinical isolates were collected from 18 hospitals and the minimal inhibitory concentrations (MICs) were tested using agar/broth dilution method recommended by Clinical and Laboratory Standards Institute (CLSI) in central laboratory.
A total of 4 681 pathogenic isolates from 18 tertiary hospitals in 18 cities nationwide over the period from July 2023 to June 2024 were studied. Based on the MIC results, Escherichia coli and Klebsiella pneumoniae showed extended spectrum β-lactamase (ESBLs) phenotype rates of 50.7% and 20.7%, respectively, ESBLs phenotype rate keeps going down. The ratio of carbapenems resistance Klebsiella pneumoniae (CRKP) was 35.4%, increased by 10 percentage points compared with the previous monitoring. Carbapenems, β-lactam combination agents and amikacin displayed desirable antibacterial activity against Enterobacterales, susceptibal rates were above 78%. In addition, tigacycline, eravacycline, colistin maintained good antibacterial activity against their respective effective bacteria/species, and the bacterial sensitivity rates by more than 90%. Resistance rates of Pseudomonas aeruginosa and Acinetobacter baumannnii to imipennnem were 32.7% and 70.7% and multidrug-resistant (MDR) detection rates were 43.3% and 78.3%, Extensively drug-resistant (MDR) were 17.0% and 71.0%, respectively. Comparison of drug resistance rates from different wards, ages and specimen sources indicated that the proportion of resistance in Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter baumannii isolated from intensive care unit (ICU) were significantly higher than non-ICU. Resistance rates of Pseudomonas aeruginosa isolated from children were significantly lower than that in adults and the elderly. However, the detection rate of ESBLs phenotypes in Klebsiella pneumoniae in children was 57.1%, significantly higher than that in adults (16.3%) and the elderly (19.8%). In addition, the strains of Haemophilus influenzae from children had a higher resistance rates to cephalosporins, macrolides, and clindamycin than those in adults and the elderly. Comparisons of different specimen sources showed that the resistance rates of Acinetobacter baumannii isolated from urine specimens were significantly lower than that from other sources. No statistical differences were observed among other major bacterial species in different specimens, while the resistance rates of Pseudomonas aeruginosa in sputum specimens and Escherichia coli in source drainage fluids were slightly higher than those from other sources.
The detection rates of ESBLs phenotypes in Escherichia coli and Klebsiella pneumoniae have continued to decline, while the detection rates of CRKP and ampicillin-resistant Haemophilus influenzae have shown an upward trend, which requires continuous attention.
To investigate the clinical efficacy and safety of finerenone tablets combined with losartan potassium capsules in the treatment of patients with chronic kidney disease (stage 1-3) and non-diabetic immunoglobulin A (IgA) nephropathy.
Patients with chronic kidney disease (stage 1-3) and non-diabetic IgA nephropathy were divided into control group and treatment group according to different drug treatment plans. Control group was treated with losartan potassium capsules at an initial dose of 50 mg·time-1, once a day, for 3 months. Treatment group was treated with finerenone tablets at an initial dose of 20 mg·time-1, once a day, for 3 months, and combined with losartan potassium capsules, dose same as control group. The clinical efficacy and levels of renal function indexes, immunoglobulin indexes, complement indexes and inflammatory factors were compared between the two groups. The safety was evaluated.
A total of 96 cases were enrolled in this study. Among them, 47 cases were included in control group and 49 cases were included in treatment group. After treatment, the total effective rates in control group and treatment group were 82.98% (39 cases/47 cases) and 97.96% (48 cases/49 cases), and the treatment group was significantly higher (P<0.05). After treatment, glomerular filtration rates (eGFR) in control group and treatment group were (87.29±16.30) and (95.72±18.53) mL·min-1·1.73 m-2; 24 h urine protein levels were (0.69±0.14) and (0.48±0.10) g·24 h-1; urinary albumin-to-creatinine ratios (UACR) were (32.96±6.38) and (26.57±5.49) mg·mmol-1; blood urea nitrogen (BUN) levels were (12.68±2.24) and (11.15±2.17) mmol·L-1; serum creatinine (SCr) levels were (122.39±24.73) and (108.45±21.94) μmol·L-1; cystatin c (CysC) levels were (2.74±0.51) and (2.31±0.48) mmol·L-1; IgA levels were (2.18±0.46) and (1.73±0.39) g·L-1; complement (C) 3 levels were (0.95±0.18) and (1.14±0.22) g·L-1; C4 levels were (1.27±0.25) and (1.53±0.29) g·L-1; C1q levels were (0.19±0.05) and (0.23±0.06) g·L-1; interleukin (IL)-2 levels were (16.83±4.32) and (12.18±3.75) ng·L-1; IL-6 levels were (10.25±2.04) and (7.22±1.43) ng·L-1; high-sensitivity C-reactive protein (hs-CRP) levels were (0.52±0.16) and (0.40±0.11) mg·L-1. The differences in above indicators between treatment group and control group were statistically significant (all P<0.05). Adverse drug reactions in control group included dizziness, orthostatic hypotension, gastrointestinal reactions, skin rashes and hyperkalemia. Adverse drug reactions in treatment group included dizziness, orthostatic hypotension, gastrointestinal reactions and hyperkalemia. The total incidence rates of adverse reactions in treatment group and control group were 12.77% (6 cases/47 cases) and 14.29% (7 cases/49 cases), showing no statistically significant difference (P>0.05).
The clinical efficacy of fenelidone tablets combined with losartan potassium capsules in treatment of chronic kidney disease (stage 1-3) with non-diabetes IgA nephropathy is more significant than that of losartan potassium capsule alone. It can significantly increase eGFR, lower urine protein level, improve renal function and immune function and alleviate micro-inflammation, with good safety.
To analyze the clinical effect of dapagliflozin tables combined with semaglutide injection in the treatment of patients with type 2 diabetes mellitus (T2DM) accompanied by abdominal obesity.
Patients with T2DM accompanied by abdominal obesity were divided into the control group and the treatment group by the random number table method. The control group took dapagliflozin tables orally once a day, 10 mg each time. The treatment group was hypodermic injection with semaglutide injection once a week on the basis of the control group, 0.5 mg each time. Both groups were treated for 3 months. The lipid metabolism, glucose metabolism, body mass index (BMI), waist circumference(WC), serological indicators, adipokines and adverse drug reactions were compared between the 2 groups.
In this study, 84 cases were enrolled in the treatment group and 83 cases in the control group, and 3 cases fell off in both groups. Finally, 81 cases were enrolled in the treatment group and 80 cases in the control group. After treatment, the low-density lipoprotein cholesterol (LDL-C) in the treatment group and the control group were (3.21±0.43) and (3.57±0.54) mmol·L-1, respectively, and the glycated hemoglobin (HbAlc) were (5.42±0.67)% and (6.95±0.75)%, respectively; the homeostasis model assessment of insulin resistance (HOMA-IR) were (2.02±0.37) and (2.45±0.48) respectively, the BMI were (26.02±2.11) and (27.12±2.38) kg·m-2, respectively, and the WC were (90.25±8.17) and (95.07±9.14) cm, respectively; insulin-like growth factor (IGF) were (154.31±15.68) and (165.23±17.08) mmol·L-1, respectively, and asprosin (ASP) were (1.20±0.31) and (1.37±0.38) μg·L-1, respectively; the spexin (SPX) were (0.78±0.19) and (0.65±0.14) ng·mL-1, respectively, while the difference of above indexes in treatment and control groups were all statistically significant (all P<0.05). The adverse drug reaction incidence in treatment and control groups were 8.64% and 5.00%, respectively, showing no statistically significant difference (P>0.05).
Dapagliflozin tables combined with semaglutide injection can effectively regulate the glycolipid metabolism of patients with type 2 diabetes mellitus (T2DM) accompanied by abdominal obesity, reduce BMI and WC, regulate adipokines, inhibit the expression of serum IGF, and with reliable safety.
To investigate the efficacy and safety of zanubrutinib capsules-rituximab injection-lenalidomide capsules(ZR2) in the treatment of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).
Patients with R/R DLBCL were divided into control group and treatment group according to a random number table. The control group received rituximab injection 375 mg·m-2 by intravenous infusion on day 1 of the treatment cycle, and orally took lenalidomide capsules 25 mg once daily from day 1 to day 14 of the cycle. The treatment group received oral zanubrutinib capsule 160 mg twice daily from day 1 to day 21 of the cycle, in addition to the treatment given to the control group. Both groups were treated in 21-day cycles for a total of 6 cycles. The clinical efficacy, immune environment-related indicators, inflammation-related indicators, angiogenesis and metabolism-related indicators, rogression-free survival (PFS) and overall survival (OS) were compared between the two groups.
In control group, 2 cases were lost to follow-up and 1 case withdrew, resulting in 40 cases actually included; in treatment group, 3 cases were lost to follow-up, resulting in 40 cases actually included. After treatment, the disease control rates (DCR) of the control group and the treatment group were 60.00% and 82.50%, respectively; cluster of differentiation 3 positive T lymphocyte (CD3+) were (62.17±8.23)% and (67.29±7.95)%, respectively; cluster of differentiation 4 positive T lymphocyte (CD4+)/cluster of differentiation 8 positive T lymphocyte (CD8+) were 1.44±0.36 and 1.65±0.47, respectively; T helper 17 cell (Th17) were (1.37±0.34)% and (1.62±0.46)%, respectively; natural killer cell (NK) were (22.47±3.69)% and (24.86±4.12)%, respectively; tumor necrosis factor-alpha (TNF-α) were (23.35±6.28) and (19.62±5.31) pg·mL-1, respectively; soluble interleukin-2 receptor (sIL-2r) were (621.74±134.89) and (539.48±116.83) U·mL-1, respectively; lactate dehydrogenase (LDH) were (278.64±56.84) and (251.37±48.43) U·L-1, respectively; beta-2-microglobulin (β2-MG) were (1.86±0.87) and (1.49±0.74) mg·L-1, respectively; the PFS rates were 22.50% and 52.50%, respectively; the OS rates were 45.00% and 67.50%, respectively. The differences in the above data between the two groups of patients were statistically significant (all P<0.05). The total incidence of adverse drug reactions in the control group and the experimental group were 67.50% (27 cases/40 cases) and 77.50% (31 cases/40 cases) respectively, with no statistically significant difference, (P>0.05).
ZR2 regimen can improve the tumor immune microenvironment, suppress inflammatory responses and tumor angiogenesis in patients with R/R DLBCL, thereby leadingto higher DCR and improved long-term survival benefits, without increasing the risk of treatment-related adverse events.
To observe the clinical efficacy and safety of icotinib in the treatment of patients with recurrent mediastinal squamous cell carcinoma.
Patients with recurrent mediastinal squamous cell carcinoma were randomly divided into control group and treatment group using a random number table. Control group received docetaxel injection 75 mg·m-2, intravenous infusion, once every 3 weeks for 4 cycles; treatment group received icotinib 150 mg, orally, 3 times daily for 12 consecutive weeks. The clinical efficacy, disease control rate, progression-free survival, quality of life scores, physiological laboratory indicators and the incidence of adverse drug reactions were compared between the two groups.
A total of 105 patients were enrolled, 3 cases were excluded during the trial, leaving 52 participants in treatment group and 50 in control group. After treatment, the objective response rates (ORR) for treatment group and control group were 42.31% (22 cases /52 cases) and 32.00% (16 cases /50 cases); the disease control rates (DCR) were 76.92% (40 cases/52 cases) and 60.00% (30 cases/50 cases); the median progression-free survival (PFS) were 5.60 and 4.20 months; the median overall survival (OS) were 16.90 and 10.50 months; the overall health status were (72.61±13.96) and (63.62±16.94) points, respectively; the functional scale scores were (80.19±15.73) and (68.39±14.55) points, respectively; the symptom scale scores were (31.41±12.61) and (41.81±10.57) points, respectively; white blood cell count (WBC) were (2.31±1.50) and (4.45±1.00)×109 cell·L-1 ; neutrophil count (NEU) were (3.70±1.38) and (1.96±0.95)×109 cell·L-1; hemoglobin (Hb) were (119.39±17.40) and (109.98±14.04) g·L-1; platelet count (PLT) were (217.68±50.33) and (164.93±56.01)×109 cell·L-1. Compared with control group, the above indexes in treatment group all had significant differences (all P<0.05). The main adverse drug reactions in treatment group were rash, diarrhea and elevated transaminase; in control group were bone marrow suppression, alopecia, nausea and vomiting . There was no significant difference in the total incidence of adverse drug reactions between the two groups (82.69% vs. 90.00%, P>0.05). However, the incidence of grade 3-4 adverse drug reactions in treatment group was significantly lower than that in control group (11.54% vs. 30.00%, P<0.05).
Icotinib tablet is more effective than docetaxel injection in treating recurrent mediastinal squamous cell carcinoma, with less hematological toxicity, lower incidence of severe adverse reactions, and better safety profile.
To observe the effects and safety of different doses of alfentanil injection on hyperalgesia after continuous infusion of remifentanil injection in patients undergoing laparoscopic cholecystectomy.
The patients scheduled to undergo laparoscopic cholecystectomy were divided into group A, group B, group C and group D. Ten minutes before the end of the surgery, groups A, B and C were intravenously injected with alfentanil at doses of 5, 15 and 25 μg·kg-1, respectively, while group D was injected with 0.9% NaCl. The hemodynamics indices [before anesthesia induction (T0), 5 minutes after induction (T1), during intubation (T2), at skin incision (T3), during extubation (T4), 10 minutes after extubation (T5)], quality of awakening, analgesia and sedation scores, incidence of postoperative hyperalgesia, inflammatory factors and safety were compared among the 4 groups.
A total of 42 patients in each group were included in the statistical analysis. At T4, mean arterial pressure (MAP) values in groups A, B, C and D were (92.81±10.31), (87.50±10.33), (85.60±9.69) and (98.48±7.07) mmHg, respectively; heart rate (HR) values were (87.36±9.25), (81.76±9.35), (80.24±9.38) and (92.83±9.73) beat·min-1, respectively; at T5, MAP values were (95.40±8.63), (90.19±8.79), (89.71±8.86) and (99.48±8.72) mmHg, respectively; HR values were (92.31±8.56), (87.55±8.84), (86.24±8.64) and (97.33±8.51) beat·min-1, respectively; extubation time were (9.07±1.02), (9.38±1.25), (11.48±1.58) and (10.74±1.38) min; spontaneous breathing recovery time were (6.52±1.27), (6.86±1.28), (8.38±1.53) and (7.29±1.13) min; and PACU stay time were (22.64±4.57), (23.69±4.25), (32.95±4.62) and (27.26±4.98) min for groups A, B, C, and D, respectively; the incidence of hyperalgesia at 2 h postoperation were 4.76% (2 cases/42 cases), 2.38% (1 cases/42 cases), 0 and 21.43% (9 cases/42 cases), and at 24 h postoperation were 9.52% (4 cases/42 cases), 4.76% (2 cases/42 cases), 0 and 23.81% (10 cases/42 cases) in groups A, B, C, and D, respectively. Differences between group D and the other three groups were statistically significant (all P<0.05). There were no obvious adverse drug reactions in groups A and D. Adverse drug reactions in group B included nausea and vomiting, and adverse drug reactions in group C included respiratory depression. The total adverse drug reactions in groups A, B, C, and D were 0% (0 cases/42 cases), 2.38% (1 case/42 cases), 4.76% (2 cases/42 cases), and 0% (0 cases/42 cases), respectively, and there were no statistically significant differences (all P>0.05).
Compared with low dose alfentanil injection, high dose alfentanil injection applied in cholecystectomy can reduce hyperalgesia, effectively relieve pain, and alleviate inflammatory response, but the effect on improving the recovery quality of patients is not obvious.
To compare and analyze the application effects of remifentanil tosylate injection and propofol injection in painless endoscopic retrograde cholangiopancreatography (ERCP) in elderly patients.
A total of 106 elderly patients who underwent painless ERCP for treatment were included in this study. After excluding 4 patients according to the inclusion criteria, 102 patients were finally included. They were divided into two groups based on the medication used: the remimazolam group and the propofol group, with 51 patients in each group. Both groups of patients received general intravenous anesthesia. The remimazolam group was anesthetized with remimazolam mesylate combined with sufentanil, while the propofol group was anesthetized with propofol combined with sufentanil. Compared the anesthesia induction time, induction success rate, intraoperative hemodynamics, anesthesia recovery time, hemodynamics, stress response indicators between two groups of patients, and the safty was comparied.
The anesthesia induction time of the remimazolam group was (5.12±1.23) min, which was significantly longer than that of the propofol group (3.39±0.92) min. The success rate of the first induction was 52.94%, which was significantly lower than that of the propofol group 80.00% (all P<0.05). The eye-opening time of the remimazolam group and the propofol group were (4.96±1.58) and (8.00±2.03)min, respectively; the time for consciousness recovery were (5.92±1.64) and (9.10±2.59)min, respectively; the tracheal extubation time were (10.08±2.87) and (13.06±3.12) minutes, respectively; the retention time in the recovery room were (21.22±5.18) and (26.35±5.83) min, respectively. The eye opening, consciousness recovery, tracheal extubation and retention time in the recovery room in the remimazolam group were all significantly shorter than those in the propofol group (all P<0.05). After the examination, the VAS scores of the remimazolam group and the propofol group were (2.61±0.69) and (3.14±0.81) points, respectively; the VAS score of the remimazolam group was lower than that of the propofol group (P<0.05). At 24 h after the operation, the levels of epinephrine (E) in the remimazolam group and the propofol group were (42.11±5.93) and (47.12±6.01) ng·mL-1, respectively; the levels of norepinephrine (NE) were (67.28±7.84) and (72.46±8.10) ng·mL-1, respectively; the cortisol (COR) levels were (105.43±11.25) and (111.23±12.34) ng·mL-1, respectively. The E, NE and COR in the remimazolam group were all significantly lower than those in the propofol group (all P<0.05). The incidence of adverse drug reactions in the remimazolam group and the propofol group were 9.80% and 27.45%, respectively. The incidence of adverse drug reactions in the remimazolam group was lower than that in the propofol group (P<0.05).
Compared with propofol injection, the induction time of remifentanil tosylate injection for painless ERCP diagnosis and treatment in elderly patients is significantly longer than propofol injection, but the circulation after induction and during surgery is smoother, the stress response is lower, the recovery is rapid, and there are no serious adverse reactions. It can be clinically promoted and applied.
To observe clinical curative effect and safety of propofol emulsion injection combined with sufentanil citrate injection for intravenous anesthesia in children undergoing laparoscopic repair of oblique inguinal hernia.
According to historical medication regimens, children undergoing laparoscopic repair of oblique inguinal hernia were divided into treatment group and control group. The control group was given intravenous pumping of propofol emulsion injection 4-10 mg·kg-1·h-1 and fentanyl citrate injection 3 μg·kg-1·h-1 for anesthesia maintenance, while treatment group was given intravenous pumping of propofol emulsion injection 4-10 mg·kg-1·h-1 and sufentanil citrate injection 0.3 μg·kg-1·h-1 for anesthesia maintenance. The hemodynamic indexes, emergence agitation, awakening quality, pain and postoperative analgesics use were compared between the two groups at different time points, and safety evaluation was performed.
According to electronic medical record, 427 children with oblique inguinal hernia were enrolled between June 2021 and 2024. Finally, 160 cases meeting the inclusion and exclusion criteria were included for grouping analysis, including 76 cases in control group and 84 cases in treatment group. Immediately after skin incision (T1), heart rate (HR) in treatment group and control group were (92.67±5.06) and (97.53±4.97) time·min-1, and mean arterial pressure (MAP) were (98.63±5.82) and (101.31±5.49) mmHg, respectively. At 5 min after the start of surgery (T2), HR in treatment group and control group were (89.35±5.22) and (94.21±5.36) time·min-1, and MAP were (96.97±5.13) and (99.29±4.75) mmHg, respectively. After the surgery (T3), HR in treatment group and control group were (87.41±4.89) and (89.82±4.61) time·min-1, and MAP were (93.82±5.67) and (96.71±5.03) mmHg, respectively. The incidences of emergence agitation in treatment group and control group were 3.57% (3 cases/84 cases) and 11.84% (9 cases/76 cases), awakening time were (8.21±1.76) and (10.45±2.59) min, recovery time of spontaneous respiration were (6.29±1.40) and (8.63±2.02) min, and extubation time were (12.43±2.51) and (15.87±3.08) min, respectively; immediately after awakening, scores of the face, legs, activity, cry, consolability behavioral tool (FLACC) in treatment group and control group were (2.08±0.59) and (2.43±0.65) points; at 1 h after awakening, FLACC scores were (1.75±0.47) and (2.12±0.61) points; at 6 h after awakening, FLACC scores were (1.42±0.41) and (1.73±0.49); at 12 h after awakening, FLACC scores were (1.28±0.36) and (1.56±0.43) points, and differences in the above indexes between the two groups were statistically significant (all P<0.05). The total dosages of postoperative analgesics in treatment group and control group were (33.51±3.21) and (41.98±3.94) mL, and compression frequency of analgesic pump was (1.55±0.42) and (2.89±0.75) times, the differences were statistically significant (all P<0.05). The adverse drug reactions were as follows: treatment group: nausea, hypotension, vomiting, dizziness; control group: nausea, hypotension, vomiting, dizziness. There was no significant difference in total incidence of adverse drug reactions between treatment group and control group [10.71% (9 cases/84 cases) vs. 9.21% (7 cases/76 cases), (P>0.05)].
Compared with propofol emulsion injection combined with fentanyl citrate injection, propofol emulsion injection combined with sufentanil citrate injection for intravenous anesthesia is beneficial to maintain hemodynamic stability, improve emergence agitation and awakening quality, relieve postoperative pain and reduce postoperative use of analgesics in children undergoing laparoscopic repair of oblique inguinal hernia, which has good safety.
To study the clinical effect and safety of atosiban acetate injection combined with magnesium sulfate injection in inhibiting uterine contractions in premature delivery.
Patients with threatened preterm delivery were divided into treatment group (treated with atosiban acetate combined with magnesium sulfate) and control group (treated with magnesium sulfate) by random number table method. The 24 h dose magnesium sulfate injection was 30 g and this drug was stopped when uterine contraction was inhibited, the total dose of atosiban acetate injection was ≤ 330 mg and total treatment time should not exceed 48 h. The effects of contraction inhibition, serological indexes, hemodynamics, safety and perinatal outcomes of the two groups were compared.
A total of 97 cases were screened in this study, there were 47 cases in control group and 45 cases in treatment group. The treatment group and control group with success rate of fetal protection were 97.78% and 82.98%, the extended gestation time was (26.35±4.12) and (20.04±3.27) d, and the onset time of uterine contraction was (1.58±0.26) and (2.45±0.38) h, and the difference was all statistically significant (all P<0.05). After treatment, the interleukin-6 (IL-6) levels in treatment group and control group were (142.34±15.75) and (182.17±19.43) ng·L-1, respectively. Matrix metalloproteinase inhibitor-1 (TIMP-1) was (135.29±15.42) and (112.48±13.55) pg·mL-1, nitric oxide (NO) was (23.03±2.17) and (28.13±3.01) μmol·L-1; and the difference of the indexes between two groups was statistically significant (P<0.05). After treatment, there were no statistically significant differences in systolic blood pressure (SBP)[(120.07±13.97) vs. (119.28±13.51) mmHg], heart rate (HR)[(93.56±10.82) vs. (93.32±10.65) bpm] and diastolic blood pressure (DBP) [(77.22±9.05) vs. (78.32±9.47) mmHg] between 2 groups (P>0.05). There were no statistically differences in perinatal mortality and incidence of adverse reactions in 2 groups (P>0.05). The incidence of neonatal asphyxia in treatment group and control group was 2.22% and 17.02%, and the incidence of low body weight infants was 2.22% and 14.89%, the difference was statistically significant (P<0.05).
Atosiban acetate injection combined with magnesium sulfate injection can effectively inhibit uterine contraction, reduce inflammation, improve vascular endothelial function, regulate serum TIMP-1 expression, and improve perinatal outcomes in patients with threatened preterm delivery, with good safety and no significant effects on hemodynamics.
To sequence a vancomycin-resistant Enterococcus faecium and analyze the vanM gene cluster carried on its plasmid as well as the genes conferring advantage in nutrient utilization.
The broth microdilution method was used to perform drug susceptibility tests on strain 15P371 and its transconjugant J15P371. Subsequently, whole-genome sequencing was conducted using Nanopore technology for both strains, followed by analysis of the resistant plasmid sequences. Bacterial growth experiments were carried out to verify the advantage in intestinal nutrient utilization.
Strain 15P371 is a vancomycin-resistant strain carrying 6 copies of the vanM gene cluster. Its transconjugant J15P371 can tolerate a higher concentration of vancomycin but only harbors 3 copies of the vanM gene cluster. Genes conferring advantage in intestinal N-acetylgalactosamine utilization are present on the resistant plasmid.
In vanM-type vancomycin-resistant strain, the copy number of resistance genes is variable during conjugative transfer. The plasmid carrying genes with advantage in N-acetylgalactosamine utilization confer growth advantage to the host bacteria.
To explore the mechanism by which processed Radix Hedysari and vinegar-processed Rhizoma Curcumae inhibit angiogenesis in colitis-associated colorectal cancer (CAC).
Sixty SPF-grade C57BL/6J mice were randomly divided into six groups (A-F), A: Blank control; B: Model group [Azoxymethane (AOM)/Dextran sodium sulfate (DSS) AOM/DSS group]; C: Sulfasalazine group; D: Fried Astragalus group; E: Fried Astragalus-Vinegar Curcuma (4∶1) group; F: Curcuma zedoaria group. Each group contained 10 mice. A CAC mouse model was induced using combined AOM and DSS. Simultaneously, each treatment group received intervention, the blank group received 0.9% sodium chloride solution. The experiment concluded after 17 weeks of intervention. Collagen fiber area expression in colon tissues was assessed using Masson’s trichrome staining. Microvascular density in colon tissues was determined via immunohistochemistry. Serum vascular endothelial growth factor(VEGF) and nitric oxide(NO) levels were measured using enzyme linked immunosorbent assay(ELISA). Key proteins in the phosphatidylinositol-3-kinase/ protein kinase B(PI3K/AKT) pathway and VEGF expression were detected by Western blotting (WB).
After 17 weeks of pharmacological intervention, the microvessel counts in the blank group, model group, sulfasalazine group, honey-fried Radix Hedysari-vinegar-processed Rhizoma Curcumae (4:1) group, honey-fried Radix Hedysari group, and vinegar-processed Rhizoma Curcumae group were (23.20±4.21), (73.60±13.52), (44.80±2.78), (33.40±6.31), (41.60±3.36), and (47.80±7.29), respectively. The serum VEGF concentrations were (83.03±24.13), (153.61±18.69), (115.08±11.43), (87.03±25.24), (91.33±32.37), and (101.93±19.74) pg·mL-1, respectively. The serum NO levels were (28.46±5.91), (40.62±2.28), (30.62±6.54), (29.18±5.37), (30.87±5.30), and (32.29±3.43) μmol·L-1, respectively. Compared with the blank group, the model group exhibited significant increases in the collagen fiber staining area and microvessel density in colonic tissue, markedly elevated serum VEGF and NO levels, and significantly enhanced phosphorylation of PI3K, AKT, and mTOR as well as upregulated VEGF expression in colonic tissue. In comparison with the model group, the honey-fried Radix Hedysari-vinegar-processed Rhizoma Curcumae (4∶1) group, honey-fried Radix Hedysari group, and vinegar-processed Rhizoma Curcumae group demonstrated significant reductions in the collagen fiber area and microvessel count in colonic tissue, decreased serum VEGF and NO concentrations, and markedly suppressed phosphorylation of PI3K, AKT, and mTOR along with downregulated VEGF expression in colonic tissue (P<0.05 or P<0.01).
The combined use of processed Radix Hedysari and vinegar-processed Rhizoma Curcumae exerts a better anti-CAC effect than the single herb. Its mechanism is closely related to regulating the expressions of key proteins in the PI3K/AKT signaling pathway, thereby inhibiting angiogenesis in colitis-associated colorectal cancer.
To compare the safety and efficacy of two different companies’ sodium hyaluronic acid gels for correcting moderate to severe nasolabial folds, and evaluate the non-inferiority of the test device to the control device.
This study included healthy subjects with the desire for nasolabial fold beauty who visited the hospital from March to August 2019, the subjects were randomly assigned to the test group and the control group at a ratio of 1∶1, and followed up to 12 months after a single injection sodium hyaluronic acid gel. The primary efficacy evaluation index was the effective rate of wrinkle improvement in the bilateral nasolabial area before and 6 months injection. The secondary efficacy evaluation indexes were the Wrinkles Severity Rating Scale (WSRS) scores of wrinkle improvement at different time points by the investigator and the subjects, and the Global Aesthetic Improvement Scale (GAIS) scores.
A total of 137 subjects were included per protocol set, with 70 in the test group and 67 in the control group, respectively. Compared with the baseline, the effective rates of improvement of one grade or above in the test group and the control group were 94.29% (66 cases/70 cases) and 94.03% (63 cases/67 cases), respectively, with a difference of 0.26% between the two groups, and the 95% limit of the difference (asymptotic normal) was [-0.08, 0.08], with the lower limit greater the non-inferiority limit of -10%, and the efficacy of the test group was not inferior to that of the control group. At 6 months post-injection, the investigator’s WSRS scores on the left of the test and control groups were (2.13±0.64) and (2.22±0.6) points, respectively, on the right side were (2.23±0.68) and (2.3±0.6) points; the subjects’ WSRS scores on the left were (2.24±0.79) and (2.32±0.84) points, on the right side were (2.18±0.77) and (2.29±0.76) points, respectively. The investigator’s GAIS of the test and control groups that were regarded as improved were 98.57% (69 cases/70 cases) and 97.01% (65 cases/67 cases), respectively; the subjects’ GAIS that were regarded as improved were 88.5% (62 cases/70 cases) and 86.57% (58 cases/67 cases), respectively, and there was no statistically significant difference between the groups all (P>0.05). In addition, there was no significant difference in the incidence of adverse reactions/adverse events between the two groups (P>0.05).
The effectiveness of the test group sodium hyaluronate gel for correcting moderate to severe nasolabial folds was not inferior to that of the control. And it has similar safety.
To evaluate the bioequivalence of clindamycin hydrochloride capsules test formulation and reference formulation in healthy subjects under fasting and postprandial conditions.
A randomized, open-label, single-dose, two-cycle crossover study was used in this study. A single dose of clindamycin hydrochloride capsules was administered in fasting and postprandial conditions, and the main pharmacokinetic parameters of clindamycin were determined by liquid chromatography tandem mass spectrometry to evaluate the bioequivalence of the two preparations.
Twenty- four healthy subjects were involved in the fasting and fed groups, respectively. The main pharmacokinetics (PK) parameters of the test formulation and reference formulation in the fasting group: Cmax were (2 174.17±616.64) and (2 288.75±678.73) ng·mL-1, AUC0-t were (8 080.29±3 707.51) and (8 496.10±4 801.26) h·ng·mL-1, AUC0-∞ were (8 333.89±3 838.97) and (8 790.21±4 987.28) h·ng·mL-1. The ratio of geometric mean and its 90% confidence interval were 95.27% (89.93%-100.93%), 97.75% (90.39%-105.70%), and 97.51% (90.13%-105.50%). The main PK parameters of the test formulation and reference formulation in the fed group: Cmax were (1 860.00±349.00) and (2 069.04±504.25) ng·mL-1, AUC0-t were (7 829.93±1431.81) and (8 317.23±2 267.65) h·ng·mL-1, AUC0-∞ were (8 053.74±1 486.71) and (8 543.98±2 328.35) h·ng·mL-1. The ratio of geometric mean and its 90% confidence interval were 91.56% (82.23%-101.95%), 96.41% (88.27%~105.31%), and 96.47% (88.14%~105.58%). The 90% confidence intervals of the geometric mean ratios of the main PK parameters of the test preparation and reference preparation for clindamycin hydrochloride capsules in the fasting group and fed group were all within 80.00% to 125.00%. The incidence of adverse events for the test and reference preparations in the fasting group were 25.00% and 20.80%, respectively, while in the postprandial group, they were 25.00% and 33.30%, respectively.
In the fasting and postprandial states, clindamycin hydrochloride capsules are bioequivalent to the original reference preparation.
To establish a highly efficient, sensitive, and accurate ultra-high performance liquid chromatography-mass spectrometry (UHPLC-MS/MS) method to determine the concentration of melatonin (MLT) in human plasma with heparin sodium.
The concentration of melatonin in plasma was measured using UHPLC-MS/MS. Plamsa sample preparation was done by protein precipitation using acetonitrile, its isotope melatonin-d4 (MLT-d4) was used as the internal standard (IS). Using UPLC BEH C18 (2.1 mm×50.0 mm, 1.7 μm) reverse phase chromatography column, gradient elution was performed with a mobile phase consisting of acetonitrile-water (0.05 mM Ammonium fluoride) at a flow rate of 0.4 mL·min-1 for 3 min. MLT was monitored using positive electrospray triple quadrupole mass spectrometer via multiple reaction monitoring (MRM) mode. The monitored transitions were set at m/z 233.0→174.0 for MLT. Moreover, the IS was set at m/z 237.2→178.2. This method was applied in a single-center, randomized, open-label, single oral dose pharmacokinetic trial, with 12 subjects in each group for fasting and after meals, administered a dose of 2 g (containing 4 mg of melatonin). Statistical analysis of pharmacokinetic parameters Cmax (ΔCmax), AUC0-t (ΔAUC0-t), and AUC0-∞ (ΔAUC0-∞) using WinNonlin version 8.3 or above or SAS version 9.4 or above.
The achieved lower limit of quantification was 50.00 pg·mL-1. The validated method had an excellent linearity in the range of 50.00-50 000.00 pg·mL-1 for MLT y=2.00x+1.12×10-4 (r2>0.999 4). The results of the intra-batch and inter-batch precision showed that the relative standard deviation (RSD) at different concentrations did not exceed 5.77%, and the accuracy was between 92.11% - 102.01% . The extraction recoveries of low, medium and high quality control samples of MLT were 103.35%, 113.75% and 131.21%, respectively. The coefficient of variation was 12.13%. No significant matrix effect was found. Through the pharmacokinetic study of 12 healthy humans, it was found for the first time that after taking the same dose of melatonin, the postprandial Cmax was about 50% of that of fasting, but the AUC was very similar, indicating that food might affect the absorption and metabolism of melatonin in the body.
This method has strong specificity, good precision and high sensitivity, which can quickly and accurately determine the content of melatonin in human plasma with heparin sodium, and is used for the detection of human blood drug concentration and pharmacokinetics of melatonin.
To explore the impact of necrotic apoptosis-related long non-coding RNA (lncRNA) on the prognosis of hepatocellular carcinoma (HCC) in high-risk populations.
LncRNAs were identified by co-expression analysis of immune genes with gene expression and clinical data from the cancer genome atlas program (TCGA) database. A risk model was established through univariate and multivariate cox proportional hazards regression model (Cox), as well as Lasso regression analysis. Patients were screened from TCGA database and divided into high-risk group and low-risk group. Combined with necrotic apoptosis-related lncRNA features, a highly predictive nomogram was created.
By analyzing data from the TCGA, a total of five lncRNAs (TMCC1-AS1, AC026412.3, AC026356.1, AC100872.2, and FOXD2-AS1) were identified as potential biomarkers. Nomogram was created, and its predictive efficiency was assessed using a calibration curve. Receiver operating characteristic (ROC) curve analysis showed that the area under curve (AUC) for predicting 1-year, 3-year, and 5-year survival rate were 0.781, 0.663, and 0.686, respectively (P<0.001).
Risk model constructed based on five necrotic apoptosis-related lncRNAs may predict prognosis in HCC patients.
The safety and efficacy of tranexamic acid in the perioperative period of burn patients remain controversial. This study aimed to investigate the safety and efficacy of tranexamic acid in perioperative burn patients.
A systematic search was conducted in Pubmed, Embase, Cochrane Library, China national know-ledge infrastructure (CNKI), Wanfang, and other databases up to March 1, 2025, for studies on the use of tranexamic acid in perioperative burn care. The primary outcomes included total perioperative blood loss, perioperative blood transfusion events, operative time, all-cause mortality, and incidence of adverse events. Meta-analysis was performed using RevMan 5.4.1, with risk of bias assessed using Cochrane’s ROB 2 tool and Robins-1 tool.
Seven studies were included, comprising a total of 465 cases (218 in the tranexamic acid intervention group and 247 in the control group). The findings demonstrated that the total perioperative blood loss in the tranexamic acid group was significantly lower than in the control group [MD=-165.01, 95% confidence interval (CI) (-210.13 to -119.89), P<0.001]. Additionally, tranexamic acid reduced operative time [MD=-8.32, 95% CI (-14.55 to -2.09), P=0.009] and perioperative blood transfusion events (OR=0.26, 95% CI 0.15-0.44, P<0.001), without increasing all-cause mortality (OR=0.67, 95% CI 0.33 to 1.36, P=0.27).
Tranexamic acid is effective in reducing total perioperative blood loss, shortening operative time, and decreasing the risk of perioperative blood transfusion events in burn patients, without increasing all-cause mortality. Thus, tranexamic acid can serve as a valuable adjunct in perioperative management for burn patients.
Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease characterized by persistent airflow limitation. Its pathogenesis is complex and involves multiple pathological processes such as oxidative stress, inflammatory response and apoptosis. The mitogen-activated protein kinase (MAPK) signaling pathway plays a significant role in regulating cell growth, proliferation, differentiation and apoptosis. Modern research has confirmed that traditional Chinese medicine can exert therapeutic effects on COPD by intervening in the MAPK signaling pathway. This article reviews the regulatory mechanism of the MAPK signaling pathway on COPD and the intervention effect of traditional Chinese medicine on COPD in recent years, aiming to provide research basis for the development of new traditional Chinese medicine and the clinical application of traditional Chinese medicine in the treatment of COPD.
The high morbidity and mortality of gastric cancer seriously affect and threaten the public's life and health. Precancerous lesions of gastric cancer (PLGC) is a key stage in the process of gastric mucosal carcinogenesis, and it is also a "golden turning point" before the formation of gastric cancer. Early and effective intervention has become an important way and research focus for the prevention and control of gastric cancer. Phosphatidylinositol-3 kinase (PI3K)/protein kinase B (Akt) signaling pathway is involved in a variety of biological processes such as inflammatory response, angiogenesis, autophagy level and apoptosis. Studies have confirmed that this pathway is abnormally activated in PLGC and can promote the malignant progression of the disease to gastric cancer by regulating a variety of pathways, which can be used as a potential target and effective way for the prevention and treatment of PLGC. In recent years, traditional Chinese medicine has achieved many research results in delaying or even reversing PLGC by targeting the PI3K/Akt signaling pathway. Based on the PI3K/Akt signaling pathway, this paper systematically expounds the role of this signaling pathway in PLGC and the research progress of traditional Chinese medicine intervention, in order to provide reference for the clinical treatment of this disease and drug development and application.
Osteoarthritis, a degenerative bone disease commonly seen in the elderly, is particularly prevalent in weight-bearing joints such as the knee. Its etiology is multifactorial and characterized by pathological changes in the joint structure, including destruction and degeneration of articular cartilage, inflammatory response and formation of bone capillaries. Up to now, clinical treatment for osteoarthritis is mainly symptomatic treatment and pain relief, and there is no exact therapy that can reverse the pathological process of cartilage damage in osteoarthritis. In recent years, domestic and foreign scholars have found that mitochondria, as important organelles of chondrocytes, plays an important role in the process of cell metabolism, proliferation and apoptosis. It is also pointed out that mitochondrial autophagy imbalance is an important factor leading to cartilage damage in joints. Meanwhile, several basic experiments have shown that Chinese medicine exhibits the potential to protect cartilage by targeting the regulation of mitochondrial autophagy, thus showing positive results in the prevention and treatment of osteoarthritis. However, studies on this area have not been systematically elaborated. In view of this, the authors will systematically elaborate on the effects of mitochondrial autophagy on the development of osteoarthritis and the role of TCM in interfering with mitochondrial autophagy in the treatment of osteoarthritis, with the aim of providing new ideas and methods for the development of new medicines and therapeutic strategies for the treatment of osteoarthritis with TCM.
The research and development of combination chemical drug occupy an important position in the development of new drugs and generic drugs. Two or more active ingredients are often formulated into combined preparations for development based on clinical needs, the mechanism of drug action and actual clinical effects. In the research and development of combined chemical drugs, clinical pharmacology research serves as a crucial bridge connecting the theories of drug research and development and the practical application in clinical practice. Based on regulations and guidelines, this article explores the application of clinical pharmacology research in the research and development of combined pharmaceutical preparations by integrating research and development cases, clinical practice and literature research.
The purpose of this article is to discuss the general statistical considerations of confirmatory clinical trial design of antiviral drugs for uncomplicated influenza patients, including estimands, sample size, bias control measures and statistical analysis methods, with reference to the Food and Drug Administration (FDA) biostatistics review report on baloxavir marboxil, the guidance of clinical trial technology for influenza treatment and prevention drugs, ICH E9R1 and statistical guidances issued by National Medical Products Administration (NMPA), in order to provide reference for clinical trial design of antiviral drugs in uncomplicated influenza patients.