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  • Yong-qing ZHENG, Zhi-gang JIAO, Teng-yan TANG, Shu-juan REN
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2275-2280.
    Objective

    To explore the clinical efficacy of fusidic acid ointment in patients with acne vulgaris who underwent non-ablative fractional 1 565 nm laser treatment.

    Methods

    Patients with common acne who received non-peeling fractional 1 565 nm laser treatment were divided into treatment group and control group. Treatment group was treated with fusidic acid ointment, 3 times a day, while control group was not treated with additional treatment.The lesion severity, skin sebum secretion, skin stratum corneum water content, clinical efficacy, matrix metalloproteinase 1 (MMP-1), matrix metalloproteinase tissue inhibitor-1 (TIMP-1), MMP-1/TIMP-1 ratio, skin elasticity indicators (R2, R5, R7), facial acne comprehensive grading system (global acne grading system, GAGS) score and acne-specific quality of life questionnaire (Acne-QOL) score were compared between the two groups.

    Results

    100 patients with acne vulgaris who received non exfoliative dot matrix 1 565 nm laser were enrolled, including 50 cases in treatment group and 50 cases in control group. After treatment, the total clinical effective rate of treatment group was 96.00% (48 cases/50 cases), and that of control group was 74.00% (37 cases/50 cases), the difference was statistically significant (P<0.05). After 3 months treatment, the skin oil secretion of treatment group and control group were (53.79±7.23) and (69.21±10.67) μg·cm-2, respectively; the moisture content of cuticle were (34.21±5.15)% and (29.68±3.92)%, respectively; MMP-1 were (1.02±0.28) and (1.24±0.43) μg·mL-1, respectively; TIMP-1 were (1.62±0.24) and (1.43±0.20) μg·mL-1, respectively; MMP-1/TIMP-1 were 0.63±0.10 and 0.87±0.15, respectively; the R2 were (53.77±8.75)% and (49.11±7.64)%, respectively; the R5 were (53.88±8.58)% and (49.67±7.69)%, respectively; the R7 were (32.55±6.05)% and (28.39±5.44)%, respectively; the GAGS scores were (13.78±2.69) and (17.83±3.35) points, respectively; the Acne-QOL scores were (105.56±5.58) and (90.21±6.32) points, respectively. After treatment, the above indexes in treatment group were significantly lower than those in control group (all P<0.05). The adverse drug reactions in treatment group and control group were dry, tingling, scaling and flushing. The total incidence of adverse drug reactions in treatment group was 10.00% (5 cases/50 cases) and in control group was 16.00% (8 cases/50 cases). There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05).

    Conclusion

    Fusidic acid ointment could significantly improve the dynamic balance of MMP-1/TIMP-1, skin elasticity and skin physiological indexes in patients with acne vulgaris receiving non-ablative fractional 1 565 nm laser, with good safety.

  • Xiang-qing SONG, Shi-peng YAN, Mi HAN, Mei-zi ZENG, Tao YANG, Wu-lin ZHANG, Yu TAN, Ming-hui LONG
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2379-2385.

    Vancomycin is the first-line drug for treating infections caused by methicillin-resistant gram positive bacteria in patients with malignant hematological diseases. However, due to significant differences in the physiological and pathological characteristics of these patients compared to the general population, the pharmacokinetic behavior of vancomycin in the body may undergo significant changes. These changes may lead to unpredictable therapeutic effects, increased safety risks, and the evolution of bacterial resistance. Personalized dosing strategies may offer potential solutions to address these issues. Nevertheless, at present, there is a lack of unified, guideline-based, or consensus-driven reference standards for personalized dosing in these patients, particularly adult patients, and relevant research data remain insufficient. This review systematically summarizes the current status of pharmacokinetic studies on vancomycin in adult patients with malignant hematological diseases and focuses on the analysis of population pharmacokinetic models and their application progress. Additionally, this paper provides a detailed discussion of the current technical approaches available for vancomycin personalized dosing, including techniques based on therapeutic drug monitoring, clinical decision support systems, novel technical methods, and the latest dynamic dosing techniques developed by our research team based on individualized dosing models. Through an organized review of existing research, this paper identifies the challenges faced in achieving broader implementation of personalized dosing. It is hoped that this study will provide valuable insights for achieving personalized vancomycin dosing in patients with malignant hematological diseases, thereby advancing clinical practice and technological development in this field.

  • Shi-yu LI, Huai-chen SHENG, Chong-fa ZHAO
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2251-2256.
    Objective

    To observe the clinical efficacy and safety of preoperative medication with lidocaine hydrochloride injection ultrasonic atomization combined with low-dose dexmedetomidine hydrochloride injection for fiberoptic bronchoscopy under general anesthesia in patients with pulmonary tuberculosis.

    Methods

    Patients with pulmonary tuberculosis scheduled for general anesthesia fiberoptic bronchoscopy were randomly divided into treatment group and control group. Both groups were given intravenous infusions of fentanyl citrate injection 0.05 mg and 1.5 mg·kg-1 propofol medium and long chain fat emulsion injection for induction of anesthesia. During the procedure, 2-3 mg·kg-1·h-1 propofol medium and long chain fat emulsion injection was used to maintain anesthesia. Control group received no additional treatment, while treatment group received an additional intravenous infusion of 0.2 μg·kg-1 dexmedetomidine hydrochloride injection through micro-pump over 15 min, combined with nebulized inhalation of lidocaine hydrochloride injection 3-4 mL, before induction of anesthesia. The postoperative anesthesia status, recovery quality, inflammation-related indicators and safety were compared between the two groups.

    Results

    Among the 95 patients with pulmonary tuberculosis who underwent fiberoptic bronchoscopy under general anesthesia, 3 cases dropped out during the treatment and finally 46 cases were included in each group. After treatment, the loss of consciousness time in control group and treatment group were (172.65±36.81) and (146.67±26.46)s, respectively; the recovery time were (18.67±1.06) and (15.50±0.75) min, respectively; the orientation recovery time were (16.63±1.76) and (9.57±1.70) min and the dosage of propofol were (130.21±13.41) and (124.02±15.43) mg, respectively; the Ramsay scores of 10 minutes after awakening were (3.09±0.51) and (2.57±0.62) points, respectively; the Ramsay scores of 20 minutes after awakening were (3.52±0.55) and (3.00±0.67) points, respectively; the levels of death-associated protein kinase 1 (DAPK1) were (88.08±9.85) and (81.88±11.55) ng·L-1, respectively; the levels of NOD-like receptor family pyrin domain-containing 3 (NLRP3) were (78.63±9.35) and (73.96±7.52) ng·L-1, respectively; the levels of interleukin-1β (IL-1β) were (46.02±4.59) and (41.04±6.62) ng·L-1, respectively and the levels of IL-18 were (5.71±1.64) and (4.78±1.23) ng·L-1, respectively. The differences of the above indexes between treatment group and control group were statistically significant (all P<0.05). The main adverse drug reactions of control group were tinnitus, dizziness, nausea, agitation and convulsion; in treatment group were dizziness, nausea, agitation and convulsion, the total incidence of adverse drug reactions in control group was 13.04% (6 cases/46 cases), while that in treatment group was 8.70% (4 cases/46 cases). There was no statistically significant difference between the two groups (P>0.05).

    Conclusion

    Lidocaine hydrochloride injection combined with low-dose dexmedetomidine hydrochloride injection has significant advantages in patients with pulmonary tuberculosis undergoing fiberoptic bronchoscopy under general anesthesia. It can effectively improve the anesthetic effect and recovery quality of patients, reduce the dosage of propofol and reduce the levels of inflammatory factors with with good safety.

  • Zhen-zhen ZHU, Ying XIE, Feng-xia DU, Li-wei LANG, Qian-yu LI, Jing ZHANG, Fang WANG
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2281-2286.
    Objective

    To investigate the influence of augmented renal clearance (ARC) on the steady-state serum concentration and pharmacodynamics of meropenem in patients with severe infections and to analyze the linear relationship between them.

    Methods

    A retrospective analysis was conducted on the inpatients who received meropenem treatment and underwent therapeutic drug monitoring (TDM) at the Fifth Medical Center of the General Hospital of the PLA from June 2021 to September 2024. Serum drug concentration data were collected, and pharmacokinetic parameters were calculated using a one-compartment model. The steady-state serum concentrations and pharmacodynamic parameters were compared between patients with normal renal function and those with ARC. Multiple linear regression analysis was performed to explore the factors influencing meropenem serum concentrations and pharmacodynamic parameters.

    Results

    When meropenem was administered at a dose of 1.0 g three times daily, the blood concentrations in patients with ARC at 3 hours and 0.5 hours before the last administration were (4.78±2.34) mg·L-1 and (2.44±1.60) mg·L-1, respectively. In contrast, the corresponding concentrations in patients with normal renal function were (14.08±10.45) mg·L-1 and (8.40±7.07) mg·L-1, respectively. The blood concentrations of meropenem were significantly lower in ARC patients compared to those with normal renal function (P<0.05). For the pharmacodynamic target of f%T>4MIC≥40%, the target attainment rates in ARC patients were 81.25%, 25.00%, 0.00%, and 0.00% at MIC values of 1, 2, 4, and 8 μg·mL-1, respectively. In comparison, the rates in patients with normal renal function were 92.31%, 76.92%, 53.85%, and 7.69%, respectively, indicating significantly lower target attainment in the ARC group. Multiple linear regression analysis revealed that creatinine clearance rate and serum albumin level significantly influenced both the plasma concentration and pharmacodynamic target attainment of meropenem.

    Conclusion

    ARC significantly reduces the steady-state serum concentration of meropenem and the rate of achieving pharmacodynamic targets, leading to the failure of anti-infective therapy. For patients with severe infections and ARC, attention should be paid to the effects of creatinine clearance, serum albumin on serum drug concentrations and therapeutic efficacy. TDM should be performed to adjust the dosing regimen in a timely manner.

  • Qian-you SHEN, Jun-li SONG, Yun REN, Zi-chang NIU, Shao-xia WANG, Hao-ping MAO
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2305-2310.
    Objective

    To investigate the improving effect of ginseng (GS) on metoprolol(meto) induced bradycardia in mice with chronic heart failure(CHF)and its molecular mechanism.

    Methods

    The CHF model in C57BL/6J mouse was established through left anterior descending coronary artery ligation. Mice were randomly divided into 6 groups, including sham group(underwent the same surgical procedure without coronary artery ligation), model group, control group(26 mg·kg-1·d-1 metoprolol), experimental-low group(26 mg·kg-1·d-1 metoprolol + 1.3 g·kg-1·d-1 GS), experimental-midium group(26 mg·kg-1·d-1 metoprolol + 2.6 g·kg-1·d-1 GS)and experimental-high group(26 mg·kg-1·d-1 metoprolol + 5.2 g·kg-1·d-1 GS). Each group contained 9 mice. After continuous administration for 8 weeks, heart rate changes were monitored using non-invasive blood pressure monitors in small animals; transcriptome sequencing was employed to analyze differentially expressed genes in cardiac tissues with functional enrichment analysis; calcium ion concentration in myocardial tissue was measured using a calorimetric assay; Western blot analysis was used to detect relative expression levels of sarcoplasmic reticulum calcium ATPase 2a(SERCA2a), phosphorylated phospholamban(p-PLB)and sodium-calcium exchanger 1(NCX1)in myocardial tissue.

    Results

    The heart rates of sham group, model group, control group and experimental-L, -M, -H groups were(528.61±60.86),(448.67±84.58),(260.07±74.97),(352.84±40.47),(436.27±90.84)and(501.91±43.11)beats·min-1, respectively. Control group was compared with model group, experimental-L, -M, -H groups were compared with control group, the differences showed statistical significance in heart rates(P<0.05,P<0.01). Transcriptome gene ontology(GO)analysis revealed that differentially expressed genes were significantly enriched in pathways related to myocardial contraction and calcium ion transmembrane transport(all P<0.05). The myocardial tissue calcium ion concentrations in sham group, model group, control group and experimental-L, -M, -H groups were(30.09±2.36),(35.97±1.15),(16.15±2.37),(19.59±1.04), (23.64±0.54)and(28.54±2.82)mmol·L-1,respectively. Compared with control group, experimental-L, -M, -H groups all showed significantly increase(P<0.01, P<0.05). The relative expression levels of SERCA2a in sham group, model group, control group and experimental-L, -M, -H groups were 1.00±0.14, 0.83±0.05, 1.23±0.12, 1.00±0.03, 0.98±0.05 and 0.90±0.11, respectively; the relative expression levels of p-PLB were 1.38±0.24, 1.05±0.19, 2.12±0.35, 1.08±0.24, 0.54±0.57,and 0.52±0.13; while the relative expression levels of NCX1 were 1.00±0.13, 1.08±0.20, 1.69±0.34, 1.06±0.35, 1.15±0.22 and 0.81±0.21. Compared with model group, the relative expression levels of all 3 proteins in control group showed significant increases. Except for SERCA2a in experimental -L group and NCX1 in experimental -M group, the relative expression levels of the above three proteins in the experimental group were significantly lower than that in the control group (P<0.01, P<0.05).

    Conclusion

    Meto may induce bradycardia adverse drug reaction by increasing the p-PLB/PLB ratio and elevating the expression levels of SERCA2a and NCX1 proteins, which reduces intracellular free calcium ion concentration in cardiomyocytes. Ginseng could significantly down regulate the p-PLB/PLB ratio, increase the protein expression levels of SERCA2a and NCX1, and up regulate the concentration of intracellular free calcium ion, so as to improve Meto induced bradycardia, suggesting that it may antagonize the negative frequency effect of Meto by remodeling the calcium cycle homeostasis.

  • Wen-ying CHEN, Ding-peng ZHOU, Cun-rong LIU, Ya-ping HE, Juan LIU, Xiao-wei SHI
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2363-2367.

    Diabetic kidney disease (DKD) is a clinical syndrome in which diabetes leads to microvascular lesions and then glomerulosclerosis. In the progression of DKD, the hypoxia inducible factor-1α (HIF-1α) signaling pathway is involved in the occurrence, development and pathological formation of DKD. Related studies have shown that the HIF-1α pathway is the most critical pathway for the treatment of DKD with traditional Chinese medicine. Among them, Chinese medicine monomers, Chinese medicine compounds, and Chinese patent medicines play a role in preventing interstitial fibrosis and glomerulosclerosis by regulating the HIF-1α pathway. Its mechanism is closely related to inflammation, oxidative stress, cell apoptosis, and ferroptosis. This article reviews the existing research results on the treatment of DKD with the intervention of traditional Chinese medicine in the HIF-1α pathway in recent years, in order to provide a theoretical basis for the prevention and treatment of DKD and the development of new drugs.

  • Jiao-jiao ZUO, Rui-ze WANG, Wen-ting WANG, Rui-ping SONG, Peng-cheng DOU, Xin-yi CHEN, Zhuang-zhuang FENG, Jin SHU
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2393-2400.

    Precancerous lesions of gastric cancer (PLGC) are considered as a high-risk factor for the development of gastric cancer. Existing studies have confirmed that hypoxia inducible factor-1α (HIF-1α) plays a key role in the progression of PLGC. HIF-1α promotes the malignant transformation of PLGC by regulating various cellular processes, including angiogenesis, aerobic glycolysis, autophagy, cell proliferation, and apoptosis. Traditional Chinese medicine (TCM) has been shown to modulate the HIF-1α signaling pathway and inhibit these pathological processes, thereby intervening in the development of PLGC. This review will focus on the mechanisms by which HIF-1α mediates PLGC and summarize the potential applications of TCM in the prevention and treatment of PLGC, aiming to provide a clear molecular framework for TCM intervention in PLGC and offer theoretical support and research directions for the development of innovative HIF-1α-targeted Chinese medicines.

  • Jing-han ZHANG, Tao ZUO, Lei ZHAO
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2386-2392.

    The treatment of posterior segment diseases has always been a challenge in the field of ophthalmology. How to overcome obstacles in drug delivery and improve the bioavailability of drugs in the posterior segment of the eye is one of the most challenging aspects in the field of drug research. The innovation of drug delivery routes and dosage forms, as well as breakthroughs in drug development, have brought new hope for the delivery of drugs in the posterior segment of the eye. This article reviews three aspects of innovative drug delivery routes for subretinal drug delivery, suprachoroidal drug delivery, and vitreous cavity implantation, innovative drug delivery form design for nano-formulations and exosomal formulations, and innovative drug development for intraocular injections, topical drops, and oral drugs, with the aim of providing new strategies for the treatment of diseases of the posterior segment of the eye.

  • Shu-yang HU, Yan XU, Liang XU
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2263-2268.
    Objective

    To observe the clinical efficacy and safety of finerenone tablets combined with dapagliflozin tablets in the treatment of elderly diabetic nephropathy (DN).

    Methods

    Elderly patients with DN in hospital were divided into treatment group and control group. The patients in control group were treated with oral dapagliflozin tablets once a day in the morning, with a dose of 5 mg each time, while the patients in the treatment group were combined with finerenone tablets on the basis of control group, and adjusted according to the estimated glomerular filtration rate (eGFR) levels of patients. Serum creatinine (SCr), blood urea nitrogen (BUN), 24 h urine protein quantification, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high-sensitivity C-reactive protein (hs-cRP), total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C) and clinical efficacy were compared between groups of patients, and the safety was evaluated.

    Results

    A total 90 patients were enrolced; 45 in treatment group and 45 in control group. After treatment, the SCr levels in treatment group and control group were (127.63±10.28) and (140.27±11.95) μmol·L-1, BUN levels were (11.45±3.57) and (18.62±3.29) mmol·L-1, 24 h urine protein quantification levels were (99.28±11.42) and (117.92±12.00) mg·24 h-1, IL-6 levels were (12.32±2.15) and (16.41±3.50) ng·L-1, TNF-α levels were (31.68±10.52) and (43.09±11.83) ng·L-1, hs-cRP levels were (6.08±1.20) and (9.56±1.57) ng·L-1, TC levels were (4.49±0.55) and (4.83±0.72) mmol·L-1, TG levels were (2.57±0.63) and (2.79±0.48) mmol·L-1, LDL-C levels were (2.71±0.63) and (3.06±0.45) mmol·L-1 respectively, and the above indicators in treatment group were significantly lower than those in control group, with statistically significant differences (all P<0.05). The total clinical effective rate in treatment group was 93.34% (42 cases/45 cases), and that in control group was 75.56% (34 cases/45 cases), with statistically significant difference (P<0.05). The adverse drug reactions in treatment group were hypotension, hypoglycemia, acute kidney injury, hyperkalemia and pruritus, and the adverse drug reactions in control group included hypoglycemia, acute kidney injury and hyperkalemia. The total incidence rates of adverse drug reactions in treatment group and control group were 22.22% (10 cases/45 cases) and 8.89% (4 cases /45 cases) respectively, without statistically significant difference (P>0.05).

    Conclusion

    Compared with dapagliflozin tablets, the combined use of finerenone tablets for elderly DN can better improve the renal function, and regulate the lipid metabolism, with good safety.

  • Shun ZENG, Yi-tao LIN, Hao ZHOU, Ying PAN, Miao YU
    Chinese Journal of Clinical Pharmacology. 2025, 41(16): 2269-2274.
    Objective

    To analyze the effect of urapidil sustained release capsules combined with finasteride tablet in the treatment of benign prostatic hyperplasia with lower urinary tract symptoms.

    Methods

    Patients with benign prostatic hyperplasia accompanied by lower urinary tract symptoms were included and randomly divided into treatment group and control group. Both groups received basic treatment with finasteride tablets, 5 mg each time, once daily, orally. The treatment group was treated with urapidil sustained release capsules, with an initial dose of 30 mg per day. If the patient’s clinical symptoms did not improve within 1-2 weeks, the dose could be gradually increased to 60 mg per day, with a maximum dose not exceeding 60 mg per day, twice a day, orally. Control group did not receive additional treatment. Compare the improvement of symptoms, quality of life, urodynamic indicators, laboratory indicators, clinical efficacy and evaluate safety between two groups.

    Results

    A total of 45 patients in treatment group and control group were included respectively. Ten patients withdrew from the study due to lost to follow-up or personal factors during the study, 5 patients in each groups. Finally, a total of 80 patients completed the study, 40 patients in treatment group and 40 patients in control group. The total effective rate of treatment group was 95.00% (38 cases/40 cases), while that of control group was 80.00% (32 cases/40 cases), which was statistically significantly higher in treatment group than in control group (P<0.05). After treatment, the international prostate symptom score (IPSS) of treatment group and control group were (10.52±0.98) and (13.79±1.05) points; the prostate quality of life score (QoL) were (2.01±0.77) and (2.51±0.52) points, above indicators in treatment group were statistically significantly lower than those in control group (all P<0.05). After treatment, post-void residual urine volume (PVR) levels of treatment group and control group were (31.60±3.75) and (35.79±3.24) mL, respectively; the average urinary flow rates (AER) were (16.88±1.46) and (14.37±1.22) mL·s-1, respectively; the maximum urinary flow rates (Qmax) were (24.09±2.03) and (21.96±2.77) mL·s-1, respectively. The PVR level in treatment group was statistically significantly lower than that in control group, while the AER and Qmax levels were statistically significantly higher than those in the control group (all P<0.05). After treatment, the prostate-specific antigen (PSA) levels in treatment group and control group were (0.51±0.09) and (0.74±0.10) ng·L-1, respectively; the numbers of red blood cells in urine sediment were (37.41±3.06) and (40.25±3.22) cells per HP, respectively, and the above indicators in treatment group were statistically significantly lower than those in control group (all P<0.05). After treatment,the testosterone (T) levels in treatment group and control group were (974.05±16.87) and (929.78±16.77) ng·mL-1, respectively; the estradiol (E2) levels were (136.47±10.55) and (127.58±10.35) pg·mL-1, respectively. The above indicators in treatment group were significantly higher than those in control group (all P<0.05). The main adverse drug reactions in both groups were gastrointestinal discomfort, headache, etc. The incidence of adverse drug reactions in treatment group was 12.50% (5 cases/40 cases), while in control group was 5.00% (2 cases/40 cases). There was no statistically significant difference between the two groups (P>0.05).

    Conclusion

    Patients with benign prostatic hyperplasia accompanied by lower urinary tract symptoms were treated with combination therapy of urapidil sustained-release capsules and finasteride tablet, which improved their urodynamic indicators and clinical symptoms, restored their sex hormone levels, improved their treatment efficacy and quality of life.