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  • Cong-cong XU, Sha LIU, Jun LI
    Chinese Journal of Clinical Pharmacology. 2026, 42(9): 1301-1307.
    Objective

    To discuss the effects of osthol (Ost) on melanocyte loss in vitiligo mice by regulating the Wnt/β-catenin signaling pathway.

    Methods

    A mouse model of vitiligo was established by applying hydroquinone cream. The successfully modeled mice were divided into model group (only modeling), low-dose experimental group (15 mg·kg-1 Ost), high-dose experimental group (45 mg·kg-1 Ost), positive control group (50.4 mg·mL-1 vitiligo capsules) and inhibitor group (45 mg·kg-1 Ost + 10 mg·kg-1 XAV939). The control group was given an equal volume of normal saline. Each group consisted of 10 mice. After the intervention, the degree of skin depigmentation in the treatment area was scored; orbital blood was collected, and the levels of malondialdehyde (MDA), α-melanocyte-stimulating hormone (α-MSH), tyrosinase (TYR) and tumor necrosis factor-α (TNF-α) in the serum were detected by enzyme-linked immunosorbent assay (ELISA); skin lesion tissues were collected, and the number of melanin-containing hair follicles and melanocytes in the basal layer were evaluated by hematoxylin-eosin (HE) and Masson staining; the positive expression levels of tyrosinase-related protein (TRP) 1 and TRP2 in the skin lesion tissues was detected by immunohistochemistry; the mRNA expression levels of tyrosinase (TYR) and microphthalmia-associated transcription factor (MITF) mRNA in the skin lesion tissues were detected by real-time fluorescence quantitative reverse transcription polymerase chain reaction (qRT-PCR); the protein expression levels of β-catenin and phosphorylated glycogen synthase kinase-3β (p-GSK-3β)/GSK-3β in the skin lesion tissues were detected by Western blotting.

    Results

    The depigmentation scores of control group, model group, low-dose experimental group, high-dose experimental group, positive control group and inhibitor group were (0±0), (4.11±0.52), (2.41±0.28), (0.77±0.09), (0.55±0.07) and (2.55±0.28) score, respectively; the levels of α-MSH were (26.53±2.84), (7.56±0.84), (12.62±1.36), (22.91±2.44), (23.51±2.48) and (13.05±1.38) μg·L-1, respectively; the levels of MDA were (2.05±0.24), (7.94±0.85), (4.31±0.49), (2.27±0.25), (2.19±0.24) and (4.28±0.45) nmol·mg prot-1, respectively; the levels of TNF-α were (38.52±4.02), (105.65±10.94), (68.84±7.05), (42.84±4.45), (41.85±4.37) and (70.05±7.21) ng·mL-1, respectively; the levels of TYR were (105.62±11.14), (45.22±4.67), (65.41±6.77), (98.62±9.98), (97.65±9.89) and (66.08±6.81) μg·L-1, respectively; the numbers of melanocytes in the basal layer were (148.62±15.08), (52.11±5.34), (68.84±6.91), (108.64±11.14), (112.08±11.44) and (70.54±7.21) cells, respectively; the numbers of melanin-containing hair follicles were (98.64±9.98), (41.52±4.31), (62.05±6.37), (95.62±9.74), (96.05±9.78) and (61.08±6.29) cells, respectively; the positive expression levels of TRP1 were 17.05±1.94, 4.62±0.77, 8.05±0.85, 14.98±1.58, 15.22±1.64 and 8.11±0.88, respectively; the positive expressions levels of TRP2 were 14.32±1.55, 3.05±0.33, 5.74±0.66, 10.42±1.15, 11.05±1.17 and 6.05±0.62, respectively; the relative expression levels of TYR mRNA were 1.09±0.12, 0.19±0.02, 0.49±0.05, 0.79±0.08, 0.88±0.09 and 0.55±0.07, respectively; the relative expression levels of MITF mRNA were 0.98±0.11, 0.24±0.03, 0.44±0.05, 0.81±0.09, 0.85±0.10 and 0.51±0.06, respectively; the relative expression levels of β-catenin were 1.25±0.13, 0.34±0.05, 0.68±0.08, 1.07±0.11, 1.11±0.12 and 0.71±0.09, respectively; the relative expression levels of p-GSK-3β/GSK-3β were 0.85±0.09, 0.22±0.03, 0.44±0.06, 0.71±0.08, 0.79±0.09 and 0.42±0.05, respectively. There were statistically significant differences between model group and control group, between low, high dose experimental group and model group, and between inhibitor group and high-dose experimental group (all P<0.05).

    Conclusion

    Ost reduces melanocyte loss in vitiligo mice by activating the Wnt/β-catenin signaling pathway.

  • Song-jie ZHANG, Li-li ZHANG, Ting LI, Qian-ru LIN, Bin-bin CUI
    Chinese Journal of Clinical Pharmacology. 2026, 42(9): 1308-1315.
    Objective

    To investigate the effect and mechanism of dihydroartemisinin (DHA) on ferroptosis in cervical cancer by the microRNA (miRNA)-346/Kruppel-like factor 14 (KLF14) axis.

    Methods

    In cell experiment, human cervical cancer Hela cells were treated and divided into several groups including cell normal control group (only HcerEpic cell), cell negative control group (only Hela cell), cell experimental group (Hela cell treated with 246.90 μmol·L-1 DHA for 48 h), DHA+mimic NC group (transferred with mimic NC based on the cell experimental group), DHA+miR-346 mimic group (transfected with miRNA-346 mimic based on the cell experimental group), DHA+sh-NC group (transfected with sh-NC based on the cell experimental group) and DHA+sh-KLF14 group (transfected with sh-KLF14 based on the cell experimental group). In animal experiment, a xenograft tumor model was established by subcutaneous injection of Hela cells into 30 female BALB/c nude mice, which were then divided into the animal control group (gavaged with saline), animal experimental-L group (gavaged with 100 mg·kg-1 DHA) and animal experimental-H group (gavaged with 200 mg·kg-1 DHA), with 10 mice in each group. The relative expression level of miRNA-346 was detected by quantitative real-time polymerase chain reaction. The relative expression levels of KLF14 protein, glutathione peroxidase 4 (GPX4) and solute carrier family 7 member 11 (SLC7A11) were measured by Western blot. Intracellular Fe2+ levels were detected using FerroOrange fluorescent probe. The apoptosis rate was determined by the terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) assay.

    Results

    In cell experiment, the relative expression levels of miRNA-346 in the cell negative group and cell experimental group were 1.00±0.18 and 0.42±0.06, respectively; the relative expression levels of KLF14 mRNA were 1.00±0.17 and 2.22±0.32, respectively; the relative expression levels of KLF14 protein were 1.00±0.15 and 1.72±0.23, respectively; the relative fluorescence intensities of Fe2+ of cell negative control group, cell experimental group, DHA+mimic NC group, DHA+miRNA-346 mimic group, DHA+sh-NC group and DHA+sh-KLF14 group were 1.00±0.15, 4.86±0.81, 4.32±0.62, 3.12±0.57, 4.23±0.59 and 2.02±0.33, respectively; the relative expression levels of GPX4 protein were 1.00±0.17, 0.45±0.06, 0.48±0.07, 0.78±0.11, 0.44±0.06 and 0.59±0.08, respectively; the relative expression levels of SLC7A11 protein were 1.00±0.12, 0.37±0.05, 0.35±0.04, 0.86±0.12, 0.40±0.07 and 0.77±0.10, respectively; the cell proliferation rates were (100.00±3.65)%, (54.32±7.65)%, (56.32±8.02)%, (72.33±8.65)%, (52.32±9.23)% and (88.25±10.35)%, respectively; the apoptosis rates were (14.32±1.61)%, (61.33±8.25)%, (57.32±7.13)%, (32.44±5.37)%, (59.63±8.98)% and (23.88±3.49)%, respectively. Significant differences were observed in the aforementioned parameters when comparing the cell experimental group with the cell negative group, comparing the DHA + miRNA-346 mimic group with the DHA + mimic NC group, and comparing the DHA + sh-KLF14 group with the DHA + sh-NC group (P<0.01,P<0.001). In animal group, the tumor volumes in the animal control, experimental-L and experimental-H groups were (542.36±92.33), (402.85±92.28) and (295.52±60.56) mm3, respectively; the tumor masses were (1.55±0.33), (1.22±0.22) and(0.88±0.15)g, respectively; the relative positive levels of GPX4 were 1.00±0.18, 0.55±0.07 and 0.42±0.04, respectively; the relative positive levels of SLC7A11 were 1.00±0.16, 0.48±0.06 and 0.29±0.03, respectively. Significant differences were also detected between the animal experimenal-L, -H group and the animal control group (P<0.05, P<0.01, P<0.001).

    Conclusion

    DHA promotes ferroptosis in cervical cancer by the miRNA-346/KLF14 axis-mediated GPX4 signaling pathway.

  • Zhao-yang DU, Qiang SHI, Jin-jing MA, Xin LIU, Lei ZHANG, Zi-yang SONG, Xin-wei CHEN, Jing-hai WEI, Peng GUO
    Chinese Journal of Clinical Pharmacology. 2026, 42(9): 1316-1322.
    Objective

    To analyze the rationality of outpatient and emergency nebulization medication prescriptions in a tertiary pediatric specialty hospital based on the hospital’s rational drug use system, identify the main types, distribution characteristics, influencing factors of irrational prescriptions, and provide evidence for standardizing clinical medication use.

    Methods

    All outpatient and emergency prescriptions containing nebulized drugs from January to December 2024 were collected. Prescriptions were initially screened using the Puhua Hecheng rational drug use system, followed by manual review by pharmacists according to standards such as the "clinical practice guidelines for nebulized inhalation therapy in pediatric respiratory diseases (2024 edition)". A retrospective analysis was conducted on irrational prescriptions.

    Results

    A total of 233 736 prescriptions were included. Initial screening identified 8 569 positive irrational prescriptions, and after review, 3 681 were confirmed as true positive irrational prescriptions, resulting in an overall irrationality rate of 1.57% (3 681 prescriptions/233 736 prescriptions). Irrational prescriptions were mainly from outpatient departments 70.33% (2 589 prescriptions/3 681 prescriptions), with emergency departments accounting for 29.67% (1 092 prescriptions/3 681 prescriptions). School-age children (36.00%, 1 325 prescriptions/3 681 prescriptions) and preschool children (35.51%, 1 307 prescriptions/3 681 prescriptions) were the high-risk groups. The departmental distribution showed a "long-tail distribution," with the top 10 departments accounting for 60.69% (2 234 prescriptions/3 681 prescriptions), primarily the respiratory center, gastroenterology department, and internal medicine teaching and research department. Among irrational prescription types, inappropriate indication was the most common (86.80%, 3 853 cases/4 439 cases), followed by inappropriate usage and dosage (9.89%,439 cases/4 439 cases), duplicate medication (1.85%, 82 cases/4 439 cases) and inappropriate route of administration (1.46%, 65 cases/4 439 cases). Among medication categories, inhaled corticosteroids (71.13%, 3 065 cases/4 309 cases) had the highest incidence of issues, with budesonide suspension for inhalation accounting for 60.43% (2 604 cases/4 309 cases), followed by bronchodilators, with ipratropium bromide solution for inhalation accounting for 23.25% (1 002 cases/4 309 cases).

    Conclusion

    The overall rationality of nebulized drug prescriptions in the outpatient and emergency departments of the hospital is favorable. Irrational medication issues are dominated by inappropriate indications, mainly concentrated in young children and departments with high-frequency use of nebulized drugs. To improve the rationality of clinical medication, a full-process management system of "prevention-control-optimization" should be established by strengthening guideline training, optimizing audit rules of the rational drug use system, and enhancing targeted management in key departments.

  • Bao-mei XU, Zhen-yu YANG, Li-ping YANG, Xiao-peng ZHAO, Li ZHANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(9): 1323-1329.

    Heart failure (HF) refers to a clinical syndrome caused by structural or functional cardiac disorders that impair ventricular filling and/or ejection function, resulting in insufficient cardiac output to meet the metabolic demands of bodily tissues. Its clinical manifestations include congestion in the pulmonary and/or systemic circulation, as well as inadequate blood perfusion to organs and tissues. As the terminal stage of various cardiovascular diseases, HF ranks among the leading causes of death for urban and rural residents in China. microRNA (miRNA) is a class of endogenous non-coding single-stranded ribonucleic acids (RNAs) that regulate gene expression at the post-transcriptional level. They are involved in multiple pathological processes of HF, such as myocardial remodeling, cell death, energy metabolism and inflammatory immunity, thus exhibit potential as therapeutic targets for the disease. Traditional Chinese medicine (TCM), characterized by multi-targeted and multi-pathway actions, has shown unique advantages in the prevention and treatment of HF by modulating miRNAs. This article reviews the recent research status on miRNA-mediated regulation of HF and the mechanisms underlying TCM interventions, with the aim of providing insights for subsequent HF-related studies.

  • Ya-lan ZOU, Deng-juan MA, Ting-ting WU, Dong-kai YANG, Wei-jie YANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(9): 1330-1337.

    Diabetic kidney disease (DKD) is the most common and severe microvascular complication in clinical practice and one of the main causes for diabetic patients to develop chronic kidney disease and end-stage renal disease. The pathogenesis of this disease involves the combined effects of multiple factors, such as genetic factors, dysregulation of glucose and lipid metabolism, changes in renal hemodynamics, inflammatory responses and oxidative stress, among others. Among these, oxidative stress is the core process in the occurrence and development of DKD. The nuclear transcription factor E2-related factor (Nrf2) is an important regulatory factor for antioxidant stress transcription. Activating Nrf2 can stimulate the expression of downstream heme oxygenase-1 (HO-1), thereby widely participating in various biological processes such as regulating oxidative stress, reducing inflammatory responses and inhibiting cell apoptosis in the body. Recent studies have shown that the Nrf2/HO-1 signaling pathway is involved in the occurrence, development and drug intervention process of DKD. Traditional Chinese medicine (TCM) has the characteristics of multi-target, multi-pathway and multi-level, and the advantages of synergism and attenuation, showing unique advantages in making up for the shortcomings of modern medicine. However, there is still a lack of systematic summary of the mechanism of this pathway in the prevention and treatment of DKD and the research progress of traditional Chinese medicine. In this paper, the biological function and activation process of Nrf2/HO-1 pathway, the relationship between Nrf2/HO-1 pathway and DKD, the related research of traditional Chinese medicine to improve DKD by targeting the pathway in recent years, the treatment strategy of integrated traditional Chinese and western medicine, and the future research direction were systematically reviewed, in order to provide theoretical reference for the clinical treatment and drug development of DKD.

  • Yu-xin YUAN, Chen-yao SUN, Zhao-kai ZHANG, Ying-ze ZHANG, Sheng-nan ZHANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(9): 1338-1344.

    Cerebral ischemia-reperfusion injury (CIRI) refers to a secondary neurological injury that occurs after blood flow is restored in patients with ischemic stroke, and its pathological process involves inflammatory cascade imbalance, mitochondrial energy metabolism disorders, calcium ion overload and oxidative stress, which significantly affects the recovery of postoperative neurological function. In recent years, studies have shown that a variety of commonly used anesthetic drugs such as sevoflurane, propofol and dexmedetomidine can exert neuroprotective effects in the perioperative period through multi-target and pathway-specific mechanisms, thereby effectively alleviating CIRI. This paper summarizes the pathway and clinical application evidence of anesthetic drugs on neuroinflammation, energy metabolism, cell death and other pathways to alleviate CIRI, aiming to provide theoretical basis and research ideas for the optimization of clinical anesthesia regimens and the formulation of neuroprotective regimens.

  • Jü LIU, Chang XU, Xiao-yun LIU, Xin-na ZHOU, Xiao-qiang CHENG, Xiao-hua HAO
    Chinese Journal of Clinical Pharmacology. 2026, 42(9): 1345-1350.
    Objective

    To analyze the application effect of the intelligent management system for clinical trial drugs.

    Methods

    Based on the overall architecture established for the intelligent module and the management of experimental drugs, we compared the error rates of monthly prescriptions and recovery forms from 2024 to 2025, as well as the error rates of annual prescriptions and recovery forms from 2024 to 2025.

    Results

    The prescription error rates for January 2024 and 2025 were 33.33% (4 prescriptions/12 prescriptions) and 0% (0 prescriptions/19 prescriptions), respectively; for May, they were 30.00% (6 prescriptions/20 prescriptions) and 5.56% (2 prescriptions/36 prescriptions), respectively; for June, they were 36.00% (9 prescriptions/25 prescriptions) and 3.21% (6 prescriptions/187 prescriptions), respectively; for July, they were 23.91% (11 prescriptions/46 prescriptions) and 5.14% (9 prescriptions/175 prescriptions), respectively; for August, they were 10.71% (6 prescriptions/56 prescriptions) and 1.82% (3 prescriptions/165 prescriptions), respectively; for September, they were 10.20% (10 prescriptions/98 prescriptions) and 2.84% (5 prescriptions/176 prescriptions), respectively; for October, they were 13.21% (7 prescriptions/53 prescriptions) and 2.70% (2 prescriptions/74 prescriptions), respectively; for December, they were 12.50% (6 prescriptions/48 prescriptions) and 3.02% (13 prescriptions/430 prescriptions), respectively. The above indicators were statistically significant differences between the two groups (P<0.05, P<0.01). The prescription error rates for the years 2024-2025 were 12.41% (82 prescriptions/661 prescriptions) and 3.38% (60 prescriptions/1 777 prescriptions), respectively, showing a downward trend, and there were statistically significant differences between the two groups(P<0.000 1). The overall error rate of the collected forms decreased, but differences were not statistically significant (P>0.05).

    Conclusion

    The intelligent management system can improve the efficiency and accuracy of drug management, and it is recommended to further optimize the recovery process.

  • Zhen WANG, Xue-yan HAO, Xiang-hua ZHANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(8): 1051-1057.
    Objective

    To investigate the clinical efficacy and safety of budesonide/formoterol/glycopyrronium inhalation aerosol combined with bacterial lysate capsules in the treatment of patients with moderate-to-severe stable chronic obstructive pulmonary disease (COPD) complicated with bronchiectasis.

    Methods

    The patients with moderate-to-severe stable COPD complicated with bronchiectasis admitted to our hospital were divided into control group and treatment group based on their treatment regimens. Patients in control group were administered budesonide/formoterol/glycopyrronium inhalation aerosol (1 inhalation per time, twice daily), while treatment group additionally received oral bacterial lysate capsules (7 mg once daily on an empty stomach, 10 consecutive days followed by a 20-day break as one cycle). Patients in both groups were treated for 6 months. Differences in clinical efficacy, acute exacerbation, airway inflammation indicators, immune function indicators and pulmonary function were compared, and safety evaluation was performed.

    Results

    A total of 116 participants were enrolled, with 57 cases in control group and 59 cases in treatment group. The treatment group achieved an overall effective rate of 91.53% (54 cases/59 cases), which was statistically significantly higher to 77.19% (44 cases/57 cases) observed in control group(P<0.05). After treatment, the number of acute exacerbations in treatment and control group were (1.53±0.50) and (1.74±0.48) episodes, respectively; the duration of acute exacerbations were (9.80±2.75) and (11.16±3.06) days, respectively; the soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) levels were (33.89±7.47) and (38.34±8.35) pg·mL-1, respectively; the endothelin (ET) levels were (27.75±4.68) and (30.25±6.12) pg·mL-1, respectively; the soluble urokinase-type plasminogen activator receptor (suPAR) levels were (244.01±44.13) and (264.13±52.27) pg·mL-1, respectively; the immunoglobulin (Ig) A levels were (2.97±0.51) and (2.75±0.52) g·L-1, respectively; the IgG levels were (12.05±2.55) and (10.89±2.34) g·L-1, respectively; the IgM levels were (1.95±0.40) and (1.76±0.32) g·L-1, respectively; the IgE levels were (87.67±10.26) and (93.61±13.58) IU·mL-1, respectively; the diffusing capacity for carbon monoxide (DLCO) were (67.80±8.43)% and (64.38±7.81)%, respectively; the residual volume/total lung capacity ratio (RV/TLC) were (41.57±4.25)% and (43.61±4.11)%, respectively; the maximum minute ventilation during exercise (VEmax) were (54.24±5.61) and (51.96±5.58) L·min-1, respectively. Intergroup comparisons revealed statistically significant differences in the aforementioned indicators (P<0.05, P<0.01). Adverse drug reactions in treatment group included nausea, dizziness, mild elevated transaminase, dry mouth and hoarseness; those in control group included nausea and retching, rash, pharyngeal discomfort and elevated bilirubin. The total incidence of adverse reactions in treatment group and control group were 11.86% (7 cases/59 cases) and 8.77% (5 cases/57 cases), respectively, with no statistically significant difference (P>0.05).

    Conclusion

    Budesonide/formoterol/glycopyrronium inhalation aerosol combined with bacterial lysate capsules can reduce the risk of acute exacerbations and effectively improve pulmonary function in patients with moderate-to-severe stable COPD complicated with bronchiectasis. The underlying mechanism may be associated with the alleviation of airway inflammation and the enhancement of immune function

  • Hui ZHOU, Fang-jie HAO, Liang LIU
    Chinese Journal of Clinical Pharmacology. 2026, 42(8): 1058-1063.
    Objective

    To explore the clinical therapeutic effect of inclisiran injection combined with rosuvastatin tablets in the treatment of patients with extremely high-risk atherosclerotic cardiovascular disease (ASCVD).

    Methods

    The patients with extremely high-risk ASCVD were divided into the treatment group and the control group according to the actual clinical medication regimens they received. The control group was given rosuvastatin calcium tablets 10 mg, po, qd, while the treatment group was given inclisiran sodium injection 284 mg, ih, for the first time, and 284 mg, ih, again after 3 months on the basis of control group. The treatment duration for both groups was 6 months. The clinical efficacy, lipid profile, low-density lipoprotein cholesterol (LDL-C) target attainment rate, proprotein convertase subtilisin/kexin type 9 (PCSK9) levels, cardiac function, plaque stability, safety evaluation, and cardiovascular benefits were compared between the two groups.

    Results

    A total of 98 patients were enrolled, with 51 in the control group and 47 in the treatment group. After treatment, the overall response rates in the control group and the treatment group and were 68.63% (35 cases/51 cases) and 87.23% (41 cases/47 cases), respectively; the LDL-C levels were (1.42±0.27) and (1.26±0.22) mmol·L-1, respectively; the LDL-C goal attainment rates at 3 months were 41.18% (21 cases/51 cases) and 61.70% (29 cases/47 cases), respectively; LDL-C goal attainment rates at 6 months were 52.94% (27 cases/51 cases) and 74.47% (35 cases/47 cases), respectively; PCSK9 levels at 3 months were (313.66±41.35) and (295.63±39.43) ng·mL-1, respectively; PCSK9 levels at 6 months were (203.71±33.39) and (184.29±31.54) ng·mL-1, respectively; carotid intima-media thickness were (1.01±0.27) and (0.91±0.11) mm, respectively; plaque areas were (18.52±3.76) and (16.31±3.63) mm2, respectively; proportions of unstable plaques were 39.22% (20 cases/51cases) and 19.15% (9 cases/47 cases), respectively; high-density lipoprotein cholesterol (HDL-C) levels were (1.46±0.55) and (1.47±0.33) mmol·L-1, respectively; apolipoprotein A (ApoA) levels were (1.11±0.25) and (1.10±0.29) g·L-1, respectively. Except HDL-C level and ApoA level, comparisons of other indexes between the two groups showed statistically significant differences (P<0.05, P<0.01). No significant difference in the incidence of adverse events was observed between the control group (5.88%, 3 cases/51 cases) and treatment group (8.51%, 4 cases/47 cases) (P>0.05).

    Conclusion

    The combination of inclisiran injection and rosuvastatin tablet is effective in the treatment of extremely high-risk ASCVD, significantly improving the total effective rate and the early and sustained LDL-C target attainment rate, and more effectively reducing LDL-C levels and stabilizing plaques. The mechanism may be related to significantly inhibiting PCSK9 levels and further enhancing lipid-lowering and plaque-stabilizing effects.

  • Yun-xia GUO, Hong-xia WANG, Yan-hui LIU, Kun YANG
    Chinese Journal of Clinical Pharmacology. 2026, 42(8): 1064-1069.
    Objective

    To observe the clinical efficacy and safety of allylestrenol tablet combined with ritodrine hydrochloride tablet in the treatment of patients with gestational diabetes mellitus and threatened premature labor.

    Methods

    The patients with gestational diabetes mellitus threatened premature delivery were divided into treatment group and control group according to the treatment method. The control group received conventional treatment+ritodrine hydrochloride injection (100 mg, intravenous drip, continuous infusion after stopping uterine contraction for 12 h)+ritodrine hydrochloride tablets (10 mg, oral, q2 h on the first day, q4 h on the second day, q6 h on the day 3-7); on the basis of control group, the treatment group was added with allylestradiol tablets (5 mg, orally, 3-4 times a day). The course of treatment for both groups was 7 days. The clinical efficacy, blood glucose-related indicators, inflammatory-related indicators, pregnancy outcomes and neonatal outcomes were compared between the two groups, and safety was evaluated.

    Results

    A total of 98 cases were included in this study, including 50 cases in control group and 48 cases in treatment group. After treatment, the total clinical effective rates in treatment group and control group were 93.75% (45 cases/48 cases) and 80.00% (40 cases/50 cases), respectively, with statistically significant difference (P<0.05). After treatment, the fasting blood glucose (FBG) levels in treatment group and control group were (5.26±0.11) and (5.28±0.17) mmol·L-1, respectively; the 2-hour postprandial blood glucose (2 h PG) levels were (6.35±0.25) and (6.42±0.24) mmol·L-1, respectively; interleukin-6 (IL-6) levels were (6.49±1.06) and (7.13±1.43) pg·mL-1, respectively; IL-8 levels were (12.59±2.17) and (13.94±2.60) pg·mL-1, respectively; IL-10 levels were (12.30±2.49) and (11.09±1.95) pg·mL-1, respectively; prolonged pregnancy duration were (11.67±3.84) and (9.82±2.96) days, respectively; the proportions of vaginal delivery was 66.67% (32 cases/48 cases) and 46.00% (23 cases/50 cases), respectively; postpartum blood loss levels were (185.21±21.49) and (196.58±24.75) mL, respectively; the 1-minute Apgar scores of newborns were (9.04±0.20) and (8.86±0.35) points, respectively; the live birth rates were 97.92% (47 cases/48 cases) and 90.00% (45 cases/50 cases), respectively; the incidences of neonatal respiratory distress syndrome (NRDS) were 4.17% (2 cases/48 cases) and 20.00% (10 cases/50 cases), respectively; the incidences of apnea in premature infants were 4.17% (2 cases/48 cases) and 18.00% (9 cases/50 cases), respectively; the incidences of hematosepsis were 6.25% (3 cases/48 cases) and 14.00% (7 cases/50 cases), respectively; the incidences of neonatal pneumonia were 2.08% (1 cases/48 cases) and 6.00% (3 cases/50 cases), respectively. Except for FBG, 2 h PG, live birth rate, incidences of neonatal sepsis and neonatal pneumonia, the differences in the above indicators between treatment group and control group were all statistically significant (P<0.05, P<0.01). The adverse drug reactions in treatment group were primarily palpitations, nausea and vomiting, and headache, while those in control group mainly included palpitations, constipation, nausea and vomiting. The incidences of adverse drug reactions in treatment group and control group were 6.25% (3 cases/48 cases) and 8.00% (4 cases/50 cases), respectively, with no statistically significant difference (P>0.05).

    Conclusion

    Allylestrenol tablet combined with ritodrine hydrochloride tablet can effectively treat threatened preterm labor in gestational diabetes mellitus, significantly prolong gestational age, improve inflammatory responses, and optimize pregnancy and neonatal outcomes without increasing the risk of adverse drug reactions.