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山东大学学报 (医学版) ›› 2025, Vol. 63 ›› Issue (10): 72-79.doi: 10.6040/j.issn.1671-7554.0.2024.1336

• 临床医学 • 上一篇    

八宝丹胶囊联合米拉贝隆治疗女性膀胱过度活动症的有效性与安全性

贾振存1,2,3,吴晨睿3,赵德龙1,朱可嘉1,丁森泰1,3   

  1. 1.山东第一医科大学附属省立医院泌尿外科, 山东 济南 250021;2.莘县人民医院泌尿外科, 山东 莘县 252400;3. 山东大学齐鲁医学院, 山东 济南 250012
  • 发布日期:2025-10-17
  • 通讯作者: 丁森泰. E-mail:dingsentai@126.com
  • 基金资助:
    山东省自然科学基金创新发展联合基金(ZR2023LZL005);山东省自然科学基金(ZR2021QH313)

Efficacy and safety of Babaodan Capsule in combination with mirabegron for the treatment of overactive bladder in women

JIA Zhencun1,2,3, WU Chenrui3, ZHAO Delong1, ZHU Kejia1, DING Sentai1,3   

  1. 1. Department of Urology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan 250021, Shandong, China;
    2. Department of Urology, Shenxian Peoples Hospital, Shenxian 252400, Shandong, China;
    3. Cheeloo College of Medicine, Shandong University, Jinan 250012, Shandong, China
  • Published:2025-10-17

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摘要： 目的 探讨八宝丹胶囊联合米拉贝隆治疗女性膀胱过度活动症(overactive bladder, OAB)的临床疗效及安全性。 方法 选取2021年 10月至 2023年 1月在山东第一医科大学附属省立医院就诊的60例女性OAB患者为研究对象,按随机数字表法进行分组,30例给予八宝丹胶囊和米拉贝隆联合治疗(试验组)、30例给予安慰剂和米拉贝隆联合治疗(对照组),治疗12周。分别于治疗前及治疗后给予女性OAB症状评分(overactive bladder syndrome score, OABSS)、生活质量评估(quality of life, QOL)、记录排尿日记,检测治疗前后一氧化氮(nitric oxide, NO)、内皮素-1(endothelin-1,ET-1)及炎症因子相关指标白细胞介素-6(interleukin- 6, IL-6)、肿瘤坏死因子-α(tumor necrosis factor-α, TNF-α)的水平,比较2个组的临床疗效及不良反应的发生率和严重程度。 结果 治疗后 4周、12周,试验组OABSS低于对照组(P=0.001,P<0.001);两组QOL评分均低于治疗前,且试验组低于对照组(P<0.001);治疗后12周两组TNF-α、IL-6、ET-1表达降低,NO水平升高,组内比较差异均有统计学意义(P<0.001);试验组和对照组治疗总有效率分别为90.0%、73.0%,差异无统计学意义(P=0.182);治疗过程中,两组均未出现Ⅲ级及以上的不良反应。 结论 八宝丹胶囊与米拉贝隆联合使用治疗女性OAB能明显减轻患者的临床症状,缩短治疗周期,减轻患者痛苦,其疗效优于单用米拉贝隆。

关键词: 八宝丹胶囊, 米拉贝隆, 女性膀胱过度活动症, 临床疗效

Abstract: Objective To investigate the clinical efficacy and safety of Babaodan capsule combined with mirabegron in the treatment of female overactive bladder syndrome(OAB). Methods A total of 60 female patients with OAB who were treated at the Affiliated Provincial Hospital of Shandong First Medical University from October 2021 to January 2023 were selected as the research subjects. They were divided into 2 groups by the random number table method: 30 cases received combined treatment with Babaodan and mirabegron(trial group), and 30 cases received combined treatment with placebo and mirabegron(control group), with a treatment course of 12 weeks. Before and after treatment, the overactive bladder syndrome score(OABSS), quality of life assessment(QOL), and micturition diaries were recorded. The levels of nitric oxide(NO), endothelin-1(ET-1), and inflammatory factors ［interleukin-6(IL-6), tumor necrosis factor-α(TNF-α)］ were detected. The clinical efficacy, incidence, and severity of adverse reactions were compared between the two groups. Results Four weeks and 12 weeks after treatment, the OABSS in the trial group was lower than that in the control group(P=0.001, P<0.001). The QOL scores of both groups were lower than those before treatment, and the trial group had a lower score than the control group(P<0.001). At 12 weeks after treatment, the expressions of TNF-α, IL-6, and ET-1 decreased, while the NO level increased in both groups, with statistically significant differences within the groups(P<0.001). The total effective rates of the trial group and the control group were 90.0% and 73.0%, respectively, with no statistically significant difference(P=0.182). During the treatment, neither group showed grade Ⅲ or above adverse reactions. Conclusion The combined use of Babaodan capsule and mirabegron in the treatment of female OAB can significantly alleviate clinical symptoms, shorten the treatment cycle, and reduce patient suffering, with better efficacy than mirabegron alone.

Key words: Babaodan capsule, Mirabegron, Female overactive bladder, Clinical efficacy

中图分类号: 

  • R694.5
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