补中益气中药联合盆底肌训练治疗女性压力性尿失禁临床疗效的Meta分析

Meta Analysis of Clinical Effects of Buzhongyiqi Pills Combined with Pelvic Floor Muscle Training in Treating Female Stress Urinary Incontinence

摘要: 目的：评价补中益气中药联合盆底肌训练治疗女性压力性尿失禁的临床疗效与安全性。方法：通过计算机检索中国知网、万方数据库、维普等数据库、CBM、Embase、the Cochrane Library、PubMed、Web of Science中发表的临床随机对照试验，检索时间为建库至2021年8月6日，按照Cochrane质量评价标准评价文献质量，二分类变量和连续变量的合并效应量分别选择95% CI的均值差(MD/SMD)或风险比(RR)表示，用其对应的显著性值(P-value)估计效应量。运用RevMen5.3统计软件进行Meta分析。结果：共纳入16个研究，共涉及1411例患者，治疗组709例，对照组702例。Meta分析结果显示：与盆底肌训练相比，补中益气中药联合盆底肌训练可以提高女性压力性尿失禁的临床疗效[RR = 1.41, 95% CI (1.32, 1.51), P < 0.05]；治疗后ICI-Q-SF评分优于单纯盆底肌训练组，[MD = −1.91, 95% CI (−2.68, −1.13), P < 0.05]；治疗后I-QOL评分优于单纯盆底肌训练组，[MD = 6.72, 95% CI (5.40, 8.03), P < 0.05]；使1 h尿垫试验的漏尿量更低[MD = −2.73，95% CI (−2.92, −2.54), P < 0.05]；治疗后24 h平均尿失禁频次更低[MD = −1.82, 95% CI (−2.16, −1.49), P < 0.05]；治疗后最大尿道闭合压更高[MD = 11.16, 95% CI (5.75, 16.57), P < 0.05]；治疗后排尿症状评分更低[MD = −1.92, 95% CI (−3.11, −0.73), P < 0.05]。结论：补中益气中药联合盆底肌训练治疗女性压力性尿失禁有一定的优势，但由于纳入文献的方法学质量不高及研究者对服用中药的不良反应报道较少，因此补中益气中药的临床疗效和安全性还需要有更多高质量、多中心，大样本的随机对照试验来证实。

Abstract: Objective: To compare clinical effects of Buzhongyiqi pills combined with pelvic floor muscle training and only pelvic floor muscle training in treating Female Stress Incontinence. Methods: PubMed, CNKI, Wan Fang, VIP, CBM, Embase, the Cochrane Library, PubMed and Web of Science were retrieved in the computer, and the retrieval time is from the database construction to August 6, 2021. The combined effect size of binary variables and continuous variables is respectively represented by the mean difference (MD/SMD) or risk ratio (RR) of 95% CI, and the corresponding P-value is used to estimate the effect size, according to the Cochrane Handbook5.1.0 for Systematic Reviews of Intervention of quality evaluation standard evaluation literature quality, use statistical software RevMen5.3 Meta analysis papers. Results: A total of 15 articles met the inclusion criteria, involving 1411 research objects, including 709 patients in the treatment group and 702 patients in the control group. Results of Meta Analysis: The total response rate of Buzhongyiqi pills in the treatment of female stress incontinence was better than the control group (RR = 1.41, 95% CI (1.32, 1.51), P < 0.05). The scores of ICI-Q-SF was improved compared to the control group (MD = −1.91, 95% CI (−2.68, −1.13), P < 0.05). The score of I-QOL in the experimental group was better than that in the control group [MD = 6.72, 95% CI (5.40, 8.03), P < 0.05]. The results of 1 h pad test in the experimental group were better than those in the control group [MD = −2.73, 95% CI (−2.92, −2.54), P < 0.05]. The 24 h mean frequency of urinary incontinence in the experimental group was better than that in the control group [MD = −1.82, 95% CI (−2.16, −1.49), P < 0.05]. The maximum urethral closure pressure of the experimental group was significant than that of the control group [MD = 11.16, 95% CI (5.75, 16.57), P < 0.05]. The maximum urethral closure pressure was better after treatment [MD = 11.16, 95% CI (5.75, 16.57), P < 0.05]. Lower urinary symptom scores after treatment [MD = −1.92, 95% CI (−3.11, −0.73), P < 0.05). Conclusion: Buzhongyiqi pills combined with pelvic floor muscle training possess the advantages in treating female stress incontinence, since the quality of test methodology isn’t high and few reports on adverse reactions, clinical effects and security couldn’t be confirmed fully, high quality, multicenter, large-sample randomized clinical trial is needed to be further verified.