目的 系统评价癃闭舒胶囊联合化学药治疗良性前列腺增生（BPH）的临床疗效和安全性。方法 检索中国学术期刊全文数据库（CNKI）、万方数据库（Wanfang Data）、中国生物医学文献数据库（CBM）、维普中文科技期刊数据库（VIP）、Cochrane Library、Embase、PubMed，检索时限为建库至2023年4月30日癃闭舒胶囊联合化学药治疗BPH临床随机对照试验（RCT），筛选文献后，应用RevMan 5.4软件进行Meta分析。结果 共纳入17项RCTs，涉及患者1 997例，其中治疗组1 015例、对照组982例。Meta分析结果显示，与对照组比较，治疗组可提高总有效率［RR＝1.22，95% CI（1.16，1.29），P<0.000 01］，降低国际前列腺症状评分［MD＝-4.27，95% CI（-4.58，-3.95），P<0.000 01］，减少膀胱残余尿量［MD＝-8.02，95% CI（-9.58，-6.06），P<0.000 01］，缩小前列腺体积［MD＝-2.52，95% CI（-4.79，-0.25），P=0.03］，提高最大尿流率［MD＝3.15，95% CI （2.24，4.07），P<0.000 01］，降低生活质量评分［MD＝ - 0.80，95% CI（-1.35，-0.25），P=0.004］，降低中医症状评分［MD＝-2.58，95% CI（-4.88，-0.29），P<0.03］，减少不良反应发生率［MD＝0.66，95% CI（0.51，0.86），P=0.002］。结论 癃闭舒胶囊联合化学药治疗BPH疗效优异、安全性高，应用前景广泛，但仍需高质量、大样本、多中心RCT验证。

Objective To systematically evaluate the clinical efficacy and safety of Longbishu Capsules combined with chemical drug for the treatment of benign prostatic hyperplasia (BPH). Methods The databases of CNKI, Wanfang Data, CBM, VIP, Cochrane Library, Embase and PubMed were searched for the randomized controlled trial (RCT) of Longbishu Capsules combined with chemical drug for the treatment of BPH from the database established to April 30, 2023. After screening the literature, RevMan 5.4 software was used to Meta-analyis. Results A total of 17 RCTs involving 1 997 patients were included, including 1 015 cases in the treatment group and 982 cases in the control group. The results of Meta-analysis showed that compared with the control group, the treatment group could improve the overall effective rate [RR = 1.22, 95%CI (1.16, 1.29), P< 0.000 01], reduce international prostate symptom score [MD = -4.27, 95%CI (-4.58, -3.95), P< 0.000 01], decrease the residual bladder urine volume [MD = -8.02, 95%CI (-9.58, -6.06), P< 0.000 01], reduced prostate volume [MD = -2.52, 95%CI (-4.79, -0.25), P= 0.03], increased maximum urinary flow rate [MD = 3.15, 95%CI (2.24, 4.07), P< 0.000 01], and decreased quality of life scores [MD = - 0.80, 95%CI ( - 1.35, - 0.25), P= 0.004], reduced TCM symptom scores [MD = - 2.58, 95%CI (- 4.88, - 0.29), P< 0.03], and reduced the incidence of adverse events [MD = 0.66, 95%CI (0.51, 0.86), P= 0.002]. Conclusion The combination of Longbishu Capsules with chemical medicine for BPH has excellent efficacy, high safety and wide application prospects, but high-quality, large sample and multicentre RCT validation is still needed.

R287.3

中国中医科学院科技创新工程重大攻关项目（CI2021A02205）