摘要
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1997例,其中治疗组1015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<0.00001],降低国际前列腺症状评分[MD=-4.27,95%CI(-4.58,-3.95),P<0.00001],减少膀胱残余尿量[MD=-8.02,95%CI(-9.58,-6.06),P<0.00001],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<0.00001],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 1997 patients were included,including 1015 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<0.00001],reduce international prostate symptom score[MD=−4.27,95%CI(−4.58,−3.95),P<0.00001],decrease the residual bladder urine volume[MD=−8.02,95%CI(−9.58,−6.06),P<0.00001],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<0.00001],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.
作者
唐益文
周艳艳
魏永强
张泽家
王雄
丁家森
程鹏伃
李铭
高瞻
TANG Yiwen;ZHOU Yanyan;WEI Yongqiang;ZHANG Zejia;WANG Xiong;DING Jiasen;CHENGPengyu;LI Ming;GAO Zhan(Graduate School of Beijing University of Chinese Medicine,Beijing 100029,China;Xiyuan Hospital of China Academy of Chinese Medical Sciences,Beijing 100091,China)
出处
《药物评价研究》
CAS
2023年第9期1986-1996,共11页
Drug Evaluation Research
基金
中国中医科学院科技创新工程重大攻关项目(CI2021A02205)。
关键词
癃闭舒胶囊
良性前列腺增生
META分析
临床疗效
不良反应
Longbishu Capsules
benign prostatic hyperplasia
Meta-analyis
clinical efficacy
adverse reactions