摘要
系统评价宁泌泰胶囊治疗慢性前列腺炎的临床疗效与安全性。整合中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献数据库(SinoMed)、Cochrane Library、PubMed、EMbase、Medline、Web of Science中截至到2022年7月的宁泌泰胶囊治疗慢性前列腺炎相关文献,最终筛选出宁泌泰胶囊治疗慢性前列腺炎的随机对照试验(RCTs),并综合采用国际Cochrane协作组提供的ROB工具与RevMan 5.3软件进行数据整合与Meta分析。共纳入21项研究,总样本量2584例,试验组1289例,对照组1295例。结果显示,宁泌泰胶囊+常规西医药物/宁泌泰胶囊单药治疗慢性前列腺炎患者的治愈率(RR=1.60,95%CI[1.28,2.00],P<0.0001;RR=1.63,95%CI[1.35,1.97],P<0.00001;RR=1.89,95%CI[1.43,2.48],P<0.00001)、白介素水平(MDIL-2=-10.09,95%CI[-14.13,-6.04],P<0.00001;MDIL-6=-35.06,95%CI[-37.44,-32.68],P<0.00001;MDIL-10=-118.59,95%CI[-124.41,-112.77],P<0.00001;MD(IL-1β(ng/L))=-17.13,95%CI[-22.31,-11.95],P<0.00001;MD(IL-1β(μg/L))=-0.48,95%CI[-0.50,-0.45],P<0.00001)、NIH-CPSI评分(MD=-3.70,95%CI[-6.04,-1.37],P=0.002;MD=-5.43,95%CI[-6.51,-4.34],P<0.00001;MD=-7.65,95%CI[-14.77,-0.52],P=0.04)、均优于仅使用常规西医药物治疗;宁泌泰胶囊+盐酸坦洛新可改善慢性前列腺炎患者的尿动力学指标(MDMFR=14.17,95%CI[13.50,14.84],P<0.00001;MDRVU=-5.05,95%CI[-5.62,-4.48],P<0.00001)。不良反应主要为胃肠道反应,均较轻微。基于现有数据分析,宁泌泰胶囊联合常规西药/单用治疗可提高慢性前列腺炎患者的治愈率,改善白介素水平、尿动力学指标、NIH-CPSI评分,且暂未发现严重的不良反应。纳入高质量文献所占比例低,提示今后研究需纳入设计严谨、样本量充足、结局指标完备的临床观察实验以更有效验证宁泌泰胶囊治疗慢性前列腺炎的临床疗效与安全性。
Systematic review of the clinical efficacy and safety of Ningmitai Capsules in the treatment of chronic prostatitis.Integrate Ningbi as of July 2022 from CNKI,Wanfang,VIP,SinoMed,Cochrane Library,PubMed,EMbase,Medline,and Web of Science After reviewing relevant literature on the treatment of chronic prostatitis by Tai Capsules,we finally screened out randomized controlled trials(RCTs)of Ningmitai Capsules in the treatment of chronic prostatitis,and used the ROB tool and RevMan 5.3 software provided by the International Cochrane Collaboration Group to conduct data integration and meta-analysis.A total of 21 studies were included,with a total sample size of 2584 cases,including 1289 cases in the experimental group and 1295 cases in the control group.The results showed that the cure rate of Ningmitai Capsule+conventional Western medicine drugs/Ningmitai Capsule alone in the treatment of patients with chronic prostatitis(RR=1.60,95%CI[1.28,2.00],P<0.0001;RR=1.63,95%CI[1.35,1.97],P<0.00001;RR=1.89,95%CI[1.43,2.48],P<0.00001),interleukin level(MDIL-2=-10.09,95%CI[-14.13,-6.04],P<0.00001;MDIL-6=-35.06,95%CI[-37.44,-32.68],P<0.00001;MDIL-10=-118.59,95%CI[-124.41,-112.77],P<0.00001;MDIL-1β(ng/L)=-17.13,95%CI[-22.31,-11.95],P<0.00001;MDIL-1β(μg/L)=-0.48,95%CI[-0.50,-0.45],P<0.00001),NIH-CPSI score(MD=-3.70,95%CI[-6.04,-1.37],P=0.002;MD=-5.43,95%CI[-6.51,-4.34],P<0.00001;MD=-7.65,95%CI[-14.77,-0.52],P=0.04),are better than conventional Western medicine treatment alone;Ningmitai Capsule+Tamsulosin Hydrochloride can improve the urodynamic indicators of patients with chronic prostatitis(MDMFR=14.17,95%CI[13.50,14.84],P<0.00001;MDRVU=-5.05,95%CI[-5.62,-4.48],P<0.00001).Adverse reactions were mainly gastrointestinal reactions,all of which were mild.Based on the analysis of existing data,Ningmitai Capsules combined with conventional western medicine/monotherapy can improve the cure rate of patients with chronic prostatitis,improve interleukin levels,urodynamic indicators,and NIH-CPSI scores,and no serious adverse reactions hav
作者
王自强
吕健
厉将斌
谢雁鸣
WANG Ziqiang;LV Jian;LI Jiangbin;XIE Yanming(Institute of Basic research in Clinical Medicine of China Academy of Chinese Medical Sciences,Beijing 100700,China;Guang’anmen Hospital of China Academy of Chinese Medical Sciences,Beijing 100053,China;Xiyuan Hospital,China Academy of Chinese Medical Sciences,Beijing 100091,China;Monitoring and Statistical Research Center,National Administration of Traditional Chinese Medicine,Beijing 100027,China)
出处
《中医药临床杂志》
2023年第12期2361-2370,共10页
Clinical Journal of Traditional Chinese Medicine
基金
国家重点研发计划“中医药现代化研究”项目(2018YFC1707400)。
