他达拉非联合坦索罗辛治疗男性下尿路症状合并勃起功能障碍疗效及安全性的Meta分析  

Efficacy and Safety of Combination Therapy with Tadalafil and Tamsulosin in Treating Lower Urinary Tract Symptoms and Erectile Dysfunction in Men:a Meta-analysis

作　　者：李金泽 彭磊 李云祥[1] 韦堂墙 熊蔚 牛超 张宗平[1] LI Jinze;PENG Lei;LI Yunxiang;WEI Tangqiang;XIONG Wei;NIU Chao;ZHANG Zongping(Department of Urology,the Affiliated Nanchong Central Hospital of North Sichuan Medical College,Nanchong 637000,China)

机构地区：[1]川北医学院附属南充市中心医院泌尿外科,四川省南充市637000

出　　处：《中国全科医学》2021年第14期1813-1819,共7页Chinese General Practice

基　　金：国家青年自然科学基金资助项目(81900617);四川省科技厅重点研发项目(2020YFS0320)。

摘　　要：背景坦索罗辛与他达拉非(TAD)已广泛用于治疗下尿路症状(LUTS)和勃起功能障碍(ED),但联合方案治疗男性LUTS合并ED的疗效与安全性仍存在争议。目的系统评价TAD联合坦索罗辛与TAD单药治疗男性LUTS合并ED的疗效和安全性。方法系统检索PubMed、EMBase、Cochrane Controlled Trials Register、中国生物医学文献数据库、中国知网、万方数据知识服务平台以及维普网,查找关于TAD联合坦索罗辛与TAD单药治疗男性LUTS合并ED疗效比较的研究,检索时限为建库至2020-02-29。提取第一作者姓名、发表年份、国家、研究类型、样本量、研究对象的年龄及体质指数、干预措施、药物剂量、随访时间、结局指标〔国际前列腺症状(IPSS)总评分、IPSS储尿期症状评分、IPSS排尿期症状评分、生活质量评分、最大尿流率、残余尿量以及国际勃起功能指数5(IIEF-5)评分、不良反应发生率(包括总不良反应发生率和头痛、肌痛、背痛、眩晕、鼻咽炎、射精功能障碍发生率)、因发生不良反应而终止治疗率〕等信息,并采用RevMan 5.3.0软件对数据进行评估和统计分析。结果最终纳入6篇文献(均为高质量文献),共包括776例患者,其中联合治疗组394例,TAD组382例。Meta分析结果显示,联合治疗组在降低IPSS总评分〔MD=-2.67,95%CI(-3.82,-1.50),P<0.001〕、IPSS储尿期症状评分〔MD=-0.55,95%CI(-0.85,-0.26),P=0.0002〕、IPSS排尿期症状评分〔MD=-0.97,95%CI(-1.43,-0.51),P<0.001〕、生活质量评分〔MD=-0.37,95%CI(-0.51,-0.23),P<0.001〕,改善最大尿流率方面〔MD=1.45,95%CI(0.90,1.99),P<0.00001〕优于TAD组。两组残余尿量〔MD=-4.22,95%CI(-12.82,4.39),P=0.34〕、IIEF-5评分〔MD=0.44,95%CI(-0.23,1.11),P=0.19〕、总不良反应发生率〔OR=1.43,95%CI(0.98,2.08),P=0.06〕、头痛发生率〔OR=1.34,95%CI(0.66,2.72),P=0.42〕、肌痛发生率〔OR=1.56,95%CI(0.64,3.82),P=0.33〕、背痛发生率〔OR=1.45,95%CI(0.40,5.22),P=0.57〕�Background Tamsulosin and tadalafil(TAD)have been widely used for the treatment of lower urinary tract symptoms(LUTS)and erectile dysfunction(ED).However,the efficacy and safety of the combination therapy of these two medicines for LUTS and ED in men is still controversial.Objective To systematically investigate the efficacy and safety of TAD plus tamsulosin compared with TAD monotherapy in treating men with LUTS and ED.Methods PubMed,EMBase,Cochrane Central Register of Controlled Trials,SinoMed,CNKI,WanFang Data Service Platform,and CQVIP databases were searched extensively from inception to February 29,2020 to obtain eligible studies comparing the efficacy and safety of TAD plus tamsulosin and TAD monotherapy in treating men with LUTS and ED.Data were extracted,such as the name(s)of the first author(s),year of publication,geographical location(country)of the research setting,types of research,sample size,age and BMI of the subjects,interventions,dosage,follow-up time and outcome indicators〔total International Prostate Symptom Score(IPSS)score,IPSS storage subscore,IPSS voiding subscore,quality of life score,maximum urinary flow rate,postvoid residual urine volume and International Index of Erectile Function-5(IIEF-5)score〕,incidence of adverse events(including total incidence of adverse events,incidence of headache,myalgia,back pain,dizziness,nasopharyngitis and ejaculation dysfunction),and rate of treatment discontinuation due to adverse events.Revman 5.3.0 was used for data evaluation and statistical analysis.Results Six studies were included,all were assessed with high methodological quality,involving 776 cases,394 in the combination group and 382 in the TAD group.The results of the meta-analysis indicated that compared with the TAD group,the combination group obtained more benefits from treatment in aspects of total IPSS score〔MD=-2.67,95%CI(-3.82,-1.50),P<0.001〕,IPSS storage subscore〔MD=-0.55,95%CI(-0.85,-0.26),P=0.0002〕,IPSS voiding subscore〔MD=-0.97,95%CI(-1.43,-0.51),P<0.001〕,quality of

关 键 词：下尿路症状 勃起功能障碍 他达拉非 坦索罗辛 META分析 系统评价 

分 类 号：R691[医药卫生—泌尿科学] R698.1[医药卫生—外科学]