他达拉非5mg治疗前列腺增生继发下尿路症状的荟萃分析

A meta-analysis of tadalafil 5mg for treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia

摘要:

目的 评价他达拉非(tadalafil)5mg治疗前列腺增生继发下尿路症状(BPH/LUTS)的疗效及安全性。方法 计算机及手工检索相关的随机对照研究(RCTs)。计算机检索时间限定为数据库建立至2018年10月,数据库包括万方数据库、中国期刊全文数据库(CNKI)、中国科技期刊数据库(VIP)、中国生物医学文献数据库(CBM),EMBASE、PubMed、Cochrane Library、Clinicaltrials.gov。对符合纳入标准的研究进行质量评估,提取数据并使用RevMan 5.3软件进行荟萃分析。结果 本次分析纳入9个RCTs,共计3501例患者,其中他达拉非5mg组1758例,安慰剂对照组1743例。与安慰剂组相比,他达拉非5mg组可降低国际前列腺症状评分(IPSS)[MD=-1.79,95%CI(-2.19, -1.39)],改善生活质量(IPSS-Qol)[MD=-0.26,95%CI(-0.36, -0.16)],但对最大尿流率(Qmax)没有明显改善[MD=0.15,95%CI(-0.35,0.64), P=0.55]。与安慰剂组相比,他达拉非5mg组不会明显增加因不良事件而退出的患者比例[RR=1.54,95%CI(0.96,2.49),P=0.08,I²=0%]。结论 他达拉非5mg治疗前列腺增生可改善患者的下尿路症状,并具有良好的耐受性。

Abstract:

Objective To evaluate the efficacy and safety of tadalafil 5mg in the treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). Methods Randomized controlled trials (RCTs) were collected via computer-based and manual retrieval. The computer retrieval was limited to the time of database establishment until October 2018, and no limit was set for langauge. The databases searched included Wanfang database, China Journal Full-text Database (CNKI), China Science and Technology Periodical Database (VIP), China Biomedical Literature Database (CBM), EMBASE, PubMed, Cochrane. Library, and Clinicaltrials.gov. Quality assessments were performed for studies that met the inclusion criteria, data were extracted, and a meta-analysis was performed using RevMan 5.3. Results Included for analysis were 9 RCTs with a total of 3501 patients, 1758 being treated with the tadalafil 5mg and 1743 with placebo. Compared with placebo, tadalafil 5mg reduced the International Prostate Symptom Score (IPSS) [MD=-1.79,95%CI (-2.19, -1.39)], improved quality of life (IPSS-Qol) [MD=-0.26,95%CI (-0.36, -0.16)], but did not lead to significant improvement in maximum urinary flow rate (Qmax) [MD=0.15,95%CI (-0.35,0.64), P=0.55]. The proportion of patients who withdrew due to adverse events was not significantly increased in the tadalafil 5mg group [RR=1.54,95%CI (0.96,2.49), P=0.08, I²=0%]. Conclusion Tadalafil 5mg can improve the LUTS in the patients with BPH and is well tolerated.