低能量冲击波治疗勃起功能障碍疗效及安全性:随机对照试验的meta分析

Efficacy and safety of low-intensity extracorporeal shock wave therapy in the treatment of ED: A meta-analysis of randomized controlled trials

目的:依据现有临床证据评价低能量冲击波(LI-ESWT)治疗勃起功能障碍(ED)的临床疗效及安全性。方法:通过计算机检索PubMed、Medline、EMBASE、Cochrane图书馆和CNKI、VIP、CBM、万方数据库建库至2018年6月有关LI-ESWT治疗ED的随机对照试验(RCT),由2名研究者按照纳入与排除标准进行文献筛选、资料提取和质量评价,并采用RevMan 5.3软件进行meta分析。结果:共纳入来自8项随机双盲对照研究的595例ED患者,其中LI-ESWT治疗组362例,对照组233例。meta分析结果显示,与对照组相比较,LI-ESWT治疗可显著提高ED患者的IIEF评分[WMD=1.70, 95%CI (0.44, 2.96),P=0.008]和勃起硬度分级(EHS)[RR=11.72, 95%CI (5.13, 26.80),P<0.01]。进一步分析表明LI-ESWT治疗后随访4周和24周ED患者的IIEF评分均显著提高[WMD=1.43, 95%CI (0.10, 2.75),P=0.03; WMD=3.09, 95%CI (1.49, 4.68),P=0.000 2];LI-ESWT治疗10～12次ED患者的IIEF评分显著提高,而治疗5～6次IIEF评分并未显示出明显增加[WMD=1.81, 95%CI (0.31, 3.31),P=0.02; WMD=1.88,95%CI (-2.10, 5.86),P=0.35];基线IIEF≥12分ED患者LI-ESWT治疗后IIEF评分明显增加而基线IIEF≤11分治疗后IIEF评分并未显示出明显增加[WMD=2.13, 95%CI (0.51, 3.75),P=0.01; WMD=1.04, 95%CI (-0.96, 3.03),P=0.31]。8项研究报告了LI-ESWT治疗后均无明显不良反应发生。结论:LI-ESWT作为一种非侵入性治疗手段,其可明显改善ED患者的IIEF评分和EHS分级,临床应用安全有效。

Objective: To evaluate the clinical efficacy and safety of low-intensity extracorporeal shock wave therapy(LI-ESWT) in the treatment of ED based on the available clinical evidence. Methods: We searched PubMed, MEDLINE, EMBASE, Cochrane Library, CNKI, VIP, CBM and Wanfang Database up to June 2018 for published randomized controlled trials on the treatment of ED by LI-ESWT. We performed literature screening, data extraction and quality evaluation according to inclusion and exclusion criteria, and conducted a meta-analysis of the data obtained using the RevMan 5.3 software. Results: A total of 595 ED cases in 8 double-blind randomized controlled trials(RCT) were included in this study, 362 in the LI-ESWT and 233 in the control group. Compared with the controls, the patients treated by LI-ESWT showed significantly improved IIEF(WMD = 1.70, 95% CI: 0.44-2.96, P = 0.008) and erection hardness score(EHS)(RR = 11.72, 95% CI: 5.13-26.80, P < 0.01). The IIEF scores of the patients were markedly increased at 4 and 24 weeks after LI-ESWT(WMD = 1.43, 95% CI: 0.10-2.75, P = 0.03;WMD = 3.09, 95% CI: 1.49-4.68, P = 0.0002), as well as after the 10 th to 12 th treatment(WMD = 1.81, 95% CI: 0.31-3.31, P = 0.02) though not after the 5 th to 6 th(WMD = 1.88, 95% CI:-2.10 to 5.86, P = 0.35). LI-ESWT also significantly increased the IIEF scores in the patients with the baseline IIEF ≥12(WMD = 2.13, 95% CI: 0.51-3.75, P = 0.01) but not in those with the baseline IIEF ≤11(WMD = 1.04, 95% CI:-0.96 to 3.03, P = 0.31). No significant adverse events were reported in the 8 RCTs. Conclusion: As a non-invasive treatment, LI-ESWT is safe and effective and can significantly improve IIEF and EHS in ED patients.