基于Meta分析评估补肾活血法在治疗糖尿病性勃起功能障碍中的效果与安全性

A Meta-Analysis Evaluating the Efficacy and Safety of Tonifying Kidney and Activating Blood Therapy for Diabetic Erectile Dysfunction

摘要: 目的：系统评价补肾活血法治疗糖尿病性勃起功能障碍(diabetes mellitus erectile dysfunction, DMED)的临床疗效及安全性。方法：通过计算机检索CNKI、万方、维普、SinoMed、PubMed、Cochrane Library、Embase和Web of Science等中外数据库，筛选采用补肾活血法治疗DMED的随机对照试验，检索时间范围为各数据库建库至2025年5月31日。文献质量使用Cochrane风险偏倚评估工具进行评价，Meta分析采用Stata 12.0软件进行。对于纳入研究超过10项时，采用Egger检验评估发表偏倚。证据质量通过GRADE系统进行分级评价。结果：共纳入16项研究，涉及病人1539例。Meta分析结果表明，试验组在临床总有效率[RR = 1.39, 95%CI (1.24, 1.56), P < 0.0001]、国际勃起功能指数-5 (International Index of Erectile Function-5, IIEF-5) [WMD = 4.16, 95%CI (2.17, 6.16), P < 0.0001]、空腹血糖(Fasting Blood Glucose, FBG) [WMD = −0.89, 95%CI (−1.35, −0.44), P < 0.0001]、睾酮(Testosterone, T) [WMD = 3.21, 95%CI (1.43, 4.99), P < 0.0001]、雌二醇(Estradiol, E₂) [WMD = −19.34, 95%CI (−30.54, −8.14), P = 0.001]上均优于对照组，且差异具有统计学意义(P < 0.05)。糖化血红蛋白(Glycated Hemoglobin, HbA1c)由于研究数量不足，仅1项研究报告了具体数据，未能进行Meta分析，仅对其进行描述性分析。两组间不良事件的发生率差异无统计学意义[RR = 1.00, 95%CI (0.51, 1.96), P = 0.993]。在GRADE证据质量评估中，临床总有效率的证据质量被评为“极低”，而其他各项指标的证据质量均为“低”。结论：补肾活血法治疗DMED具有一定的临床疗效和安全性，但考虑到纳入研究的方法学质量普遍偏低、高异质性，且发表偏倚分析提示疗效可能被高估，上述结论的可靠性有限，未来需更多高质量研究予以验证。

Abstract: Aim: This systematic review examines the clinical efficacy and safety of Tonifying Kidney and Activating Blood Therapy for treating diabetes mellitus erectile dysfunction (DMED). Methods: A computer-based search was conducted across both Chinese and international databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, Embase, and Web of Science, to select randomized controlled trials (RCTs) that used Tonifying Kidney and Activating Blood Therapy for treating DMED. The search covered literature from the inception of each database to May 31, 2025. The quality of the included studies was assessed using the Cochrane Risk of Bias tool, and the meta-analysis was performed using Stata 12.0 software. When more than 10 studies were included, Egger’s test was applied to evaluate publication bias. The quality of evidence was graded using the GRADE system. Results: A total of 16 studies, encompassing 1539 patients, were included in this analysis. The meta-analysis demonstrated that, compared with the control group, the experimental group showed significant superiority in overall clinical efficacy [RR = 1.39, 95%CI (1.24, 1.56), P < 0.000 01], International Index of Erectile Function-5 (IIEF-5) score [WMD = 4.16, 95%CI (2.17, 6.16), P < 0.0001], fasting blood glucose [WMD = −0.89, 95%CI (−1.35, −0.44), P < 0.0001], testosterone [WMD = 3.21, 95%CI (1.43, 4.99), P < 0.0001], and estradiol [WMD = −19.34, 95%CI (−30.54, −8.14), P = 0.001], all with statistically significant differences (P < 0.05). Due to the insufficient number of studies, only one study reported specific data on glycated hemoglobin (HbA1c), and a meta-analysis could not be performed; instead, a descriptive analysis was conducted. The difference in the incidence of adverse events between the two groups was not statistically significant [RR = 1.00, 95% CI (0.51, 1.96), P = 0.993]. In the GRADE assessment of evidence quality, the level of evidence for clinical total efficacy was rated as “very low”, while the evidence quality for all other indicators was rated as “low”. Conclusion: Tonifying Kidney and Activating Blood Therapy may provide clinical benefit and exhibit an acceptable safety profile in DMED. However, because the included studies are generally of low methodological quality, display substantial heterogeneity, and show indications of publication bias suggesting that effects may be overestimated, the overall reliability of these conclusions is limited. Further high-quality studies are warranted to validate these findings.