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肾炎康复片联合缬沙坦治疗糖尿病肾病的疗效:一项系统评价与Meta分析

The efficacy of Shenyankangfu tablets in combination with valsartan in diabetic nephropathy: A systematic review and meta-analysis.

作者信息

Yang Yang, Zhang Xinyu, Yuan Yin, Wang Mengyang, Xue Yuqing, Wang Hongwu, Zhao Tieniu

机构信息

School of Public Health and Health Sciences, Tianjin University of Traditional Chinese Medicine, Tianjin, China.

出版信息

Medicine (Baltimore). 2025 Feb 28;104(9):e41518. doi: 10.1097/MD.0000000000041518.

Abstract

BACKGROUND

Diabetic nephropathy (DN) is the most prevalent and critical microvascular complication of diabetes mellitus, constituting a significant contributor to end-stage renal disease. Shenyankangfu tablets (SYKFP) are a pure traditional Chinese medicine compound. Current studies have shown that SYKFP combined with valsartan in the treatment of DN had therapeutic advantages. However, there is still a lack of systematic research. Therefore, meta-analysis was used to systematically evaluate the efficacy and safety of SYKFP combined with valsartan in treating DN and to provide evidence-based medical evidence for clinical application.

METHODS

CNKI, VIP, Wanfang, Chinese Biomedical Literature Service System, American Clinical Trial Registry, Embase, Web of Science, PubMed, and Cochrane Library databases were searched from the date of database establishment to August 2024. All randomized controlled trials of SYKFP in combination with valsartan for treating DN were collected, and the data of clinical trials that met the inclusion criteria were extracted. Meta-analysis was performed using Review Manager 5.4 and Stata 17.0.

RESULTS

Sixty-nine pieces of literature were retrieved, and 14 eligible randomized controlled trials were selected, with 1281 participants. The results of the meta-analysis showed that compared with valsartan alone in the treatment of DN, Shenyanangfu tablets combined with valsartan can improve the clinical efficacy rate (relative risk = 1.16, 95% CI [1.11, 1.22], P < .00001) and reduce blood creatinine (mean difference [MD] = -28.79, 95% CI [-31.16, -26.42], P < .00001), urea nitrogen (MD = -1.37, 95% CI [-1.52, -1.22], P < .00001), 24-hour urine protein quantification (MD = -0.59, 95% CI [-0.77, -0.40], P < .00001), fasting blood glucose (MD = -0.51, 95% CI [-0.77, -0.25], P = .0001) and the incidence of adverse events (relative risk = 0.74, 95% CI [0.43, 1.23], P = .24) were better than valsartan alone, and the difference was statistically significant.

CONCLUSION

SYKFP combined with valsartan can improve the clinical treatment efficiency of DN. They can effectively reduce the occurrence of urea nitrogen, blood creatinine, 24-hour urine protein quantification, fasting blood glucose, and adverse events.

摘要

背景

糖尿病肾病(DN)是糖尿病最常见且严重的微血管并发症,是终末期肾病的重要原因。肾炎康复片(SYKFP)是一种纯中药复方制剂。目前研究表明,SYKFP联合缬沙坦治疗DN具有治疗优势。然而,仍缺乏系统研究。因此,采用荟萃分析系统评价SYKFP联合缬沙坦治疗DN的疗效和安全性,为临床应用提供循证医学依据。

方法

检索中国知网、维普、万方、中国生物医学文献服务系统、美国临床试验注册库、Embase、Web of Science、PubMed及Cochrane图书馆数据库,检索时间从各数据库建库至2024年8月。收集所有SYKFP联合缬沙坦治疗DN的随机对照试验,提取符合纳入标准的临床试验数据。使用RevMan 5.4和Stata 17.0进行荟萃分析。

结果

共检索到69篇文献,筛选出14项符合条件的随机对照试验,共1281例参与者。荟萃分析结果显示,与单用缬沙坦治疗DN相比,肾炎康复片联合缬沙坦可提高临床有效率(相对危险度=1.16,95%可信区间[1.11, 1.22],P<0.00001),并降低血肌酐(平均差值[MD]=-28.79,95%可信区间[-31.16, -26.42],P<0.00001)、尿素氮(MD=-1.37,95%可信区间[-1.52, -1.22],P<0.00001)、24小时尿蛋白定量(MD=-0.59,95%可信区间[-0.77, -0.40],P<0.00001)、空腹血糖(MD=-0.51,95%可信区间[-0.77, -0.25],P=0.0001),且不良事件发生率(相对危险度=0.74,95%可信区间[0.43, 1.23],P=0.24)优于单用缬沙坦,差异有统计学意义。

结论

SYKFP联合缬沙坦可提高DN的临床治疗效果,能有效降低尿素氮、血肌酐、24小时尿蛋白定量、空腹血糖的水平及不良事件的发生。

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