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口服补肾类中成药治疗糖尿病肾病有效性与安全性的网状Meta分析

Efficacy and safety of oral kidney-tonifying Chinese patent medicines in treatment of diabetic kidney disease:a network meta-analysis
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摘要 目的采用网状Meta分析比较不同口服补肾类中成药联合常规治疗对糖尿病肾病的临床疗效及安全性。方法计算机检索中国知网、维普数据库、万方数据库、中国生物医学文献数据库、PubMed、Embase、Cochrane Library,检索时间为建库至2024年11月30日。筛选符合纳入标准的文献,数据采用STATA 15、RevMan 5.4进行网状Meta分析。结果共纳入65篇文献,涉及6种补肾类中成药,5个结局指标,共5916例患者。网状Meta分析结果显示,在改善尿白蛋白排泄率(UAER)方面,百令胶囊联合常规治疗(SMD=-2.27,95%CI:-3.50~-1.04)和糖脉康颗粒联合常规治疗(SMD=-2.88,95%CI:-4.35~-1.41)优于单用常规治疗;在改善24 h尿蛋白定量(24 h UTP)方面,百令胶囊联合常规治疗优于单用常规治疗(SMD=-2.95,95%CI:-3.94~-1.96);在改善尿素氮(BUN)方面,肾炎康复片联合常规治疗疗效相对较优[累积排序曲线下面积(SUCRA)87.7%];在改善血肌酐(Scr)方面,六味地黄丸联合常规治疗相对较优(SUCRA 65.0%)。在临床有效率方面,六味地黄丸、金匮肾气丸、糖脉康颗粒、金水宝胶囊、肾炎康复片、百令胶囊联合常规治疗均优于单用常规治疗。对降糖和降压不同常规治疗方案的亚组分析显示,联合六味地黄丸改善血肌酐的疗效均较优(分别为SUCRA 82.9%和SUCRA 77.3%)。在安全性方面,与单用常规治疗相比,百令胶囊联合常规治疗的不良反应发生概率更小(RR=3.51,95%CI:1.29~9.70)。结论口服补肾类中成药联合常规治疗对糖尿病肾病具有较好的临床疗效,可显著改善UAER、24 h UTP、BUN等指标,受纳入研究所限,所得出结果需更多高质量、多中心、大样本及后期随访的随机对照试验进行补充完善。 AIM To compare the clinical efficacy and safety of different oral kidney-tonifying Chinese patent medicines combined with conventional therapy for diabetic kidney disease(DKD)using a network meta-analysis.METHODS Databases including CNKI,VIP,Wanfang,SinoMed,PubMed,Embase,and the Cochrane Library were searched from inception to November 30,2024.Literature meeting the inclusion criteria was screened.Datas were analyzed using STATA 15 and RevMan 5.4.RESULTS A total of 65 articles were included,involving 6 types of kidney-tonifying Chinese patent medicines,5 outcome indicators,and 5916 patients.The network meta-analysis results showed that Bailing capsule combined with conventional therapy(SMD=-2.27,95%CI:-3.50 to-1.04),and Tangmaikang granule combined with conventional therapy(SMD=-2.88,95%CI:-4.35 to-1.41)were superior to conventional therapy alone in improving urinary albumin exeretion rate(UAER).Regarding improvement in 24-hour urinary total protein(24 h UTP),Bailing capsule combined with conventional therapy was superior to conventional therapy alone(SMD=-2.95,95%CI:-3.94 to-1.96).For improving blood urea nitrogen(BUN),Shenyan Kangfu tablet combined with conventional therapy showed relatively superior efficacy[surface under the camulative ranking curve(SUCRA)87.7%].For improving serum creatinine(Scr),Liuwei Dihuang pill combined with conventional therapy was relatively superior(SUCRA 65.0%).In terms of clinical effective rate,Liuwei Dihuang Wan,Jingui Shenqi pill,Tangmaikang granule,Jinshuibao capsule,Shenyan Kangfu tablet,and Bailing capsule combined with conventional therapy were all superior to conventional therapy alone.Subgroup analysis indicated that under different conventional treatment for blood glucose and blood pressure reduction,the combination of Liuwei Dihuang Wan stil showed relatively better efficacy in improving Scr(SUCRA 82.9%,SUCRA 77.3%).Regarding safety,the probability of adverse events with Bailing capsule combined with conventional therapy was lower compared to conventional therapy alone(RR=3.51,95%CI:1.29 to 9.70).CONCLUSION Kidney-tonifying Chinese patent medicines combined with conventional therapy demonstrate good clinical efficacy for DKD,significantly improving indicators such as UAER,24 h UTP,and BUN.However,limited by the included studies,the findings require further supplementation and validation through more highquality,multi-center,large-sample,and long-term follow-up randomized controlled trials.
作者 邢叶一祎 荣红国 阎传雅 张雅淇 梁舒畅 杜毓炜 刘珊珊 靳冉 严玉萍 XING Ye-yi-yi;RONG Hong-guo;YAN Chuan-ya;ZHANG Ya-qi;LIANG Shu-chang;DU Yu-wei;LIU Shan-shan;JIN Ran;YAN Yu-ping(Beijing University of Chinese Medicine,BEIJING 102488,China;Dongzhimen Hospital,Beijing University of Chinese Medicine,BEIJING 100700,China;Beijing Tong Ren Tang Technology Development Co.,Ltd.,BEIJING 100079,China)
出处 《中国新药与临床杂志》 北大核心 2025年第12期942-952,共11页 Chinese Journal of New Drugs and Clinical Remedies
基金 国家中医药管理局高水平中医药重点学科建设项目—中医药循证医学(zyyzdxk-2023249) 国家中医药管理局课题(YGZXKT2024046) 河北省中医药管理局课题(B2025019)。
关键词 中成药 糖尿病肾病 网状Meta分析 六味地黄丸 金匮肾气丸 Chinese patent medicines diabetic kidney disease network meta-analysis Liuwei Dihuang Wan Jinkui Shenqi Wan
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