解毒通络法治疗糖尿病肾病有效性及安全性的Meta分析  

Efficacy and Safety of"Jiedu Tongluo Therapy"for Diabetic Kidney Disease:A Systematic Review and Meta-analysis

作　　者：刘禹辛[1] 尚晓玲[1] 邬宏亮[2] LIU Yuxin;SHANG Xiaoling;WU Hongliang(School of Basic Medical Sciences,Changchun University of Chinese Medicine,Changchun 130117,China;Jilin Provincial Institute of Education,Changchun 130022,China)

机构地区：[1]长春中医药大学基础医学院,长春130117 [2]吉林省教育学院,长春130022

出　　处：《中国实验方剂学杂志》2023年第21期165-171,共7页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：2023年度吉林省教育厅课题(02006-010402067)。

摘　　要：目的:系统评价运用解毒通络法治疗糖尿病肾病(DKD)的有效性及安全性。方法:系统检索中国知网(CNKI)、万方数据库分析平台(Wangfang)、VIP数据库,PubMed、Web of Science等数据库,检索时限从2003年1月至2022年12月,查找、筛选近20年基于解毒通络法治疗DKD的临床随机对照试验(RCT),其中在常规治疗(包括糖尿病及肾病健康宣教,血糖、血压控制,低生活方式干预等)的基础上,对照组施以西药治疗或中成药治疗,试验组施以解毒通络为主要治疗方法的单纯中药口服剂治疗或联合西药治疗。采用Cochrane风险偏倚评估工具进行文献质量评价,使用R 4.1.0统计学软件进行分析。结果:最终纳入41篇RCT,共计3478例患者。Meta分析结果显示,试验组相对于对照组能有效提高临床总疗效[比值比(OR)=2.46,95%置信区间(CI)(2.08,2.92),I2=0%];有效降低血肌酐(Scr)水平[均数差(MD)=-15.83,95%CI(-21.5,-10.37),P<0.01]、24h尿蛋白排泄率(24h-Up)[MD=-350.88,95%CI(-419.49,-282.28),P<0.01]、中医证候积分[MD=-6.08,95%CI(-7.81,-4.36),P<0.01]、有效调节空腹血糖(FBG)[MD=-0.57,95%CI(-0.75,-0.38),P<0.01],并且具有一定的用药安全性[OR=0.99,95%CI(0.35,2.76)]。结论:解毒通络法治疗DKD具有良好临床疗效及用药安全性,但受纳入文献质量、数量的限制,以上结论尚需更大规模高质量的RCT试验进行验证。Objective:To systematically evaluate the efficacy and safety of Jiedu Tongluo therapy in the treatment of diabetic kidney disease(DKD).Method:Databases including CNKI,Wanfang Data,PubMed,and Web of Science were systematically searched from January 2003 to December 2022 for clinical randomized controlled trials(RCTs)on the application of Jiedu Tongluo therapy for DKD treatment over the past 20 years.In these trials,the control group received conventional treatment(including diabetes and kidney health education,glycemic and blood pressure control,and lifestyle interventions),along with western medicine or Chinese patent medicine treatment.The experimental group received primarily Jiedu Tongluo therapy via oral administration of Chinese medicine or in combination with western medicine.The Cochrane risk of bias assessment tool was used for the quality evaluation of the trials,and R 4.1.0 statistical software was used for analysis.Result:Forty-one RCTs with 3478 participants were included.The Meta-analysis results demonstrated that the experimental group,compared with the control group,showed significant improvement in overall clinical efficacy[odds ratio(OR)=2.46,95%confidence interval(CI)(2.08,2.92),I2=0%],effective reduction of serum creatinine(Scr)levels[mean difference(MD)=-15.83,95%CI(-21.5,-10.37),P<0.01],24-hour urinary protein excretion rate(24 h-Up)[MD=-350.88,95%CI(-419.49,-282.28),P<0.01],TCM syndrome score[MD=-6.08,95%CI(-7.81,-4.36),P<0.01],and effective regulation of fasting blood glucose(FBG)[MD=-0.57,95%CI(-0.75,-0.38),P<0.01].The treatment also demonstrated certain safety[OR=0.99,95%CI(0.35,2.76)].Conclusion:Jiedu Tongluo therapy in DKD treatment exhibits favorable clinical efficacy and safety.However,due to limitations in the quality and quantity of the included literature,these conclusions should be further validated through larger-scale,high-quality RCTs.

关 键 词：糖尿病肾病 解毒通络法 中医药 中西医联合 META分析 

分 类 号：R284[医药卫生—中药学] R285[医药卫生—中医学] R289R287R22R2-031R33R24