雷公藤制剂联合中医药治疗慢性肾脏病安全性的Meta分析

A Meta-analysis of the Safety of Tripterygium wilfordii Polyglycoside Tablets Combined with Traditional Chinese Medicine in the Treatment of Chronic Kidney Disease

目的采用系统评价和Meta分析方法评价雷公藤总甙片(TwHF polyglycoside tablets,TWPT)联合中医药防治慢性肾脏病(Chronic kidney disease,CKD)引起的不良反应情况,评价中医药辨证治疗的特色优势。方法通过检索中国知网、万方学术期刊数据库、中文科技期刊数据库等中文数据库,及Pub Med、Web of science、The Cochrane Library等英文数据库,自建库至2023年3月31日期间所发表的中医药联合TWPT对比TWPT单用治疗CKD的随机对照试验(Randomized controlled trials,RCT),对符合纳入、排除标准的RCT进行偏倚风险评价,采用RevMan 5.4软件进行分析,并对中医药干预进行频次统计和关联分析。结果纳入33个RCTs,共2770例患者。Meta分析结果显示:对比TWPT单独用药,中医药联合治疗能有效改善不良反应(Adverse drug reaction,ADR)的发生事件,主要表现在肝胆系统(RR=0.45,95%CI[0.32,0.64],Z=4.45,P<0.00001),胃肠系统(RR=0.55,95%CI[0.40,0.74],Z=3.90,P<0.0001),血液系统(RR=0.35,95%CI=[0.21,0.57],Z=4.17,P<0.0001),生殖系统(RR=0.46,95%CI=[0.31,0.67],Z=3.93,P<0.0001),皮肤及附件(RR=0.72,95%CI=[0.30,1.74],Z=0.74,P<0.0001),中药频次前5位依次为黄芪、茯苓、当归、白花蛇舌草、白术,其中配伍5次以上中药共21味。结论中医药治疗可以有效改善雷公藤总甙片治疗CKD不良反应事件的发生,但由于纳入文献的质量较低,有待更多高质量的临床研究RCT加以验证,从而为中医药防治雷公藤总甙片ADR提供更高的循证医学证据。

Objective To evaluate the adverse reactions caused by Tripterygium wilfordii polyglycoside tablets(TWPT)in the prevention and treatment of chronic kidney disease(CKD)and the characteristic advantages of traditional Chinese medicine(TCM)treatment based on syndrome differentiation.Methods The China National Knowledge Infrastructure(CNKI),Wanfang Data,China Science and Technology Journal Database,PubMed,Web of Science,and The Cochrane Library were searched for the randomized controlled trials(RCTs)of TCM combined with TWPT versus TWPT alone in the treatment of CKD that were published from inception to March 31,2023.The RCTs meeting the inclusion criteria were evaluated for risk of bias,and RevMan5.4 was used for the meta-analysis.The frequency statistics and association analysis of TCM interventions were performed.Results A total of 33 RCTs involving 2770 patients were included.The meta-analysis results showed that compared with TWPT alone,TWPT combined with TCM reduced the occurrence of adverse drug reactions(ADRs)in the hepatobiliary system(RR=0.45,95%CI[0.32,0.64],Z=4.45,P<0.00001),gastrointestinal system(RR=0.55,95%CI[0.40,0.74],Z=3.90,P<0.0001),blood system(RR=0.35,95%CI[0.21,0.57],Z=4.17,P<0.0001),reproductive system(RR=0.46,95%CI[0.31,0.67],Z=3.93,P<0.0001),and skin and accessories(RR=0.72,95%CI[0.30,1.74],Z=0.74,P<0.0001).The top five Chinese herbal medicines in terms of frequency were Astragali Radix,Poria,Angelicae Sinensis Radix,Hedyotis Diffusae Herba,and Atractylodis Macrocephalae Rhizoma.A total of 21 Chinese herbal medicines showed the frequency above 5.Conclusion The combination with TCM can effectively reduce the occurrence of ADRs in the treatment of CKD with TWPT.dDue to the low quality of the included studies,more high-quality RCTs are needed to verify the conclusion and provide higher-level evidence for the prevention and treatment of ADRs induced by TWPT.