Nephrology Department, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.
The China-Australia International Research Centre for Chinese Medicine, RMIT University, Melbourne, Victoria, Australia.
BMJ Open. 2019 May 1;9(4):e025653. doi: 10.1136/bmjopen-2018-025653.
To provide a broad evaluation of the efficacy and safety of oral Chinese herbal medicine (CHM) as an adjunctive treatment for diabetic kidney disease (DKD), including mortality, progression to end-stage kidney disease (ESKD), albuminuria, proteinuria and kidney function.
A systematic review and meta-analysis.
Randomised controlled trials (RCTs) comparing oral CHM with placebo as an additional intervention to conventional treatments were retrieved from five English (Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Allied and Complementary Medicine Database and Cumulative Index of Nursing and Allied Health Literature) and four Chinese databases (China BioMedical Literature, China National Knowledge Infrastructure, Chonqing VIP and Wanfang) from inception to May 2018. RCTs recruiting adult DKD patients induced by primary diabetes were considered eligible, regardless of the form and ingredients of oral CHM. Mean difference (MD) or standardised mean difference (SMD) was used to analyse continuous variables and RR for dichotomous data.
From 7255 reports retrieved, 20 eligible studies involving 2719 DKD patients were included. CHM was associated with greater reduction of albuminuria than placebo, regardless of whether renin-angiotensin system (RAS) inhibitors were concurrently administered (SMD -0.56, 95% CI [-1.04 to -0.08], I=64%, p=0.002) or not (SMD -0.92, 95% CI [-1.35 to -0.51], I=87%, p<0.0001). When CHM was used as an adjunct to RAS inhibitors, estimated glomerular filtration rate was higher in the CHM than placebo group (MD 6.28 mL/min; 95% CI [2.42 to 10.14], I=0%, p=0.001). The effects of CHM on progression to ESKD and mortality were uncertain due to low event rates. The reported adverse events in CHM group included digestive disorders, elevated liver enzyme level, infection, anaemia, hypertension and subarachnoid haemorrhage, but the report rates were low and similar to control groups. The favourable results of CHM should be balanced with the limitations of the included studies such as high heterogeneity, short follow-up periods, small numbers of clinical events and older patients with less advanced disease.
Based on moderate to low quality evidence, CHM may have beneficial effects on renal function and albuminuria beyond that afforded by conventional treatment in adults with DKD. Further well-conducted, adequately powered trials with representative DKD populations are warranted to confirm the long-term effect of CHM, particularly on clinically relevant outcomes.
CRD42015029293.
广泛评估中药（CHM）作为辅助治疗糖尿病肾病（DKD）的疗效和安全性，包括死亡率、进展为终末期肾病（ESKD）、白蛋白尿、蛋白尿和肾功能。
系统评价和荟萃分析。
从五个英文数据库（Cochrane 对照试验中心注册库、MEDLINE、Embase、辅助与补充医学数据库和护理学与辅助卫生文献累积索引）和四个中文数据库（中国生物医学文献、中国国家知识基础设施、重庆 VIP 和万方）检索了比较口服 CHM 与安慰剂作为常规治疗附加干预的随机对照试验（RCT），检索时间截至 2018 年 5 月。符合条件的 RCT 招募了由原发性糖尿病引起的成年 DKD 患者，无论口服 CHM 的形式和成分如何。使用均数差（MD）或标准化均数差（SMD）分析连续变量，使用相对危险度（RR）分析二分类数据。
从 7255 份报告中，纳入了 20 项符合条件的研究，涉及 2719 例 DKD 患者。与安慰剂相比，CHM 可更显著降低白蛋白尿，无论是否同时使用肾素-血管紧张素系统（RAS）抑制剂（SMD-0.56，95%CI[-1.04 至-0.08]，I=64%，p=0.002）。与安慰剂相比，当 CHM 作为 RAS 抑制剂的辅助治疗时，CHM 组肾小球滤过率更高（MD 6.28mL/min；95%CI[2.42 至 10.14]，I=0%，p=0.001）。由于事件发生率较低，CHM 对进展为 ESKD 和死亡率的影响尚不确定。CHM 组报告的不良事件包括消化系统疾病、肝酶水平升高、感染、贫血、高血压和蛛网膜下腔出血，但报告率较低，与对照组相似。基于中等至低质量证据，CHM 可能对成人 DKD 的肾功能和白蛋白尿有有益的影响，超过了常规治疗的效果。需要进一步进行设计良好、充分有效的、具有代表性的 DKD 人群试验，以确认 CHM 的长期效果，特别是对临床相关结局的影响。
PROSPERO 注册号：CRD42015029293。
