刺五加降低糖尿病肾病患者尿蛋白的系统评价

Systematic Review on Manyprickle Acathopanax Root in Reducing Urine Protein in Patients with Diabetic Nephropathy

目的系统评价中药刺五加治疗糖尿病肾病尿蛋白的疗效和安全性。方法检索Cochrane图书馆临床试验注册库、Pubmed、Embase、中国生物医学文献数据库、中国学术期刊全文数据库、万方数据库中刺五加治疗糖尿病肾病的随机对照临床试验,并手工检索相关参考文献。由两位研究者对符合纳入标准的试验进行独立筛选、质量评价和原始资料提取并交叉核对。评价指标包括:124小时尿微量白蛋白排泄率及尿蛋白定量;2空腹血糖;3不良反应。结果 9个随机对照临床试验,739例糖尿病肾病患者被纳入,试验地点均在中国。系统评价结果显示:1与对照组相比,刺五加能显著减少糖尿病肾病患者24小时尿微量白蛋白排泄率(WMD=-41.53,95%CI(-46.53,-36.52),P<0.00001)、24小时尿蛋白定量(WMD=-0.08,95%CI(-0.09,-0.06),P<0.0001);2刺五加能显著降低空腹血糖(WMD=-0.62,95%CI(-1.08,-0.17),P=0.007);3刺五加并不显著增加药物不良反应。结论刺五加能够显著减少糖尿病肾病患者的尿蛋白及患者的空腹血糖,未见严重的不良反应。由于本系统评价纳入的试验方法学质量较低且样本量较小,因而有必要进行大样本、多中心、随机、双盲的研究,以进一步证实刺五加治疗糖尿病肾病的疗效。

Objective To evaluate the effect and safety of manyprickle acathopanax root in reducing urine protein in patients with diabetic nephropathy. Methods Randomized controlled trials were identified from the Cochrane library clinical trial registry, Pubmed, Embase, Chinese biomedical literature database, China academic journal full-text database, and Wanfang database. Publications of the randomized controlled trials in the treatment of diabetic nephropathy with manyprickle aeathopanax root were included. We also hand searched the references of all eligible articles and related previous review articles. According to the inclusion criteria, two reviewers independently screened abstracts, assessed the quality of those included studies and extracted data from included studies. Evaluation indicators include 24 - hour urinary albumin excretion rates and urine protein quantitative, fasting plasma glucose and adverse effect. Results Nine randomized controlled trials involving 739 patients with diabetic nephropathy were included. All the trials were done in China. Systematic review indicated that mauypricklc acathopanax root-treated patients with diabetic nephropathy had a statistically significant reduction in 24 - hour urinary albumin excretion rates （ WMD = - 41.53,95% CI （ - 46.53, - 36.52 ） , P 〈 0. 00001 ） and 24 - hour urine protein quantitative （WMD = -0.08,95% CI（ -0.09, -0.06） ,P 〈 0. 0001 ） comparing with the control group. The manyprickle acathopanax root can reduce the fasting plasma glucose significantly （WMD = -0.62, 95% CI（ - 1.08, -0. 17） , P =0. 007）. In addition, manyprickle acathopanax root did not increase the incidence of adverse effects. Conclusion The manyprickle acathopanax root can ameliorate proteinuria, and reduce fasting plasma glucose in patients with diabetic nephropathy. And it does not increase any adverse effects. But due to the limited randomized controlled trials of high quality, more clinical researches with large sample, muhicenter, randomized and double-blind should be taken in the future.