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中西医结合治疗小儿原发性肾病综合征随机对照试验的meta分析

A meta-analysis of randomized controlled trials on integration Chinese and western medicine therapy for children with primary nephritic syndrome

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【作者】 吕彩兰戴恩来吴建军史正刚魏锦慧徐厚谦

【机构】 甘肃中医学院甘肃中医学院附属医院

【摘要】 目的:评价中西医结合治疗小儿原发性肾病综合征的疗效。方法:计算机检索2000-2010年PubMed、Medline、中国生物医学文献光盘数据库(CBM disc)、中文期刊网全文数据库(CNKI)、中国优秀博硕士学位论文全文数据库(CDMD)、万方数据库Cochrane Library(2010,第2期);并手工检索纳入文献的参考文献、相关学位论文和会议论文集。由两名研究人员分别独立检索、筛选有关中西医结合治疗小儿原发性肾病综合征的中、英文临床随机对照研究文献,并独立对纳入文献依据Jadad量表进行质量评价和数据提取。用RevMan5.1.5软件进行Meta分析。结果:(1)共纳入17篇文献,980例病人,其中治疗组535例,对照组445例。除一篇Jadad评分3分的文献外,其余均为1-2分的低质量文献。各研究均明确指出基线均衡,具有可比性。有两篇文献提到使用随机数字表,其余文献只提到随机分组,但并未详细描述随机序列的产生方法。所有纳入文献均未对随机分配方案进行隐藏,均未使用盲法;(2)meta分析结果显示:中西医结合和常规激素或激素加免疫抑制剂治疗小儿原发性肾病综合征相比在减少24h尿蛋白定量(SMD-0.74,95%CI[-1.12,-0.37])、升高ALB水平(SMD 0.64,95%CI[0.38,0.90])、降低血脂(TC:MD-1.24,95%CI[-1.80,-0.69];TG:MD-0.41,95%CI[-0.66,-0.17])、减少复发率(RR0.39,95%CI[0.30,0.52])和缩短水肿消退时间(MD-4.30,95%CI[-5.19,-3.41])方面优于激素常规治疗,且差异有显著性意义。结论:在激素或激素加免疫抑制剂常规治疗的基础上加用中医药治疗,对小儿原发性肾病综合征患者24h尿蛋白定量,血脂(TC、TG)、复发率的降低及水肿消退时间的缩短方面的作用优于常规治疗,且敏感性分析未能从实质上改变meta分析的结果 ,但纳入本meta分析的文献方法学质量较低,而且可能存在发表性偏倚,因此,尚有待于设计严密规范的大样本、多中心、随机双盲对照研究的进一步证实。

【Abstract】 Objective To evaluate the efficacy of Chinese and western medicine integrated treat for children with primary nephrotic syndrome.Methods We searched PubMed(2000-2010),Medline(2000-2010),The Cochrane Library(2010.2),CBM(2000-20100),CNKI(2000-2010),CDMD(2000-2010) and Wanfang Database(2000-2010) to collect randomized controlled trials(RCTs) of Chinese and western medicine integrated curing primary nephrotic syndrome,The selection of studies,assessment of methodological quality and data extraction were performed independently by two researchers.The methodological quality assessment was undertaken according to the Jadad scale score and meta-analyses were performed by using The Cochrane Collaboration’s RevMan 5.1.5 software.Results A total of 17 studies,only one literature Jadad scale score is 3 points,the rest are 1-2 points. Baseline data of the studies were comparable.And all reported that there were random methods but did not mention blinding and allocation concealment.There are two articles mentioned the use of random number table by random grouping;The results of the meta-analysis indicated that combination of Traditional Chinese and Western medicine therapy is superior to conventional glucocorticoid in decreasing TC(MD-1.24,95%CI[-1.80,-0.69]);TG(MD-0.41,95%CI:[-0.66,-0.17]);relapse rate(RR0.39, 95%CI[0.30,0.52]);24h urine protein(SMD-0.74,95%CI[-l.12,-0.37]) and shorten the time of edema subsided(MD-4.30,95%CI[-5.19,-3.41]) and elevated serum ALB level(SMD0.64, 95%CI[0.38,0.90]).Conclusion the meta-analysis results suggest that the efficacy of integration Chinese and western medicine therapy for children with primary nephrotic syndrome is better.And the sensitivity analysis did not essentially change the results of meta-analysis.However,the literature included in the meta-analysis are lower methodological quality,and publication bias may exist,Therefore,has yet to be designed to a strict standard of the large sample,multicenter,randomized,double-blind controlled study further confirmed.

  • 【会议录名称】 第二十九次全国中医儿科学术大会暨“小儿感染性疾病的中医药防治”培训班论文汇编
  • 【会议名称】第二十九次全国中医儿科学术大会暨“小儿感染性疾病的中医药防治”培训班
  • 【会议时间】2012-09-01
  • 【会议地点】中国湖南张家界
  • 【分类号】R726.9
  • 【主办单位】中华中医药学会儿科分会
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