摘要
目的通过Meta分析评估槐杞黄颗粒联合糖皮质激素治疗儿童原发性肾病综合征(nephroticsyndrome,NS)的有效性和安全性。方法检索主要的中英文数据库,收集槐杞黄颗粒联合糖皮质激素治疗儿童NS的随机临床对照试验(RCT),采用Cochrane handbook 5. 1. 0中的偏倚风险评估工具对纳入文献进行风险评估,用STATA12. 0和RevMan 5. 3软件进行Meta分析,并按照GRADE标准进行证据质量评价。结果 (1) Meta分析共纳入12个RCT,结果显示:槐杞黄颗粒联合糖皮质激素等西医常规疗法与单一西医疗法在缩短尿蛋白转阴时间、升高免疫球蛋白G(IgG)、免疫球蛋白A(IgA)、CD3、CD4、CD4/CD8、NK细胞、降低复发率和感染率等方面疗效差异有统计学意义(P <0. 05),在降低免疫球蛋白M(IgM)、CD8方面疗效差异无统计学意义(P> 0. 05)。(2)共有7项研究阐述不良反应,试验组218例中有6例出现不良反应,不良反应发生率为3%。(3)漏斗图与Egger's检验结果提示无明显发表偏倚。(4)根据GRADE方法评价证据质量,结果显示在感染率和IgG方面质量为中级,其他方面为低级或极低。结论槐杞黄颗粒联合糖皮质激素疗法可以调节NS患儿免疫功能,降低复发率和感染率,且不良反应较小;但因纳入研究的质量较低,证据质量级别较低,临床使用该证据时尚需谨慎。
Objective To evaluate the efficacy and safety of the combination therapy of Huaiqihuang Granule and glucocorticoid in the treatment of children with primary nephrotic syndrome( NS) by Meta-analysis. Methods All randomized controlled trials( RCTs) of the combination therapy of Huaiqihuang Granule and glucocorticoid in the treatment of children with NS were collected by searching the main Chinese and English medical databases. Risk assessments were conducted for the screened articles by the bias risk assessment tool in Cochrane handbook 5. 1. 0,meta-analysis was performed by using STATA12. 0 and Rev Man 5. 3 software,and the quality of evidence was evaluated according to the GRADE criteria. Results( 1) The meta-analysis including a total of 12 RCTs showed that there were significant differences between the combination therapy and monotherapies of modern Western medicine in shortening the course of proteinuria,increasing immunoglobulin G( Ig G),immunoglobulin A( Ig A),CD3,CD4,CD4/CD8,NK cells,and reducing recurrence rate and infection rate(P <0. 05). And there were no differences in reducing the immune globulin M( Ig M),CD8(P > 0. 05).( 2) A total of 7 studies described adverse reactions,of which there had been 6 patients with adverse reactions in 218 cases of the combined group,and the incidence of adverse reactions was 3%.( 3) There was no obvious publication bias based on funnel plot and Egger’s test.( 4) The quality of evidence which evaluated by GRADE system showed the middle quality in infection rate and Ig G,and low or very low quality in other aspects. Conclusions The combination therapy of Huaiqihuang Granule and glucocorticoid in the treatment of children with NS could regulate the immunity of children with NS,reduce the recurrence and infection rate and with less adverse reactions. However,due to the low quality of included studies and the low level of evidence quality,clinical use of this evidence should be cautious.
作者
李冰
杨濛
翟文生
LI Bing;YANG Meng;ZHAI Wen-sheng(Graduate School,Henan University of Chinese Medicine,Zhengzhou (450046);Department of Pediatric,First Affiliated Hospital of Henan University of Chinese Medicine,Zhengzhou (450000))
出处
《中国中西医结合杂志》
CAS
CSCD
北大核心
2019年第2期169-177,共9页
Chinese Journal of Integrated Traditional and Western Medicine
基金
河南省优势特色学科资助项目(No.STS-ZYX-2017007)
