摘要
目的通过Meta分析系统评价真武汤加减联合西药治疗水肿的有效性和安全性,为其临床应用提供循证依据。方法计算机检索中国知网数据库(CNKI)、万方数据库(Wan Fang)、维普数据库(VIP)、中国生物医学文献数据库(CBM)、PubMed、Embase、Cochrane library 7个数据库中真武汤加减联合西药治疗水肿的随机对照试验(RCT),检索时限从各数据库建库至2022年11月11日,检索语种限定为中英文。由两位研究者按照纳入排除标准独立筛选文献并提取资料,采用Cochrane偏倚风险评估工具对纳入的文献进行质量评价,运用RevMan 5.3软件进行Meta分析。结果检索获得相关文献169篇,通过筛选最终纳入14篇文献,共1043例水肿患者,其中试验组521例,对照组522例。Meta分析结果显示,与对照组相比,真武汤加减联合西药治疗水肿在总有效率的提高[OR=4.70,95%CI(3.06,7.22),Z=7.06,P<0.00001]、24 h尿蛋白定量的降低[MD=-0.31,95%CI(-0.41,-0.20),Z=5.83,P<0.00001]、血肌酐的降低[MD=-9.26,95%CI(-17.92,-0.60),Z=2.10,P=0.04]、血清白蛋白的升高[MD=4.76,95%CI(2.76,6.76),Z=4.67,P<0.00001]、中医证候积分的降低[MD=-1.62,95%CI(-3.06,-0.17),Z=2.20,P=0.03]、水肿积分的降低[MD=-0.72,95%CI(-0.99,-0.45),Z=5.25,P<0.00001]6个方面均优于对照组。在降低血尿素氮[MD=-0.87,95%CI(-2.50,0.75),Z=1.05,P=0.29]和不良反应发生率[OR=0.73,95%CI(0.24,2.22),Z=0.56,P=0.57]方面,两组比较,差异无统计学意义(P>0.05)。其他结局指标,由于仅纳入一两项研究,无法进行Meta分析,而无法得出结论。由于大部分研究未提及不良反应,故不能对其安全性做出肯定性评价。结论真武汤加减联合西药治疗水肿可以提高总有效率、降低24 h尿蛋白定量、降低血肌酐、升高血清白蛋白、降低中医证候积分、降低水肿积分,但在降低血尿素氮和不良反应发生率方面无统计学差异,初步证实真武汤加减联合西药治疗水肿疗效显著。
Objective This systematic review aimed to evaluate the effectiveness and safety of Modified Zhenwu Decoction combined with western medicines in the treatment of edema through Meta-analysis,providing an evidence-based basis for its clinical application.Method Randomized controlled trials of Modified Zhenwu Decoction combined with western medicines in the treatment of edema were searched in seven databases:CNKI,Wan Fang Data,VIP,CBM,PubMed,Embase and Cochrane library.The search period was from the databases’establishment to November 11,2022,and limited to Chinese and English language publications.Two researchers independently screened and extracted relevant literature based on inclusion and exclusion criteria.The quality of the included literature was evaluated using the Cochrane bias risk assessment tool,and the Meta-analysis was performed using RevMan 5.3 software.Results A total of 169 related literature were identified through the initial search,of which 14 were finally included in the analysis.These studies involved 1043 patients with edema,including 521 cases in the experimental group and 522 cases in the control group.Meta-analysis showed that compared with the control group,Modified Zhenwu Decoction combined with western medicines in the treatment of oedema was superior to the control group in the following aspects:increase in the total effective rate[OR=4.70,95%CI(3.06,7.22),Z=7.06,P<0.00001],decrease in the quantitative amount of 24 h urinary protein[MD=-0.31,95%CI(-0.41,-0.20),Z=5.83,P<0.00001],decrease in blood creatinine[MD=-9.26,95%CI(-17.92,-0.60),Z=2.10,P=0.04],increase in serum albumin[MD=4.76,95%CI(2.76,6.76),Z=4.67,P<0.00001],and decrease in TCM evidence score[MD=-1.62,95%CI(-3.06,-0.17),Z=2.20,P=0.03],decrease in oedema score[MD=-0.72,95%CI(-0.99,-0.45),Z=5.25,P<0.00001].There was no statistically significant difference between the two groups(P>0.05)in terms of reducing blood urea nitrogen[MD=-0.87,95%CI(-2.50,0.75),Z=1.05,P=0.29]and the incidence of adverse reactions(OR=0.73,95%CI[0.24,2.22],Z=0.56,P=0.57).For other outcome indicators,no conclusions could be drawn because only one or two studies were included and Meta-analysis could not be performed.A positive evaluation of safety could not be made as most of the studies did not mention adverse effects.Conclusion This systematic review provides preliminary evidence for the efficacy of Modified Zhenwu Decoction combined with western medicine in the treatment of edema.It significantly improves various parameters related to the condition.It can improve the total effective rate,reduce the 24-hour urinary protein quantity,reduce the serum creatinine,elevate the serum albumin,reduce TCM syndrome score and the points of edema,However,no statistically significant differences were found in the reduction of blood urea nitrogen and the incidence of adverse reactions.Preliminary evidence suggests that the efficacy of Modified Zhenwu Decoction combined with western medicine in the treatment of oedema is significant.
作者
贾琼
王春莉
赵汉青
JIA Qiong;WANG Chunli;ZHAO Hanqing(College of Traditional Chinese Medicine,Hebei University,Baoding 071000,China)
出处
《湖北民族大学学报(医学版)》
2023年第3期13-19,共7页
Journal of Hubei Minzu University(Medical Edition)
基金
河北省中医药管理局科研计划项目(2021176)。