活血利水类中药对膝关节镜术后下肢肿胀的有效性和安全性Meta分析及GRADE证据等级评价

Meta-analysis and GRADE Evidence Level Evaluation of the Efficacy and Safety of Huoxue Lishui Traditional Chinese Medicine in Treating Swelling after Knee Arthroscopy

目的系统评价活血利水类中药治疗膝关节术后下肢肿胀的临床有效性及安全性。方法检索数据库从数据库(中国知网、万方、维普、中国生物医学文献数据库、PubMed、Embase、The Cochrane Library、Web of science)建库至2021年12月符合纳入排除标准的活血化瘀类中药治疗膝关节术后肿胀的随机对照试验,并筛选出文献数据,运用改良Cochrane偏倚风险评估工具对文献进行评价,运用RevMan5.3对临床总有效率、降低视觉模拟量表(visual analogue scale,VAS)、不良反应结局指标进行Meta分析,并对实验数目≥10的结局指标以漏斗图和Egger's图进行发表偏倚分析,以GRADE标准对结局指标行证据质量评价。结果共纳入10项研究,总样本量830例,实验组415例,对照组415例。Meta分析结果显示:活血利水类中药联合非中药组在提高有效率[RR=1.15(1.06,1,24),P<0.001],降低VAS评分[SMD=-2.18,95%CI(-3.09,-1.26),P<0.001],[降低膝关节肿胀度SMD=-1.83,95%CI(-2.00,-1.65),P<0.001],降低Lysholm评分[MD=4.46,95%CI(0.08,8.85),P<0.001],膝关节活动度[MD=15.28,95%CI(11.97,18.60),P<0.001]方面均优于非中药组。结论活血利水类中药组联合非中药组不仅可以提高膝关节镜术后肿胀的临床疗效,而且更加安全。但目前研究的样本量较少,文献的证据质量较低,缺乏多中心、大样本的数据。

Objective To systematically evaluate the clinical efficacy and safety of huoxue lishui Traditional Chinese medicine in the treatment of postoperative swelling of knee joint.Methods Databases were searched from CNKI,Wanfang,VIP,China Biomedical Literature Database,Pubmed,EMbase,The Cochrane Library,Web of Science randomized controlled trials of huoxue huayu Traditional Chinese medicines in the treatment of postoperative swelling of knee joint that met the inclusion and exclusion criteria,and literature data were screened out,and the quality of literature was evaluated by using the improved Cochrane bias risk assessment tool.Meta-analysis was conducted on total clinical response rate,visual analogue scale(VAS)reduction and adverse outcome indicators by RevMan5.3,and publication bias analysis was performed on outcome indicators with the number of trials≥10 using funnel plot and Egger's plot.GRADE was used to evaluate the quality of evidence for outcome indicators.Results A total of 10 studies were included with a total sample size of 830 cases,including 415 cases in the experimental group and 415 cases in the control group.Meta-analysis results showed that:the combination of huoxue lishui traditional Chinese medicine and non-traditional Chinese medicine group increased the effective rate[RR=1.15(1.06,1,24),P<0.001]and decreased the VAS score[SMD=-2.18,95%CI(-3.09,-1.26),P<0.001],[lower degree of swelling in the knee joint SMD=1.83,95%CI(2.00,1.65),P<0.001],reduce the Lysholm scale[MD=4.46,95%CI(0.08,8.85),P<0.001]and knee motion[MD=15.28,95%CI(11.97,18.60),P<0.001].Conclusion Huoxue lishui group combined with non-traditional Chinese medicine group can not only improve the clinical efficacy of swelling after knee arthroscopy,but also be safer.However,the sample size of current studies is small,the quality of literature evidence is low,and there is a lack of multi-center,large sample RCT.