中药干预联合外科手术治疗下肢静脉溃疡临床效果的Meta分析

Chinese Medicine Intervene in the Treatment of Lower Extremity Venous ulcer:A Meta-analysis

目的:系统评价中药干预联合外科手术治疗下肢静脉溃疡的疗效及安全性。方法:通过检索CNKI、万方、维普、CBM、Pubmed、Embase、The Cochrane Library数据库,查找相关文献,筛选符合纳入标准的随机对照试验,采用Stata 15.1软件对提取效应指标的相关数据进行统计分析。结果:本研究共纳入15篇文献,纳入1097例下肢静脉溃疡患者,其中治疗组552例,对照组545例,对照组均行外科手术治疗或给予常规清洁换药;治疗组均给予中药(外治、内治、内外结合)联合外科手术,疗程为3 d~3个月。Meta分析结果显示,中药干预能明显提高临床疗效[ARR=-0.13(-0.18,-0.09),I2=0.0%,P=0.627,NNT=-8(-11,-6)],缩短溃疡愈合时间[SMD=-1.52(-2.08,-0.97),P<0.001],减小溃疡面积[SMD=-1.69(-3.27,-0.11),P=0.036];治疗组与对照组的溃疡复发率差异无统计学意义[ARR=-0.14(-0.24,-0.03),I2=0.00%,P=0.868,NNT=-7(-33,-4)]。结论:中药干预联合外科手术提高了手术治疗下肢静脉溃疡的临床疗效,能够缩短溃疡愈合时间,减小溃疡面积,降低溃疡复发率。

Objective To evaluate the efficacy and safety of traditional Chinese medicine intervention combined with surgery in the treatment of lower extremity venous ulcer.Methods Searching the databases of CNKI,Wanfang,VIP,CBM,PubMed,EMBASE and the Cochrane Library,we searched for relevant literatures,screened the randomized controlled trials that met the inclusion criteria,and used Stata 15.1 software to extract the relevant data of effect indicators and conduct statistical analysis.Results a total of 15 articles were included in this study,including 1097 patients with venous ulcers of the lower limbs,including 552 patients in the treatment group and 545 patients in the control group.All patients in the control group underwent surgical treatment or routine cleaning and dressing change;All patients in the treatment group were treated with traditional Chinese medicine(external treatment,internal treatment and combination of internal and external treatment)combined with surgery for 3 days to 3 months.Results TCM intervention could significantly improve the clinical efficacy[ARR=-0.13(-0.18,-0.09),I2=0.0%,P=0.627,NNT=-8(-11,-6)],shorten the ulcer healing time[SMD=-1.52(-2.08,-0.97),P<0.001],and reduce the ulcer area[SMD=-1.69(-3.27,-0.11),P=0.036];There was no significant difference in ulcer recurrence rate between the treatment group and the control group[ARR=-0.14(-0.24,-0.03),I2=0.00%,P=0.868,NNT=-7(-33,-4)].Conclusion Traditional Chinese medicine intervention combined with surgery can improve the clinical efficacy of surgical treatment of venous ulcer of lower limbs,shorten the healing time of ulcer,reduce the area of ulcer and reduce the recurrence rate of ulcer.