腔内射频消融术与传统大隐静脉高位结扎剥脱术治疗下肢慢性静脉疾病临床疗效的系统评价和Meta分析

Effects of endovenous radiofrequency ablation versus conventional stripping for chronic venous disease:a systematic review and Meta-analysis

目的探讨腔内射频消融术(RFA)与传统大隐静脉高位结扎剥脱术(HSL)治疗下肢慢性静脉疾病的临床疗效。方法计算机检索Cochrance图书馆、PubMed、Embase、Medline、OVID、中国知网、万方数据库等,中英文检索词为"随机对照试验(RCT)"、"高位结扎剥脱"及"腔内射频消融",检索时间为2000年1月至2018年10月。按照纳入及排除标准进行文献筛选和质量评价,采用RevMan5.3软件进行Meta分析,比较两种术式在手术时间、并发症、术后疼痛评分(VAS)、疗效和复发率方面的差异。结果最终纳入11项RCT,共891例患者、949条患肢(CEAP分级为C2~C6)。(1)手术时间:两种术式在手术时间方面比较,差异无统计学意义(OR=-1.03,95%CI-18.76~16.69,P=0.91);(2)并发症:两种术式在术后血肿(OR=0.20,95%CI 0.10~0.37)、炎症或感染(OR=0.22,95%CI 0.06~0.79)及静脉炎或血栓性静脉炎(OR=3.05,95%CI 1.31~7.09)方面比较,差异均有统计学意义(P均<0.05);但在感觉异常方面比较,差异无统计学意义(OR=0.03,95%CI-0.01~0.07,P=0.97)。(3)VAS:两种术式在VAS方面比较,差异有统计学意义(OR=-2.60,95%CI-3.57~1.63,P<0.05);(4)手术疗效:与HSL术式比较,RFA术式患者能更早地恢复正常活动(OR=-3.60,95%CI-6.00~1.20,P<0.05)和工作(OR=-6.57,95%CI-10.69~2.44,P<0.05)。(5)手术复发率:两种术式在手术复发率方面比较差异无统计学意义(OR=0.86,95%CI 0.51~1.44,P=0.56)。结论RFA术式后的近期疗效优于HSL。

Objective To investigate the clinical efficacy of radiofrequency ablation(RFA)and conventional high ligation and stripping(HLS).Methods A systematic review with Meta-analysis was conducted using the PubMed,Embase,Cochrane Database,OVID,wangfang and CNKI for relevant randomize controlled trails(RCTs)published either in English or in Chinese from January 2000 to October 2018 according to inclusion criteria and exclusion criteria.RevMan 5.3 software was utilized to evaluate the operative time,complications,visual analogue scale,efficacy and recurrence rate.Results Eleven RCTs met the inclusion criteria,with a total of 891 patients(949 legs).All of the patients were classified as CEAP 2 to 6.Meta-analysis evaluating RFA compared with HSL revealed no difference in operative time(OR=-1.03,95%CI-18.76-16.69,P=0.91).RFA was associated with a lower rate of hematoma(OR=0.20,95%CI 0.10-0.37,P<0.05)and infection(OR=0.22,95%CI 0.06-0.79,P<0.05),and a higher rate of thrombophlebitis(OR=3.05,95%CI 1.31-7.09,P<0.05)compared with HLS.There was no difference in the incidence of paresthesia between RFA and HLS(OR=0.03,95%CI-0.01-0.07,P=0.97).In addition,RFA was superior to HLS in the duration of early return to normal activity and work(OR=-3.60,95%CI-6.00--1.20,P<0.05;OR=-3.60,95%CI-6.00--1.20,P<0.05,respectively).There was no difference in the rate of recurrent varicose veins between RFA and HLS(OR=0.86,95%CI 0.51-1.44,P=0.56).Conclutions RFA has a better short-term clinical efficacy than HLS.