贺氏火针疗法治疗原发性下肢静脉曲张:随机对照研究

Primary varicose veins treated with HE's fire needle therapy:a randomized controlled trial

目的:评价贺氏火针疗法治疗原发性下肢静脉曲张的临床疗效。方法:将50例原发性下肢静脉曲张患者随机分为观察组(25例)和对照组(25例)。观察组接受8周的贺氏火针疗法,以火针点刺曲张静脉,使瘀血流出并自止,再以毫针针刺患侧合阳、承筋、承山、昆仑。对照组在入组后8周内不予任何干预,定期接受随访,第8周后接受与观察组相同的治疗。主要评价指标是修订版静脉疾病临床严重程度评分(RVCSS),次要疗效指标包括静脉功能不全生活质量问卷(VEINES-QOL/Sym questionnaire)的症状评分(VEINES-Sym score)和生活质量评分(VEINES-QOL score)、洪堡静脉曲张严重程度评分(HVVSS)的症状评分。入组后及入组后第4周末、第8周末对两组进行评价,第16周末对观察组进行随访期评价。结果:研究期间共5例脱落,脱落率为10%。观察组RVCSS评分在第4周末和第8周末低于对照组(均P<0.05);观察组VEINES-QOL评分和HVVSS评分在第4周末和第8周末高于对照组(P<0.05,P<0.01);观察组VEINES-Sym评分与对照组相比,在第4周末和第8周末均有增加,但仅在第8周末时差异有统计学意义(P<0.01);观察组HVVSS评分在第8周末、第16周末与组内第4周末相比降低(均P<0.05)。结论:贺氏火针疗法治疗原发性下肢静脉曲张有效,可显著减轻疾病严重程度、减轻症状严重程度、减少症状发作频率,从而改善患者生活质量,并且在治疗后8周内仍保持较好的远期疗效。将疗程从4周增至8周,可明显提高贺氏火针疗法对症状严重程度的疗效。

Objective To evaluate the clinical efficacy on primary varicose veins treated with He＇s fire needle therapy.Methods Fifty patients of primary varicose veins were randomized into an observation group（25 cases）and a control group（25 cases）.In the observation group,He＇s fire needle therapy was applied for 8 weeks.The fire needling was done on the sites of varicose veins till the bleeding stopped automatically.Additionally,acupuncture with filiform needle was applied to Heyang（BL 55）,Chengjin（BL 56）,Chengshan（BL 57）and Kunlun（BL 60）on the affected side.In the control group,no intervention was given.The follow-up visit was conducted regularly and since the 8th week,the same treatment as the observation group was provided in the control group.The revised venous clinical severity score（RVCSS）was used for the evaluation of the primary outcomes.The methods for the evaluation of the secondary efficacy outcomes included the venous insufficiency epidemiologic and economic study of quality of life questionnaire scale（VEINES-QOL/sym questionnaire）,the venous insufficiency epidemiologic and economic study of symptom score（VEINES-Sym score）,the venous insufficiency epidemiologic and economic study of quality of life scale（VEINES-QOL score）and the Homburg varicose vein severity score（HVVSS）.The evaluation was conducted at the baseline,at the end of the 4th week and the 8th week separately.The follow-up evaluation was done at the end of the 16th week in the observation group.Results During the study,5 cases were dropped out,accounting for 10%.RVCSS score in the observation group was lower than that in the control group at the end of the 4th and 8th weeks separately（both P〈0.05）.VEINES-QOL score and HVVSS score in the observation group were higher than those in the control group at the end of the 4th and 8th weeks separately（P〈0.05,P〈0.01）.VEINES-Sym score in the observation group was increased as compared with that of the control group at the end of the 4th and 8th weeks,but the difference was significant at the end of the 8th week（P〈0.01）.HVVSS score at the end of the 8th and 16th weeks was reduced as compared with that at the end of the 4th week in the observation group（both P〈0.05）.Conclusion HE＇s fire needle therapy is effective on primary varicose veins.It significantly reduces the severity of disease,the severity of symptoms and the attack frequency of symptoms so that the quality of life is improved in the patients.Additionally,the good long-term efficacy is maintained in 8 weeks after treatment.When the duration of treatment is increased from 4 weeks to 8 weeks,HE＇s fire needle therapy remarkably improves the efficacy for reducing the symptom severity.