芪龙祛瘀合剂加味方联合外治调护治疗气虚血瘀型下肢静脉性溃疡的临床研究

Clinical study on the treatment of lower limb venous ulcer of qi deficiency and blood stasis syndrome with Modified Qilong Quyu Mixture plus external treatment and conditioning

目的观察芪龙祛瘀合剂加味方联合外治调护治疗气虚血瘀型下肢静脉性溃疡的临床疗效。方法将100例气虚血瘀型下肢静脉性溃疡患者随机分为治疗组、对照组,每组50例。对照组给予外治调护及脉血康胶囊内服治疗,治疗组给予外治调护及芪龙祛瘀合剂加味方内服治疗,两组疗程均为8周。观察临床疗效,比较治疗前后两组创面面积及局部中医证候积分、疼痛视觉模拟评分(VAS)的变化情况。结果①试验过程中,治疗组脱落或剔除4例,对照组脱落或剔除5例,最终完成试验者治疗组46例、对照组45例。②治疗组、对照组总有效率分别为76.1%、66.7%;治疗组临床疗效优于对照组(P<0.05)。③治疗前后组内比较,两组创面面积缩小(P<0.05);组间治疗后比较,治疗组创面面积小于对照组(P<0.05)。④治疗前后组内比较,治疗组创周色素沉着、缺乏新生上皮、渗出量、肉芽色泽暗淡不鲜或紫暗、脓腐量、创周肿胀评分及局部中医证候总积分减少(P<0.05),对照组仅渗出量、肉芽色泽暗淡不鲜或紫暗、创周肿胀评分减少(P<0.05);组间治疗后比较,治疗组创周色素沉着、缺乏新生上皮、渗出量、肉芽色泽暗淡不鲜或紫暗评分及局部中医证候总积分少于对照组(P<0.05)。⑤治疗前后组内比较,两组疼痛VAS评分降低(P<0.05);组间治疗后比较,治疗组疼痛VAS评分低于对照组(P<0.05)。结论芪龙祛瘀合剂加味方联合外治调护治疗气虚血瘀型下肢静脉性溃疡疗效满意,能有效改善创面局部症状,减轻创面疼痛,促进创面愈合。

Objective To observe the clinical efficacy of Modified Qilong Quyu Mixture plus external treatment and conditioning in the treatment of lower limb venous ulcer of qi deficiency and blood stasis syndrome.Methods One hundred patients with lower limb venous ulcer of qi deficiency and blood stasis syndrome were randomly divided into treatment group(n=50)and control group(n=50).Patients in the control group were given external treatment and conditioning plus oral administration of Maixuekang Capsules,and patients in the treatment group were given external treatment and conditioning plus oral administration of Modified Qilong Quyu Mixture.The course of treatment in both groups was 8 weeks.The clinical efficacy was observed,and the changes in trauma area,topical traditional Chinese medicine(TCM)syndrome score and the visual analogue scale(VAS)score of pain were compared between the two groups before and after treatment.Results①During the trial,4 cases dropped or got removed from the treatment group,and 5 cases dropped or got removed from the control group.Finally,46 cases in the treatment group and 45 cases in the control group completed the trial.②The total effective rate of the treatment group and control group was 76.1%and 66.7%,respectively,and the clinical efficacy of the treatment group was better than that of the control group(P<0.05).③After treatment,the trauma area of patients became smaller in both groups(P<0.05);and the trauma area of patients in the treatment group was smaller than that in the control group(P<0.05).④After treatment,the score in the items including peritraumatic pigmentation,lack of new epithelial cells,exudation,dull or dark purple granulation tissue,pus decay and peritraumatic swelling and the total score of topical TCM syndrome decreased in the treatment group(P<0.05),while in the control group only the score in exudation,dull or dark purple granulation tissue and peritraumatic swelling decreased(P<0.05);After treatment,the score in the items of peritraumatic pigmentation,lack of new epithelial cells,exudation and dull or dark purple granulation tissue,and the total score of topical TCM syndrome in the treatment group were lower than those in the control group(P<0.05).⑤The pain VAS score decreased in both groups after treatment(P<0.05);After treatment,the pain VAS score was lower in the treatment group than that in the control group(P<0.05).Conclusion Modified Qilong Quyu Mixture plus external treatment and conditioning has achieved a satisfactory therapeutic result in treating lower limb venous ulcer of qi deficiency and blood stasis syndrome since the combined therapy can effectively improve the topical traumatic symptoms,alleviate pain and promote wound healing.