祛腐化瘀补虚生肌外治法治疗慢性下肢溃疡的临床研究  

Clinical research on the external treatment of chronic lower-extremity ulcers by Qufu Huayu Buxu Shengji Therapy

作　　者：王云飞[1] 阙华发[1] 王军[2] 李斌[3] 曹烨民 吕延伟 王小平[6] 薛慈民[7] 唐汉钧[1] 徐杰男[1] 向寰宇[1] 张臻[1] 邢捷[1] 沈亮[1] 单玮[1] 刘安民[1] WANG Yun-fei;QUE Hua-fa;WANG Jun;LI Bin;CAO Ye-min;LYU Yan-wei;WANG Xiao-ping;XUE Ci-min;TANG Han-jun;XU Jie-nan;XIANG Huan-yu;ZHANG Zhen;XING Jie;SHEN Liang;SHAN Wei;LIU An-min(Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032;First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300193;Yueyang Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200437;Shanghai Integrated Traditional Chinese and Western Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200082;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110033;Shanghai Hospital of Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200000;Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021)

机构地区：[1]上海中医药大学附属龙华医院,上海200032 [2]天津中医药大学第一附属医院,天津300193 [3]上海中医药大学附属岳阳中西医结合医院,上海200437 [4]上海中医药大学附属上海市中西医结合医院,上海200082 [5]辽宁中医药大学附属医院,沈阳110033 [6]上海中医药大学附属上海市中医医院,上海200000 [7]上海中医药大学附属曙光医院,上海200021

出　　处：《世界中西医结合杂志》2020年第1期29-35,共7页World Journal of Integrated Traditional and Western Medicine

基　　金：“十一五”国家科技支撑计划(2008BAI53B013);上海市科委资助项目(17401934800)

摘　　要：目的对祛腐化瘀补虚生肌外治法治疗慢性下肢溃疡,开展多中心、随机、平行对照的前瞻性研究,科学客观地评价其临床疗效及安全性。方法将全国七个分中心的200例慢性下肢溃疡患者,随机分为中医组与西医组,分别采用祛腐化瘀补虚生肌外治法及西医常规(中性油纱布及贝复济)外治疗法,疗程为8周,以创面愈合率作为主要疗效指标,以创面愈合时间、创面愈合速度、中医症候量化指标作为次要疗效指标,血常规、尿常规、肝功能、肾功能、血汞、尿汞含量作为安全性指标,对两组患者进行观察。该研究项目在“中国临床试验注册中心”进行中英文注册(注册号:CHICTR-TRC-11001365)。该项目由负责单位(上海中医药大学附属龙华医院)的医学伦理委员会审查通过(伦理委员会批件文号:2011LCSY001)。结果(1)疾病疗效,中、西医组均可促进慢性下肢溃疡愈合,两组创面愈合率分别为(83.11±32.98)%与(81.98±33.08)%,两组比较差异无统计学意义(P>0.05)。中医组总有效率93.10%,痊愈率67.82%,创面愈合时间(29.31±14.38)d,创面愈合速度(0.09±0.16)cm^2/d;西医组总有效率88.30%,痊愈率69.15%,创面愈合时间(27.74±14.59)d,创面愈合速度(0.06±0.09)cm^2/d,两组比较差异无统计学意义(P>0.05)。(2)中医症候疗效方面,中医组总有效率96.55%,西医组总有效率86.02%,两组有显著性差异(P<0.05);中医组在改善症候方面(下肢水肿、疼痛、创周肤温、皮肤创周活力、创面脓、创面肌、对生活质量的影响)明显优于西医组(P<0.05)。(3)安全性方面,祛腐化瘀补虚生肌外治法治疗慢性下肢溃疡是安全的。结论祛腐化瘀补虚生肌外治法与西医常规疗法均可有效治疗慢性下肢溃疡;在改善中医症候疗效及部分中医证候方面,祛腐化瘀补虚生肌外治法明显优于西医组,并且是安全的,值得临床推广。Objective To evaluate the effect and safety of external treatment of putridity-eliminating,stasis-resolving,deficiency-tonifying,granulation-promoting therapy(Qufu Huayu Buxu Shengji Therapy)on lower-extremity ulcers by a multicenter,randomized,parallel-control prospective study.Methods A total of 200 patients with chronic lower-extremity ulcers in 7 treatment centers in China were randomly divided into the TCM group and the western medicine group and were treated by Qufu Huayu Buxu Shengji Therapy and conventional treatment of western medicine(bFGF with petrolatum gauze)respectively for 8 weeks.The main outcome measure was the wound healing rate;the secondary outcome measure and the secondary outcome measures were the wound healing time,speed and TCM syndrome score.The safety indicators were blood routine,urine routine,liver function,renal function,blood mercury and urine mercury.The two groups were compared.This research was registered in the Chinese Clinical Trial Registry in Chinese and English(Register Number CHICTR-TRC-11001365).The program was examined and approved by the Medical Ethics Committee of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(Ethics Committee Approval No.2011 LCSY001).Results(1)Efficacy:Both groups could promote would healing of the lower extremity ulcer.The wound healing rate in the two groups were(83.11±32.98)%and(81.98±33.08)%respectively,without significant difference(P>0.05).The total effective rate,wound healing rate,time,and speed were 93.10%,67.82%,29.31±14.38 days,and 0.09±0.16 cm^2/d in the TCM group and 88.30%,69.15%,27.74±14.59 days,and 0.06±0.09 cm^2/d in the western medicine group,without significant difference(P>0.05).(2)TCM syndrome:The total effective rate in the TCM group and the western medicine group were 96.55%and 86.02%respectively,with significant difference(P<0.05).The TCM group was significantly better than the western medicine group in the improvement of symptoms(lower extremity edema,pain,skin temperature,skin vitality

关 键 词：下肢溃疡 祛腐化瘀 补虚生机 外治法 

分 类 号：R364.16[医药卫生—病理学] R632.1[医药卫生—基础医学]