“祛瘀补虚煨脓长肉”外治疗法治疗下肢慢性溃疡临床研究  

Clinical Research on External Therapy of Dissolving Stasis,Supplementing Deficiency,Removing Pus and Promoting Granulation

作　　者：徐杰男[1] 阙华发[1] 唐汉钧[1] XU Jienan;QUE Huafa;TANG Hanjun(Surgical of TCM,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China)

机构地区：[1]上海中医药大学附属龙华医院中医外科

出　　处：《辽宁中医杂志》2018年第9期1882-1887,共6页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金青年科学基金项目(81202697);上海卫生局中医药科研基金(2010QL005A);上海市卫生和计划生育委员会中医药科研基金(2014S14)

摘　　要：目的：对＂祛瘀补虚煨脓长肉＂外治疗法治疗下肢慢性溃疡开展前瞻性、随机、平行对照的研究,科学客观地评价其临床疗效及安全性。方法：将门诊96例下肢慢性溃疡患者,随机分为治疗组与对照组,分别采用＂祛瘀补虚煨脓长肉＂外治疗法和西医常规外治疗法,疗程为4周,对两组患者的创面愈合率、愈合时间、愈合速度、创面细菌检出情况、中医证候积分、创面愈合后瘢痕面积,安全性指标、治疗药物费用以及随访复发率等进行观察。结果：（1）疾病疗效方面,治疗组总有效率95.45%,痊愈显效率79.55%,对照组总有效率68.89%,痊愈显效率55.56%（P〈0.01,P〈0.01）;两组创面愈合时间差异无统计学意义（P〉0.05）;治疗组第（28±3）天的创面愈合率明显高于对照组（P〈0.05）;治疗组第（14±3）天的创面愈合速度明显快于对照组（P〈0.01）。（2）中医证候疗效方面,治疗组总有效率95.45%,痊愈显效率59.09%,对照组总有效率51.11%,痊愈显效率48.89%,（P〈0.01,P〈0.05）。（3）中医证候积分方面,治疗组中医证候总积分及创面脓液（形质、色泽、性状）、肉芽（色泽、量、质地）、新生上皮量、创周肤色、创周瘀滞区范围、创面疼痛（程度、频率）等各项积分在第（14±3）天、第（28±3）天均较对照组下降更为明显（P〈0.01,P〈0.05）,而治疗组创面脓液量在第（14±3）天较对照组增多（P〈0.01）。（4）治疗组创面愈合后瘢痕面积较对照组小（P〈0.01）。（5）安全性评价方面,观察4周,两组安全性均为1级,即安全。（6）卫生经济学指标评价方面,治疗组药物费用明显低于对照组（P〈0.01）。（7）随访6个月,两组复发率均为0%。结论：＂祛瘀补虚煨脓长肉＂外治疗法能明显促进下肢慢性溃疡创面修复愈合,改善下肢慢性溃疡局部中医证候,其疗效明显优于b FGF联合凡士林纱布的西�Objective： To carry out perspective and RCT research on external therapy of dissolving stasis,supplementing deficiency,removing pus and promoting granulation in treating chronic ulcer of lower limbs,and evaluate its clinical efficacy and safety scientifically and objectively. Methods： Ninety-six out-patients with chronic ulcer of lower limbs were divided into therapy group and control group at random,receiving treatment of external therapy of dissolving stasis,supplementing deficiency,removing pus and promoting granulation and routine western external therapy respectively,with 4 weeks as a course. The indexes such as wound healing rate,healing time,healing speed,existence of germs in wound surface,TCM pattern score,scar size after would healing,safety indices,therapeutic medicine cost and recurrence rate during follow-up visit of the patients were then observed.Results：（1） Disease efficacy： The total effective rate and recovery significant efficiency were 95. 45% and 79. 55% for the therapy group respectively and those were 68. 89% and 55. 56% for the control group（P〈0. 01,P〈0. 01）. There was no significance in the difference of wound healing time in two groups（P〉0. 05）. While the wound healing rate on day 28 ± 3 was much higher（P〈0. 05） and the wound healing speed was significantly faster（P〈0. 01） on day 14 ± 3 in the therapy group than that in the control group.（2） TCM pattern efficacy： The total effective rate and recovery significant efficiency were 95. 45% and 59. 09% for the therapy group respectively and those were 51. 11% and 48. 89% for the control group（P〈0. 01,P〈0. 05）.（3） TCM pattern score： The total pattern score and subentry scores such as wound surface pus（quality,color and luster,property）,granulation（color and luster,quantity,property）,regenerated epithelium quantity,skin color surrounding wound,stagnation and stasis region surrounding wound,and pain of wound surface（intensity,frequency） on day 14 ± 3 and day 28 ± 3 in the

关 键 词：下肢慢性溃疡 祛瘀补虚 煨脓长肉 复黄生肌愈创油膏 

分 类 号：R26[医药卫生—中医外科学]