“祛腐化瘀补虚生肌外治法治疗慢性下肢溃疡的临床示范性研究”的研究方案

Assessment of external methods of traditional Chinese medicine in patients with chronic ulcer of the lower extremities: study protocol of a multicenter,randomized,parallel-group,prospective trial

背景:慢性下肢溃疡是一个严重危害人类健康的公共卫生问题。西医治疗多集中于抗感染、改善循环、清创、植皮等方面,存在一定的治疗瓶颈。中医药治疗具有悠久的历史和良好的临床疗效,形成了独特的中医外治理论及卓有成效的大量外用方药和外治技术。如何进一步体现和挖掘中医药治疗慢性下肢溃疡的这些优势,形成一个能够推广使用的、安全有效的慢性下肢溃疡的中医治疗方案,其研究意义重大。中国在"十一五"期间对中医外治特色疗法和外治技术设立专项研究项目,慢性下肢溃疡的研究是此重大专项研究课题之一。方法与设计:系统采集慢性下肢溃疡患者的各项资料。纳入的下肢溃疡患者将来自7家医院,随机分为治疗组和对照组。分别接受中医外治法和西药外治法后,以创面愈合率作为主要疗效评价指标,以创面愈合时间、创面愈合速度、创面腐去时间、创面腐去速度、中医证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,开展多中心、大样本、随机、平行对照前瞻性研究。讨论:本次研究评价祛腐化瘀补虚生肌外治法治疗慢性下肢溃疡的临床疗效及安全性,形成可供推广应用的中医外治法治疗慢性下肢溃疡的规范化方案,建立体现中医治疗特点和优势的临床疗效评价体系。临床试验注册号:研究方案于2011年6月在中国临床试验注册中心进行中英文注册,注册号为ChiCTR-TRC-11001365。

BACKGROUND： Chronic ulcer of the lower extremities amounts for a grave and serious problem for public health. Western medicine focuses on controlling infection, improving blood circulation, surgical debridement, skin grafting, etc, but there are bottlenecks in the treatment. Traditional Chinese medicine （TCM） has a long history and a legacy of sound clinical efficacy in this area. TCM has developed a unique, effective external theory, and a large number of topical prescriptions and external technology. Through this research, a safe and effective treatment protocol of TCM for chronic ulcer of the lower extremities can be formed. During China＇s ＂Eleventh Five-Year＂ Plan, special research committees and projects on TCM external treatments and external technologies were established. This study on ulcer of the lower extremities constitutes one of the major research topics. METHODS AND DESIGN： Clinical information of patients with chronic ulcer of the lower extremities will be first collected in a large, multicenter, epidemiological survey. Concurrently, a large multicenter, randomized, parallel-group, prospective study will be launched based on evidence-based medical principles to evaluate the efficacy and safety of external methods for removing carrion, dissolving stasis, reinforcing deficiency and promoting tissue regeneration. The evaluated indexes will include the wound healing percentage for primary outcome, wound healing time, wound healing rate, time and rate of removal of necrotic tissue, and TCM syndromes for secondary outcomes and routine blood test, routine urine test, liver and kidney function, blood mercury content and finally urine mercury content for adverse events. DISCUSSION： In this trial, the authors will evaluate the efficacy and safety ot external metnoas tor remowng carrion, dissolving stasis, reinforcing deficiency and promoting tissue regeneration in cases of chronic ulcer of the lower extremities for standardizing external therapy of TCM for treatment of this condition, and establishinq the clinical assessment system for TCM. TRIAL REGISTRATION NUMBER： The research program was registered in the Chinese Clinical Trial Registry in both English and Chinese in June 2011. Registration number： ChiCTRTRC-11001365.