【作者】 李宇卫；

【导师】 黄桂成；

【作者基本信息】 南京中医药大学 ， 中医骨伤科， 2013， 博士

【摘要】 目的：(1)中医外治法因具有“简、便、验、廉”的优点,已广泛应用于骨科临床,其经局部皮肤给药,使药物直达病所,避免了胃肠吸收过程,减少了对胃肠的刺激及对肝肾的损害,是一种治疗伤筋(踝关节扭伤)及骨痹(膝OA)较为理想的中医治疗技术。本研究拟通过文献检索,探讨伤筋及骨痹的病因病机及治疗原则。(2)探讨“易层”贴敷疗法治疗伤筋的优化方案,并通过对伤筋与骨痹临床疗效的客观评估及统计分析,评价“易层”贴敷疗法的技术参数优化方案的有效性和安全性。方法：以国家“十一五”科技支撑计划课题《“易层”贴敷疗法临床应用的规范化研究》的前期工作为基础,分成两个阶段进行研究。第一阶段：根据贴敷药物湿度,药物分层两个技术参数,设定不同水平进行评价,优化“易层”贴敷疗法技术操作规程。第二阶段：通过对伤筋与骨痹临床疗效的客观评估及统计分析,对方案的安全性与有效性作出整体评价,以形成基于临床疗效的技术操作规范。使用非盲法研究,采用盲态评价。委托第三方对研究结果进行评估,客观评价“易层”贴敷疗法对踝关节扭伤及膝OA治疗的临床疗效,探讨“易层”贴敷疗法的组方研究及作用机理,为“易层”贴敷技术的创新及治疗踝关节扭伤及膝OA寻找新的途径。结果：(1)“易层”贴敷疗法技术参数的优化研究：共入组200例(其中22例无疗后疗效数据和安全性数据,治疗期间共脱落1例)。完成试验177例。A组(每天换药+三色敷药层+三黄油膏层)45例；B组(每天换药+单用三黄油膏层)47例；C组(3天换药+三色敷药层+三黄油膏层)42例；D组(3天换药+单用三黄油膏层)43例。A组在疼痛、肿胀、功能障碍方而的疗效明显优于其他各组,B组次之,C组再之,D组最差。(2)“易层”贴敷疗法治疗伤筋、骨痹的技术参数优化方案的疗效评价研究(伤筋)：共入组160例(其中9例无疗后疗效数据和安全性数据,2例治疗期间出现药物过敏)。A组(经过技术参数优化方的“易层”贴敷疗法治疗)79例,B组(按奇正消痛贴膏说明书,清洁患部皮肤,开封后将药贴的塑料薄膜揭除,将小袋内的润湿剂均匀的涂在中间药垫表而,敷于患处,每贴24小时一换)81例,完成试验149例(A组74例、B组75例)。证候疗效有效率分别为：A组,98.7%,B组94.7%,构成比差异无统计学意义(P>0.05),提示两组疗效相当。A组,临床痊愈4/74(5.4%),显效38/74(51.4%),有效31/74(41.9%),无效1/74(1.4%)；B组,临床痊愈1/75(1.3%),显效23/75(30.7%),有效48/75(64.0%),无效3/75(4.0%)。构成比差异有统计学意义(P<0.05),提示A组疗效优于B组。(3)“易层”贴敷疗法治疗伤筋、骨痹的技术参数优化方案的疗效评价研究(骨痹)：共入组240例(其中17例无疗后疗效数据和安全性数据,治疗期间共3例因药物皮肤过敏中止)。完成试验220例。A组(经过技术参数优化方的“易层”贴敷疗法治疗)111例、B组(按复方南星止痛膏使用说明书,清洁患部皮肤,开封后将药贴的药而对准患处贴敷,贴24小时,隔日1次)109例。A组,临床痊愈3/111(2.7%),显效44/111(39.6%),有效62/111(55.9%),无效2/111(1.8%)；B组,临床痊愈0/112(0.0%),显效31/112(27.7%),有效63/112(56.2%),无效18/112(16.1%)。两组比较,A组疗效优于B组,差异有统计学意义。结论：(1)“易层”贴敷疗法技术参数的优化研究：A组(每天换药+三色敷药层+三黄油膏层)治疗组是四个组中疗效最佳的方案。(2)“易层”贴敷疗法治疗伤筋、骨痹的技术参数优化方案的疗效评价研究(伤筋)：易层贴敷疗法在治疗伤筋时是安全的,并且在改善疼痛、肿胀、功能、中医症候方面均有效果,并且比奇正消痛贴组具有更好的疗效。(3)“易层”贴敷疗法治疗伤筋、骨痹的技术参数优化方案的疗效评价研究(骨痹)：易层贴敷疗法在治疗伤筋时是安全的,并且在改善疼痛、肿胀、功能、中医症候方面均有效果,并且比关节止痛膏组具有更好的疗效,安全性更高。更多还原

【Abstract】 Objective:(1) Traditional Chinese Medicinal has been widely used in clinical orthopedics, just because of the advantage of " Simple, convenient,effective,inexpensive", and by the transdermal drug deliver, the drugs directly to the lesions, avoiding the gastrointestinal absorption process,which can reduce gastrointestinal irritation and liver and kidney damage.So the external treatment of TCM is considered a ideal treatment technology for Tendon-injury (ankle sprain) and Bone-pain(knee OA). This study is planted to discuss the etiology, pathogenesis, and treatment of Tendon-injury and Bone-pain through the literature retrieval.(2)Explore the optimization program of "Layers adjusting" external application therapy on the treatment of acute tissue injury of ankle joint. Evaluate the clinical effectiveness and safety of the optimization by the way of objective evaluation and statistical analysis the clinical efficacy of Tendon-injury and Bone-pain.Methods:This study is devided into two stages, which based on the preparatory work of National’s11th five-year science and technology supporting plan. The1st stage, to select main parameter, namely dampness of drug which can affect clinical efficacy of "Layers Adjusting" external application therapy, evaluate clinical efficacy by setting different levels, find parameter level of optimized technology, and optimize operating procedure of "Layers Adjusting" external application therapy. The2nd stage, through objective assessment and statistical analysis of the clinical efficacy of Tendon-injury and Bone-pain, making a comprehensive evaluation of the safety and effectiveness of the program, and forming a technical operating specifications based on the clinical efficacy of the therapy.Entrust a third party to assess the results of the study by using non-blinded study with blinded evaluation. Objective evaluation the clinical efficacy of "Layers Adjusting" external application therapy for Tendon-injury and Bone-pain, and explore the mechanism of it.Results:(1) Optimized parameter levels research of drug dampness in acute soft tissue injuries treated with layers adjusting external application therapy:200cases(22cases removed by no follow-up,1case off) of acute soft tissue injury of ankle joint were separated into four groups randomly,177cases completed..The treatment proposal:group A(changing dressing everyday with both Sanse drug layers and Sanhuang layers)45cased:group B(changing dressing everyday only with Sanhuang layers)47cases; group C(changing dressing every3days with both Sanse drug layers and Sanhuang layers)42cases; group D(changing dressing every3days only with Sanhuang layers)43cases. Group A was proved much better than the other3groups on indexes of pain, swelling, dysfunction of joints and other indexes. The efficacy of group B secendly, group C following, and Group D worst.(2)Evaluate clinical efficacy of optimized parameter for Tendon-injury with "Layers Adjusting" external application therapy:160cases(9cases removed by no follow-up,2case off for drug allergy) of Tendon-injury were separated into two groups randomly, group A(Optimized Parameter of "Layers adjusting" external application therapy)79cases, group B(for Qizheng Xiaotong Plaster,according to the manual,changing dressing every24hours)8lcases.149cases(groupA74, groupB75). completed. The syndromes efficiency were:group A,98.7%and B,94.7%, the Constituent ratio was not statistically significant (P>0.05), suggesting that the two groups’ efficiency was quite the same. A group, clinical cure4/74(5.4%), Markedly38/74(51.4%), effective31/74(41.9%), invalid1/74(1.4%); B group, the clinical cure1/75(1.3%).Markedly23/75(30.7%), effective48/75(64.0%), invalid3/75(4.0%). The Constituent ratio was statistically significant (P<0.05), prompting the efficacy of group A better than group B.(3)Evaluate clinical efficacy of optimized parameter for Bone-pain with "Layers Adjusting" external application therapy:240cases(17cases removed by no follow-up,3case off for Drug allergy) of Bone-pain were separated into two groups randomly, group A(Optimized Parameter of "Layers adjusting" external application therapy)111cases, group B(for Compound Nanxing Zhitong Plaster according to the manual,continued24hours,changing dressing every2days)109cases.220cases(groupA111, groupB109)completed. A group, clinical cure3/111(2.7%), Markedly44/111(39.6%), effective62/111(55.9%), invalid2/111(1.4%); B group, the clinical cure0/112(0.0%),Markedly31/112(27.7%), effective63/112(56.2%), invalid18/112(16.1%).the Constituent ratio was statistically significant (P<0.05),prompting the efficacy of group A better than group B. Conclution:(1) Optimized parameter levels research of drug dampness with "Layers Adjusting" external application therapy:(1)group A(changing dressing everyday with both Sanse drug layers and Sanhuang layers) was the best optimized parameter of the4groups.(2)Evaluate clinical efficacy of optimized parameter for Tendon-injury with "Layers Adjusting" external application therapy:it is a safe treatment for Tendon-injury, and has better efficacy than Qizheng Xiaotong Plaster in improving pain, swelling, function, and TCM symptoms.(3)Evaluate clinical efficacy of optimized parameter for Bone-pain with "Layers Adjusting" external application therapy:it has better efficacy than Compound Nanxing Zhitong Plaster in improving pain, swelling, function, and TCM symptoms, and it is a safe treatment for Tendon-injury,and has a higher security.更多还原