Study Of Standardization For "Layers Adjusting" External Application Therapy On Tendon-injury And Bone-pain

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.