【摘要】：目的:探討“大防風湯加減”治療氣血并肝腎不足型髕骨軟化癥的療效;探討“治未病”思想對髕骨軟化癥的指導作用。方法:本課題采用簡單隨機化的方法,將符合納入標準的患者分為治療組和對照組平行對照,同時進行兩組觀察指標自身治療前后對照的臨床研究設計。治療組予服用中藥治療,對照組服用鹽酸氨基葡萄糖膠囊(香港澳美制藥廠生產0.75g/粒)。治療組和對照組均進行常規(guī)治療股四頭肌鍛煉。根據(jù)病例納入標準納入髕骨軟化癥的患者,根據(jù)入組順序將其分至治療組和對照組,同時完成膝功能評價表(WOMAC評分),對不良反應、不良事件及脫落情況進行記錄�；颊咧委熃Y束后完成出組檢查(與入組時檢查項目相同)后出組,完成數(shù)據(jù)統(tǒng)計分析(臨床計數(shù)資料采用卡方檢驗;計量資料以均數(shù)土標準差((x|-)±s)表示,并采用獨立樣本t檢驗或配對樣本t檢驗分析;臨床療效分析采用秩和檢驗分析),根據(jù)設計時的療效評價標準,最后明確大防風湯加減治療氣血并肝腎不足型髕骨軟化癥的臨床療效。結果:1、本課題按設計要求共納入80髕骨軟化癥患者,歷時2年,其中有5例患者因合并用藥,中途被剔除出課題組,有7例患者脫落失訪,兩組均無不良反應及不良事件發(fā)生,共計68例患者完成本次研究,療程為6周�；�分析示治療組和對照組在患者性別、年齡、病程等方面無明顯差異(p0.05),入組時兩組的WOMAC評分值無明顯差異(p0.05)。兩組具有可比性,符合隨機設計。2、根據(jù)課題設定的臨床有效標準,35例治療組患者中32例為臨床有效,有效率91.4%;33例對照組患者中28例為臨床有效,有效率84.8%;治療組和對照組臨床有效率之間差異無顯著性(p=0.359)。3、次要結局指標分析發(fā)現(xiàn),治療結束后,兩組觀察指標(膝關節(jié)WOMAC評分)都有所改善;治療前后觀察指標的變化在治療組和對照組組之間無明顯差異(p值均大于0.05)。結論:主要結局指標分析發(fā)現(xiàn),應用大防風湯加減治療氣血并肝腎不足型髕骨軟化癥,在臨床上是有效的,而和口服鹽酸氨基葡萄糖膠囊治療氣血并肝腎不足型髕骨軟化癥的臨床有效率無顯著差別。次要結局指標分析發(fā)現(xiàn),應用大防風湯加減和鹽酸氨基葡萄糖膠囊均可改善膝關節(jié)的功能;觀察指標的改善程度在治療組和對照組之間無明顯差異�！爸挝床　彼枷朐隗x骨軟化癥的治療中具有積極的指導意義。
[Abstract]:Aim: to explore the curative effect of "Dafangfeng decoction" in treating patellar chondromalacia due to qi-blood and liver-kidney deficiency, and to explore the guiding effect of "treating no disease" on patellar chondromalacia. Methods: a simple randomized method was used to divide the patients who met the inclusion criteria into two groups: treatment group and control group. The clinical study design of two groups of observation indexes before and after treatment was carried out at the same time. The treatment group was treated with traditional Chinese medicine, and the control group was treated with glucosamine hydrochloride capsule (0.75g/ granules produced by Hong Kong Australia and the United States Pharmaceutical Factory). Both the treatment group and the control group were treated with routine treatment of quadriceps femoris exercise. The patients with patellar chondromalacia were divided into the treatment group and the control group according to the inclusion criteria, and the knee function evaluation (WOMAC score) was completed to record the adverse reactions, adverse events and shedding of the patellae. The patients were divided into the treatment group and the control group according to the order of the treatment group and the control group. After the treatment, the patients completed the group examination (the same as the items at the time of admission) and completed the statistical analysis of the data (clinical counting data were tested by chi-square test). The measured data were expressed in the mean soil standard deviation (x | -) equation (s) and analyzed by independent sample t test or paired sample t test. The clinical curative effect was analyzed by rank sum test (Rank sum test). According to the evaluation criteria of therapeutic effect at the time of design, the clinical efficacy of Dafangfeng decoction in the treatment of patellar chondromalacia with qi-blood and deficiency of liver and kidney was confirmed at the end of the paper. Results: 1. According to the design requirements, 80 patella chondromalacia patients were included in this project for two years. Among them, 5 patients were dropped out of the research group in the middle of the course due to combined medication, and 7 patients were dropped out of the study group, and 7 patients lost follow-up. There were no adverse reactions and adverse events in both groups. 68 patients completed the study for 6 weeks. Baseline analysis showed that there was no significant difference in sex, age and course of disease between the treatment group and the control group (p0.05), and there was no significant difference in the WOMAC score between the two groups at the time of entering the group (p0.05). 2. According to the standard of clinical efficacy, 32 of the 35 patients in the treatment group were clinically effective, and the effective rate was 91.4%. In 33 cases of control group, 28 cases were clinically effective, and the effective rate was 84.8%. There was no significant difference between the treatment group and the control group in the clinical effective rate (p = 0.359). 3. The secondary outcome analysis showed that after the treatment, the observation index (knee joint WOMAC score) was improved in both groups. There was no significant difference between the treatment group and the control group before and after treatment (p > 0.05). Conclusion: the analysis of main outcome indexes showed that Dafangfeng decoction was effective in treating patellar chondromalacia due to deficiency of liver and kidney with Qi-blood and liver-kidney deficiency. However, there was no significant difference in the clinical efficacy of Glucosamine Hydrochloride capsule in the treatment of patellar chondromalacia due to deficiency of liver and kidney. The secondary outcome analysis showed that both Dafangfeng decoction and Glucosamine Hydrochloride capsule could improve the function of knee joint, but there was no significant difference between the treatment group and the control group in the improvement degree of the observed indexes. The thought of "treating no disease" has positive guiding significance in the treatment of patellar chondromalacia.
【學位授予單位】：廣西中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R274.9

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