大防风汤加减治疗气血并肝肾不足型髌骨软化症的临床疗效观察
发布时间：2019-04-30 09:47
【摘要】：目的:探讨“大防风汤加减”治疗气血并肝肾不足型髌骨软化症的疗效;探讨“治未病”思想对髌骨软化症的指导作用。方法:本课题采用简单随机化的方法,将符合纳入标准的患者分为治疗组和对照组平行对照,同时进行两组观察指标自身治疗前后对照的临床研究设计。治疗组予服用中药治疗,对照组服用盐酸氨基葡萄糖胶囊(香港澳美制药厂生产0.75g/粒)。治疗组和对照组均进行常规治疗股四头肌锻炼。根据病例纳入标准纳入髌骨软化症的患者,根据入组顺序将其分至治疗组和对照组,同时完成膝功能评价表(WOMAC评分),对不良反应、不良事件及脱落情况进行记录。患者治疗结束后完成出组检查(与入组时检查项目相同)后出组,完成数据统计分析(临床计数资料采用卡方检验;计量资料以均数土标准差((x|-)±s)表示,并采用独立样本t检验或配对样本t检验分析;临床疗效分析采用秩和检验分析),根据设计时的疗效评价标准,最后明确大防风汤加减治疗气血并肝肾不足型髌骨软化症的临床疗效。结果:1、本课题按设计要求共纳入80髌骨软化症患者,历时2年,其中有5例患者因合并用药,中途被剔除出课题组,有7例患者脱落失访,两组均无不良反应及不良事件发生,共计68例患者完成本次研究,疗程为6周。基线分析示治疗组和对照组在患者性别、年龄、病程等方面无明显差异(p0.05),入组时两组的WOMAC评分值无明显差异(p0.05)。两组具有可比性,符合随机设计。2、根据课题设定的临床有效标准,35例治疗组患者中32例为临床有效,有效率91.4%;33例对照组患者中28例为临床有效,有效率84.8%;治疗组和对照组临床有效率之间差异无显著性(p=0.359)。3、次要结局指标分析发现,治疗结束后,两组观察指标(膝关节WOMAC评分)都有所改善;治疗前后观察指标的变化在治疗组和对照组组之间无明显差异(p值均大于0.05)。结论:主要结局指标分析发现,应用大防风汤加减治疗气血并肝肾不足型髌骨软化症,在临床上是有效的,而和口服盐酸氨基葡萄糖胶囊治疗气血并肝肾不足型髌骨软化症的临床有效率无显著差别。次要结局指标分析发现,应用大防风汤加减和盐酸氨基葡萄糖胶囊均可改善膝关节的功能;观察指标的改善程度在治疗组和对照组之间无明显差异。“治未病”思想在髌骨软化症的治疗中具有积极的指导意义。
[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.
【学位授予单位】：广西中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R274.9
本文编号：2468685
[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.
【学位授予单位】：广西中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R274.9
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