中药复方辨证加减随机对照治疗2型糖尿病200例疗效评价  

Therapeutic Efficacy Evaluation by a Randomized Controlled Clinical Research on Traditional Chinese Medical Formulas,with Herb Modification According to Syndrome Differentiation,in the Treatment of 200 Type 2 Diabetic Patients

作　　者：林兰[1] 倪青[1] 庞健丽[1] 魏军平[1] 苏诚炼[1] 闫秀峰[1] 

机构地区：[1]中国中医科学院广安门医院,北京100053

出　　处：《医学研究杂志》2013年第2期102-107,共6页Journal of Medical Research

基　　金：中国中医科学院优势病种研究基金资助项目(CACMS05Y0026)

摘　　要：目的探讨中药复方辨证加减随机交叉对照治疗200例2型糖尿病的疗效。方法符合纳入标准的200例2型糖尿病患者,按入组先后顺序,随机进入中西药合用组(中西药组)和西药治疗组(西药组)(西药组∶中西药组=1∶3)。中西药组根据辨证论治原则,将患者分为清润方组、滋益方组、双调方组。临床观察12周后,采集临床信息形成数据库,采用主观指标(中医证候评价方法)与客观指标相结合的方法,评价中医药的疗效优势,建立临床疗效评价指标体系。结果空腹血糖、餐后血糖及糖化血红蛋白各时点两组均在较好控制范围。3方疗效比较,滋益方降低空腹血糖和餐后血糖疗效较好;清润方降低餐后血糖疗效较好;双调方降低空腹血糖和糖化血红蛋白疗效较好。主观指标方面,中西药组与西药组治疗后症状比治疗前均有明显改善,在症状改善方面中西药组明显优于西药组。滋益方改善症状效果最好。结论滋益方改善症状效果最好,清润方降低餐后血糖最有效,双调方降低糖化血红蛋白最有效。主客观相结合的疗效评价方法值得推广使用。Objective To investigate and evaluate the therapeutic efficacy by a randomized controlled crossover clinical research on traditional Chinese medical formulas,with herb modification according to syndrome differentiation,in the treatment of 200 type 2 diabeticpatients. Methods A total of 200 diabetic patients who met the inclusion criteria, according to the order, were randomly divided into two groups,namely, the Chinese ＆ western medicine combination group （the C＆WM group） and the western medicine group （the WM group） （ the WM group： the C ＆ WM group = 1 ： 3 ）. Then, patients in the C＆WM group were further divided into three sub - groups,namely, the QingRunFang group（formula with nature of clearing and moisting）, the ZiYiFang group （formula with nature of tonifying and nurishing） and the ShuangTiaoFang group （formula with nature of double adjusting, especially on Yin and Yang）, based on the principle of ＂treatment based on syndrome differentiation＂ in traditional Chinese medicine （TCM）. According to the research protocol, clinical observation was done for 12 weeks, clinical information was collected to create the database, the combination method of subjective indicators （TCM syn- drome evaluation） and objective indicators was taken for the evaluation of Chinese medicine efficacy advantages and the establishment of clinical evaluation index system. Results The fasting plasma glucose, postprandial blood glucose and glycosylated hemoglobin at each time point in both groups were under better control. For the subjective indicators, symptoms in both groups were improved than those before treatment, and the C＆WM group was better significantly than the WM group. Conclusion The ZiYiFang showed the best therapeutic effects in symptom improvement; the QingRunFang showed the best therapeutic effects in reduction the postprandial blood glucose;and the ShuangTiaoFang showed the best therapeutic effects in reduction in glycosylated hemoglobin. The combination of subjective and ob

关 键 词：2型糖尿病 辨证论治 随机对照 临床研究 疗效评价 

分 类 号：R654.2[医药卫生—外科学]