芪药消渴胶囊干预2型糖尿病前期患者76例的临床观察

目的观察芪药消渴胶囊对2型糖尿病前期患者临床疗效。方法糖尿病前期患者116例，按2：1比例分为中药组、对照组，其中中药组76例，对照组40例，两组患者均给予适当控制饮食、健康教育、运动等一般治疗。中药组在此基础上口服芪药消渴胶囊（0．4g／粒）每次6粒，每日3次，对照组以单纯生活方式干预，观察两组患者干预前后空腹血糖（FBG）及餐后2h血糖（PBG）、胰岛素（FINS、2hINS）、糖化血红蛋白（HbAlc）、血脂（TG、TC、HDL-C、LDL—C）及中医证候疗效，并观察疗程结束及随访转归情况。结果两组患者FBG、PBG、HbAlc治疗后均较治疗前下降（P〈0．05，P〈0．01），尤以2hPBG下降显著，但两组间比较，差异无统计学意义（P〉0．05）；两种方法皆能改善FINS分泌，尤以中药组2hINS较治疗前下降明显，与对照组比较，差异有统计学意义（P〈0．05）；两种方法皆能改善患者血脂代谢，中药组TG显著降低，HDL-C升高，与治疗前比较，差异有统计学意义（P〈0．05）；中药组中医证候较治疗前明显改善，与对照组比较，差异有统计学意义（P〈0．05）；疗程结束及随访中药组复常率优于对照组（P〈0．05）。结论中药芪药消渴胶囊结合生活方式干预，能改善糖尿病前期患者空腹及餐后胰岛素分泌、调节糖脂代谢，纠正胰岛素抵抗状态，改善气阴两虚症状，有一定延缓或阻止2型糖尿病的发生发展作用，较单纯生活方式持久有效。

Clinical Observation of Qiyao Xiaoke Capsule in Intervening 76 Patients with Type 2 Pre-diabetes

Objective To observe the clinical effects of Qiyao Xiaoke Capsule （QXC） on patients with type 2 pre-diabetes. Methods Totally 116 pre-diabetes patients were randomly assigned to the Chinese medicine group （CM, 76 cases） and the blank control group （ BC, 40 cases） in the ratio of 2： 1. All patients received proper diet control, health education, and exercises, and so on. Besides, patients in the CM group took QXC （0.4 g/pill）, 6 pills each time, three times a day. But patients in the BC group were intervened by life style a- lone. The fasting blood glucose （ FBG）, postprandial blood glucose （ PBG）, insulin （ FINS, 2h INS）, glycosylat- ed hemoglobin （HbAlc）, blood lipids （TG, TC, HDL-C, and LDL-C）, and efficacy of CM symptoms were ob- served in the two groups before and after intervention. The sequelae were observed at the end of the treatment and at follow-ups. Results After treatment FBG, PBG, and HbAlc decreased in all patients of the two groups （P〈0.05, P〈 0.01 ）, with 2 h PBG decreased more significantly. But there was no statistical difference be- tween the two groups （ P〉0. 05）. The two methods could improve the secretion of FINS. Especially 2 h INS de- creased more significantly in the CM group, showing statistical difference when compared with the BC group （ P 〈 0.05）. The two methods could improve the metabolism of blood lipids. CM could significantly lower TG and ele- vate HDL-C, showing statistical difference when compared with before treatment （P 〈0.05）. After treatment the CM symptoms were obviously improved, showing statistical difference when compared with the BC group （ P 〈 0.05）. The normalization rate was better in the CM group than in the BC group at the end of the treatment and at follow-ups （ P 〈0. 05）. Conclusions QXC combined life style intervention could improve fasting and postprandial insulin secretion of type 2 pre-diabetes patients, regulate glycolipid metabolism, correct the insulin resistance state, and improve the symptoms of qi-yin insufficiency. It could postpone or hinder the occurrence and development of type 2 diabetes. It was more effective and durable than changing the life style alone.