目的 探讨参芪降糖胶囊联合格列本脲片治疗2型糖尿病的临床疗效及安全性。方法 选取2013年1月-2014年6月来上海市徐汇区康健街道社区卫生服务中心内分泌科接受治疗的2型糖尿病患者104例,随机分为对照组(52例)和治疗组(52例)。对照组患者给予口服格列本脲片,2.5 mg/次,3次/d,于餐前0.5 h口服;治疗组在对照组基础上加服参芪降糖胶囊,3粒/次,3次/d。两组患者均治疗8周。测定两组患者治疗前后的空腹血糖(FPG)、餐后2 h血糖(2 h PG)、糖化血红蛋白(HbA1C)、血糖达标率、达标时间、中医症候积分,比较两组的临床疗效和低血糖发生率。结果 治疗后,两组的FPG、2 h PG、HbA1C血糖指标较治疗前均显著下降,同组治疗前后差异有统计学意义(P<0.05、0.01)。治疗组经治疗后FPG、2 h PG、HbA1C下降更明显,两组比较差异具有显著性(P<0.05、0.01)。治疗后,与对照组比较,治疗组患者血糖达标迅速且达标率高,血糖波动相对较小,低血糖发生率低,两组比较差异有显著性(P<0.05)。治疗后,两组的中医临床证候积分较治疗前均明显减少,差异具有统计学意义(P<0.05、0.01);治疗后,治疗组证候积分较对照组明显降低,两组比较差异有显著性(P<0.05)。治疗组总有效率94.23%,与对照组84.62%比较,差异具有统计学意义(P<0.05)。两组患者治疗期间均未见药物相关的不良反应。结论 参芪降糖胶囊联合格列本脲片治疗2型糖尿病在血糖控制、血糖达标率、达标时间、低血糖发生率方面优于单用格列本脲片,临床疗效确切,未见严重不良反应,适合临床推广应用。

Objective To study the efficacy and security of Shenqi Jiangtang Capsules combined with Glyburide Tablets in treatment of type 2 diabetes mellitus. Methods The patients with type 2 diabetes mellitus (104 cases) in Kangjian Community Health Service Center of Xuhui District from January 2013 to June 2014 were randomly divided into control and treatment groups, and each group had 52 cases. The patients in the control group were po administered with Glyburide Tablets 0.5 h before meals, 2.5 mg/time, three times daily. The patients in the treatment group were po administered with Shenqi Jiangtang Capsules at the basis of the control group, 3 capsules/time, three times daily. The patients in two groups were treated for 8 weeks. The level of fasting plasma glucose (FPG), the 2-hour postprandial blood glucose (2 h PG), HbA1C, blood glucose target rate, blood glucose standard time, and score of TCM syndrome in two groups before and after treatment were determined. Efficacy and the incidence of hypoglycemia between two groups before and after treatment were also compared. Results After treatment, FPG, 2hPG, and HbA1C of two groups were significantly decreased, and the difference was statistically significant in the same group before and after treatment (P< 0.05, 0.01). After treatment, FPG, 2 h PG, and HbA1C in treatment group were lower than those in the control group, and there were differences between two groups (P< 0.05, 0.01). Blood glucose standard time, changes of blood glucose, and hypoglycemia incidence in the treatment group were lower than those in the control group, and there were differences between two groups (P< 0.05). After treatment, the score of TCM syndrome in two groups were significantly reduced, and the difference was statistically significant in the same group before and after treatment (P< 0.05, 0.01). After treatment, the indicators in the treatment group were lower than those in the control group, and there were differences between two groups (P< 0.05). The efficacies in the treatment and control groups were 94.23% and 84.62%, respectively, with differences between the two groups (P< 0.05). Patients in two groups did not appear serious adverse reactions. Conclusion Shenqi Jiangtang Capsules combined with Glyburide Tablets has the good clinical effect in treatment of controlling blood glucose, shortening blood glucose target rate, reaching blood glucose standard time, and lowering incidence of hypoglycemia on the patients with type 2 diabetes mellitus than Glyburide Tablets alone. It exactly improves the clinical curative effect and helps reduce long-term complications, which is worth clinical application.