糖尿灵片治疗阴虚热盛型2型糖尿病的疗效及安全性观察

目的：以玉泉丸为对照,评价糖尿灵片治疗阴虚热盛型2型糖尿病的疗效和安全性。方法：采用随机、双盲、平行对照的试验方法,将纳入的48例病例分为试验组24例口服糖尿灵片,对照组24例口服玉泉丸。每2周复诊1次,疗程1个月。治疗前后监测疗效和安全性指标。结果：对照组病例脱落1例,实际完成47例。中医证候积分2组治疗前后均有下降,组间比较有统计学意义（P〈0.01）;空腹血糖（FBG）、餐后血糖（PBG）、糖化血红蛋白（HbA1c）2组治疗前后比较均有改善,组间比较无统计学意义（P〉0.05）;2组安全性指标治疗前、治疗后2周、治疗结束比较,均无统计学意义（P〉0.05）。结论：糖尿灵片可改善2型糖尿病患者临床症状,但降糖作用不明显;试验过程中无不良事件发生。

Safety and Clinical Effects of TangNiaoLing Tablets in Treating Type 2 Diabetes Mellitus of YinXu ReShengXing

Objective： To evaliaate the safety and clinical effects of TangNictoLing tablet in treating type 2 dia-betes mellitus of YinXu ReShengXing compared with YuQuanWan. Method： Forty-eight cases were divided into test group and control group with randomized, double-blind, parallel, controlled method. Test group took TangNiaoLing tablets while control group were administered with YuQuanWan. Return visits were made once each two week, one session was one month. Indexes of safety and clinical effects were monitored before and after treating. Result： Forty-seven cases were actually completed in control group except dropping of one case. Scores of TCM syndromes fell before and after treating, comparison between both groups suggested statistical meaning（P〈0.01）; FBG, PBG and HbAlc improved before and after treating in both groups and comparison between both groups indicated no statistical meaning （P〉0.05）; comparisons of safe indexes before treating, at the second week after treating and by the end of treatment indicated no statistical meaning （P〉0.05）. Conclusion： TangNiaoLing tablets can improve clinical symptoms of patients with type 2 diabetes mellitus, but not clearly in lowering blood glucose; there is no adverse event in the ex- oeriment.