桑叶总碱降糖胶囊联合控制饮食运动疗法治疗2型糖尿病等效性随机平行对照研究

The Treatments of Total Alkali from Morus Folium Jiangtang Capsule combined with Diet and Exercise Program for Type 2 Diabetes Mellitus Equivalence Randomized Controlled Study

[目的]观察桑叶总碱降糖胶囊联合饮食控制运动疗法治疗2型糖尿病疗效。[方法]使用随机平行对照方法,将60例门诊及住院患者按随机数字表法分为两组。入组前正在用降糖药或胰岛素,停止用药5d后进入试验。门诊病例严格控制可变因素。两组饮食和运动基础疗法相同。对照组30例拜糖平50mg,3次/d,餐时嚼服。治疗组30例桑叶总碱降糖胶囊30mg/次,3次/d,餐前30min。连续治疗90d为1疗程。观测临床症状、生化指标。连续治疗1疗程,判定疗效。[结果]治疗组显效17例,有效10例,无效3例,总有效率90.00%。对照组显效12例,有效11例,无效7例,总有效率76.67%,两疗效无显著差异(P>0.05)。血糖指标治疗组均明显改善(P<0.01),对照组餐后2h血糖、糖化血红蛋白均明显下降(P<0.05),空腹血糖无明显改善(P>0.05),血糖指标改善治疗组优于对照组(P<0.05)。肝、肾功、血常规、血压、体重指数等治疗组无显著变化(P>0.05),低密度脂蛋白(LDL-C)有明显改善(P<0.05)。对照组肾功、血脂、血常规、血压、体重指数等无显著变化(P>0.05),肝酶(AST)组间比较有显著差异(P<0.05)。[结论]桑叶总碱降糖胶囊能有效降低空腹、餐后2h血糖及糖化血红蛋白,有一定降脂作用,能改善临床症状,与拜糖平相比降低空腹血糖及调脂作用更具优势,且无腹胀、肝酶升高等不良反应。

[Objective]To observe the clinical effect of Total Alkali from Morus Folium Jiangtang Capsule combined with diet and exercise program on type 2 Diabetes mellitus.[Methods]Randomized controlled Trial was designed to study 60 Outpatient or hospitalized patients with type 2 Diabetes mellitus（DM） who were randomly allocated into the treatment and control groups.The previous therapies including drugs and insulin were all ceased for more than 5 days,and all patients were assigned to receive the same diet and exercise program.30 patients in the treatment group were treated with Total Alkali from Morus Folium Jiangtang Capsule（30mg,tid）,while those in the control group were treated with Acarbose Tablets（50mg,tid）,90 days for a course.All data were compared between before and after treatment,including symptoms and blood chemistry.[Results]After treatment,the effective rate in the treatment group was 90%（markedly effective： 17cases,effective： 10 cases,ineffective： 3 cases）,respectively,while 77% was in the control group（markedly effective： 12cases,effective： 11 cases,ineffective： 7 cases）,and no statistic difference was found between the two groups（P0.05）.In the treatment group,FPG、2hPG、HbA1c 、LDL-C decreased,there was significant difference between before and after treatment（P0.01）.In the control group,statistic significances of 2hPG、HbA1c were found between before and after treatment（P0.05）,but no significance of FPG was found（P0.05）.Significant differences of FPG、2hPG、HbA1c、LDL-C were found between the two groups（P 0.01 or P 0.05）.Meanwhile,there were no harmful effects on liver function,renal function,blood routine test,blood pressure and body mass index in the two groups（P0.05）,except the level of AST increased significantly in the control group,compared with the treatment group（P0.05）.[Conclusion]Total Alkali from Morus Folium Jiangtang Capsule is safe and effective drug for type 2 Diabetes mellitus（DM）,which may effectively control the hyperglycemia and hyperlipidemia,containing FPG,2hPG,HbA1c and LDL-C.Moreover,Total Alkali from Morus Folium can significantly reduce FPG and adverse drug reaction,compared with Acarbose.