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复方蝉花片对2型糖尿病患者的临床疗效及安全性评价
引用本文:孙长胜,王玉芹,兰小燕,李春如,龙文君,王静春,陈桃宝,周宏灏,刘伟敬. 复方蝉花片对2型糖尿病患者的临床疗效及安全性评价[J]. 药物评价研究, 2020, 0(4): 655-659
作者姓名:孙长胜  王玉芹  兰小燕  李春如  龙文君  王静春  陈桃宝  周宏灏  刘伟敬
作者单位:中南大学湘雅医院临床药理研究所;遗传药理学湖南省重点实验室;浙江泛亚生命科学研究院;浙江泛亚生物医药股份有限公司;华东理工大学;北京中医药大学东直门医院
基金项目:国家星火计划(2015GA700011)。
摘    要:目的评价复方蝉花片对2型糖尿病患者的治疗作用及安全性评价。方法选择中国人民解放军第二四五医院血糖偏高的成年2型糖尿病患者109例,随机分为2组,对照组(n=54)采用常规治疗,治疗组(n=55)在常规治疗基础上口服复方蝉花片2片/次、2次/d,服用量2.4 g/d,连续服用2个月,评价其疗效与安全性。结果两组治疗前空腹血糖、餐后2 h血糖、尿糖比较无差异。治疗后,两组空腹血糖、尿糖均较治疗前降低,治疗组餐后2 h血糖降低;治疗组空腹血糖降低率(13.50±6.71)%与对照组比较差异显著(P<0.01)、餐后2 h血糖降低率(13.85±8.74)%,与对照组比较差异显著(P<0.01);治疗组尿糖积分下降率72.2%,对照组尿糖积分下降率10.52%,两组比较差异有显著性(P<0.001);且两组无不良反应发生。结论复方蝉花片对于2型糖尿病患者具有治疗作用,且比较安全,值得推广应用及深入开发。

关 键 词:复方蝉花片  2型糖尿病  空腹血糖  临床疗效

Clinical efficacy and safety evaluation of Compound Cicada Flower Tablets on patients with type 2 diabetes
SUN Changsheng,WANG Yuqin,LAN Xiaoyan,LI Chunru,LONG Wenjun,WANG Jingchun,CHEN Taobao,ZHOU Honghao,LIU Weijing. Clinical efficacy and safety evaluation of Compound Cicada Flower Tablets on patients with type 2 diabetes[J]. Drug Evaluation Research, 2020, 0(4): 655-659
Authors:SUN Changsheng  WANG Yuqin  LAN Xiaoyan  LI Chunru  LONG Wenjun  WANG Jingchun  CHEN Taobao  ZHOU Honghao  LIU Weijing
Affiliation:(Department of Clinical Pharmacology,Xiangya Hospital,Central South University,Changsha 410008,China;Hunan Key Laboratory of Pharmacogenetics,Changsha 410078,China;Zhejiang Bioasia Life Science Institute,Pinghu 314200,China;Zhejiang Bioasia Pharmaceutical Co.,Ltd.,Pinghu 314200,China;School of Pharmacy,East China University of Science and Technology,Shanghai 200237,China;Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine,Beijing 100700,China)
Abstract:Objective To evaluate the clinical effect and safety of Compound Cicada Flower Tablets on patients with type 2 diabetes Methods One hundrend and nine patients with type 2 diabetes mellitus(DM) who had high blood glucose in the 245 th Hospital of the Chinese People’s Liberation Army were randomly divided into 2 groups. The control group(n = 54) received conventional treatment and treatment group(n = 55) received onventional treatment and oral administration Compound Cicada Flower Tablets 2 tablets/times, 2 times/d, taking a dose of 2.4 g/d, and taking it continuously for 2 months to evaluate its efficacy and safety. Results There was no difference in fasting blood glucose, blood glucose 2 h after meal, and urine glucose between two groups. After treatment, the fasting blood glucose and urine glucose of two groups were lower than those of before treatment, and the blood glucose 2 h after meal of ttreatment group was lowered. The freduction rate of asting blood glucose in treatment group was(13.50 ±6.71)%, significantly different from the control group(P < 0.01), and the reduction rate of blood glucose 2 h after meal in treatment group was(13.85 ± 8.74)%, significantly different from ontrol group(P < 0.01). The decrease rate of urine glucose score in the treatment group and the control group were 72.2% and 10.52%, respectively and there was a significant difference between the two groups(P < 0.001);and no adverse reactions occurred in the two groups. Conclusion The Compound Cicada Flower Tablet is an clinical therapy for patients with type 2 diabetes, and it is safer, and it is worthy of promotion and further development.
Keywords:Compound Cicada Flower Tablet  type 2 diabetes  2 h postprandial blood glucose  clinical efficacy
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