健康受试者同时服用磷酸瑞格列汀与二甲双胍的安全性、耐受性研究

发布时间：2018-05-22 17:14

本文选题：瑞格列汀 + 二甲双胍　；参考：《中国新药杂志》2015年05期

【摘要】：目的:在中国健康成年志愿者中评价同时服用磷酸瑞格列汀(SP2086)片和二甲双胍(Met)缓释片的安全性、耐受性。方法:采用随机、开放、三交叉的设计方法,将15例健康受试者按照ABC,BCA,CAB3种给药序列进行随机分配,每个序列组5例受试者,每个阶段连续口服给药5 d,各阶段间隔5 d洗脱期,完成整个试验共需26 d。3个治疗组分别为A:SP2086(100 mg qd),B:Met(1 500 mg qd),C:SP2086(100 mg qd)+Met(1 500 mg qd)。观察指标包括生命体征、实验室检查指标、临床症状和不良事件等。结果:瑞格列汀与二甲双胍合用后生命体征、血生化、血常规、尿常规、心电图、彩超均未出现有临床意义的异常改变。SP2086主要不良事件为恶心、厌食、呕吐、腹泻等胃肠道反应。单用二甲双胍导致不良事件发生的几率明显高于单用瑞格列汀片。合并用药组不良事件发生率和反应类型与单用二甲双胍相似。结论:SP2086与Met联合用药时二者具有良好的安全性和耐受性,推荐二者联合使用。
[Abstract]:Objective: to evaluate the safety and tolerability of reaglentin phosphate SP2086 and metformin in Chinese healthy adult volunteers. Methods: 15 healthy subjects were randomly assigned according to the ABC BCAB CAB 3 administration sequence by random, open and cross design. Five patients in each sequence group were administered orally continuously for 5 days in each stage, and the elution period was 5 days interval in each stage. A total of 26d.3 treatment groups were used: A:SP2086(100 mg QD: B: 1 500mg QD: CSP2086 100mg QD) Met(1 500mg QDX. Observation indicators include vital signs, laboratory indicators, clinical symptoms and adverse events. Results: there were no significant abnormal changes in vital signs, blood biochemistry, blood routine, urine routine, electrocardiogram and color Doppler ultrasound after the combination of reaglentin and metformin. The main adverse events were nausea, anorexia and vomiting. Diarrhea and other gastrointestinal reactions. The incidence of adverse events caused by metformin alone was significantly higher than that of reaglitine alone. The incidence and type of adverse events in the combined medication group were similar to those of metformin alone. Conclusion the combination of Met and SP2086 has good safety and tolerance, and it is recommended that they be used in combination.
【作者单位】：中国人民解放军成都军区总医院临床药学科;
【分类号】：R969.1

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