原研与仿制苯磺酸氨氯地平治疗高血压的有效性和安全性比较  

Comparison of Efficacy and Safety of Original-Patented and Generic Amlodipine Besylate in the Treatment of Hypertension

作　　者：毛静 董卫华[2] 魏挺[1] 梁熹[1] 邹雅敏[1] MAO Jing;DONG Weihua;WEI Ting;LIANG Xi;ZOU Yamin(Xi′an Jiaotong University,Xi′an,Shaanxi,China 710049;The First Affiliated Hospital of Xi′an Jiaotong University,Xi′an,Shaanxi,China 710061)

机构地区：[1]西安交通大学,陕西西安710049 [2]西安交通大学第一附属医院,陕西西安710061

出　　处：《中国药业》2024年第3期112-115,共4页China Pharmaceuticals

基　　金：陕西省重点研发计划一般项目[2021SF-111]。

摘　　要：目的比较原研与仿制苯磺酸氨氯地平治疗高血压的有效性和安全性。方法选取2021年1月1日至6月30日在西安交通大学第一附属医院分别接受苯磺酸氨氯地平原研药和仿制药进行高血压治疗的患者243例和272例,采用倾向性匹配分析法匹配(1∶1)为原研组和仿制组,各155例。两组患者均持续治疗3个月。结果治疗后,两组患者的收缩压、舒张压和脉压差均显著降低(P<0.05),但差异无统计学意义(P>0.05)。两组患者的临床疗效、用药依从性优良率、不良反应发生率比较,差异均无统计学意义(P>0.05)。结论原研与仿制苯磺酸氨氯地平治疗高血压的有效性、用药依从性和安全性均相当。Objective To compare the efficacy and safety of original-patented and generic amlodipine besylate in the treatment of hypertension.Methods A total of 243 patients who received original-patented amlodipine besylate and 272 patients who received generic amlodipine besylate for the treatment of hypertension in the First Affiliated Hospital of Xi′an Jiaotong University from January 1 to June 30,2021 were selected.Propensity matching analysis(1∶1)was used to match the original-patented group and the generic group,with 155 cases in each group.Both groups were continuously treated for three months.Results After treatment,the systolic blood pressure,diastolic blood pressure,and pulse pressure difference in the two groups significantly reduced(P<0.05),but the difference was not statistically significant(P>0.05).There was no statistically significant difference in clinical efficacy,excellent and good rate of medication compliance,and incidence of adverse reactions between the two groups(P>0.05).Conclusion Generic amclodiplain besylate has the same efficacy,medication compliance and safety as the original-patented amclodiplain besylate in the treatment of hypertension.

关 键 词：苯磺酸氨氯地平 原研药 仿制药 高血压 有效性 安全性 

分 类 号：R969.4[医药卫生—药理学] R972.4[医药卫生—药学]