基于倾向性评分匹配法的国产与原研苯磺酸氨氯地平片治疗高血压的疗效和安全性研究

Effectiveness and safety of benazepril amlodipine tablets benazepril amlodipine tablets of domestic and the original drug in treatment of hypertension by propensity score matching

目的 对比国产与原研两种苯磺酸氨氯地平片治疗高血压(high blood pressure, HBP)的临床疗效与安全性。方法 基于医院信息系统(HIS),抽取2018年1月1日至2020年12月31日在上海市浦东医院心内科门诊收治的轻、中度HBP患者的电子病历,按照纳排标准从中筛选210例进行本次研究。通过电话随访以及病例记录完善患者相关信息。以苯磺酸氨氯地平片(京新,5.0 mg, 1次/d)为实验组,苯磺酸氨氯地平片(络活喜,5.0 mg, 1次/d)为对照组,以年龄、病程和身体质量指数(body mass index, BMI)为因变量,性别、吸烟、饮酒和合并疾病等为混杂变量,用倾向性评分匹配法(propensity score matching, PSM)进行均衡性匹配,考察两组患者使用氨氯地平的有效性及安全性;使用Kaplan-Meier乘积极限法对210个病例进行多因素生存分析,以考察各因素对药品持有时间的影响。结果 (1)匹配前对照组100份病例,实验组110份病例,实验组与对照组进行1∶1匹配后得到两组所有变量在组间均衡性良好。(2)以不良反应(adverse drug reactions, ADRs)和疗效不佳为结局变量,匹配两组相关混杂因素后,对照组的不良反应发生率为4.35%,疗效不佳发生率为15.94%;实验组的不良反应发生率为11.59%,疗效不佳发生率为20.29%,两者均没有显著性差异(P>0.05)。(3)以药品保有时间为因变量,匹配相关混杂因素后,根据K-M曲线得到中位数,对照组和实验组的中位数分别为10.0(月)和9.3(月),无统计学差异(P>0.05)。结论 PSM法可有效均衡观察性研究中的组间混杂变量。苯磺酸氨氯地平片(京新,5.0 mg, 1次/d)与苯磺酸氨氯地平片(络活喜,5.0 mg, 1次/d)在治疗轻、中度HBP时疗效与安全性相当。

Objective This study aimed to compare the clinical effectiveness and safety of domestically produced and original benazepril amlodipine tablets in the treatment of hypertension(HBP). Methods Electronic medical records of mild to moderate HBP patients admitted to the Cardiology Outpatient Department of Pudong Hospital in Shanghai from January 1, 2018 to December 31, 2020 were extracted from the Hospital Information System(HIS). A total of 210 cases were selected for this study based on inclusion criteria. Patient information was supplemented through telephone follow-up and case records. The experimental group received benazepril amlodipine tablets(Jingxin, 5.0 mg, QD), while the control group received benazepril amlodipine tablets(Luohuoxi, 5.0 mg, QD). Age, duration of illness, and body mass index(BMI) were considered as dependent variables, while gender, smoking, drinking, and comorbidities were considered as confounding variables. Propensity score matching(PSM) was employed to achieve balance, and the effectiveness and safety of amlodipine use were examined in both groups. Kaplan-Meier survival analysis was performed on 210 cases to assess the impact of various factors on drug duration. Results Before matching, there were 100 cases in the control group and 110 cases in the experimental group. After 1∶1 matching, all variables were well-balanced between the groups. Adverse drug reactions(ADRs) and poor efficacy were chosen as outcome variables. After matching confounding factors, the incidence of ADRs in the control group was 4.35%, and the incidence of poor efficacy was 15.94%, while in the experimental group, the incidence of ADRs was 11.59%, and poor efficacy was 20.29%. There was no significant difference between the two groups(P>0.05). Using drug possession time as the dependent variable, the median duration for the control group and the experimental group was 10.0(months) and 9.3(months), respectively, with no statistical difference(P>0.05). Conclusion PSM method effectively balances confounding variables in observational studies. Benazepril amlodipine tablets(Jingxin, 5.0 mg, QD) and benazepril amlodipine tablets(Luohuoxi, 5.0 mg, QD) demonstrated comparable effectiveness and safety in treating mild to moderate HBP.