培哚普利氨氯地平单片复方制剂治疗高血压的临床综合评价

Clinical comprehensive evaluation of single-pill combination of perindopril and amlodipine for treatment of hypertension

目的评价高血压治疗中培哚普利氨氯地平单片复方制剂(SPC)的临床综合价值,为医疗机构药品遴选和合理使用提供循证依据。方法基于文献研究和专家论证法,构建临床综合评价指标体系,围绕药品安全性、有效性、经济性、创新性、适宜性和可及性进行定性和定量分析。结果共纳入12篇文献报道培哚普利氨氯地平SPC有效性和安全性相关结局指标。培哚普利氨氯地平SPC安全性较好,与单药、单药联合或其他降压SPC相比,治疗期间不良事件发生率差异无统计学意义。有效性方面,培哚普利氨氯地平SPC降压疗效明确,能显著降低患者收缩压、舒张压、脉压差和心率,血压控制达标率优于氨氯地平或培哚普利单药组;与其他降压SPC相比,表现出更优或非劣效果。培哚普利氨氯地平SPC作为专利药品,具有较好创新性,患者用药依从性高,且已纳入我国医保目录,但目前医疗机构配备率偏低,药品价格和可负担性仍处于相对较高水平。结论培哚普利氨氯地平SPC在安全性、有效性、适宜性和创新性上具有显著优势,但经济性和可及性仍有待提高。

Objective To evaluate the clinical value of single-pill combination(SPC)of perindopril and amlodipine for the treatment of hypertension and provide reference for the selection and rational use in medical institutions.Methods A comprehensive clinical evaluation index system was established based on literature research and expert demonstration.Therefore,the safety,effectiveness,economy,innovation,suitability and accessibility of drugs were analyzed qualitatively and quantitatively.Results A total of 12 studies reported the outcome of perindopril and amlodipine SPC,including efficacy and safety.Perindopril amlodipine SPC was safe,and there was no significant difference in the incidence of adverse events during treatment compared with monotherapy,monotherapy combination or other antihypertensive SPC.In terms of effectiveness,perindopril and amlodipine SPC had clear antihypertensive effect,which could significantly reduce systolic blood pressure,diastolic blood pressure,pulse pressure difference and heart rate,and the blood pressure compliance rate of perindopril and amlodipine SPC was better than that of amlodipine or perindopril monotherapy group.Compared with other depressurized SPCs,it showed better or noninferior effect.Perindopril amlodipine SPC,as a patented drug,has good innovation,high patient compliance,and has been included in China's medical insurance catalog,but the current medical institutions have a low supply rate,and drug prices and affordability are still at a relatively high level.Conclusion Perindopril amlodipine SPC has significant advantages in safety,effectiveness,suitability and innovation,but its economy and accessibility still need to be improved.