目的 为各级医疗机构药品目录的遴选工作及临床合理用药提供科学支撑，针对前蛋白转化酶枯草溶菌素9（PCSK9）抑制剂开展多维度临床综合评价研究。方法 研究参照《中国医疗机构药品评价与遴选快速指南（第二版）》的评估框架，从药学特性、临床有效性、用药安全性、经济性以及其他综合属性5个维度进行考量。对依洛尤单抗（商品名瑞百安，每支1 mL∶140 mg）、阿利西尤单抗（商品名波立达，每支1 mL∶75 mg或1 mL∶150 mg）、托莱西单抗（商品名信必乐，每支1 mL∶150 mg）、伊努西单抗（商品名伊喜宁，每支1.5 mL∶150 mg）、昂戈瑞西单抗（商品名君适达，每支1 mL∶150 mg）、瑞卡西单抗（商品名艾心安，每瓶150 mg）、英克司兰（商品名乐可为，每支1.5 mL∶284 mg）进行综合评价。结果 经评价测算，上述药品综合评分由高至低分别为：英克司兰77.5分、依洛尤单抗76.9分、阿利西尤单抗73.94分、托莱西单抗72.65分、瑞卡西单抗68.34分、伊努西单抗66.77分、昂戈瑞西单抗66.38分。结论 英克司兰、依洛尤单抗、阿利西尤单抗与托莱西单抗具备较强临床推荐价值；瑞卡西单抗、伊努西单抗、昂戈瑞西单抗因上市周期较短、循证医学证据积累不足等问题，在当前临床用药选择中相较于其他PCSK9抑制剂未体现出明显优势。

Objective To provide scientific support for the selection of drug list and clinical rational drug use in medical institutions at all levels, this paper carried out a multi-dimensional clinical comprehensive evaluation study on PCSK9 inhibitors. Methods According to the evaluation framework of “A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (the Second Edition)”, the study was considered from five dimensions: pharmaceutical characteristics, clinical effectiveness, drug safety, economy and other attributes. The following drugs were comprehensively evaluated: Evolocumab (trade name: Repatha, 1 mL∶ 140 mg per vial), alirocumab (trade name: Praluent, 1 mL∶ 75 mg or 1 mL∶ 150 mg per vial), tafolecimab (trade name: Xinbile, 1 mL∶ 150 mg per vial), ebronucimab (trade name: Yixining, 1.5 mL∶ 150 mg per vial), ongericimab (trade name: Junshida, 1 mL∶ 150 mg per vial), recaticimab (trade name: Aixinan, 150 mg per bottle), and inclisiran (trade name: Leqvio, 1.5 mL∶ 284 mg per vial). Results According to the evaluation and calculation, the comprehensive scores of the above drugs from high to low are: 77.5 points for Inclisiran, 76.9 points for evolocumab, 73.94 points for alirocumab, 72.65 points for tafolecimab, 68.34 points for recaticimab, 66.77 points for ebronucimab and 66.38 points for ongericimab. Conclusion Inclisiran, evolocumab, alirocumab and tafolecimab have strong clinical recommendation value; Compared with other PCSK9 inhibitors, recaticimab, ebronucimab and ongericimab have no obvious advantages in the current clinical drug selection due to their short marketing cycle and insufficient accumulation of evidencebased medical evidence.

R965

国家自然科学基金委青年基金项目（71804025）