目的 分析鲁拉西酮药物不良反应的临床表现及特点，为临床安全用药提供参考。方法 通过检索中国知网、万方数据、维普网、PubMed、Web of Science、Embase数据库收集建库起至2023年12月31日鲁拉西酮致不良反应的个案报道，进行统计分析。结果 共纳入案例报道25篇，合计35例患者。患者年龄15～81岁，平均年龄为46岁。女性（18例）与男性（17例）不良反应发生率相近。患者来源于7个国家，美国最多（15例，42.9%）。给药剂量在20～160 mg。用药后6个月内不良反应发生率较高（27例，77.1%）。不良反应累及系统器官以各类神经系统疾病（13例次，37.1%）为主，其次是精神病类（10例次，28.6%）以及血液和淋巴系统疾病、内分泌系统疾病、心脏器官疾病和代谢及营养类疾病。35例患者中，32例患者停用鲁拉西酮后，不良反应逐渐改善或消失；3例患者鲁拉西酮减量后，不良反应有所缓解。结论 鲁拉西酮存在多系统和器官的不良反应，使用期间需要持续进行药学监护和随访，尤其是前6个月内，以便发生不良反应时能及时采取措施，确保患者临床用药安全，降低用药风险。

Objective To analyze the clinical manifestations and characteristics of adverse drug reactions induced by lurasidone, and to provide reference for clinically safe drug use. Methods Case reports of adverse reactions caused by lurasidone from the establishment of the database to December 31, 2023 were collected by searching CNKI, Wanfang Data, VIP, PubMed, Web of Science, and Embase databases for statistical analysis. Results 25 case reports were included with 35 patients. The ages of the patients were among 15-81 years old, with the average age of 46 years old. There was no significant difference between female (18 cases) and male (17 cases). The patients were from 7 countries. The United States accounted for the most (15 cases, 42.9%). The dosage is between 20 to 160 mg. The most adverse drug reactions cases (27 cases, 77.1%) occurred within 6 months. Organs/systems involved in adverse drug reactions were mainly nervous system disorders (13 cases, 37.1%), followed by the psychiatric disorders (10 cases, 28.6%), and the blood and lymphatic system disorders, endocrine disorders, cardiac disorders and metabolism and nutrition disorders. Among 35 patients, adverse drug reactions gradually diminished or disappeared in 32 patients after stopping lurasidone, adverse drug reactions was alleviated by reducing lurasidone dosage in 3 patients. Conclusion Lurasidone cause adverse drug reactions involving multiple organs/systems. Continuous pharmaceutical monitoring and follow-up should be carried out during drug use, especially in the first 6 months, so that timely measures can be taken when adverse drug reactions occurs to ensure the safety of clinical use of patients and reduce the risk of drug use.

R971

天津药学中青年科研项目（TJYX2023-10）