目的 分析魯拉西酮藥物不良反應(yīng)的臨床表現(xiàn)及特點，為臨床安全用藥提供參考。方法 通過檢索中國知網(wǎng)、萬方數(shù)據(jù)、維普網(wǎng)、PubMed、Web of Science、Embase數(shù)據(jù)庫收集建庫起至2023年12月31日魯拉西酮致不良反應(yīng)的個案報道，進(jìn)行統(tǒng)計分析。結(jié)果 共納入案例報道25篇，合計35例患者?；颊吣挲g15～81歲，平均年齡為46歲。女性（18例）與男性（17例）不良反應(yīng)發(fā)生率相近?；颊邅碓从?個國家，美國最多（15例，42.9%）。給藥劑量在20～160 mg。用藥后6個月內(nèi)不良反應(yīng)發(fā)生率較高（27例，77.1%）。不良反應(yīng)累及系統(tǒng)器官以各類神經(jīng)系統(tǒng)疾病（13例次，37.1%）為主，其次是精神病類（10例次，28.6%）以及血液和淋巴系統(tǒng)疾病、內(nèi)分泌系統(tǒng)疾病、心臟器官疾病和代謝及營養(yǎng)類疾病。35例患者中，32例患者停用魯拉西酮后，不良反應(yīng)逐漸改善或消失；3例患者魯拉西酮減量后，不良反應(yīng)有所緩解。結(jié)論 魯拉西酮存在多系統(tǒng)和器官的不良反應(yīng)，使用期間需要持續(xù)進(jìn)行藥學(xué)監(jiān)護(hù)和隨訪，尤其是前6個月內(nèi)，以便發(fā)生不良反應(yīng)時能及時采取措施，確?；颊吲R床用藥安全，降低用藥風(fēng)險。

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

天津藥學(xué)中青年科研項目（TJYX2023-10）