Adverse Drug Events on the Use of Sertraline in Clinical Studies: A Review

Syahrul Hidayat, I. Puspitasari
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Abstract

Major depressive disorder (MDD) and anxiety are known as a widespread public health problem treated with sertraline, a class of Selective Serotonin Reuptake Inhibitor (SSRI) drugs as first-line therapy. However, clinical evidence showed that MDD and anxiety therapy with sertraline has not been optimal due to patient non-compliance associated with adverse drug events (ADE) occurring. A literature search on sertraline clinical study was conducted on the PubMed and Science Direct electronic database in April 2020. A total of 12 articles from 5.664 articles have been selected at the initial screening. A total of 6 articles used sertraline as a testing drug in MDD patients, 2 articles used sertraline as testing drug in anxiety patients, 2 articles with sertraline as a comparative drug, 1 article with sertraline as a positive control, and 1 article with sertraline as an adjuvant in MDD patients. Studies on these articles were carried out worldwide from 2010 to 2019. ADEs that occur due to the use of sertraline were: gastrointestinal disorders, nutritional and metabolic disorders, central nervous system disorders, sweating, sleep disorders, irritability, eye disorders, as well as disorders of the skin and subcutaneous tissues. Nausea is the most common ADE of sertraline. ADEs are affected by several factors such as, age, the sertraline combination therapy, and alcohol consumption.
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舍曲林在临床研究中使用的药物不良事件:综述
严重抑郁障碍(MDD)和焦虑是一种广泛存在的公共卫生问题,使用舍曲林治疗,舍曲林是一类选择性血清素再摄取抑制剂(SSRI)药物作为一线治疗。然而,临床证据表明,由于患者不依从性与不良药物事件(ADE)的发生有关,使用舍曲林进行MDD和焦虑治疗并非最佳。2020年4月,在PubMed和Science Direct电子数据库上检索了舍曲林临床研究的文献。初步筛选共从5.664篇文章中选出12篇。共有6篇文章在MDD患者中使用了舍曲林作为测试药物,2篇文章在焦虑患者中使用舍曲林为测试药物,两篇文章将舍曲林用作比较药物,1篇文章将舍曲林用作阳性对照,以及1篇文章以舍曲林作为MDD患者的佐剂。从2010年到2019年,在全球范围内对这些文章进行了研究。由于使用舍曲林而发生的ADE包括:胃肠道疾病、营养和代谢疾病、中枢神经系统疾病、出汗、睡眠障碍、易怒、眼部疾病以及皮肤和皮下组织疾病。恶心是舍曲林最常见的ADE。ADE受到几个因素的影响,如年龄、舍曲林联合治疗和饮酒。
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