【摘要】 目的 探讨氢溴酸伏硫西汀片临床用药的合理性和安全性,为临床合理用药提供参考。方法 采用医院集中监测法从本院医院信息系统跟踪2019年1月～2020年12月住院期间使用氢溴酸伏硫西汀片的125例患者,由临床药师跟踪及记录患者基本信息、药品使用情况和不良反应发生情况,评价其联合用药的安全性和临床应用合理性。结果 125例患者中,男39例,女86例,男女比例为1∶2.2；年龄最大86岁,最小11岁,平均年龄38.22岁；其中年龄≥60岁患者25例,年龄<18岁患者19例。125例患者中26例患者在使用氢溴酸伏硫西汀片的基础上联合使用其他抗抑郁药物,占比为20.80%;89例患者联合使用抗精神病药物,占比为71.20%;104例患者联合使用镇静催眠药,占比为83.20%。125例患者中有61例在氢溴酸伏硫西汀片联合用药过程中发生不良反应,占比为48.8%。不良反应主要发生在胃肠系统、内分泌系统、神经系统以及肝功能、心脏系统。联合用药时间≤14 d及联合用药时间>14 d,不同性别、是否首次住院、是否联合抗抑郁药以及是否合并躯体疾病患者的不良反应发生率比较差异均无统计学意义(P>0.05)；联合用药时间≤14 d,联合抗精神病药物患者的不良反应发生率37.50%(30/80)明显高于未联合抗精神病药物患者的10.71%(3/28),差异具有统计学意义(P<0.05)；联合用药时间>14 d,是否联合抗精神病药物患者的不良反应发生率比较,差异无统计学意义(P>0.05)。联合用药时间≤14 d,氢溴酸伏硫西汀片联合喹硫平、奥氮平、阿立哌唑患者的不良反应发生率比较差异无统计学意义(P>0.05)。联合用药时间≤14 d,氢溴酸伏硫西汀片联合抗精神病药物的锥体外系反应、高催乳素血症发生率63.33%高于胃肠道反应的36.67%和其他不良反应的36.67%,差异具有统计学意义(P<0.05)；氢溴酸伏硫西汀片联合抗精神病药物的胃肠道反应发生率和其他不良反应比较差异无统计学意义(P>0.05)。结论 氢溴酸伏硫西汀片联合抗精神病药物的近期不良反应发生率增加,不良反应类型多与多巴胺受体相关；氢溴酸伏硫西汀片联合抗精神病药物的远期不良反应发生率并未增加,远期安全性高。更多还原

【Abstract】 Objective To discuss the rationality and safety of clinical medication of votioxetine hydrobromide tablets and provide reference for clinical rational use of drugs. Methods Using the hospital centralized monitoring method, the medical records of 125 patients using vortioxetine hydrobromide tablets were tracked from the hospital information system during the hospitalization period from January 2019 to December 2020; the general of patients’ drug information, drug utilization and the occurrence of adverse drug reactions were traced and recorded by clinical pharmacists to evaluate the safety of combination medication and rationality of its clinical application. Results Among the 125 patients, there were 39 males and 86 females, with a male to female ratio of 1∶2.2. Age ranged from 11 to 86 years old, with an average of 38.22 years old. There were 25 patients aged ≥60 years and 19 patients aged <18 years. Among the 125 patients, 26 patients were combined with other antidepressants on the basis of votioxetine hydrobromide tablets, accounting for 20.80%; 89 patients were treated with antipsychotics, accounting for 71.20%; 104 patients were treated with sedative and hypnotics, accounting for 83.20%. 61 of the 125 patients had adverse reactions during the combination of votioxetine hydrobromide tablets, accounting for 48.8%. Adverse reactions mainly occurred in gastrointestinal system, endocrine system,nervous system, liver function and cardiac system. There was no statistically significant difference in the incidence of adverse reactions in patients with combination duration ≤14 d and combination duration >14 d, patients of different gender, patients with first hospitalization or not, patients with combination of antidepressants or not and patients with combined physical diseases or not(P>0.05). For patients with combination duration >14 d,there was no statistically significant difference in the incidence of adverse reactions in patients with or without antipsychotics(P>0.05). For patients with combination duration ≤14 d, there was no statistically significant difference in the incidence of adverse reactions in patients with votioxetine hydrobromide tablets combined with quetiapine, olanzapine or aripiprazole(P>0.05). For patients with combination duration ≤14 d, the incidence of extrapyramidal reaction and hyperprolactinemia of votioxetine hydrobromide tablets combined with antipsychotics was 63.33%, which was higher than that of gastrointestinal reaction(36.67%) and other adverse reactions(36.67%),and the differences were statistically significant(P<0.05). There was no statistically significant difference in the incidence of gastrointestinal reactions and other adverse reactions of votioxetine hydrobromide tablets;combined with antipsychotics(P>0.05). Conclusion The incidence of recent adverse reactions of vothioxetine hydrobromide combined with antipsychotics has increased, and the types of adverse reactions are mostly related to dopamine receptors; the incidence of long-term adverse reactions of vortioxetine hydrobromide tablet combined with antipsychotics has not increased, and the long-term safety is high.更多还原