安罗替尼不良反应的文献计量学分析

Bibliometric Analysis of ADR of Anlotinib

目的:探讨安罗替尼所致不良反应(ADR)的一般规律及特点,为临床用药提供参考。方法:检索中国知网数据库、维普中文科技期刊数据库、万方数据库和Pubmed数据库建库至2020年1月国内外医药期刊上公开发表的有关安罗替尼所致ADR相关报道,对其进行统计、分析。结果:共检索出同期对照临床研究和非比较性病案报告21篇,合计使用安罗替尼总计1240例,报告不良反应4596次。发生最多的ADR是高血压、手足综合征、疲劳乏力和血脂异常;三级及以上ADR发生最多的是高血压、手足综合征、血脂异常和低钠血症。个案报道10篇,报道不良反应13例次,男性8例(占61.54%),女性5例(占38.46%);年龄最小者48岁,最大者76岁。有6例患者出现新的ADR,包括食管气管支气管瘘(2例)、支气管胸膜瘘、主动脉夹层、可逆性后部白质脑病综合征和过敏性紫癜,其中发生支气管胸膜瘘的患者因呼吸衰竭死亡,其余患者均通过停药或停药后对症治疗症状好转。结论:临床医师和药师应加强安罗替尼不良反应的监测,及时发现潜在危害并采取适当措施预防或治疗。

Objective: To discuss the general rules and characteristics of anlotinib-induced ADR so as to provide references for clinical rational drug use. Methods: Anlotinib-induced ADR reports published on domestic and foreign medical journals from CNKI VIP Wanfang database and Pubmed were retrieved and statistically analyzed during the construction of the database until January 2020. Results: A total of 21 controlled clinical studies and non-comparative medical records were retrieved. A total of 1240 cases of anlotinib were used, and 4596 adverse reactions were reported. The most common ADRs were hypertension, HFS, fatigue and dyslipidemia;and the most common ADRs(grade ≥3) were hypertension, HFS, dyslipidemia and hyponatremia. Ten cases were reported, and 13 adverse reactions were reported. There were 8 males(61.54%) and 5 females(38.46%), among whom the youngest was 48 years old and the oldest was 76 years old. There were 6 patients with new ADR, including esophagotracheal and bronchial fistula(2 cases), bronchopleural fistula, aortic dissection, reversible posterior leukoencephalopathy syndrome and anaphylactoid purpura. Among them, the patients with bronchopleural fistula died of respiratory failure, and the rest of the patients got better after stopping drug therapy or conducting symptomatic treatment after drug withdrawal. Conclusion: Clinicians and pharmacists should strengthen the monitoring of adverse reactions of arotinib, find out potential hazards in time and take appropriate measures to prevent or treat them.