小儿抗结核药物治疗255例不良反应临床分析

Clinical analysis of adverse drug reactions in hospitalized children treated with anti-tuberculosis agents

目的了解儿童结核病治疗过程中药物不良反应(ADRs)的发生情况以及采用的处理方法。方法回顾性分析2009—2011年同济大学附属上海肺科医院16岁以下儿童抗结核治疗过程中出现的与结核药有关的不良反应发生率、出现时间、发生种类以及处理方法。结果 255例接受抗结核治疗儿童中发生药物不良反应53例(占20.78%),共11种类型、76例次。不良反应发生组与未发生组间患儿的年龄、性别、体重指数、用药种类差异无统计学意义(P>0.05)。56.0%的不良反应发生在2周以内,69.8%发生在1个月及以内,90.0%发生在2个月及以内。发生频次居前3位者为:药物性肝损伤25例次(32.89%);白细胞减少19例次(25.00%);过敏反应14例次(18.42%)。肝损伤患儿中72%为轻中度肝损伤。通过加强对抗性治疗、短暂停用或改换部分抗结核药物,不良反应得以恢复,结核病情逐渐控制。结论儿童抗结核药物不良反应是常见的。在结核病治疗过程中应重视药物不良反应的检测,及时发现及治疗,可减轻药物不良反应的严重程度、减少对化学治疗的影响。

Objective To evaluate the adverse drug reations （ADRs） in children receiving anti-tuberculosis （TB） therapy. Methods Records of hospitalized children younger than 16 years of age with tuberculosis and receiving anti-TB therapy from Jan. 2009 to Dec. 2011 were evaluated retrospectively, who were visited post-discharge. The major side effects, which resulted in a definitive termination or modification from one or more drugs related to anti-TB therapy, and the risk factors associated with these side effects, were analyzed. Results Fifty-three patients （20.78%）, constituting 11 types of side effects and 76 cases in total, experienced adverse effects. No differences of gender, age, body mass index （BMI） or the kinds of using drugs were observed between children with and without adverse effects. There was 56.0% of ADRs occurrence in the first two weeks, 69.8% in the first month and 90.0% in the first two month of anti-tuberculosis. The propol^ion of first three ADRs was liver injulT in 25 cases （32.89%）, leukocytopenia in 19 cases, and allergic reaction in 14 cases （25.00%） respectively. About 72% of ADRs belonged to mild and moderate injury. ADRs could be stopped through pertinent therapy of abnormality, suspending or changing some anti-tuberculosis drugs. Tuhereulosis disease was gradually controlled. Conclusion Adverse anti-TB drug reactions are common in children with tu- berculosis. These patients should be followed up by closer monitoring for side effects related to anti-TB drugs so that ADRs can be detected early and treated correctly, and severe adverse events can be clinically reduced.