抗结核药物不良反应发生率及其影响因素分析

Analysis on the incidence of adverse reaction and risk factors caused by anti-tuberculosis drugs

目的了解肺结核患者服用抗结核固定剂量复合制剂(fixed-dose combination,FDC)致不良反应的发生情况,并探讨其影响因素,为FDC的安全使用提供政策依据。方法选取新疆乌鲁木齐市某区结核病定点防治医院接受治疗的420例初治肺结核患者,监测其疗程中抗结核药物不良反应(adverse drug reactions,ADRs)发生情况,采用单因素和多因素分析方法,研究其ADRs发生的影响因素。结果总不良反应发生率较高,为62.6%。多因素非条件Logistic回归分析显示患有糖尿病与ADRs的发生有关联,与未患糖尿病患者相比,合并糖尿病患者发生ADRs危险的OR=2.509(95%CI:1.226~5.135)。结论糖尿病患者是服用FDC致发生ADRs的高危人群。对于合并糖尿病的结核患者,治疗期间应加强相关指标检测或采用其他治疗方案。

Objective To understand the incidence of adverse reactions caused by the anti-tuberculosis（anti-TB） fixed-dose combination（FDC） , and to explore the relevent influencing factors, and to provide the policy basis for the use of FDC. Methods We monitored the incidence of adverse reactions in treatment of 420 newly diagnosed TB patients from a district of Urumqi Tuberculosis Prevention designated hospital, and explored the relevant factors by univariate and muhiva- riate analysis. Results The overall incidence of adverse reactions was 62. 6%. Multivariate Logistic regression analysis showed that diabetes was associated with ADRs. Compared with patients without diabetes, patients with diabetes mellitus had higher risk of ADRs, the OR（95% CI） was 2. 509 （ 1. 226-5. 135）. Conclusions Diabetic patients with FDCs had high risk of ADRs. For these petients, we should detect the relevant indicators closely or use other treatments.