Javadi Mohammad Reza, Shalviri Gloria, Gholami Kheirollah, Salamzadeh Jamshid, Maghooli Golshan, Mirsaeedi Seid Mahdi
Shahid Beheshti University of Medical Sciences, Department of Clinical Pharmacy, Tehran, Islamic Republic of Iran.
Pharmacoepidemiol Drug Saf. 2007 Oct;16(10):1104-10. doi: 10.1002/pds.1468.
Tuberculosis (TB) has been a common chronic infectious disease in human communities. Besides disease-related complications, there could be serious adverse reactions due to anti-tuberculosis (anti-TB) drug therapy.
To assess the incidence and severity of adverse drug reactions (ADRs) induced by anti-TB drugs. To determine possible covariates associated with detected ADRs.
All patients with respiratory TB admitted to a teaching hospital who received anti-TB drugs during the research period entered the study and were monitored for ADRs. Socio-demographic and medical history of patients were used as independent covariates. The relationship between independent covariates with frequency and severity of ADRs was analysed using multivariate logistic regression. Preliminary analyses of the Mann-Whitney, Chi-square, Kruskal-Wallis and the Fisher's exact tests were applied to determine factors unlikely associated with the independent variables.
Among 204 patients admitted, there were 92 patients (45.1%) with ADRs induced by anti-TB drugs. Patients with a previous history of anti-TB drugs usage (OR = 5.81, 95% confidence interval [95%CI]: 1.31-25.2), patients with a history of drug allergy (OR = 6.68, CI: 1.28-36.2), those from Afghani ethnic (OR = 4.91, 95%CI: 1.28-18.30) as well as smoker patients with concurrent diseases (OR = 19.67, CI: 1.24-341.51) had a higher rate of ADR incidence. Being female (OR = 1.63, 95%CI: 1.96-36.40) and having previous history of ADR (OR = 17.46, 95%CI: 1.96-20.42) were identified as risk factors.
Anti-TB drugs could cause severe and frequent adverse effects. Females, those with a previous history of ADRs to anti-TB drugs and Afghani patients, should be considered as high-risk groups.
结核病一直是人类社会常见的慢性传染病。除了疾病相关并发症外，抗结核药物治疗还可能引发严重不良反应。
评估抗结核药物引起的药物不良反应（ADR）的发生率和严重程度。确定与检测到的ADR相关的可能协变量。
在研究期间入住教学医院并接受抗结核药物治疗的所有呼吸道结核病患者均纳入研究，并监测ADR。患者的社会人口统计学和病史用作独立协变量。使用多因素逻辑回归分析独立协变量与ADR频率和严重程度之间的关系。应用Mann-Whitney、卡方、Kruskal-Wallis和Fisher精确检验进行初步分析，以确定不太可能与自变量相关的因素。
在204例入院患者中，有92例（45.1%）出现抗结核药物引起的ADR。既往有抗结核药物使用史的患者（OR = 5.81，95%置信区间[95%CI]：1.31 - 25.2）、有药物过敏史的患者（OR = 6.68，CI：1.28 - 36.2）、阿富汗族患者（OR = 4.91，95%CI：1.28 - 18.30）以及患有并发疾病的吸烟患者（OR = 19.67，CI：1.24 - 341.51）的ADR发生率较高。女性（OR = 1.63，95%CI：1.96 - 36.40）和既往有ADR病史（OR = 17.46，95%CI：1.96 - 20.42）被确定为危险因素。
抗结核药物可引起严重且频繁的不良反应。女性、既往有抗结核药物ADR病史的患者以及阿富汗患者应被视为高危人群。
