耐多药肺结核患者抗结核药物所致不良反应发生情况

Analysis of adverse drug reactions in multidrug-resistant pulmonary tuberculosis patients

目的 分析耐多药肺结核患者标准化治疗过程中药物不良反应的发生情况，并评价其对治疗的影响。方法 采用回顾性调查的方法，收集305例耐多药肺结核患者病案的临床资料和检验数据，分析患者药物不良反应的发生情况。计数资料采用χ2检验或者Fisher精确检验，计量资料采用t检验或者非参数检验。结果 305例耐多药肺结核患者中，282例（92.5%）发生了至少一种不良反应，不良反应发生率较高的依次为胃肠道反应（46.9%）、甲状腺功能减退（41.3%）、低钾血症（34.1%）、肾功能异常（29.8%）、血液系统损伤（21.6%）、药物性肝损伤（19.0%）、关节或肌肉疼痛（11.1%），以及耳毒性和前庭功能障碍（8.5%）。性别、年龄、户籍、既往二线抗结核药物用药史以及是否合并糖尿病对不良反应的发生均无明显影响（均P〉0.05）。依据Naranjo不良反应因果关系评估量表法，本研究中不良反应与所使用抗结核药物肯定有关的有34例，很可能有关的为236例，可能有关的为12例，可疑有关的为0。发生不良反应的282例患者中，175例（62.1%）对症处理后能够维持原方案继续治疗，89例（31.6%）治疗方案进行了调整未停止治疗，只有18例（6.4%）因不良反应停止治疗。不良反应是否发生对治疗转归无明显影响（P〉0.05）。结论 尽管耐多药肺结核患者治疗过程中容易发生不良反应，但是大多数不良反应是可以处理的，通过及时监测、妥善处理，还是能够保证患者的治疗效果。

Objective To analyze the adverse drug reactions （ADR） during the standardized treatment of multidrug-resistant pulmonary tuberculosis （MDR-PTB）, and to evaluate its impact on treatment outcomes.Methods A retrospective study was carried out on 305 MDR-PTB patients. Medical records of clinical treatment and laboratory examinations were collected, and the ADR data were analyzed.Chi-square test or Fisher exact test was used for discontinuous variables, and t test or non-parametric test was used for continuous variables.Results Among 305 MDR-PTB patients , 282 （92.5%） had at least one ADR. The major ADR were gastrointestinal reaction （46.9%）, thyroid dysfunction （41.3%）, hypokalemia （34.1%）, renal injury （29.8%）, hematological system impairment （21.6%）, hepatotoxicity （19.0%）, arthralgia or courbature （11.1%）, and ototoxicity and vestibular dysfunction （8.5%）. Sex, age, native place, the history of using second-line TB drugs or the history of diabetes mellitus had no significant effect on the incidence of ADR （all P〉0.05）. As per the Naranjo causality assessment of ADR, 34 patients had definite, 236 had probable, 12 had possible and 0 had doubtful causal relations. Among the 282 cases with ADR, 175 （62.1%） patients continued the original treatment regimen, 89 （31.6%） patients changed or stopped ADR-related drugs, only 18 （6.4%） cases stopped MDR-PTB treatment. The episodes of ADR had no significant effect on the treatment outcomes （P〉0.05）.Conclusions Although ADR are common in MDR-PTB patients during the treatment course, most of the ADR can be managed. Through timely monitoring and appropriate treatment of ADR, most of the patients could continue MDR-PTB treatment.