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

Abstract

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. Key words: Tuberculosis, pulmonary; Tuberculosis, multidrug-resistant; Therapy; Adverse drug reactions