[Occurrence and recovery of adverse drug reactions of preventive treatment in elderly population with latent tuberculosis infection].

ABSTRACT

Objective: To evaluate the occurrence and recovery of adverse drug reactions (ADRs) of preventive treatment in the elderly population with latent tuberculosis infection (LTBI). Methods: A total of 2 583 elderly patients with LTBI were recruited in Zhongmu, Henan Province from July 1 to October 17, 2015. Face-to-face surveys and physical examinations were used to obtain the basic information of the participants, and the body mass index (BMI) was calculated. Fasting venous blood was collected from the participants for blood biochemical and routine blood tests. The random numbers were generated by Excel 2010, and the participants were divided into group A (1 284 cases) and group B (1 299 cases) by simple randomization. Both group A and group B received combination treatment of isoniazid and rifapentine. Group A was treated for 8 weeks with weekly doses of isoniazid at 15 mg/kg and 900 mg for those with body weight ≤50 and>50 kg, respectively, and the doses of rifapentin were 750 and 900 mg, respectively. Group B was treated twice a week for 6 weeks, the doses of isoniazid in patients with body weight ≤50 and>50 kg were [600-(50-body weight)×15] (rounded up) and 600 mg, respectively, and the doses of rifapentin were 600 and 450 mg, respectively. During the treatment period, doctors observed, inquired about and recorded symptoms related to ADRs, and blood biochemical and routine blood tests were performed at 4 weeks after taking the drug, the end of the treatment, and 3 months after the end of the treatment. The patients with ADRs were treated accordingly by severity. The ADRs and graded treatment outcomes of LTBI patients in group A and group B were compared. Results: The ageï¼»M（Q1，Q3）］of the participants was 60 (55,65) years old, and 54.7% (1 412/2 583) were males. There were no statistical differences in age, gender, BMI and baseline biochemical indexes between groups A and B (all P values>0.05). The incidence of ADRs in group A and group B were 18.5% (237/1 279) and 16.3% (209/1 279), respectively, and those with alanine aminotransferase (ALT)≥5 ULN accounted for 0.8% (7/931) and 1.1% (11/987), aspartate aminotransferase (AST)≥5 ULN accounted for 0.3% (3/931) and 0.3% (3/987), respectively, and there were no statistically significant differences (all P values>0.05). There were 7 and 11 patients with ALT≥5 ULN in group A and group B, respectively, and 3 patients with AST≥5 ULN for each group, respectively. After treatment, except for 2 patients with ALT≥5 ULN in group B, ALT and AST levels in all the other patients returned to normal. There were 15 and 10 patients with abnormal white blood cell count in group A and group B, respectively, and 10 and 9 patients returned to normal after treatment. Conclusion: LTBI preventive treatment has a high incidence of adverse drug reactions, but it can be effectively controlled through active monitoring and graded management.