Adverse events when treating XDR tuberculosis

Abstract

The article presents the results of a clinical study on the frequency and spectrum of adverse events (AEs) that occur during treatment with an anti-tuberculosis drug (thioureidoiminomethylpyridinium perchlorate, Tpp).

The purpose of the study was to determine the frequen­cy and nature of adverse events when TPP is included in the treatment regimen and to develop an algorithm for the prevention of adverse reactions.

Materials and methods: 125 (N=125) patients with MDR and XDR tu­berculosis were examined. 70.4% (88) patients developed adverse events. Results and discussion: At the same time, adverse reactions occurred in 58.3% (35) of the main group, and in 69.2% (45) of the control group. There were no significant differences in the frequency of adverse events between the main and control groups (?2=1.608, 95% CI 0.298-1.298, p>0.05). In the control group, diges­tive and hepatobiliary AEs were more frequent (up by 8.6% and 3.5%, respectively). On the other hand, derma­tological reactions prevailed in the main group (up by 3.8%). Tpp was not shown to be the main cause of drug induced hypothyroidism, it can jointly reinforce thyrotox­ic effect when used in combination with protionamide and/or PASA (para-aminosalicylic acid). Statistic analy­sis showed no significant differences in any class of AEs between the groups (p>0.05 for all AE categories). Up to 68% of adverse reactions were mild (1 and 2 grade).

Con­clusion. Thioureidoiminomethylpyridinium perchlorate is not the main cause of drug induced hypothyroidism, it can jointly reinforce thyrotoxic effect when used in combina­tion with protionamide and/or PASA.