The Changes in Levels of Serum Alanine Aminotransferase (ALT) During Anti Tubercular Treatment With 4FDC (Fixed Drug Combination)

Abstract

Tuberculosis (TB) is emerging as a major public health problem in Bangladesh, which now has the fifth highest burden of TB cases globally. Treatment of TB hampered with poor patient compliance and intolerance at least partly due to the adverse drug reactions, one of which is hepatotoxicity. Serum alanine aminotransferase level is an important indicator of such condition and impacts upon the continuation of anti tubercular treatment. A prospective randomized case study was conducted among 62 patients diagnosed as pulmonary tuberculosis receiving category I anti-TB drug treatment regimen in the DOTS (Direct observation therapy shortcourse) providing centers at Pabna district under DOTS during the period of July 2004 to July 2006. Category I comprised of four drugs (Rifampicin, Isoniazid, Ethambutol, Pyrazinamide) combination patients treated for initial 2 months, serum alanine aminotransferase levels were estimated at the first and fourth week of the treatment. Serum billirubin, HBsAg, Anti-HCV was also done to exclude some other liver diseases. 14(22.58%) patients were found to have no significant change, 34(54.84%) patients had their levels in the upper limits, 13(20.97%) patients had their levels in-between the upper limit and twice of the upper limit, while only 1(1.6%) patient crossed the level twice the upper limit.

Implementation of Self Reporting Pharmacovigilance in Anti Tubercular Therapy Using Knowledge Based Approach

“…Among the full population 43 (39.09%) patients experienced at least one ADR during the time of study period ( Figure 1). The prevalence of ADR occurrence as per three different studies [5,10,11] during the intensive phase of ATT were found to be 22%, 30%, and 55%.…”

“…It is found that males were more prone to tuberculosis when compared to females with a ratio of 7:3. A study conducted by Mahmood et al [5], reveals that the pervasiveness of tuberculosis is more in males than females with a ratio of 5:1. Also the National Tuberculosis Program (NTP) summarized as the ratio of the occurrence of TB between the male and female were 5:2.…”

“…ATT exhibits greater level of efficacy with a satisfactory degree of toxicity; however combination treatment may produce severe adverse events. Important adverse effects are hepatitis, joint pain, skin rash, gastro intestinal upset (nausea/vomiting/GI upset), hyperuricemia, constipation, peripheral neuropathy, and visual disturbances [5][6][7][8][9][10][11][12][13][14]. TB hampered with poor patient compliance and intolerance at least partially due to the ADRs.…”