A comparative study on the adverse effects of two antituberculosis drugs regimen in initial two-month treatment period
DOI:
https://doi.org/10.3329/bjp.v1i2.488Keywords:
Bangladesh, Isoniazid, Pyrazinamide, Rifampicin, TuberculosisAbstract
Tuberculosis (TB) is a leading cause of death throughout the world and Bangladesh stands 4th among high burden countries. Treatment of TB hampered with poor patient compliance and intolerance at least partly due to the adverse drug reactions. A prospective longitudinal non-randomized case study was conducted on 64 Hospital admitted patients diagnosed as primary (category I) and resistant or treatment failure (category II) to compare adverse effects between two anti-TB drug treatment regimen based on diagnostic category. Category I received four drug (rifampicin, isoniazid, ethambutol, pyrazinamide) and category II received five drug (rifampicin, isoniazid, ethambutol, pyrazinamide, sparfloxacin) combination treatments for initial 2 months under DOTS during the period of July 2004 to July 2005. Adverse effect parameters e.g. gastrointestinal disturbances, arthralgia, hepatic dysfunction and renal impairment were estimated before, two and eight weeks after initiation of treatment. Predisposing risk factors for adverse effects e.g. age, sex, nutritional status, associated disease, habits were also analyzed. In our study, 76.47% of total patients experienced some sorts of adverse effects. In 4- and 5-drug regimen groups adverse reaction were observed in 50% and 95% of patients respectively. Serum bilirubin, SGPT, creatinine did not change in neither of the treated group while alkaline phosphatase tended to decrease and uric acid to increase. No disease was established to be risk factor for drug intolerance.
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References
Bass JB, Farer LS, Hopewell PC, OBrien R, Jacobs RF, Ruben F, Snider DEJ, Thornton G. Treatment of tuberculosis and tuberculosis infections in adults and children. Am J Respir Crit Care Med. 1994: 149: 1359-74.
Benoor KS, Mahmood AM. Huq AKMS. Multidrug resistant tuberculosis: Problem arise. Abstract, The National Conference of Chest; 1998, p 15.
Blomberg B, Spinaci S, Fourie B, Laing R. The rationale for recommending fixed-dose combination tablets for treatment of tuberculosis. WHO 2001; 79: 61-68.
Chowdhury AM. Chowdhury S. Islam MN, Islam A, Vaughan JP. Control of tuberculosis by community health workers in Bangladesh. Lancet 1997; 350: 169-72.
Dutt AK. Moers D, Stead WW. Undesirable side-effect of isoniazid and rifampicin in largely twice-weekly short-course chemotherapy for tuberculosis. Am Rev Respir Dis. 1983; 128: 419-24.
Fattinger K, Braunschweig S, Reichen J, Meier-Abt PJ, Krahenbuhl S. Liver injury under tuberulostatic treatment. Schweiz Rundsch Med Prax. 1997; 86: 626-29.
Fauzi AR, Shah A, Rathor MY, Satwi S, Risk factors for antituberculous drugs-induced hepatitis: A prospective survey from a chest clinic in a general hospital. Med J Malaysia. 2004; 59: 72-77.
Girling DJ. The hepatictoxicity of antituberculosis regimens containing isoniazid, rifampicin and pyrazinamide. Tubercle 1978; 59: 13-32.
Grange JM. Drug resistance and tuberculosis elimination. Bull Int Union Tuberc Lung Dis. 1990; 65: 57-59.
Haque MA, Golam Nabi PD. Achievements of national TB control program. Bangladesh Med Res Counc Bull. 1999; 25: 71-82.
Haque ME, Yousuf M, Haque AKMS. A study on side effects of thiacetazone. Chest Heart Bull. 1995; 2: 63-65.
Hussain Z, Kar P, Hussain SA. Antituberculosis drug- induced hepatitis: Risk factors, prevention and management. Indian J Exp Biol. 2003; 41: 1226-32.
Lee AM, Mennone JZ, Jones RC, Paul WS. Risk factors for hepatotoxicity associated with rifampicin and pyrazinamide for the treatment of latent tuberculosis infection: Experience from three public health tuberculosis clinics. Int J Tuberc Lung Dis. 2002; 6: 995-1000.
Lee WM. Drug-induced hepatotoxicity. N Engl J Med. 2003; 349: 474-85.
Maddrey WC. Drug-induced hepatotoxicity. J Clin Gastroenterol. 2005; 39: S83-89.
Marti L, Del Olmo JA, Tosca J, Ornia E, Garcia-Torres ML, Serra MA, Rodriguez F, Lluch P, Escudero A, Rodrigo JM. Clinical evaluation of drug-induced hepatitis. Rev Esp Enferm Dig. 2005; 97: 258-65.
Mathus KC, Jain VK, Gupta PP, Jain A. Multiple drug reaction during chemotherapy of tuberculosis. Indian Med Gazette. 1979; 8: 274.
Mohan A, Sharma SK. Side effects of anti-tuberculosis drugs. Am J Respir Crit Care Med. 2004; 169: 882-83.
Ohkawa K, Hashiguchi M, Ohno K, Kiuchi C, Takahashi S, Kondo S, Echizen H, Ogata H. Risk factors for anti-tuberculosis chemotherapy-induced hepatotoxicity in Japanese pediatric patients. Clin Pharmacol Ther. 2002; 72: 220-26.
Ormerod LP, Horsfield N. Frequency and type of reactions to anti-tuberculosis drugs: Observation in routine treatment. Tuberc Lung Dis. 1996; 77: 37-42.
Pande JN, Singh SP, Khilnani GC, Khilnani S, Tandon RK. Risk factors for hepatotoxicity from anti-tuberculosis drugs: A case-control study. Thorax 1996; 51: 132-36.
Pereira RM, Tresoldi AT, Hessel G. Isoniazid-induced hepatic failure report of a case. Arq Gastroenteral. 2000; 37: 72-75.
Postlethwaite AE, Bartel AG, Kelley WN. Hyperuricemia due to ethambutol. N Engl J Med. 1972; 286: 761-62.
Resi D, Gangliotti C, Moro ML. Side effects of anti-tuberculosis therapy. Am J Respir Crit Care Med. 2004; 169: 542.
Schaberg T, Rebhan K, Lode H. Risk factors for side-effect of isoniazid, rifampicin and pyrazinamide in patients hospitalized for pulmonary tuberculosis. Eur Respir J. 1996; 9: 2026-30.
Scott JT. Drug-induced gout. Baillieres Clin Rheumatol 1991; 5: 39-60.
Shakya R, Rao BS, Shrestha B. Incidence of hepatotoxicity due to anti-tubercular medicines and assessment of risk factors. Ann Pharmacother. 2004; 38: 1074-79.
Smith JM, Zirk MH. Toxic and allergic drug reaction during the treatment of tuberculosis. Tubercle. 1961; 42: 287.
Solangi GA. Zuberi BF, Shaikh S, Shaikh WM. Pyrazinamide-induced hyperuricemia in patients taking anti-tuberculosis therapy. J Coll Physicians Surg (Pak). 2004; 14: 136-38.
Thamari JP, Gupta VK. Hypersensitivy of multiple drug in treatment of pulmonary tuberculosis. Indian J Tuberc. 1981; 28: 143.
Tost JR, Vidal R, Cayla J, Diaz-cabanela D, Jimenez A, Broquetas JM. Study group for severe hepatotoxicity due to anti-tuberculosis drugs. Int J Tuberc Lung Dis. 2005; 9: 534-40.
Tsai RK, Lee YH. Reversibility of ethambutol optic neuropathy. J Ocul Pharmacol Ther. 1997; 13: 473-77.
Van leuven M. De Groot M, Shean K. Pulmonary resection as an adjunct in the treatment of multidrug resistant tuberculosis. Ann Throac Surg. 1997; 63: 1370-72.
Vandeun A. Portalels F. Limitation and requirement for quality control of sputum smear microscopy for AFB. Int J Tuberc Lung Dis. 1998; 2: 756-57.
WHO. Guide line for the management of drug resistant tuberculosis. 1998, pp 5-8.
WHO. Standardized treatment regimens. Treatment of tuberculosis. Guide lines for national programs, WHO/ TB. 2nd ed. 1997, pp 23-31.
WHO. TB deaths reach historic levels. Press release WHO; 1996, pp 1-3.
WHO. Treatment of tuberculosis guidelines for national program 3rd ed. Geneva, WHO/CDS/TB/ 2003, p 313.
Wright PW, Wallace RJ Jr, Write NW, Brown BA, Griffith DE. Sensitivity of flurochrome microscopy for detection of mycobacteria. J Clin Microbial. 1998; 4: 1046-49.
Zierski M, Bek E. Side-effect of drug regimens used in short course chemotherapy for pulmonary tuberculosis a controlled clinical study. Tubercle 1980; 61: 41-49.
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