Comparison of the WHO Retreatment Regimen with the Six Drugs Regimen in Patients of Pulmonary Tuberculosis
Keywords:Tuberculosis, Mycobacterium Tuberculosis, Retreatment regimen
Objective: To compare the frequency of early response of WHO retreatment regimen with the six drugs regimen in pulmonary tuberculosis retreatment Category patients.
Study design: Randomized control trial (RCT)
Place and Duration: Chest Department, Fauji Foundation Hospital Rawalpindi from 22nd May 2016 to 22nd November 2016.
Methodology: Patients who had previously been treated for pulmonary tuberculosis for at least 1 month duration and is a failure, relapse or defaulter case presenting in Fauji Foundation Hospital Rawalpindi, both indoor and outdoor were enrolled in the study. Patients were randomized by lottery method to either of the two treatment arms; WHO retreatment regimen or six drug formulations. Clinical features were documented, baseline investigations, AFB smear, Gene Xpert and AFB Culture were sent. Drugs were given on once daily dosage. AFB smear and AFB culture were repeated at 3rd month of treatment. They had a regular follow up in Chest OPD and had monthly visits to the ophthalmology department for visual acuity, fundoscopy and to ENT department for audiometry. Their chest X-ray was done baseline then 3 months. Blood complete picture and liver function tests, serum uric acid, renal function tests were performed baseline, at 2 weeks then 3 months. After their treatment was completed they were followed to look for relapse.
Results: Total 490 patients were included according to the inclusion criteria of the study. Patients were divided into two equal groups. Mean age (years) in the study was 40.00+21.10. There were 33 (6.7) male and 457 (93.3) female patients whereas the frequency of early response of WHO retreatment regimen with the six drugs regimen in pulmonary tuberculosis retreatment category patients was 187 (76.3) and 211 (86.1) respectively which was statistically significant (p-value 0.000).
Conclusion: The study concludes that six drug regimen was superior to WHO standard regimen in the success rate of pulmonary tuberculosis retreatment category patients which useful in bringing new facts regarding management of retreatment category patient in our country as well as worldwide because of the limited research was done on this category of tuberculosis.