|A CONTROLLED CLINICAL TRIAL OF 3 AND 5 MONTH REGIMENS
IN THE TREATMENT OF SPUTUM POSITIVE PULMONARY TUBERCULOSIS IN SOUTH
|Tuberculosis Research Centre, Madras and National Tuberculosis
Institute, Bangalore: Ame Rev Respir Dis 1986, 134, 27-33.
A controlled clinical trial of the three Short
Course Chemotherapy (SCC) regimens was carried out at the Lady Willingdon
State Tuberculosis Centre, Bangalore and Tuberculosis Research Centre,
Madras with the collaboration of National Tuberculosis Institute,
Bangalore. The regimens were (1) R3: (rifampicin, streptomycin,
isoniazid and pyrazinamide daily for 3 months (3RSHZ); (2) R5: same
as regimen R3, followed by streptomycin, isoniazid, pyrazinamide
twice weekly for 2 months (3RSHZ/2S2H2Z2); (3) Z5: same as regimen
R5 but without rifampicin (3SHZ/2S2H2Z2). Newly diagnosed tuberculosis
patients who were aged 12 years or more had no history of previous
treatment and two sputum cultures positive for M.tuberculosis were
taken to the study and allocated at random to one of the above stated
three regimens. The patients were given supervised chemotherapy
as out patients. Sputum specimens were examined by fluorescent microscopy,
culture by modified Petroff's method, tested for sensitivity to
INH, rifampicin, streptomycin and ethambutol. The follow up was
done by sputum smear and culture examination at the end of every
month for 2 years. The distribution of various pre treatment characteristics
like age, sex, and initial sensitivity status were similar in the
three series. At the end of 3 months, of the 455 patients on R3,
and R5 series, 96% with drug sensitive organism became culture negative
and of 235 on Z5 series 93% became culture negative. For R5 and
Z5 series favourable response at the end of chemotherapy were 96%,
99% and 97% respectively. In all, 6 patients (3 R3 & 3 Z5) were
classified as having unfavourable response. At the end of 24th month
from the date of start of treatment, 20% of the 200 patients
on R3, 4% of 187 patients on R5 and 13% of 199 patients on
Z5 had bacteriological relapse. The difference between R3 and Z5
series was highly significant. (p = 0.00001). The relapse rates
in R3 & Z5 series were significantly higher than that in R5.
Of the 57 patients with initial drug resistance organisms in R3
and R5 series combined 4 had an unfavourable response to treatment
compared with 13 of 26 in the Z5 series (p = 0.0001). Of the 4 patients
with an unfavourable response in R3 and R5 series combined, resistance
to rifampicin emerged in 2 patients. Complaints of arthralgia were
made by 45% of the R3 and R5 patients combined and 70% of Z5 patients
(p = 0.00001). However, chemotherapy was modified in only 5 and
12% respectively. Jaundice occurred in 7% of the R3 and R5 patients
and 1% of the Z5 patients (p = 0.0001).
|KEY WORDS: SCC REGIMEN, DAILY REGIMEN, CLINICAL
TRIAL, EFFICACY, ADVERSE REACTIONS.
|A STUDY ON ADVERSE DRUG REACTIONS IN TWO REGIMENS
OF SHORT COURSE CHEMOTHERAPY
|Sudha Xirasagar, P Jagota, N Parimala & K Chaudhuri:
NTI Newsletter 1989, 25, 51-60.
In a study of feasibility of treatment of smear
positive patients with Short Course Chemotherapy (SCC) regimens
under District TB Programme (DTP) conditions in a city, adverse
drug reactions in terms of frequency of episodes, incidence in the
cohort of patients, time of occurrence, major adverse reactions
requiring modification of chemotherapy and or symptomatic treatment,
Patients were allocated to one of the two 8 month
SCC regimens i.e., Regimen 'A' 1 SHRZ/6TH, Regimen 'B' 2SHR/6TH.
Overall incidence of adverse drug reaction in cohort of 265 patients
was 37%, 9% of which were considered as major in nature. 34 episodes
of such reactions resulted in modification of chemotherapy in 15
patients during intensive phase. Though gastro intestinal symptoms
were predominant, cutaneous toxicity was the pre eminent cause of
modification of regimen. No case of exfoliative dermatitis occurred.
A total of 333 episodes of adverse drug reactions of minor nature
occurred; 50% being gastro intestinal symptoms followed by cutaneous
symptoms. More than 70% of all adverse drug reactions of intensive
phase occurred in the first half of the period. There was no significant
difference between the two regimens in the incidence of adverse
drug reactions of either major or minor in nature.
SCC is being implemented in a phased manner in
the DTP. Before introducing SCC in large number of districts, it
would be prudent to find out whether SCC would be acceptable to
both doctor and patient in terms of adverse drug reactions.
It can, therefore, be concluded that adverse reactions may not be
a major constraint for inclusion of SCC under DTP for treating sputum
positive tuberculosis patients provided that additional resources
and man power are allocated to the DTCs to manage patients in the
centre and extend effective guidance to staff working in peripheral
|KEY WORDS: SCC REGIMEN, DAILY REGIMEN, ADVERSE
REACTIONS, CONTROL PROGRAMME, FEASIBILITY.