|SOME OBSERVATIONS ON THE DRUG COMBINATION OF IN
H+THIACETAZONE UNDER THE CONDITIONS OF DISTRICT TUBERCULOSIS PROGRAMME
|GD Gothi, J O'Rourke & GVJ Baily: Indian J TB
1966, 14, 41-48.
A study was carried out to investigate the applicability
of INH-Thiacetazone (TH) combination with special reference to acceptability
and toxicity in Tumkur district. 150 patients from Tumkur town and
some nearby villages were discovered during a mass Case-finding
programme. Of them, 127 including 43 sputum positives were given
chemotherapy with 300 mgm INH and 150 mgm thiacetazone (TH), in
a single tablet to be taken once a day. All but one patient had
the treatment on an ambulatory basis. Results of treatment in respect
of 103 patients are presented in the paper.
The overall death rate was of the order of 15%.
About twice the number of deaths occurred among the sputum positive
patients than among the negative ones. About 40% of deaths occurred
during the first quarter. In all, 23 patients developed side effects,
in 18 of them thiacetazone had to be withdrawn. Serious side effects
occurred among 5 (4%) patients. These patients did not report to
the treatment centre by themselves and could not have been detected,
if home visits were not made, thus giving an erroneous impression
about side effects with TH. The sputum conversion at the end of
one year was of the order of 50% among all survivors. Among those
who were drug sensitive and examined at one year, conversion rate
was 63%. Favourable radiological response was seen in 74%.
Thus, though cheap and clinically effective, Thioacetazone
in combination with INH was found to produce serious and significant
side effects. Hence, vigilance by the treatment centres were thought
to be necessary when the patients are on this regimen.
|KEY WORDS: TH REGIMEN, ADVERSE REACTIONS, APPLICABILITY,
ACCEPTABILITY, CASE HOLDING.
|ORGANIZATIONAL EFFORT IN A CLINICAL TRIAL AND ITS
RELEVANCE TO APPLICABILITY OF SHORT-COURSE CHEMOTHERAPY IN NATIONAL
|KS Aneja & GE Rupert Samuel: Indian J TB 1982,
The high rate of treatment completion and the regularity
of drug intake achieved in clinical trials of Short Course Chemotherapy
(SCC), could possibly be attributed to efficient organizational
set-up, careful selection of cases and all-out effort to control
defaulters. The organizational effort put forth to achieve the regularity
is relevant to the applicability of SCC in the existing set-up of
District Tuberculosis Centres (DTCs) under National Tuberculosis
Programme (NTP). First 300 patients admitted to SCC trial to assess
the efficacy of three drug regimens of 3/5 months duration under
fully supervised conditions, carried out jointly by National Tuberculosis
Research Centre, Madras and National Tuberculosis Institute (NTI),
Bangalore, have been analysed for the purpose.
To keep up the regularity, 1/3rd of the patients
required home visits-some of them repeatedly. If the actions of
the same intensity of defaulter retrieval in the form of home visiting
are envisaged to be taken in a DTC with the normal working pattern
catering to 500 patients, 250 to 300 home visits will have to be
made in a month. This may not be feasible in the existing set-up
of NTP. A new strategy of defaulter retrieval actions for programme
conditions may have to be devised. Further, selection of drug regimen
which has the maximum potential of being given on self-administered
basis may reduce the work-load to a considerable extent. Drug toxicity,
side effects and the cost of drugs may not be major handicaps. However,
the only way to understand various operational problems is to undertake
scientific operational studies in actual working conditions of NTP.
|KEY WORDS: SCC, APPLICABILITY, CLINICAL TRIAL,
COMPLIANCE, CONTROL PROGRAMME.
|A STUDY OF OPERATIONAL FACTORS INFLUENCING THE APPLICABILITY
OF TWO REGIMENS OF SHORT COURSE CHEMOTHERAPY UNDER CONDITIONS OF AN
URBAN TUBERCULOSIS PROGRAMME
|P Jagota, Sudha Xirasagar, N Parimala & K Chaudhuri:
Indian J TB 1989, 36, 213-23.
An operational study of two regimens of Short Course
Chemotherapy (SCC) to assess their efficacy under programme conditions,
applicability and feasibility in District TB Programme (DTP) was
undertaken in an urban TB centre. The two regimens studied were
1SHRZ/7TH and 2SHR/6TH. Their operational efficacy (efficiency)
was found to be 87% and 92% respectively which had already been
reported in an earlier paper. The various factors i.e., initial
willingness, drug default, treatment completion pattern, adverse
drug reactions and initial drug resistance with their potential
harmful effects on the treatment outcome as well as work load and
extra cost these regimens entail for DTP organisation are discussed
in this paper.
Out of a total of 1822 smear positive patients
diagnosed at the Lady Willingdon State TB Centre during intake period
(Feb '84 to March '85), 1126 were residents of Bangalore City. Of
these 695 (61.7%) were unwilling to attend the clinic daily for
2 months, 27 were unfit and one was excluded by mistake. Thus, 403
(38.3%) initially willing patients were classified either as 'core
group' or 'Non core group, according to the history of previous
anti TB treatment (321 and 82 respectively). Of the 695 (77.6%)
unwilling persons, majority were those who pleaded inability to
attend daily for 2 months without specifying any particular reason.
Refusal of SCC due to injections accounted for 12.8% and 9.5% wanted
to take treatment elsewhere. Old age influenced willingness adversely.
Of the 321 patients in the core group, 56 were
excluded due to missing more than 50% of intensive phase doses.
Among the remaining patients, 61 (48%) out of 127 patients on Regimen
A and 48 (34%) out of 138 on Regimen B, did not make a single default
in the intensive phase. Of the total 910 defaults for which actions
were taken, 640 (70%) were retrieved by letter writing,
among the remaining 293 (72%) were retrieved by home visiting.
Main reasons for default elicited during home visits were: going
out of station (52.9%) followed by patients being busy with work
(19.1%). Compensatory phase was availed by 156 of the 265 patients
who missed one or more doses due to default in the treatment. The
pattern of treatment completion of 321 core group patients in the
two regimens were similar i.e., in both the phases 65% for Regimen
A and 63% for Regimen B. Incidence of minor adverse reactions was
28% and major toxic reactions were experienced by 8.4% of patients.
Workload for treating 321 patients was due to supervised administration
of drug 45 patients per day. Letter writing to 3.1 per patients,
home visiting 1.1 per patient and doctor's attention for adverse
reaction 2 occasions per patient. This could be managed with the
existing staff. The cost of Regimen A was Rs.220/ per patient and
for Regimen B, 268/ per patient. Cost to patient for transportation
was Rs.70/ and Rs.113/ for Regimen A and B respectively.The major
disturbing finding of the study was initial low acceptability of
about 40% for SCC. The home visiting which was crucial in increasing
the completion rate in this study is usually not available in most
of the DTCs. Workload, adverse reactions etc. were not of any problem
for implementation of SCC in the programme.
|KEY WORDS: SCC, DAILY REGIMEN, OPERATIONAL FACTORS,
APPLICABILITY, CONTROL PROGRAMME.