|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in 18 of them thiacetazone had to be withdrawn.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.
|DRUG TOXICITIES OBSERVED AMONGST THE PATIENTS TREATED
WITH INH AND THIOACETAZONE UNDER THE CONDITIONS OF DISTRICT TUBERCULOSIS
|GD Gothi, James O'Rourke & GVJ Baily: Proceed
21st Natl TB & Chest Dis Workers Conf, Calcutta 1966, 368-73.
Application of a combined regimen of INH and Thioacetazone
(TH) under conditions of District Tuberculosis Programme having
become a distinct possibility, the study observed its applicability
and toxicity. In all, 127 patients discovered during a mass Case-finding
investigation were treated in their homes with 300 mgm of INH and
150 mgm of thioacetazone in a single tablet once a day. Close supervision
of patients, laboratory or clinical examination to elicit toxic/side
effects were not practicable. During their initial motivation, patients
were asked to report back in the event of occurrence of unpleasant
symptoms. At subsequent drug collection, indirect questioning for
side effects was done. An active search for toxicity was also made
by the home visiting staff when they visited patients' homes for
In all, 23 patients complained of possible side
effects of thioacetazone, of which 5 were major and 18 of minor
nature. Among the 5 patients, two had exfoliative dermatitis and
three had generalised petechial haemorrhages. All were males above
the age of 40 years. All recovered with withdrawal of drugs and
anti histamines. The minor side effects were giddiness and vomiting.
None died of thioacetazone toxicity. It is concluded that TH regimen
can be used for mass application on account of therapeutic efficacy
and low price but consequences of side effects must be borne in
mind while using this drug combination under district programme
|KEY WORDS: CONTROL PROGRAMME, ADVERSE REACTIONS,
TH REGIMEN APPLICABILITY.
|A CONCURRENT COMPARISON OF AN UNSUPERVISED SELF-ADMINISTERED
DAILY REGIMEN AND A FULLY SUPERVISED TWICE WEEKLY REGIMEN OF CHEMOTHERAPY
IN A ROUTINE OUT-PATIENT TREATMENT PROGRAMME
|GVJ Baily, GE Rupert Samuel & DR Nagpaul: Indian
J TB 1974, 21, 152-67.
The relative merits of a fully supervised twice
weekly regimen of Streptomycin and INH (SHtW) and an unsupervised
daily regimen of INH and Thioacetazone (TH) in routine programme
conditions in an urban area are compared in terms of acceptability
and response to treatment at one year. Of the 474 newly diagnosed
sputum positive cases at Lady Willingdon TB Demonstration &
Training Centre, Bangalore during 1968-69, 134 were allocated to
SHtW regimen and 189 to TH regimen. All others who were unwilling
to take the allocated regimen or were excretors of bacilli resistant
to INH and or SM were analysed as a subsidiary group.
About 25% of the patients allocated to SHtW regimen
expressed unwillingness to start treatment on account of unsuitability
of working hours and or distance. Refusal to TH regimen was negligible
(5%). As regards drug acceptability after start of treatment, while
the duration of treatment taken was similar for both the regimens,
the level of drug intake achieved by the SHtW patients was lower
compared with TH patients i.e., 31.3% of the SHtW patients and 56.1%
of TH patients took more than 80% of treatment. If concealed irregularity
among TH patients is taken into consideration, it is likely that
the drug intake among TH patients would be similar to the drug intake
among SHtW patients. The acceptability was therefore almost similar
among SHtW and TH patients. Very low level (28%) of treatment completion
was achieved by SHtW patients. With TH regimen, 46% had made 10
or more monthly collections during 12 months. Among the SHtW patients
there was greater irregularity in the later months which was not
apparent among TH patients. However, the favourable response among
patients on SHtW and on TH regimen was 68% and 60%
respectively. Deaths among SHtW patients were 4%,
13.5% among TH patients, the difference being statistically significant.
The response was directly related to the level of drug collection
or supervised consumption. The large proportion of the patients
who stopped treatment prematurely, continued to remain positive
with drug sensitive organisms, if initially they were so. In the
subsidiary group there were 62 patients who were excretors
of drug resistant organisms. They were treated with drugs to which
their organisms were resistant and nearly 30% of these patients
had negative culture at the end of one year.
It is concluded that (i) SHtW regimen was superior
to TH as it prevented deaths and showed better bacteriological conversion
among patients with level 3 & 4 of treatment and (ii) treatment
organization is the most important factor in obtaining better results
in routine chemotherapy with available drug regimens.
|KEY WORDS: TH REGIMEN, DAILY REGIMEN, SUPERVISED
INTERMITTENT REGIMEN, ACCEPTABILITY, EFFICACY, CONTROL PROGRAMME.
|CONTROLLED STUDY OF THE EFFECT OF SPECIFIC TREATMENT
ON BACTERIOLOGICAL STATUS OF "SUSPECT CASES"
|Aneja KS, Gothi GD and GE Rupert Samuel: Indian
J TB 1979, 26, 50-61.
The effect of specific anti TB drugs on patients
having smear negative radiologically positive pulmonary tuberculosis
(suspect cases), was studied in Lady Willingdon Tuberculosis Demonstration
& Training Centre (LWTDTC), Bangalore during 1975 & 1976.
The main objective was to know the proportion of suspect cases treated
under the programme requiring the specific treatment with anti TB
drugs. A total of 457 suspect cases were randomly allocated to one
of the two regimens; 228 patients were treated with INH + Thioacetazone
(TH) and 229 with calcium gluconate (Placebo) regimens, for one
year. The placebo group allowed a concurrent comparison of status
of suspect cases without any specific treatment. After the intake,
sputum examination by direct smear, culture for M.tuberculosis and
sensitivity for drugs as well as X-ray examinations were carried
out at 0, 2nd, 4th, 6th, 9th and 12th month of treatment.
Among the 228 patients on TH, 103 (45.2%) were
real suspect cases, 83 (36.4%) sputum positive and remaining 42
non- tubercular. Similarly, out of the 229 patients on placebo regimen,
110 (48%) were real suspect cases, 61 (26.5%) sputum positive and
58 non- tubercular. The effect of treatment was measured by observing
the incidence of bacteriologically positive or radiologically active
disease from among the real suspect cases of the two groups.
At the end of the treatment period, 12.6% of TH group and
29.7% of placebo group were broken down, the difference
being statistically significant. Further, an element of self healing
was also observed, as about 40% of patients in placebo group showed
either clearance of lesions or continuing regression which could
be due to self healing or the lesion being non- tubercular in nature.
About 30% of the 457 patients at the start of the study were real
cases of tuberculosis who under the programme were missed and 20%
broke down with bacteriological positive or progress to radiologically
active disease when treatment was not offered. Thus, nearly 50%
of the suspect cases diagnosed in the programme required anti TB
treatment and for those requiring treatment, perhaps TH is not sufficient,
as 12.6% broke down in spite of treatment. It would be appropriate
to treat suspect cases both from the clinical and epidemiological
point of view after taking due precautions to remove non- tubercular
cases by doing repeat sputum examination.
|KEY WORDS: CONTROL STUDY, SUSPECT CASE, TH REGIMEN,