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108 |
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,
were investigated.
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
centres.
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KEY WORDS: SCC REGIMEN, DAILY REGIMEN, ADVERSE
REACTIONS, CONTROL PROGRAMME, FEASIBILITY. |
110 |
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.
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KEY WORDS: SCC, DAILY REGIMEN, OPERATIONAL FACTORS,
APPLICABILITY, CONTROL PROGRAMME. |
111 |
THE FATE OF RESISTANT CASES TREATED WITH THREE DIFFERENT
DRUG REGIMENS OF SHORT COURSE CHEMOTHERAPY UNDER PROGRAMME CONDITIONS |
P Jagota, TR Sreenivas, N Parimala & K Chaudhuri:
Indian J TB 1990, 37, 83-87. |
The fate of patients with isoniazid (H) resistant
pulmonary tuberculosis, treated with 3 different Short Course Chemotherapy
regimens (Regimen A-1 SHRZ/7TH, Regimen B-2SHR/6TH, Regimen C-2EHR/4H2R2)
was examined in two sequential studies. One hundred H resistant
patients belonging to two groups-one without history of previous
treatment(core group) and second with history of previous treatment
>=15 days (non-core group), were followed up at the end of 12th,
15th and 24th/36th month of chemotherapy. Bacteriological favourable
response among patients in the core group at the end of chemotherapy
with Regimen A, B and C were 65.2% of 23 patients, 50% of l8 patients,
and 57.1% of 18 patients respectively. The response among patients
in the non-core group were 27.3% with Regimen A and 52.6% with Regimen
B.
At the end of 24/36th month of chemotherapy, 62.5%
patients in the core group and 2 out of 7 in the non-core group
on regimen A and 68.7% patients on regimen C in the core group and
5 out of 15 in the core group and 41.7% in the non-core group on
regimen B were culture negative. The relapses were significantly
high in regimen B & C in comparison with regimen A. Thus, of
the total 100 patients, 99.3% were eligible for examination (1 died
during chemotherapy), 67 were examined and of them 37 (62.7%) were
culture negative, 22 positive and 8 were dead. The development of
drug resistance to rifampicin was directly related to the duration
of its use.
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KEY WORDS: SCC, DRUG RESISTANCE, EFFICACY, CONTROL
PROGRAMME, FATE. |
112 |
IMPROVEMENT IN CASE-FINDING IN DISTRICT TUBERCULOSIS
PROGRAMME BY EXAMINING ADDITIONAL SPUTUM SPECIMENS |
MA Seetha GE Rupert Samuel & N Parimala: Indian
J TB 1990, 37, 139-44. |
A study was conducted to augment Case-finding in
the programme by increasing case yield through repeated sputum examinations
by collecting 2-3 samples on the same day. The study was conducted
in nine Peripheral Health Institutions (PHIs) of Bangalore district.
They were all Microscopy Centres and were drawn on the basis of
random allocation. A Health Visitor (HV), Laboratory Technician
and Laboratory Attendants of National TB Institute (NTI) were posted
at the PHIs during the entire study period. After collection of
first sputum sample from the eligible chest symptomatics, 2nd, 3rd
or 4th samples were collected at an interval of half an hour from
those whose first specimen was negative. Separate smears were prepared
from all the specimens for examination at NTI. The duration of the
study was nine months.
From among 4233 total new outpatients, 458 chest
symptomatics were identified. Of them, 451 gave the first specimen,
416 the second specimen and 379 and 332 the 3rd and 4th specimen
respectively. There were a total of 25 smear positive cases; 18
were detected by the first specimen, 3 were added by second and
the remaining 4 by the 4th specimen. Of the 451 chest symptomatics,
185 were selected by the PHI Medical Officers (MOs) and 266 were
picked up by the NTI HVs from the remaining outpatients. Of the
25 cases detected, 10 came from the chest symptomatics selected
by the MOs and 15 came from those selected by the NTI HV. The study
has shown the feasibility of collecting multiple specimens of sputum
from each symptomatic on the same day. A loss of 60% cases was due
to casual symptom questioning by the MOs. It was further observed
that the intensity of the physical suffering has influenced the
behaviour of patients towards action taking. The sputum positivity
rate was 5.5%
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KEY WORDS: CASE-FINDING, CONTROL PROGRAMME,
SPUTUM EXAMINATION. |
115 |
RESULTS OF TREATMENT WITH A SHORT COURSE CHEMOTHERAPY
REGIMEN USED UNDER FIELD CONDITIONS IN DISTRICT TUBERCULOSIS PROGRAMME |
K Chaudhuri, P Jagota & N Parimala: Indian J
TB 1993, 40, 83-89. |
The treatment results of an unsupervised Short
Course Chemotherapy (SCC) regimen used under conditions of District
Tuberculosis Programme (DTP) are presented. The District Tuberculosis
Centre (DTC), Kolar and six of its Peripheral Health Institutions
(PHIs) formed the study area. No extra efforts except ensuring of
adequate availability of drugs at the participating centres were
made to obtain patients' compliance. In all, 584 smear positive
tuberculosis patients were diagnosed during the study period but
28.3% of the patients could not be initiated on treatment with the
chosen self administered SCC regimen -2EHRZ/6TH(EH).
Of the 382 put on treatment, only 33.2% completed
over 75% drug collections in both intensive and continuation phases.
The pattern of treatment compliance did not vary with the place
of treatment, i.e. DTC or PHI. Irrespective of treatment compliance,
nearly 72-77% of the patients attained smear negative status at
the end of the period of treatment, there being no difference between
PHI and DTC. However, deaths were higher in the PHI patients. This
could be attributed to a significantly higher proportion of aged
patients taking treatment at PHI than at DTC. Considering death
as an unfavourable outcome, overall favourable response was 65.9%.
Patients with drug sensitive bacilli had a higher rate of culture
negativity (70%), as compared to those with drug resistant bacilli
(48%). It was concluded that unsupervised SCC could give encouraging
results in a DTP setting, provided adequate drug supply was ensured.
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KEY WORDS: SCC, CONTROL PROGRAMME, OPERATIONAL
EFFICACY. |
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