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B : Programme Development
 
089
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 In all, 23 patients developed side effects, in 18 of them thiacetazone had to be withdrawn.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.

095
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.

099
ACCEPTABILITY OF BCG VACCINATION AMONG RURAL COMMUNITY
MA Seetha, N Srikantaramu & Hardan Singh: Indian J Prev & Soc Med 1980, 2, 57-63.

A study on acceptability of BCG vaccination, through specialised technicians in a population of 8350 residing in 8 villages of Channapatna taluk of Bangalore district, was carried out by National Tuberculosis Institute. Of the 1106 households satisfactorily interviewed, 956 (86.4%) had at least one child eligible for vaccination. For the purpose of analysis they were classified into three groups. Group I consisted of 312 (32.6%) households in which all children were vaccinated, Group II 270 (28.2%) where non-e of the children were vaccinated and Group III 374 (39.2%) households where only some of their children were vaccinated. Overall vaccination coverage was 52.7% with a range of 33.9% to 79.3%.

The reasons for refusing vaccination were studied. The caste, occupation, education etc., of the household did not have any influence on the refusals. When analysed according to the knowledge and opinion about vaccination it was observed that 55.9% of the children were not vaccinated because of the lack of knowledge in the group where no child was vaccinated. Even when 42% had favourable opinion about vaccination, 52% of the households did not vaccinate any of their children. The refusals were mainly due to (i) absence from the village on the day of vaccination, (ii) fear of prick. Among households where there was unfavourable opinion, all had refused due to fear. The reasons for accepting BCG vaccination were (i) the vaccination was done in the school and hence there was no option for the parents to accept or refuse, (ii) parents felt that the vaccination was good for children, (iii) parents knew that it would prevent TB.

KEY WORDS: BCG VACCINATION, ACCEPTABILITY, RURAL COMMUNITY.
 

 
  BCG  
 
 
127
SIMULTANEOUS SMALLPOX AND BCG VACCINATION
Kul Bhushan, GVJ Baily & VB Naidu: Indian J TB 1968, 15, 52-56.

A study was carried out in Bangalore city corporation area with the following objectives; when BCG vaccination is administered simultaneously with primary smallpox vaccination to infants; (i) whether any immunological interferences take place as indicated by the development of vaccination lesion and post-vaccination allergy due to BCG vaccination and the development of the local lesion (take rate) of smallpox vaccination; (ii) whether the incidence of complications are higher among those simultaneously vaccinated and, (iii) whether the population will accept a procedure involving two vaccinations. BCG technicians and the smallpox vaccinators registered all the eligible children after house to house visit and randomly allocated to three groups. A total of 789 children aged below one year were admitted to the study. While 315 were vaccinated simultaneously with BCG and smallpox vaccines (BCG on the right arm and smallpox on the left), 255 were vaccinated with smallpox vaccine only and 219 with BCG vaccine. All 789 children were followed up on the 5th, 21st, 90th and 93rd day of vaccination. The 5th and 21st day followups were to study the development and healing of smallpox vaccination lesions, whereas the 21st, 90th and 93rd day followups were for BCG vaccination lesions. The 90th and 93rd followups were for tuberculin testing and reading.

It was found that there was no evidence of immunological interference between the two vaccines when administered simultaneously i.e., the development of lesion of smallpox vaccination among the simultaneously vaccinated group was similar to the development of the smallpox vaccination lesion among the only smallpox vaccinated group and, the post-vaccination allergy due to BCG among the simultaneously vaccinated group was similar to the post-vaccination allergy among the only BCG vaccinated group. The complications due to vaccinations were very few and similar among the simultaneously vaccinated as compared to the other respective groups. The acceptability of simultaneous vaccination was higher than BCG alone. The above study has demonstrated that BCG and smallpox vaccinations can be administered simultaneously.

KEY WORDS: SIMULTANEOUS BCG & SMALLPOX VACCINATION, ASSESSMENT, ACCEPTABILITY, COMMUNITY.
 
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