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.

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.

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.

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%

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.