Introduction

One Fifth of the global T.B. incidence is in India, with 1.8 million new cases every year, 0.8 million of these being infective and smear positive cases. The disease incidence peaks in people belonging to the most economically productive age group of 15-60 years.

Peripheral lymph node involvement is the commonest form of extra pulmonary mycobacterial tuberculosis and the cervical region is the most commonly affected site. Tuberculous cervical lymphadenitis tends to occur more often in females and presents in young adults. According to Raviglione et al, HIV is the single most important risk factor for the progression of dormant tuberculosis into clinical disease, the virus compromising the immune response.

The Revised National Tuberculosis Control program was introduced in India in 1993, and expanded to cover the entire population by June 2005. The RNTCP applied the WHO recommended DOTS strategy (Directly Observed Treatment Short Course), thus shifting the responsibility for cure from the patient to the health system.

A study was carried out in the Goa Medical College (GMC) – Bambolim, Goa, comparing the standard Three-drug anti-tuberculous treatment regimen to DOTS in the management of Tuberculous Lymphadenitis on an outpatient basis.

Material And Methods

Study Population

Pretreatment Investigations

Logistics

Patients with self administered regimen were asked to visit the GMC OPD once a month to collect the drugs to be self administered at home. They also had to follow up at the end of two months and at completion of treatment.

Patients started on Category III DOTS were registered under the same and asked to follow up at the closest health centre for drug collection. For the first two months (24 doses), the patient visited the health centre thrice weekly and took anti-tuberculous treatment under direct supervision of the DOTS provider. For the next four months (54 doses), the patient visited the DOTS centre once weekly to collect the blister pack for the weekly treatment.

One separate box containing blister packed rugs was earmarked for the patient in the health centre from Day 1 of treatment to avoid treatment interruption due to drug shortage. The patient followed up in GMC OPD at two months and six months for assessment.

Figure 1

After Default to Migration to Other States

Results

Patient Allocation: Fifty patients fulfilling the criteria of eligibity were admitted to the study. By random allocation, twenty-five were prescribed AKT3 regimen and the remaining were prescribed DOTS regimen

Response at two months: All twenty-five patients in the DOTS group showed a favorable response (reduction in size of lymph node size) at the end of two months. No such reduction was seen in the AKT3 group(statistical difference p<0.001)

Response after six months:Both groups showed a favorable response after six months of therapy. There were three defaulters in the DOTS group due to migration to other states, and could not be followed up

Figure 2

Chart Showing Response Of Lymphnode Regression To Dots V/S Akt3

Discussion

Chaube et al ³ in a study comparing THSH2/SH2, SH2 and TH showed that all three chemotherapeutic regimens were equally efficacious, acceptable and well tolerated. Our study compared daily administered 2HRZ/4HR to supervised intermittent 2HRZ/4HR and showed that while DOTS achieved better initial gland clearance, it was equally efficacious as AKT3 over six months.

Baily et al ² in a concurrent comparison of unsupervised self administered daily regimen and a fully supervised twice weekly regimen of chemotherapy in routine OPD treatment program, showed that, in rural areas, due to distance and nature of employment, refusal for supervised regimen played a role in reducing drug collection for SHTW as compared to TH patients. In our study, defaults were recorded in the DOTS group, primarily due to migration to other states, during the course of the study.