Does Drug-Resistant Extrapulmonary Tuberculosis Hinder TB Elimination Plans? A Case from Delhi, India
Abstract
:1. Introduction
2. Methods
2.1. Study Design
2.2. Setting
General Setting
- Cure: Treatment completed as recommended by the national policy without evidence of failure, and three or more consecutive cultures taken at least 30 days apart during CP are negative, including culture at the end of treatment.
- Treatment completed: Treatment completed as recommended by the national policy without evidence of failure, but no record that three or more consecutive cultures taken at least 30 days apart are negative after the intensive phase.
- Treatment success: This is a combination of cure plus treatment completed.
- Treatment failure: Treatment terminated or a need for permanent regimen change of at least two or more anti-TB drugs in CP because of the lack of microbiological conversion by the end of the extended intensive phase or microbiological reversion in the continuation phase after conversion to negative or evidence of additional acquired resistance to FQ or SLI drugs or adverse drug reactions (ADR).
- Death: A patient who dies for any reason during the course of treatment.
- Treatment lost-to-follow-up: A patient whose treatment was interrupted for one month or more for any reasons prior to being declared as failed.
- Not evaluated: A patient for whom no treatment outcome is assigned.
- Regimen changed: A TB patient’s need for permanent regimen change of at least one or more anti-TB drugs prior to being declared as failed.
- Treatment stopped due to adverse drug reactions: A patient who develops adverse drug reactions and cannot continue the M/XDR-TB treatment in spite of the management of adverse drug reactions as per the defined protocols and a decision has been taken by the DR-TB Centre committee to stop treatment.
2.3. Study Site
2.4. Study Population
2.4.1. Data Variables, Sources of Data and Data Collection
2.4.2. Data Analysis and Statistics
3. Ethics Approval
4. Results
4.1. Patient Characteristics
4.2. Adverse Drug Reactions (ADRs)
4.3. Delay in Treatment Initiation
4.4. Treatment Outcomes
5. Discussion
6. Conclusions
Supplementary Materials
Author Contributions
Funding
Acknowledgments
Conflicts of Interest
References
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Characteristics | Number | (%) | |
---|---|---|---|
Sex | Male | 92 | (45.3) |
Female | 111 | (54.7) | |
Age (years) | < 15 | 50 | (24.6) |
15–44 | 147 | (72.4) | |
45 and above | 06 | (3.0) | |
Weight (in kilograms) | < 30 | 41 | (20.2) |
31–50 | 93 | (45.8) | |
Above 50 | 69 | (34.0) | |
DR-TB Centre | Centre 1 | 56 | (27.6) |
Centre 2 | 59 | (29.1) | |
Centre 3 | 88 | (43.3) | |
Site of disease | Peripheral lymph node | 108 | (53.2) |
Deep lymph node | 10 | (4.9) | |
Brain | 09 | (4.4) | |
Bone | 69 | (34.0) | |
Pleural effusion | 19 | (9.4) | |
Abdomen | 10 | (4.9) | |
Heart | 0 | (0) | |
Genital | 02 | (1.0) | |
Basis of diagnosis | CBNAAT | 173 | (85.2) |
Culture | 2 | (1.0) | |
Line Probe Assay | 20 | (9.9) | |
Clinical | 8 | (3.9) | |
Drug Resistance | HR | 19 | (9.4) |
Rifampicin | 195 | (96.1) | |
Fluoroquinolone | 05 | (2.5) | |
Other injectables | 02 | (1.0) | |
History of TB | Yes | 178 | 87.7 |
No | 24 | 11.8 | |
Not recorded | 01 | (0.5) | |
HIV status | Negative | 200 | (98.5) |
Positive | 03 | (1.5) | |
Diabetes | Yes | 05 | (2.5) |
No | 198 | (97.5) | |
Severe adverse reaction | Yes | 58 | (28.6) |
No | 145 | (71.4) |
Adverse Drug Reactions | Number | (%) |
---|---|---|
Severe vomiting | 26 | 12.8 |
Behavior disorder | 15 | 7.4 |
Hearing loss | 7 | 3.4 |
Severe joint pain | 21 | 10.3 |
Renal disturbance | 03 | 1.5 |
Allergic reaction | 04 | 2.0 |
Recurrent hepatitis | 01 | 0.5 |
Gynaecomastia | 02 | 1.0 |
Thyroid disturbance | 02 | 1.0 |
Peripheral neuropathy | 01 | 0.5 |
Vision loss | 01 | 0.5 |
Others | 02 | 1.0 |
Adverse Drug Reactions | Number | (%) |
---|---|---|
Treatment success | 134 | 66.0 |
Unfavourable treatment outcome | 69 | 34.0 |
Death | 14 | 6.9 |
Treatment failure | 1 | 0.5 |
Lost to follow up | 40 | 19.7 |
Regimen changed | 3 | 1.5 |
Treatment stopped d/t ADR | 0 | 0.0 |
Not evaluated | 11 | 5.4 |
Variables | Treatment Outcome | RR (95% CI) | p-Value | aRR (95% CI) | p-Value | |||
---|---|---|---|---|---|---|---|---|
Total | Unfavourable | |||||||
N | n | % | ||||||
Sex | Male | 92 | 35 | (38.0) | 1.2 (0.8–1.8) | 0.2 | 1.3 (0.9–1.9) | 0.13 |
Female | 111 | 34 | (30.6) | 1.0 | 1.0 | |||
Age (years) | ≥ 15 years | 153 | 57 | (37.3) | 1.6 (0.9–2.7) | 0.08 | 1.6 (0.8–3.0) | 0.14 |
< 15 years | 50 | 12 | (24.0) | 1.0 | 1.0 | |||
Weight (in Kilograms) | < 30 | 41 | 8 | (19.5) | 1.0 | 1.0 | ||
31–50 | 93 | 37 | (39.8) | 2.0 (1.1–4.0) | 0.02 | 1.8 (1.2–3.4) | 0.02 | |
Above 50 | 69 | 24 | (34.8) | 1.8 (0.9–3.6) | 0.09 | 1.6(0.8–3.0) | 0.1 | |
DR-TB Centre | Centre 1 | 59 | 16 | (27.1) | 1.0 | 1.0 | ||
Centre 2 | 88 | 37 | (42.0) | 1.6 (1.0–2.5) | 0.06 | 1.5 (1.0–2.5) | 0.05 | |
Centre 3 | 56 | 16 | (28.6) | 1.05 (0.6–1.9) | 0.8 | 1.0 (0.7–2.0) | 0.8 | |
Site of disease | Others | 104 | 38 | (36.5) | 1.2 (0.8–1.7) | 0.4 | ||
Lymph node | 99 | 31 | (31.3) | 1.0 | ||||
Basis of diagnosis | Others | 30 | 10 | (33.3) | 1.0 (0.6–1.7) | 0.9 | ||
CBNAAT | 173 | 59 | (34.1) | 1.0 | ||||
History of previous TB | Yes | 178 | 65 | (36.5) | 2.3 (1.0–5.7) | 0.04 | 2.1 (1.1–4.8) | 0.03 |
No | 25 | 4 | 16.0) | 1.0 | 1.0 | |||
HIV status | Negative | 200 | 67 | (33.5) | 1.0 | 0.3 | ||
Positive | 3 | 2 | (66.7) | 2.0 (0.9–4.5) | ||||
Diabetes | Yes | 5 | 3 | (60.0) | 1.8 (0.9–3.8) | 0.2 | 1.9 (0.9–3.4) | 0.18 |
No | 198 | 66 | (33.3) | 1.0 | 1.0 | |||
Severe adverse reaction | Yes | 58 | 16 | 27.6 | 1.0 | 0.2 | 1.0 | |
No | 145 | 53 | 36.6 | 1.3 (0.8–2.1) | 1.4 (0.9–2.2) | 0.15 |
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Lohiya, S.; Tripathy, J.P.; Sagili, K.; Khanna, V.; Kumar, R.; Ojha, A.; Bhatnagar, A.; Khanna, A. Does Drug-Resistant Extrapulmonary Tuberculosis Hinder TB Elimination Plans? A Case from Delhi, India. Trop. Med. Infect. Dis. 2020, 5, 109. https://doi.org/10.3390/tropicalmed5030109
Lohiya S, Tripathy JP, Sagili K, Khanna V, Kumar R, Ojha A, Bhatnagar A, Khanna A. Does Drug-Resistant Extrapulmonary Tuberculosis Hinder TB Elimination Plans? A Case from Delhi, India. Tropical Medicine and Infectious Disease. 2020; 5(3):109. https://doi.org/10.3390/tropicalmed5030109
Chicago/Turabian StyleLohiya, Sheelu, Jaya Prasad Tripathy, Karuna Sagili, Vishal Khanna, Ravinder Kumar, Arun Ojha, Anuj Bhatnagar, and Ashwani Khanna. 2020. "Does Drug-Resistant Extrapulmonary Tuberculosis Hinder TB Elimination Plans? A Case from Delhi, India" Tropical Medicine and Infectious Disease 5, no. 3: 109. https://doi.org/10.3390/tropicalmed5030109