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. 2019 Dec 26;14(12):e0227101. doi: 10.1371/journal.pone.0227101

Table 3. Treatment outcome and sputum smear result of tuberculosis patients.

Characteristics Tuberculosis treatment  
RHZ RHEZ-FDC
ADR
n = 55
No ADR
n = 310
p-value ADR
n = 86
No ADR
n = 279
p-value p-value*
Age in years** 35 ± 11 37 ± 13 0.32 41 ± 12 39 ± 13 0.02 0.08
Range age ≥30 years 36 (65.5) 191 (61.6) 0.65 64 (74.4) 197 (70.6) 0.005 0.01
Female 32 (58.2) 125 (40.3) 47 (54.7) 118 (42.3)
Pulmonary TB presentation 50 (90.9) 286 (92.3) 0.02 76 (88.4) 248 (88.9) 0.048 0.002
Treatment outcome 0.42 0.55 0.41
Cure1 47 (85.5) 266 (85.8) 75 (87.2) 251 (90)
Failure2 0 (0) 3 (1) 0 (0) 0 (0)
Not evaluated3 1 (1.7) 0 (0) 3(3.5) 0 (0)
Death4 3 (5.5) 6 (1.9) 2 (2.3) 5 (1.8)
Lost to follow-up5 4 (7.3) 20 (6.5) 6 (7) 10 (3.6)
MDR6 1 (1.8) 15 (4.8) 0.48 3 (3.5) 13 (4.7) 0.78 0.49
Diabetes 4 (7.3) 25 (8.1) 1.00 14 (16.3) 19 (6.8) 0.16 0.06
Hypertension 1 (1.8) 1 (0.3) 0.28 2 (2.3) 3 (1.1) 0.34 0.14
Past or current alcohol consumption 18 (33.8) 32 (2.3) <0.01 15 (17.4) 52 (18.6) 0.78 0.08
Past or current cigarette smoking 19 (34.5) 58 (18.7) 0.02 25 (29.1) 74 (26.5) 0.78 0.09
Illicit drug use 1 (1.8) 5 (1.6) 1.00 3 (3.5) 4 (1.4) 0.38 0.29
Concomitant medication 3 (5.5) 2 (0.6) 0.03 3 (3.5) 6 (2.2) 0.46 0.04

Data represent no. (%), except age, represented in mean and standard deviation (SD)

* Mantel-Haenszel Test (MH) for comparison of patients with ADRs between treatment groups

** ANOVA for com for comparison of patients with ADRs between treatment groups

1Cured: A pulmonary TB patient with bacteriologically confirmed TB at the beginning of treatment who was smear- or culture-negative in the last month of treatment and on at least one previous occasion.

2Failure: Persistence of positive sputum at the end of treatment also classified as failure cases that at the beginning of treatment, are strongly positive (++ or +++) and maintain this situation until the fourth month, or those with initial positivity followed by negativity, and new positivity for two consecutive months, from the fourth month treatment.

3Not evaluated: A TB patient for whom no treatment outcome is assigned. This includes cases “transferred out” to another treatment unit.

4Death: A TB patient who dies for any reason before starting or during the course of treatment

5Lost to follow-up: A TB patient who did not start treatment or whose treatment was interrupted for two consecutive months or more

6MDR: Multidrug-resistant tuberculosis