Adverse Events in Treating Smear-Positive Tuberculosis Patients in China
Abstract
:1. Introduction
2. Materials and Methods
2.1. Sampling Method
2.2. Data Collection
- (I)
- Liver injury, including elevated transaminase and jaundice.
- (II)
- Gastrointestinal reactions, including nausea, vomiting, loss of appetite and diarrhea.
- (III)
- Renal impairment, including decline of renal function, positive urine protein and renal failure.
- (IV)
- Blood system damage, including anemia, leukopenia, thrombocytopenia, and pancytopenia.
- (V)
- Auditory nerve damage, including tinnitus, dizziness and hearing loss.
- (VI)
- Optic nerve damage, including blurred vision, constriction of visual field, and color vision disorder.
- (VII)
- Drug allergy, including pruritus, rash, exfoliative dermatitis, and anaphylactic shock.
- (VIII)
- Neuropsychiatric symptoms, including sleep disorders, dizziness, headache, irritability, delirium and epilepsy.
- (IX)
- Joints or muscle pain, including arthralgia and Achilles pain.
- (X)
- Electrolyte abnormalities.
- (XI)
- Thyroid dysfunction.
- (XII)
- Other adverse events.
2.3. Bacteriological Examinations
2.4. Anti-Tuberculosis Therapy
2.5. Statistical Analysis
3. Results
3.1. Socio-Demographics Characteristics
Characteristics | Patients without AE | Patients with AE | Overall | p |
---|---|---|---|---|
No. (%) | No. (%) | No. (%) | ||
Age, years | 1625 (100) | 460 (100) | 2085 (100) | |
Mean ± SD | 42.3 ± 17.3 | 45.6 ± 17.3 | 43.1 ± 17.3 | |
≤18 | 52 (3.2) | 13 (2.8) | 65 (3.1) | 0.05 |
19–39 | 708 (43.6) | 167 (36.3) | 875 (42.0) | † § |
40–59 | 572 (35.2) | 180 (39.1) | 752 (36.1) | |
≥60 | 293 (18.0) | 100 (21.7) | 393 (18.8) | |
Sex | 1629 (100) | 462 (100) | 2091 (100) | |
Male | 1176 (72.2) | 335 (72.5) | 1511 (72.3) | 0.74 |
Female | 453 (27.8) | 127 (27.5) | 580 (27.7) | †¶ |
Treatment history | 1629 (100) | 462 (100) | 2091 (100) | |
New cases | 1379 (84.7) | 398 (86.1) | 1777 (85.0) | 0.29 |
Previously treated | 250 (15.3) | 64 (13.9) | 314 (15.0) | † |
Ethnic groups | 1629 (100) | 462 (100) | 2091 (100) | |
Han | 1331 (81.7) | 364 (78.8) | 1695 (81.1) | 0.13 |
Minority | 298 (18.3) | 98 (21.2) | 396 (18.9) | § |
Level of education | 1629 (100) | 462 (100) | 2091 (100) | |
Illiteracy or primary school | 549 (33.7) | 187 (40.5) | 736 (35.2) | <0.01 |
Middle school or higher | 1080 (66.3) | 275 (59.5) | 1355 (64.8) | † § |
Region | 1629 (100) | 462 (100) | 2091 (100) | |
East | 514 (31.6) | 144 (31.2) | 658 (31.5) | <0.01 |
Center | 681 (41.8) | 143 (31.0) | 824 (39.4) | † § |
West | 434 (26.6) | 175 (37.9) | 609 (29.1) | |
Smoking status | 1594 (100) | 459 (100) | 2053 (100) | |
Never smokers | 760 (47.7) | 195 (42.5) | 955 (46.5) | 0.02 |
Ex-smokers | 573 (36.0) | 168 (36.6) | 741 (36.1) | †¶ |
Current smokers | 261 (16.4) | 96 (20.9) | 357 (17.4) | |
Drinking status | 1593 (100) | 458 (100) | 2051 (100) | |
Never drinkers | 894 (56.1) | 239 (52.2) | 1133 (55.2) | 0.24 |
Ex-drinkers | 569 (35.7) | 178 (38.9) | 747 (36.4) | † |
Current drinkers | 130 (8.2) | 41 (9.0) | 171 (8.3) | |
DOT distance, kilometer | 1588 (100) | 459 (100) | 2047 (100) | |
<1 | 547 (34.5) | 118 (25.7) | 665 (32.5) | <0.01 |
1–5 | 566 (35.6) | 189 (41.2) | 755 (36.9) | † |
6–10 | 276 (17.4) | 79 (17.2) | 355 (17.3) | |
>10 | 199 (12.5) | 73 (15.9) | 272 (13.3) | |
DOT supervisor | 1591 (100) | 452 (100) | 2043 (100) | |
Doctors | 889 (55.9) | 251 (55.5) | 1140 (55.8) | 0.91 |
Others | 679 (42.7) | 194 (42.9) | 873 (42.7) | |
Nobody | 23 (1.4) | 7 (1.6) | 30 (1.5) | |
TB knowledge | 1629 (100) | 462 (100) | 2091 (100) | |
Mean ± SD | 11.3 ± 3.6 | 10.4 ± 3.8 | 11.1 ± 3.6 | |
≤5 | 134 (8.2) | 63 (13.6) | 197 (9.4) | <0.01 |
6–10 | 458 (28.1) | 146 (31.6) | 604 (28.9) | †§ |
>10 | 1037 (63.7) | 253 (54.8) | 1290 (61.7) | |
Symptom score | 1629 (100) | 462 (100) | 2091 (100) | |
Mean ± SD | 4.8 ± 2.9 | 5.7 ± 3.5 | 5.0 ± 3.1 | |
≤5 | 1082 (66.4) | 247 (53.5) | 1329 (63.6) | <0.01 |
6–10 | 476 (29.2) | 168 (36.4) | 644 (30.8) | § |
>10 | 71 (4.4) | 47 (10.2) | 118 (5.6) | |
DST | 1041 (100) | 333 (100) | 1374 (100) | |
Sensitive | 691 (66.4) | 232 (69.7) | 923 (67.2) | 0.17 |
Resistant | 350 (33.6) | 101 (30.3) | 451 (32.8) |
3.2. Clinical Characteristics
3.3. Adverse Events
AE Groups | No. | % |
---|---|---|
Liver injury * | 205 | 36.94 |
Gastrointestinal reactions * | 132 | 23.78 |
Renal impairment | 28 | 5.05 |
Blood system damage | 18 | 3.24 |
Auditory nerve damage | 4 | 0.72 |
Optic nerve damage | 15 | 2.70 |
Drug allergy | 69 | 12.43 |
Neuropsychiatric symptoms | 37 | 6.67 |
Joints/Muscle pain | 35 | 6.31 |
Electrolyte abnormalities | 1 | 0.18 |
Thyroid dysfunction | 0 | 0 |
Other adverse events | 11 | 1.98 |
3.4. Risk Factors for Adverse Events during Anti-TB Treatment
Characteristics | Overall AE | Liver Injury | Gastrointestinal Reactions | ||||||
---|---|---|---|---|---|---|---|---|---|
HR | 95% CI | p | HR | 95% CI | p | HR | 95% CI | p | |
Region | |||||||||
East | 1.33 | 0.97–1.83 | 0.07 | 1.91 | 1.35–2.71 | < 0.01 | 0.34 | 0.19–0.62 | <0.01 |
West | 1.82 | 1.35–2.45 | < 0.01 | 1.54 | 1.06–2.23 | 0.02 | 0.77 | 0.52–1.14 | 0.19 |
Center | ref | ref | ref | ||||||
Age, years | |||||||||
≤18 | – | – | – | 1.50 | 0.75–3.00 | 0.25 | – | – | – |
40–59 | – | – | – | 0.79 | 0.57–1.08 | 0.14 | – | – | – |
≥60 | – | – | – | 0.50 | 0.32–0.80 | < 0.01 | – | – | – |
19–39 | ref | ||||||||
Sex (Male) | – | – | 1.66 | 1.08–2.54 | 0.02 | – | – | – | |
Education level | – | – | – | – | – | 0.44 | 0.30–0.65 | <0.01 | |
Smoking status | |||||||||
ex-smokers | 1.20 | 0.94–1.55 | 0.15 | 1.27 | 0.87–1.85 | 0.21 | – | – | – |
current smokers | 1.64 | 1.23–2.18 | < 0.01 | 1.71 | 1.12–2.59 | 0.01 | – | – | – |
never smokers | ref | ref | |||||||
Symptom score | 1.05 | 1.02–1.09 | 0.01 | – | – | – | 1.09 | 1.03–1.14 | <0.01 |
TB Knowledge | 0.69 | 0.60–0.81 | < 0.01 | 0.79 | 0.65–0.97 | 0.02 | 0.66 | 0.52–0.84 | <0.01 |
4. Discussion
5. Conclusions
Supplementary Files
Supplementary File 1Acknowledgments
Author Contributions
Conflicts of Interest
References
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Zhang, T.; Du, J.; Yin, X.; Xue, F.; Liu, Y.; Li, R.; Luo, C.; Li, L.; Li, X. Adverse Events in Treating Smear-Positive Tuberculosis Patients in China. Int. J. Environ. Res. Public Health 2016, 13, 86. https://doi.org/10.3390/ijerph13010086
Zhang T, Du J, Yin X, Xue F, Liu Y, Li R, Luo C, Li L, Li X. Adverse Events in Treating Smear-Positive Tuberculosis Patients in China. International Journal of Environmental Research and Public Health. 2016; 13(1):86. https://doi.org/10.3390/ijerph13010086
Chicago/Turabian StyleZhang, Tao, Jian Du, Xiaoyan Yin, Fuzhong Xue, Yanxun Liu, Runzi Li, Cheng Luo, Liang Li, and Xiujun Li. 2016. "Adverse Events in Treating Smear-Positive Tuberculosis Patients in China" International Journal of Environmental Research and Public Health 13, no. 1: 86. https://doi.org/10.3390/ijerph13010086