Risk factors associated with adverse reactions to antituberculosis drugs

Resende, Laíse Soares Oliveira; Santos-Neto, Edson Theodoro dos

doi:10.1590/S1806-37132015000100010

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Review Article • J. bras. pneumol. 41 (1) • Jan-Feb 2015 • https://doi.org/10.1590/S1806-37132015000100010 copy

Risk factors associated with adverse reactions to antituberculosis drugs^* * Study carried out at the Federal University of Espírito Santo, Vitória, Brazil.

SCIMAGO INSTITUTIONS RANKINGS

This review sought to identify the available scientific evidence on risk factors associated with adverse reactions to antituberculosis drugs. We performed a systematic review of studies published in the 1965-2012 period and indexed in the MEDLINE and LILACS databases. A total of 1,389 articles were initially selected. After reading their abstracts, we selected 85 studies. Of those 85 studies, 16 were included in the review. Risk factors for adverse reactions to antituberculosis drugs included age > 60 years, treatment regimens, alcoholism, anemia, and HIV co-infection, as well as sodium, iron, and albumin deficiency. Protective factors against hepatic adverse effects of antituberculosis drugs included being male (combined OR = 0.38; 95% CI: 0.20-0.72) and showing a rapid/intermediate N-acetyltransferase 2 acetylator phenotype (combined OR = 0.41; 95% CI: 0.18-0.90). There is evidence to support the need for management of adverse reactions to antituberculosis drugs at public health care facilities.

Tuberculosis; Drug-related side effects and adverse reactions; Antitubercular agents; Review

Author	Study design	Age group (years)	Sample (n)	Study population	Study period	Study setting	Treatment regimen	Statistical analysis
Ai et al.⁽¹⁴⁾	Case-control study	≤ 60 and > 60	639	Outpatients	June of 2006 to March of 2007	China	RHZE for 2 months + RH for 4 months	Unspecified univariate and multivariate analyses
Baghaei et al.⁽¹⁵⁾	Population-based cohort study	< 65 and ≥ 65	761	Inpatients	January of 2006 to January of 2008	Iran	RHZE for 6 months	Χ², Fisher’s exact test, Mann-Whitney test, and logistic regression
Barnes et al.⁽¹⁶⁾	Cohort study	≥ 15	161	Inpatients	June of 1984 to March of 1985	USA	No data	Χ² and Fisher’s exact test
Cantalice Filho et al.⁽¹⁷⁾	Case-control study	15-49 and ≥ 60	581	Inpatients	January of 1980 to December of 1996	Brazil	RHZ for 2 months + RH for 4 months	Χ² and Fisher’s exact test
Cho et al.⁽¹⁸⁾	Cohort study	51.2 ± 17.5 46.7 ± 18.4	132	Inpatients	June of 2004 to December of 2005	South Korea	RHZE for 2 months + HRE for 4 months	Mann-Whitney test, Χ², and Fisher’s exact test
HKCS/BMRC⁽¹⁹⁾	Clinical trial	≥ 15	620	Unspecified	October of 1984 to October of 1986	China	SHRZ (3×/week for 6 months)	Relative frequency (%) and absolute frequency (n), unspecified univariate analysis
Kelly et al.⁽²⁰⁾	Cohort study	Mean, 34.9 and 41.7	187	Inpatients	November of 1991 to May of 1993	Africa	SHRZ for 2 months/TH for 6 months	Kaplan-Meier method, unspecified univariate and multivariate analyses
Khalili et al.⁽¹¹⁾	Case-control study	18-86	100	Inpatients	September of 2006 to March of 2009	Iran	RHZE for 2 months + RH for 4 months	Χ²
Lee et al.⁽²¹⁾	Retrospective cohort study	18-84	148 (Latent TB)	Outpatients/inpatients	April of 1999 to March of 2001	USA	RZ for 2 months	Relative frequency (%) and absolute frequency (n), relative risk, and multivariate analysis
Nanashima et al.⁽¹²⁾	Randomized cross-sectional study	22-94	100	Inpatients	May of 2005 to September of 2006	Japan	H (400 mg/day) + R (450 mg/day)	Mann-Whitney test, Χ², Fisher’s exact test, and logistic regression
Martínez Sanchís et al.⁽²²⁾	Cohort study	≥ 10 to ≥ 64	198 (Latent TB)	Inpatients	December of 1996 to December of 2002	Spain	H 300 mg/day (2 or 6 months)	Χ², Fisher’s exact test, and logistic regression
Sharma et al.⁽²³⁾	Cohort study	16-80	346	Inpatients	1996-2000	India	RHZE	Χ² and logistic regression
Sirinak et al.⁽²⁴⁾	Cohort study	≥ 18	769	Inpatients	May of 2005 to September of 2006	Thailand	RHZE	Unspecified univariate analysis and logistic regression
Teixeira et al.⁽²⁵⁾	Case-control study	> 18	167	Inpatients	1998-2008	Brazil	H (400 mg/day) + others	Mann-Whitney test, Χ², Fisher’s exact test, Student’s t-test, etc.
Teleman et al.⁽²⁶⁾	Retrospective cohort study	16-82	783	Outpatients	January of 1998 to December of 1998	Singapore	RHZ for 9 months + E or S	Mann-Whitney test, Χ², Fisher’s exact test, and logistic regression
No authors listed⁽¹³⁾	Clinical trial	≥ 12	908	Outpatients	Unspecified	India	R3/R5/Z5	Relative frequency (%) and absolute frequency (n), unspecified univariate analysis

Author	Risk factor	ADR		OR	95% CI	Χ² (Yates’ correction) or two-tailed Fisher’s exact test	Value of p
Kelly et al.⁽²⁰⁾	HIV	Diarrhea +	Diarrhea −	2.63	1.17-6.37	5.461	0.019
	Present	42	83
	Absent	10	52
Barnes et al.⁽¹⁶⁾	Hyponatremia	Fever +	Fever −	16.6	3.95-146.80	Two-tailed Fisher’s exact test	0.000
	Present	9	22
	Absent	5	51
Barnes et al.⁽¹⁶⁾	Hypoalbuminemia	Fever +	Fever −	6.11	2.74-13.68	23.545	0.000
	Present	88	24
	Absent	18	30
Barnes et al.⁽¹⁶⁾	Alcoholism	Fever < 7 days	Fever > 7 days	5.22	1.30-24.76	Two-tailed Fisher’s exact test	0.014
	Present	10	23
	Absent	4	48
Barnes et al.⁽¹⁶⁾	Anemia	Fever < 7 days	Fever > 7 days	∞	3.3804 to ∞	Two-tailed Fisher’s exact test	0.000
	Present	14	54
	Absent	0	59
Barnes et al.⁽¹⁶⁾	Hyponatremia	Fever < 7 days	Fever > 7 days	4.17	1.09-17.46	4.577	0.032
	Present	9	22
	Absent	5	51
Barnes et al.⁽¹⁶⁾	Hypoalbuminemia	Fever < 7 days	Fever > 7 days	∞	1.03 to ∞	Two-tailed Fisher’s exact test	0.034
	Present	14	54
	Absent	0	19
Kelly et al.⁽²⁰⁾	HIV	Fever +	Fever −	2.59	1.31-5.19	7.850	0.005
	Present	69	56
	Absent	20	42
Kelly et al.⁽²⁰⁾	HIV	Oral candidiasis +	Oral candidiasis −	10.93	1.64-461.62	Two-tailed Fisher’s exact test	0.004
	Present	19	106
	Absent	1	61
Kelly et al.⁽²⁰⁾	HIV	Kaposi’s sarcoma +	Kaposi’s sarcoma −	∞	1.15 to ∞	Two-tailed Fisher’s exact test	0.032
	Present	10	115
	Absent	0	62
Ai et al.⁽¹⁴⁾	Age	ADR +	ADR −	0.61	0.41-0.91	6.136	0.013
	< 60 years	209	288
	> 60 years	77	65
Lee et al.⁽²¹⁾	Recent infection	Hepatotoxicity +	Hepatotoxicity −	13.39	1.89-577.38	Two-tailed Fisher’s exact test	0.002
	Present	13	66
	Absent	1	68
No authors listed⁽¹³⁾	Therapeutic regimen	Jaundice +	Jaundice −	0.06	0.03-0.09	190.15	0.000
	R3	18	279
	R5 and Z5	328	283
No authors listed⁽¹³⁾	Therapeutic regimen	Jaundice +	Jaundice −	0.08	0.05-0.13	170.83	0.000
	R5	26	281
	R3 and Z5	320	281
No authors listed⁽¹³⁾	Therapeutic regimen	Jaundice +	Jaundice −	0.01	0.00-0.02	Two-tailed Fisher’s exact test	0.000
	Z5	2	302
	R3 and R5	344	260
Cho et al.⁽¹⁸⁾	NAT2	Hepatotoxicity +	Hepatotoxicity −	0.18	0.05-0.68	7.977	0.005
	Rapid or intermediate acetylator	11	102
	Slow acetylator	7	12
Khalili et al.⁽¹¹⁾	NAT2	Hepatotoxicity +	Hepatotoxicity −	0.09	0.02-0.46	10.322	0.001
	Rapid or intermediate acetylator	5	31
	Slow acetylator	9	5
Nanashima et al.⁽¹²⁾	C/C genotype at rs2070401 in BACH1	Drug-induced hepatotoxicity +	Drug-induced hepatotoxicity −	9.73	2.04-90.86	Two-tailed Fisher’s exact test	0.001
	G/A or A/A genotype at rs4720833 in MAFK
	Present	16	37
	Absent	2	45
Teixeira et al.⁽²⁵⁾	NAT2 genotype	Hepatitis +	Hepatitis −	2.71	1.03-7.65	4.084	0.043
	Slow acetylator	18	64
	Others	8	77
Baghaei et al.⁽¹⁵⁾	Age	Hepatitis +	Hepatitis −	0.6	0.39-0.94	5.013	0.025
	< 65 years	50	416
	≥ 65 years	49	246
Teleman et al.⁽²⁶⁾	Age	Drug-induced hepatotoxicity +	Drug-induced hepatotoxicity −	0.04	0.00-0.17	37.264	0.000
	≤ 60 years	26	613
	> 60 years	29	368
No authors listed⁽¹³⁾	Therapeutic regimen	Arthralgia +	Arthralgia −	0.66	0.49-0.88	8.164	0.004
	R3	137	160
	R5 and Z5	345	266
No authors listed⁽¹³⁾	Therapeutic regimen	Arthralgia +	Arthralgia −	0.55	0.41-0.74	17.158	0.000
	R5	133	174
	R3 and Z5	349	252
No authors listed⁽¹³⁾	Therapeutic regimen	Arthralgia +	Arthralgia −	2.85	2.11-3.87	49.89	0.000
	Z5	212	92
	R3 and R5	270	334

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[1] Correspondence to: Edson Theodoro dos Santos-Neto. Programa de Pós-Graduação em Saúde Coletiva, Centro de Ciências da Saúde, Universidade Federal do Espírito Santo. Av. Marechal Campos, 1468, Maruípe, CEP 29043-260, Vitória, ES, Brasil. Tel. 55 27 3335-7225. E-mail: edsontheodoro@uol.com.br

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Risk factors associated with adverse reactions to antituberculosis drugs* * Study carried out at the Federal University of Espírito Santo, Vitória, Brazil.

Risk factors associated with adverse reactions to antituberculosis drugs^* * Study carried out at the Federal University of Espírito Santo, Vitória, Brazil.