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Ensayo controlado aleatorizado2017Financiación no declarada

Cholecalciferol for prophylaxis against antituberculosis therapy-induced liver disorders among naïve patients with pulmonary tuberculosis: A randomized, comparative study

Hasanain AFA, Zayed AAH, Mahdy RE, Nafee AMA

International journal of mycobacteriology · 11 citas

Etiquetas de revisión

Financiación no declarada

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Cómo se estudió

Diseño
Ensayo controlado aleatorizado (indexado por PubMed)
Estudiado en
Personas
Resultado principal
Eventos clínicos como enfermedad o muerte

Quién lo pagó

Financiación
Financiación no declarada

Publicación

Publicado
2017-01-01 · Int J Mycobacteriol · vol. 6 · número 2 · pág. 149
Editorial
Elsevier BV
Citado
13 citas · más que el 78% de estudios similares · 1.1× el promedio de su campo
Referencias
35 trabajos
Acceso
Acceso abierto (publicación gratuita) · CC-BY-NC-SA
Áreas de investigación
Drug-Induced Hepatotoxicity and Protection · Tuberculosis Research and Epidemiology · Hepatitis C virus research
Palabras clave
Medicine, Internal medicine, Gastroenterology, Incidence (geometry), Adverse effect, Tuberculosis, Cholecalciferol, vitamin D deficiency, Population, Vitamin D and neurology, Pathology
MeSH
liver, humans, tuberculosis, pulmonary, cholecalciferol, antitubercular agents, prospective studies, adult, middle aged, female, male, young adult, chemical and drug induced liver injury

4 autores

  • AhmadFarooq Alsayed Hasanain🇪🇬 · autor de correspondenciaAssiut University
  • AliAbdel-Azeem Hasan Zayed🇪🇬Assiut University
  • ReemEzzat Mahdy🇪🇬Assiut University
  • AmanyMohamed Adawi Nafee🇪🇬Assiut University

Resumen

El texto original del estudio, en el idioma en que se publicó.

Background

Patients in countries endemic for chronic viral hepatitis are more vulnerable to antituberculosis therapy-induced liver disorders (ATT-LDs). The aim of this study was to explore the role of cholecalciferol in prophylaxis against ATT-LD among patients with pulmonary tuberculosis (TB) receiving ATT.

Material and methods

We conducted a hospital-based, prospective, randomized, comparative study which included 300 consecutive, naïve patients with pulmonary TB eligible for ATT. The patients were randomly allocated to Group A (150 patients who received ATT) and Group B (150 patients who received ATT with cholecalciferol) who had clinical evaluation, laboratory investigations, and imaging studies. Statistical analysis used student's t-test and Chi-square test were used as appropriate to compare the variables between the study groups.

Results

The study population mean age was 35.6 ± 15.3 years. The overall incidence rate of ATT-LD among the study population was 9.3%; the incidence rate was significantly higher among Group A patients compared to those of Group B (13.3 vs. 5.3%;P = 0.001). The onset of ATT-LD was significantly earlier among patients of Group A compared to those of Group B (31.4 vs. 58.7 days,P = 0.027), while the duration of ATT-LD was significantly longer among patients of Group A compared to those of Group B (34.8 vs. 16.9 days,P = 0.009). No adverse effects related to cholecalciferol use were observed.

Conclusions

Adjuvant cholecalciferol supplementation may be protective against ATT-LD without extra adverse effects. Before recommending the routine use of cholecalciferol supplementation for prevention of ATT-LD, larger scale studies are recommended.

Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.

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