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DOI 10.1056/nejmoa2507100

Медицинская библиотека · The New England journal of medicine · 2025

A Pragmatic Trial of Glucocorticoids for Community-Acquired Pneumonia.

Lucinde Ruth K, Gathuri Henry, Mwaniki Paul, Orindi Benedict, Otieno Edwin O, Mwakio Stella, Mulemi Lillian, Isaaka Lynda, Shangala Jimmy, Saisi Metrine, Isinde Elizabeth, Oginga Irene N, Wachira Alvin W, Manuthu Evans, Kariuki Hazel, Asaava Patrick, Nyikuli Jared, Wekesa Cyprian, Otedo Amos, Bosire Hannah, Okoth Steve B, Ongalo Winston, Mukabi David M, Lusamba Wilberforce, Muthui Beatrice, Adembesa Isaac, Mithi Caroline, Sood Mohammed, Aliyan Nadia A, Gituma Bernard, Matiko Matiko G, Omondi Charles A, Ombajo Loice A, Kirui Nicholas, Ochola Lucy, Abdi Abdirahman I, Kagucia Eunice W, English Mike, Hamaluba Mainga, Ochola-Oyier Isabella, Kamuya Dorcas, Bejon Philip, Barasa Edwine, Agweyu Ambrose, Akech Samuel, Etyang Anthony O

Клиническое исследование IV фазыСтатьяМногоцентровое исследованиеPragmatic Clinical TrialРандомизированное исследованиеПеревод в очереди

Аннотация

BACKGROUND

Adjunctive glucocorticoids may reduce mortality among patients with severe community-acquired pneumonia (CAP) in well-resourced settings. Whether these drugs are beneficial in low-resource settings with limited diagnostic and treatment facilities is unclear.

METHODS

In this pragmatic, open-label, randomized, controlled trial conducted in 18 public hospitals in Kenya, we assigned adult patients who had received a diagnosis of CAP and who did not have a clear indication for glucocorticoids to receive either standard care for CAP or oral low-dose glucocorticoids for 10 days in addition to standard care. The primary outcome was death from any cause at 30 days after enrollment.

RESULTS

A total of 2180 patients underwent randomization (1089 assigned to the glucocorticoid group and 1091 to the standard-care group). The median age of the patients was 53 years (interquartile range, 38 to 72); 46% were women. At day 30, deaths were reported in 530 patients (24.3%): 246 patients (22.6%) in the glucocorticoid group and 284 patients (26.0%) in the standard-care group (hazard ratio, 0.84; 95% confidence interval, 0.73 to 0.97; P = 0.02). The frequencies of adverse events and serious adverse events were similar in the two trial groups. Serious adverse events that were considered to be related to glucocorticoid administration occurred in 5 patients (0.5%).

CONCLUSIONS

In patients with CAP in a low-resource setting, adjunctive glucocorticoid therapy was associated with a lower risk of death than standard care. (Funded by Wellcome Trust and others; SONIA PACTR number, PACTR202111481740832; ISRCTN number, ISRCTN36138594.).

Для цитирования: Lucinde Ruth K, Gathuri Henry, Mwaniki Paul, Orindi Benedict, Otieno Edwin O, Mwakio Stella, Mulemi Lillian, Isaaka Lynda, Shangala Jimmy, Saisi Metrine, Isinde Elizabeth, Oginga Irene N, Wachira Alvin W, Manuthu Evans, Kariuki Hazel, Asaava Patrick, Nyikuli Jared, Wekesa Cyprian, Otedo Amos, Bosire Hannah, Okoth Steve B, Ongalo Winston, Mukabi David M, Lusamba Wilberforce, Muthui Beatrice, Adembesa Isaac, Mithi Caroline, Sood Mohammed, Aliyan Nadia A, Gituma Bernard, Matiko Matiko G, Omondi Charles A, Ombajo Loice A, Kirui Nicholas, Ochola Lucy, Abdi Abdirahman I, Kagucia Eunice W, English Mike, Hamaluba Mainga, Ochola-Oyier Isabella, Kamuya Dorcas, Bejon Philip, Barasa Edwine, Agweyu Ambrose, Akech Samuel, Etyang Anthony O. A Pragmatic Trial of Glucocorticoids for Community-Acquired Pneumonia.. The New England journal of medicine. 2025. DOI: 10.1056/nejmoa2507100.

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