近日，肯尼亚医学研究所Ruth K. Lucinde团队进行了糖皮质激素治疗社区获得性肺炎的临床试验。相关论文于2025年10月29日发表在《新英格兰医学杂志》上。

在资源充足的环境中，辅助糖皮质激素可降低严重社区获得性肺炎（CAP）患者的死亡率。这些药物在诊断和治疗设施有限的低资源环境中是否有益尚不清楚。

在这项实用、开放标签、随机、对照的试验中，研究组在肯尼亚的18家公立医院进行了试验，将被诊断为CAP且没有明确糖皮质激素适应症的成年患者分配给CAP的标准治疗或在标准治疗的基础上口服低剂量糖皮质激素10天。主要结局为入组后30天全因死亡。

共有2180例患者接受随机分组（1089例分配到糖皮质激素组，1091例分配到标准治疗组）。患者的中位年龄为53岁（四分位数范围为38 ~ 72岁）；46%是女性。在第30天，有530例患者（24.3%）死亡：糖皮质激素组有246例患者（22.6%），标准治疗组有284例患者（26.0%）（风险比为0.84；95%可信区间为0.73 ~ 0.97；P=0.02）。两组患者不良事件和严重不良事件发生频率相似。5例患者（0.5%）发生了被认为与糖皮质激素使用有关的严重不良事件。

研究结果表明，在低资源环境下的CAP患者中，辅助糖皮质激素治疗与标准治疗相比具有更低的死亡风险。

附：英文原文

Title: A Pragmatic Trial of Glucocorticoids for Community-Acquired Pneumonia

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

Issue&Volume: 2025-10-29

Abstract:

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.

DOI: NJ202510290000003

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2507100