Department of Infectious Diseases, Clínica Medellín, Grupo Quirónsalud, Medellín, Antioquia, Colombia.
Department of Mathematical Sciences, Universidad EAFIT, Medellín, Antioquia, Colombia.
PLoS One. 2021 May 25;16(5):e0252057. doi: 10.1371/journal.pone.0252057. eCollection 2021.
There is no effective therapy for the severe acute respiratory syndrome by coronavirus 2 (SARS-CoV2) responsible for the Coronavirus disease 2019 (Covid-19). To date, dexamethasone has shown a decrease in mortality in patients who require oxygen, especially those with invasive mechanical ventilation. However, it is unknown if another corticosteroid can be used, the optimal dose and its duration, to achieve a better clinical outcome. The objective of the study was to compare the differences in clinical outcome and laboratory results in hospitalized patients with severe SARS-CoV2 Pneumonia treated with dexamethasone at 6 mg doses versus patients treated with high-dose methylprednisolone.
Ambispective cohort study with survival analysis of 216 patients diagnosed with severe Covid-19 pneumonia confirmed by polymerase chain reaction for SARS-CoV2 by Berlin protocol, who were hospitalized in a high-complexity clinic in Medellín, Colombia. The patients should also have supplementary oxygen and radiological confirmation of Pneumonia by chest tomography. Sample size was not calculated since the total population that met the inclusion criteria was evaluated. 111 patients were treated with the institutional protocol with intravenous dexamethasone 6 mg QD for seven to 10 days if they required oxygen. Since September 15, 2020, the hospitalization protocol of the clinic was modified by the Infectious Diseases and Pulmonology service, recommending a high dose of methylprednisolone of 250 to 500 mg every day for three days with a subsequent change to oral prednisone 50 mg every day for 14 days. The protocol was not applied in the intensive care unit, where dexamethasone continued to be administered. The clinical outcome and differences in laboratory results of the patients who received dexamethasone vs. the prospective cohort that received methylprednisolone from September 15 to October 31, 2020, were evaluated. Follow-up was carried out by outpatient consultation one month after discharge or by telephone, inquiring about readmission or living-dead status.
216 patients had Covid-19 pneumonia documented by ground-glass imaging and alveolar pressure / inspired oxygen fraction (PaFi) less than 300. 111 patients received dexamethasone (DXM) and 105 received methylprednisolone (MTP). Patients in the DXM group evolved to severe ARDS in a higher proportion (26.1% vs 17.1% than the MTP group). Upon completion 4 days of treatment with parenteral corticosteroid, laboratory markers of severity decreased significantly in the group that received MTP, CRP 2.85 (2.3-3.8) vs 7.2 (5.4-9.8), (p-value < 0.0001), D-dimer 691 (612-847) vs 1083 (740-1565) (p-value = 0.04) and DHL 273 (244-289) vs 355 (270.6-422) (p-value = 0.01). After starting the corticosteroid, transfer to the intensive care unit (4.8% vs. 14.4%) and mortality (9,5% vs. 17.1%) was lower in the group that received MTP. Recovery time was shorter in patients treated with MTP, three days (3-4) vs. DXM 6 days (5-8) (p-value < 0.0001). At 30-day follow-up, 88 (92.6%) were alive in MTP vs 58 (63.1%) of those who received dexamethasone.
In this study, the treatment of severe Covid-19 Pneumonia with high-dose methylprednisolone for three days followed by oral prednisone for 14 days, compared with 6 mg dexamethasone for 7 to 10 days, statistically significantly decreased the recovery time, the need for transfer to intensive care and the severity markers C-reactive protein (CRP), D-dimer and LDH. Randomized controlled studies with methylprednisolone are required to corroborate its effect, and studies in a population hospitalized in intensive care wards.
目前尚无针对导致 2019 年冠状病毒病(COVID-19)的严重急性呼吸综合征冠状病毒 2(SARS-CoV2)的有效疗法。迄今为止,地塞米松已显示出可降低需要吸氧的患者,特别是需要有创机械通气的患者的死亡率。但是,尚不清楚是否可以使用另一种皮质类固醇,最佳剂量及其持续时间,以达到更好的临床结果。本研究的目的是比较接受 6 毫克剂量地塞米松治疗的严重 SARS-CoV2 肺炎住院患者与接受高剂量甲泼尼龙治疗的患者在临床结局和实验室结果方面的差异。
这是一项前瞻性队列研究,对在哥伦比亚麦德林一家高复杂度诊所住院的通过柏林方案聚合酶链反应(PCR)确诊为严重 COVID-19 肺炎的 216 名患者进行生存分析。这些患者还应补充氧气,并通过胸部 CT 证实肺炎。由于评估了符合纳入标准的总人群,因此未计算样本量。111 名患者接受了机构方案治疗,即静脉注射地塞米松 6 毫克,QD,持续 7-10 天,如果需要吸氧。自 2020 年 9 月 15 日以来,该诊所的住院治疗方案已被传染病和肺病科修改,建议每天使用 250-500 毫克高剂量甲泼尼龙治疗 3 天,随后改为每天口服泼尼松 50 毫克,持续 14 天。该方案不适用于重症监护病房,在那里继续给予地塞米松。评估了接受地塞米松的患者与 2020 年 9 月 15 日至 10 月 31 日接受甲基泼尼松龙治疗的前瞻性队列的临床结局和实验室结果差异。通过出院后门诊随访或电话进行随访,询问再入院或生存死亡情况。
216 名患者的 COVID-19 肺炎通过磨玻璃成像和肺泡压/吸入氧分数(PaFi)<300 记录。111 名患者接受地塞米松(DXM)治疗,105 名患者接受甲基泼尼松龙(MTP)治疗。DXM 组患者进展为严重急性呼吸窘迫综合征的比例更高(26.1%比 MTP 组的 17.1%)。在接受静脉皮质类固醇治疗 4 天后,MTP 组的严重程度标志物显著降低,CRP 2.85(2.3-3.8)比 7.2(5.4-9.8),(p 值<0.0001),D-二聚体 691(612-847)比 1083(740-1565)(p 值=0.04),DHL 273(244-289)比 355(270.6-422)(p 值=0.01)。开始使用皮质类固醇后,MTP 组患者转入重症监护病房(4.8%比 14.4%)和死亡率(9%,5%比 17.1%)较低。MTP 治疗患者的康复时间更短,为 3 天(3-4),而 DXM 为 6 天(5-8)(p 值<0.0001)。在 30 天随访时,MTP 组有 88 名(92.6%)患者存活,而接受地塞米松治疗的患者中有 58 名(63.1%)存活。
在这项研究中,与接受 7-10 天 6 毫克地塞米松治疗相比,3 天内给予高剂量甲泼尼龙治疗严重 COVID-19 肺炎,然后口服泼尼松治疗 14 天,可显著缩短康复时间,降低转入重症监护病房的需要以及 C 反应蛋白(CRP),D-二聚体和 LDH 等严重程度标志物。需要进行随机对照研究以证实甲泼尼龙的疗效,并在重症监护病房住院患者中进行研究。