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COVID-19 肺炎住院患者接受托法替布或安慰剂治疗的实验室特征:来自 STOP-COVID 试验的事后分析。

Laboratory profiles of patients hospitalized with COVID-19 pneumonia treated with tofacitinib or placebo: a post hoc analysis from the STOP-COVID trial.

机构信息

Hospital Israelita Albert Einstein, São Paulo, SP, Brazil.

Pfizer Inc., Rotterdam, The Netherlands.

出版信息

Einstein (Sao Paulo). 2024 Nov 4;22:eAO0821. doi: 10.31744/einstein_journal/2024AO0821. eCollection 2024.

Abstract

OBJECTIVE

Tofacitinib, an oral Janus kinase inhibitor, has been tested against a placebo in 289 patients with COVID-19 pneumonia. We analyzed the data from the tofacitinib- and placebo-treated patient cohorts to evaluate the laboratory profiles between baseline and day 7.

METHODS

We performed post hoc analyses on the following laboratory tests over time during the first 7 days after randomization: hemoglobin, leukocytes, neutrophils, lymphocytes, platelets, alanine aminotransferase, and aspartate aminotransferase.

RESULTS

Through the first 7 days after randomization, the levels of hemoglobin, white blood cells, neutrophils, and platelet counts were not significantly different between patients treated with tofacitinib or a placebo (all p>0.05). Non-significant differences were observed in aspartate aminotransferase levels over time between treatment groups, whereas alanine aminotransferase levels (U/L) were higher among tofacitinib-treated patients compared to placebo-treated patients (mean ratio, 1.30 [95% confidence interval (95%CI) = 1.14-1.48; p<0.01)].

CONCLUSION

In patients with COVID-19 pneumonia, the use of tofacitinib compared to placebo did not result in clinically meaningful changes in blood counts or liver enzymes over the first 7 days after randomization.

REGISTRY OF CLINICAL TRIALS

NCT04469114.

摘要

目的

托法替布(一种口服 Janus 激酶抑制剂)已在 289 例 COVID-19 肺炎患者中进行了安慰剂对照试验。我们分析了托法替布和安慰剂治疗患者队列的数据,以评估基线和第 7 天之间的实验室特征。

方法

我们对随机分组后第 1 天内以下实验室检测随时间的变化进行了事后分析:血红蛋白、白细胞、中性粒细胞、淋巴细胞、血小板、丙氨酸氨基转移酶和天冬氨酸氨基转移酶。

结果

在随机分组后的第 1 天内,接受托法替布或安慰剂治疗的患者的血红蛋白、白细胞、中性粒细胞和血小板计数没有显著差异(均 P>0.05)。两组间天门冬氨酸氨基转移酶水平随时间的差异无统计学意义,而与安慰剂相比,托法替布治疗的患者丙氨酸氨基转移酶(U/L)水平更高(平均比值为 1.30 [95%置信区间(95%CI)为 1.14-1.48;P<0.01])。

结论

在 COVID-19 肺炎患者中,与安慰剂相比,在随机分组后第 1 天内,托法替布的使用并未导致血液计数或肝酶发生有临床意义的变化。

临床试验注册号

NCT04469114。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3434/11634338/051d41af4400/2317-6385-eins-22-eAO0821-gf02.jpg

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