近日，美国疾控中心Lori E. Dodd团队研究了在刚果民主共和国，Tecovirimat用于治疗MPXV分支I型感染的疗效与安全性。相关论文发表在2025年4月16日出版的《新英格兰医学杂志》上。

根据动物疗效研究和健康人安全性评估的结果，Tecovirimat在欧洲和美国可用于治疗mpox（以前称为猴痘）。但目前仍缺乏来自猴痘患者安全性和有效性的随机对照试验的证据。

研究组在刚果民主共和国（DRC）猴痘患者中进行了一项双盲、随机、安慰剂对照试验。至少有一个猴痘皮肤病变和分支I MPXV聚合酶链反应阳性结果的患者以1:1的比例分配接受Tecovirimat或安慰剂治疗。所有患者均接受了支持性护理。主要终点是猴痘病变的消退，以随机化后的天数为单位进行测量。还对安全性进行了评估。

从2022年10月7日到2024年7月9日，共有597名患者接受了随机分组，其中295名接受了Tecovirimat治疗，302名接受了安慰剂治疗。从随机分组到病变消退的中位时间，Tecovirimat组为7天，安慰剂组为8天；病变消退的竞争风险危险比为1.13（95%置信区间[CI]，0.97至1.31；P=0.14）。无论患者是在报告的症状发作后7天内开始试验方案（竞争风险-危险比，1.16；95%CI，0.98至1.37）还是在发作后7天后开始试验方案，结果都是相似的（竞争风险/危险比，1.00；95%CI，0.71至1.40）。总体死亡率为1.7%，低于2023年刚果民主共和国报告的4.6%的病死率。在14天时，两组中血液、病变和口咽样本经PCR检测MPXV阴性的患者百分比相似。Tecovirimat组和安慰剂组分别有72.9%和70.5%的患者发生不良事件，严重不良事件的报告率分别为5.1%和5.0%。

研究结果表明，Tecovirimat并没有减少由分支I MPXV引起的猴痘患者的病灶消退天数。未发现任何安全问题。

附：英文原文

Title: Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo

Author: anonymous

Issue&Volume: 2025-04-16

Abstract:

BACKGROUND

Tecovirimat is available for the treatment of mpox (formerly known as monkeypox) in Europe and the United States, on the basis of findings from efficacy studies in animals and safety evaluations in healthy humans. Evidence from randomized, controlled trials of safety and efficacy in patients with mpox is lacking.

METHODS

We conducted a double-blind, randomized, placebo-controlled trial of tecovirimat in patients with mpox in the Democratic Republic of Congo (DRC). Patients with at least one mpox skin lesion and positive polymerase-chain-reaction results for clade I MPXV were assigned in a 1:1 ratio to receive tecovirimat or placebo. All patients received supportive care. The primary end point was resolution of mpox lesions, measured in number of days after randomization. Safety was also assessed.

RESULTS

From October 7, 2022, through July 9, 2024, a total of 597 patients underwent randomization — 295 to receive tecovirimat and 302 to receive placebo. The median time from randomization to lesion resolution was 7 days with tecovirimat and 8 days with placebo; the competing-risks hazard ratio for lesion resolution was 1.13 (95% confidence interval [CI], 0.97 to 1.31; P=0.14). Results were similar whether patients began the trial regimen within 7 days after the reported onset of symptoms (competing-risks hazard ratio, 1.16; 95% CI, 0.98 to 1.37) or more than 7 days after onset (competing-risks hazard ratio, 1.00; 95% CI, 0.71 to 1.40). Overall mortality was 1.7%, which was lower than the case fatality rate of 4.6% reported in the DRC in 2023. At 14 days, the percentages of patients who had blood, lesion, and oropharyngeal samples negative for MPXV by PCR were similar in the two groups. Adverse events occurred in 72.9% of the patients in the tecovirimat group and 70.5% of those in the placebo group, and serious adverse events were reported in 5.1% and 5.0%, respectively.

CONCLUSIONS

Tecovirimat did not reduce the number of days to lesion resolution in patients with mpox caused by clade I MPXV. No safety concerns were identified.

DOI: 10.1056/NEJMoa2412439

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2412439