Desai AN , et al.JAMA. 2022 Aug 22. 

猴痘是一种人畜共患正痘病毒，与天花(天花病原体)属同一种，最近的一次全球疫情已导致报告了39 000多个病例。猴痘通常是自限性的，在以前的疫情中，症状通常持续2至4周。在最近的一项研究中，13%的患者需要住院治疗，需要有效的治疗。

共纳入25例患者，1例患者接受21天治疗，其余患者接受14天治疗。10例(40%)患者在治疗第7天病变完全消失，23例(92%)患者在治疗第21天病变和疼痛消失。替科卫明治疗的耐受性良好，没有患者中断治疗。治疗第7天最常见的不良事件包括:疲劳7例(28%)，头痛5例(20%)，恶心4例(16%)，瘙痒2例(8%)，腹泻2例(8%)

在这项初步研究中，所有猴痘感染患者对口服替科卫明的耐受性良好，且不良反应最小。然而，不良反应并不总是与感染相关的症状相区别。

Abstract

Methods

Patients were eligible for tecovirimat treatment following laboratory confirmation of orthopoxvirus infection from skin lesions by polymerase chain reaction. Outpatients referred to UC Davis primarily through the Sacramento County Department of Public Health between June 3, 2022, and August 13, 2022, and who had disseminated disease or lesions in sensitive areas including the face or genital region were offered treatment. Oral treatment with tecovirimat for adult patients was weight-based, administered every 8 or 12 hours, and was taken within 30 minutes of a meal containing moderate to high fat content for improved bioavailability. The duration of therapy was 14 days but could be extended depending on the clinical status of the patient. Clinical data were collected at initial in-person evaluation for treatment and by in-person or telephone interview on day 7 and day 21 following initiation of therapy. All patients provided written informed consent. This protocol was approved by the UC Davis Institutional Review Board.

Results

As of August 13, 2022, 25 patients with confirmed monkeypox infection had completed a course of tecovirimat therapy (Table). All patients were self-reported male and the median age was 40.7 years (range, 26-76). Nine patients had HIV, 1 patient had received the smallpox vaccine more than 25 years prior, and 4 received 1 dose of JYNNEOS vaccination after symptom onset. At the time of treatment, systemic symptoms, lesions, or both were present for a mean of 12 days (range, 6-24). Systemic symptoms included fever in 19 patients (76%), headache in 8 (32%), fatigue in 7 (28%), sore throat in 5 (20%), chills in 5 (20%), backache in 3 (12%), myalgia in 2 (8%), nausea in 1 (4%), and diarrhea in 1 (4%). Almost all patients (23 [92%]) had genital and/or perianal lesions, and 13 (52%) had fewer than 10 lesions over their entire body. All patients had pain associated with lesions.

One patient received 21 days of therapy while the remainder were treated for 14 days. Complete resolution of lesions was reported in 10 patients (40%) on day 7 of therapy, while 23 (92%) had resolution of lesions and pain by day 21. Treatment with tecovirimat was generally well tolerated with no patient discontinuing therapy. The most frequently reported adverse events on day 7 of therapy included the following: fatigue in 7 patients (28%), headache in 5 (20%), nausea in 4 (16%), itching in 2 (8%), and diarrhea in 2 (8%) (Table).

Discussion

In this preliminary study, oral tecovirimat was well tolerated by all patients with monkeypox infection, with minimal adverse effects. However, adverse effects could not always be differentiated from symptoms related to the infection. No control group was included, limiting conclusions of antiviral efficacy pertaining to duration of symptoms or severity. Time from symptom onset to presentation was variable among patients, and conclusions related to antiviral use vs natural evolution of disease should be made with caution.

Limited clinical data exist on the use of tecovirimat for monkeypox infection. In one case report, no new lesions followed 24 hours of therapy and no adverse effects occurred by treatment completion at 14 days.1

文章连接：

https://jamanetwork.com/journals/jama/fullarticle/2795743

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