Dr. Boarhead’s Summary of Global Updates on the 2019 Novel Coronavirus: 14 November 2021
1.《英国医学杂志》：一项研究随机分配有症状的新冠患者，或持续 14 天接受吸入式环索奈德（ 600 毫克，每日两次）与鼻腔环索奈德给药的组合（每日 200 毫克），是为干预组；或吸入式盐水和鼻腔盐水给药的安慰剂组合，是为对照组。比较 7 天内症状消除的受试者比例，干预组（ 40% ）和对照组（ 35% ）无显著差异；绝对调整风险差异为 5.5% 。（ 11 月 2 日）
［关键信息］吸入式环索奈德和鼻腔环索奈德给药的组合对于清除新冠症状或许无效。
British Medical Journal: In a study, symptomatic COVID-19 patients were randomly assigned to receive either the combination of inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or inhaled and nasal saline placebos for 14 days. The proportion of participants with resolution of symptoms by Day 7 did not differ significantly between the intervention group (40%) and the control group (35%); absolute adjusted risk difference was 5.5%. <2 Nov.>
[key info] The combination of inhaled and intranasal ciclesonide may not be effective in clearing COVID-19 symptoms.
https://www.bmj.com/content/375/bmj-2021-068060
2.《新英格兰医学杂志》：研究人员生成了含有 Mu 变异株刺突蛋白或其他应予关注变异株刺突蛋白的假病毒。使用 13 名疫情早期感染者体内采集的血清样本进行病毒中和试验，结果表明，Mu 变异株对中和作用的抵抗力是 B.1 谱系的 10.6 倍。使用 14 名辉瑞—拜恩泰科疫苗接种者体内采集的血清样本进行试验，结果表明，Mu 变异株对中和作用的抵抗力是 B.1 谱系的 9.1 倍。（ 11 月 3 日）
［关键信息］Mu 变异株对自然感染和辉瑞—拜恩泰科疫苗激发产生的新冠抗体表现出明显抵抗力。
New England Journal of Medicine: Researchers generated pseudoviruses harboring the spike proteins of the Mu variant or other variants of concern. Virus neutralization assays, performed with the use of serum samples obtained from 13 persons infected early in the pandemic, showed that the Mu variant was 10.6 times as resistant to neutralization as the B.1 lineage. Assays, performed with serum samples obtained from 14 persons who had received the Pfizer/BioNTech vaccine, showed that the Mu variant was 9.1 times as resistant to neutralization as the B.1 lineage. <3 Nov.>
[key info] The Mu variant shows a pronounced resistance to antibodies elicited by natural SARS-CoV-2 infection and by the Pfizer/BioNTech vaccine.
https://www.nejm.org/doi/full/10.1056/NEJMc2114706?query=featured_coronavirus
3.《新英格兰医学杂志》：在 II／III 期研究中，2268 名儿童被随机分配接种辉瑞—拜恩泰科疫苗（ 1517 人）或安慰剂（ 751 人）。与其他年龄组一样，辉瑞—拜恩泰科疫苗对 5 至 11 岁儿童具有良好的安全性。研究并未发现与疫苗相关的严重不良事件。接种完第二剂疫苗 1 个月后，5 至 11 岁儿童与 16 至 25 岁人群的新冠中和抗体滴度的几何平均比为 1.04 。（ 11 月 9 日）
［关键信息］经证实，辉瑞—拜恩泰科疫苗对于 5 至 11 岁儿童安全有效。
New England Journal of Medicine: In a phase 2/3 study, 2,268 children were randomly assigned to receive the Pfizer/BioNTech vaccine (1,517 children) or the placebo (751 children). Among the 5-to-11-year-olds, as in other age groups, the Pfizer/BioNTech vaccine had a favorable safety profile. No vaccine-related serious adverse events were noted. One month after the second dose, the geometric mean ratio of SARS-CoV-2 neutralizing titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04. <9 Nov.>
[key info] The Pfizer/BioNTech vaccine proved safe and effective in 5-to-11-year-olds.
https://www.nejm.org/doi/full/10.1056/NEJMoa2116298?query=featured_coronavirus
4.《柳叶刀-肿瘤学》：在荷兰，研究人员评估了免疫疗法、化学疗法、化学免疫疗法三者对莫德纳疫苗免疫原性和安全性的影响。18 岁或以上、预期寿命超过 12 个月的人群分为四个队列：未患癌症者（队列 A ）、接受免疫疗法的实体肿瘤患者（队列 B ）、接受化疗的实体肿瘤患者（队列 C ）、接受化学免疫疗法的实体肿瘤患者（队列 D ）。每个患者队列中的新冠结合抗体反应都不低于队列 A 的反应。3 级或以上的严重不良事件在队列 A 的受试者中未出现，队列 B 的 137 名患者中有 3 人（ 2% ）， 队列 C 的 244 名患者中有 6 人（ 2% ），队列 D 的 163 名患者中有 1 人（ 1% ）。（ 11 月 9 日）
［关键信息］经证实，在接受癌症治疗的实体肿瘤患者中，莫德纳疫苗安全有效。
Lancet Oncology: Researchers assessed the impact of immunotherapy, chemotherapy, and chemoimmunotherapy on the immunogenicity and safety of the Moderna vaccine in the Netherlands. Individuals aged 18 years or older with a life expectancy of more than 12 months were enrolled into four cohorts: individuals without cancer (cohort A), and patients with solid tumors, treated with immunotherapy (cohort B), with chemotherapy (cohort C), or with chemoimmunotherapy (cohort D). The SARS-CoV-2-binding antibody response in each patient cohort was non-inferior compared with cohort A. Grade 3 or worse serious adverse events occurred in no participants in cohort A, three (2%) of 137 patients in cohort B, six (2%) of 244 patients in cohort C, and one (1%) of 163 patients in cohort D. <9 Nov.>
[key info] The Moderna vaccine proved safe and effective among patients with solid tumors receiving cancer treatment.
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00574-X/fulltext
5.《美国医学会杂志》：研究人员对 47 名感染新冠的哺乳期母亲和 30 名接种疫苗的哺乳期母亲所组成的便利样本展开队列研究。感染新冠病毒后，母乳中的抗体反应以免疫球蛋白 A 为主，且抗体水平变化很大，而接种疫苗与强劲的免疫球蛋白 G 反应相关，抗体反应在接种第二剂疫苗后 90 天内开始下降。两组母乳都显示出针对活新冠病毒的中和活性，这可归因于免疫球蛋白 A 和免疫球蛋白 G 抗体。（ 11 月 10 日）
［关键信息］感染新冠和接种疫苗后，母乳中可能产生大量抗体，虽然两种情况下抗体反应的时间模式不同，但两种抗体反应都可以中和活新冠病毒。
Journal of the American Medical Association: In a cohort study of a convenience sample of 47 lactating mothers with SARS-CoV-2 infection and 30 lactating mothers who were vaccinated, antibody response in milk after infection was IgA dominant and highly variable, while vaccination was associated with a robust IgG response, which began to decline by 90 days after the second vaccine dose. Milk from both groups showed neutralization activity against live SARS-CoV-2 virus, which can be attributed to IgA and IgG SARS-CoV-2 antibodies. <10 Nov.>
[key info] COVID-19 infection and vaccination may result in significant antibodies in human milk that exhibit different temporal patterns, but both neutralize live SARS-CoV-2 virus.
https://jamanetwork.com/journals/jamapediatrics/fullarticle/2786219?resultClick=1
6. 彭博社：一位免疫受损患者服用吉利德抗病毒药物“瑞德西韦”来治疗持续性新冠。从该患者体内采集的新冠病毒样本中，发现病毒对该药物的抵抗作用。这名 70 多岁女性患者在 2020 年 5 月感染新冠。瑞德西韦减轻了症状，但未能完全消除感染。感染持续数月，患者嗅觉受损。新冠病毒基因分析显示，病毒在药物治疗期间发生了一次基因突变，该突变似已削弱了瑞德西韦的有效性。接受单克隆抗体治疗后，该患者痊愈，嗅觉亦恢复。（ 11 月 10 日）
［关键信息］与使用瑞德西韦相关的病毒基因突变，可能降低该药物的有效性。
Bloomberg: Resistance to Gilead’s antiviral remdesivir was found in coronavirus samples collected from an immune-compromised patient treated with the drug for a persistent COVID-19. The patient, a woman in her 70s, caught COVID-19 in May 2020. Remdesivir helped alleviate symptoms but was unable to completely clear the infection. It persisted for several months, affecting her sense of smell. Genetic analysis of the virus showed that it acquired a mutation during treatment that appeared to reduce the effectiveness of the drug. The infection was successfully treated with monoclonal antibody therapy, which also led to a recovery of her sense of smell. <10 Nov.>
[key info] A viral mutation related to remdesivir use appeared to reduce the effectiveness of the drug.
https://news.bloomberglaw.com/coronavirus/mutation-linked-to-remdesivir-resistance-found-in-covid-patient
7.《美国医学会杂志》：研究人员考查了 1106 名患有前列腺癌的新冠患者，其中 24% 已接受去雄激素治疗。确诊新冠 30 天后，在接受去雄激素治疗和未接受去雄激素治疗的男性患者中，新冠重症率和死亡率无明显差别。研究人员将分析对象进一步限制在 477 名男性患者中。这些患者高度趋同，具有相似的健康状况和风险因素。研究结果与此前相同。（ 11 月 12 日）
［关键信息］接受去雄激素治疗和未接受去雄激素治疗的前列腺癌患者，在感染新冠 30 天内的死亡率并无明显差别。
Journal of the American Medical Association: Researchers studied 1,106 COVID-19 patients with prostate cancer, 24% of whom had received androgen deprivation therapy (ADT). Thirty days after COVID-19 diagnosis, there was no significant difference in COVID-19 severity or death rates between men who had or had not undergone ADT. The result was the same, when researchers restricted the analysis to 477 men closely matched on the basis of similar health status and risk factors. <12 Nov.>
[key info] No significant difference was found in 30-day mortality rates following COVID-19 infection between men with prostate cancer receiving androgen deprivation therapy and those not receiving the therapy.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786026
8. 葛兰素史克：“彗尾” III 期试验旨在评估 sotrovimab 通过肌肉注射给药和静脉注射给药的有效性、安全性、耐受度。受试者为患有新冠但未入院且有较高病情恶化风险的成人与青少年（ 12 岁及以上）。在本试验的肌肉注射给药（ 500 毫克）组中，29 天内病情恶化至住院超过 24 小时或死亡的发生率为 2.7% ，静脉注射给药（ 500 毫克）组为 1.3% 。两组中，严重不良事件与 3 至 4 级不良事件的发生率均低。（ 11 月 12 日）
［关键信息］一项试验表明，葛兰素史克的 sotrovimab 通过肌肉注射和静脉注射的效果均佳。
GSK: The COMET-TAIL Phase 3 trial was designed to evaluate the efficacy, safety, and tolerability of sotrovimab delivered via intramuscular administration compared to intravenous administration in high-risk, non-hospitalized COVID-19 adults and adolescents (aged 12 years and older). In the intramuscular administration (500mg) arm of the trial, there was a 2.7% rate of progression to hospitalization for more than 24 hours or death through day 29, compared to 1.3% in the intravenous administration arm (also 500mg). There were low rates of serious adverse events and Grade 3–4 adverse events in both arms. <12 Nov.>
[key info] GSK’s sotrovimab was shown in a trial to work as well when given as a shot in muscles as when administered via the intravenous infusion.
https://www.gsk.com/en-gb/media/press-releases/primary-endpoint-met-in-comet-tail-phase-iii-trial-evaluating-intramuscular-administration-of-sotrovimab-for-early-treatment-of-covid-19/
This is issue forty, edited on the basis of information from the official websites including but not limited to those of
The World Health Organization,
The European Centre for Disease Prevention and Control,
The Centers for Disease Control and Prevention of the United States of America, &
The Center for Infectious Disease Research and Policy of the University of Minnesota
and from the forums of FluTrackers.com.
This issue is edited by Alex Sun, Dorothy Fang, Moyan Lu, Dora Zhang, and Fred Wong, under the supervision of Dr. Jason Chu and Conch Zhang.
via 魔都晨曦来临
