An Observational, Controlled, Single Centre Study Validating the Structured Light Plethysmography Against Standard of Care in the Diagnosis and Monitoring of Dysfunctional Breathing

This is an observational, controlled, single-centre study to validate the Thora3Di™ against standard practice in patients who are undergoing investigation for disproportionate breathlessness. The core methodology involves capturing of data during a short period of measurement of breathing using SLP.

开始日期2025-10-01

申办/合作机构

PneumaCare Ltd.

NCT04190524 / RecruitingN/AIIT

Sonographic Assessment of Cricoid Pressure

Examining the effectiveness of cricoid pressure using ultrasound imaging. Pulmonary aspiration of gastric contents during tracheal intubation, although rare in pediatrics, is a potentially catastrophic complication of anesthesia. Cricoid pressure is applied during rapid sequence induction to occlude the esophagus and prevent aspiration of gastric contents. Accumulating evidence in adults suggests that cricoid pressure often is not effective, either because the esophagus normally lies lateral to the cricoid cartilage, or because downward pressure on the cricoid cartilage laterally displaces (rather than compresses) the esophagus. The investigator proposes to examine the effectiveness of cricoid pressure in children in the peri-operative setting using non-invasive ultrasound imaging. Using this approach, the investigator will investigate the normal anatomical relationship of the esophagus and the cricoid cartilage, as well as how cricoid pressures influences this relationship. Further, the investigator will examine whether alternatives to downward cricoid pressure, such as laterally directed pressure, are more effective at occluding the esophagus.

开始日期2025-09-01

申办/合作机构

Boston Children's Hospital

100 项与呼吸障碍相关的临床结果

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100 项与呼吸障碍相关的转化医学

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0 项与呼吸障碍相关的专利（医药）

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306,296

项与呼吸障碍相关的文献（医药）

2024-12-01·Epigenetics

LncRNA NEAT1 aggravates human microvascular endothelial cell injury by inhibiting the Apelin/Nrf2/HO-1 signalling pathway in type 2 diabetes mellitus with obstructive sleep apnoea.

Article

作者: Kai Chen ; Baiqing Ou ; Quan Huang ; Daqing Deng ; Yi Xiang ; Fang Hu

Long noncoding RNAs (lncRNAs) regulate the progression of type 2 diabetes mellitus complicated with obstructive sleep apnoea (T2DM-OSA). However, the role of the lncRNA nuclear paraspeckle assembly transcript 1 (NEAT1) in T2DM-OSA remains unknown. This study aimed to reveal the function of NEAT1 in T2DM-OSA and the underlying mechanism. KKAy mice were exposed to intermittent hypoxia (IH) or intermittent normoxia to generate a T2DM-OSA mouse model. HMEC-1 cells were treated with high glucose (HG) and IH to construct a T2DM-OSA cell model. RNA expression was detected by qRT-PCR. The protein expression of Apelin, NF-E2-related factor 2 (Nrf2), haem oxygenase-1 (HO-1), and up-frameshift suppressor 1 (UPF1) was assessed using western blot. Cell injury was evaluated using flow cytometry, enzyme-linked immunosorbent assay, and oxidative stress kit assays. RIP, RNA pull-down, and actinomycin D assays were performed to determine the associations between NEAT1, UPF1, and Apelin. NEAT1 expression was upregulated in the aortic vascular tissues of mice with T2DM exposed to IH and HMEC-1 cells stimulated with HG and IH, whereas Apelin expression was downregulated. The absence of NEAT1 protected HMEC-1 cells from HG- and IH-induced damage. Furthermore, NEAT1 destabilized Apelin mRNA by recruiting UPF1. Apelin overexpression decreased HG- and IH-induced injury to HMEC-1 cells by activating the Nrf2/HO-1 pathway. Moreover, NEAT1 knockdown reduced HG- and IH-induced injury to HMEC-1 cells through Apelin. NEAT1 silencing reduced HMEC-1 cell injury through the Apelin/Nrf2/HO-1 signalling pathway in T2DM-OSA.Abbreviations: LncRNAs, long non-coding RNAs; T2DM, type 2 diabetes mellitus; OSA, obstructive sleep apnoea; NEAT1, nuclear paraspeckle assembly transcript 1; IH, intermittent hypoxia; HMEC-1, human microvascular endothelial cells; HG, high glucose; Nrf2, NF-E2-related factor 2; UPF1, up-frameshift suppressor 1; HO-1, haem oxygenase-1; qRT-PCR, quantitative real-time polymerase chain reaction; ELISA, enzyme-linked immunosorbent assay; GAPDH, glyceraldehyde 3-phosphate dehydrogenase; TNF-α, tumour necrosis factor-α; CCK-8, Cell Counting Kit-8; IL-1β, interleukin-1β; ROS, reactive oxygen species; MDA, malondialdehyde; SOD, superoxide dismutase; RIP, RNA immunoprecipitation; SD, standard deviations; GSH, glutathione; AIS, acute ischaemic stroke; HMGB1, high mobility group box-1 protein; TLR4, toll-like receptor 4.

2024-12-01·The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians

Allostatic load in early pregnancy and sleep-disordered breathing.

Article

作者: Amir J Lueth ; Amanda A Allshouse ; Robert M Silver ; Marquis S Hawkins ; William A Grobman ; Susan Redline ; Phyllis Zee ; Shalini Manchada ; Grace Pien

OBJECTIVES:

To assess the association between allostatic load in early pregnancy and sleep-disordered breathing (SDB) during pregnancy.

METHODS:

High allostatic load in the first trimester was defined as ≥ 4 of 12 biomarkers (systolic blood pressure, diastolic blood pressure, body mass index, cholesterol, low-density lipoprotein, high-density lipoprotein, high sensitivity C-reactive protein, triglycerides, insulin, glucose, creatinine, and albumin) in the unfavorable quartile. SDB was objectively measured using the Embletta-Gold device and operationalized as "SDB ever" in early (6-15 weeks) or mid-pregnancy (22-31 weeks); SDB at each time point was analyzed as secondary outcomes. Multivariable logistic regression was used to test the association between high allostatic load and SDB, adjusted for confounders. Moderation and sensitivity analyses were conducted to assess the role of allostatic load in racial disparities of SDB and obesity affected the relationship between allostatic load and SDB.

RESULTS:

High allostatic load was present in 35.0% of the nuMoM2b cohort. The prevalence of SDB ever occurred among 8.3% during pregnancy. After adjustment, allostatic load remained significantly associated with SDB ever (aOR= 5.3; 3.6-7.9), in early-pregnancy (aOR= 7.0; 3.8-12.8), and in mid-pregnancy (aOR= 5.8; 3.7-9.1). The association between allostatic load and SDB was not significantly different for people with and without obesity. After excluding BMI from the allostatic load score, the association decreased in magnitude (aOR= 2.6; 1.8-3.9).

CONCLUSION:

The association between allostatic load and SDB was independent of confounders including BMI. The complex and likely bidirectional relationship between chronic stress and SDB deserves further study in reducing SDB.

2024-12-01·The aging male : the official journal of the International Society for the Study of the Aging Male

Erectile dysfunction in patient with obstructive sleep apnea: effects of continuous positive airway pressure.

Article

作者: Hyeyun Kim ; Keun Tae Kim ; Won Chul Shin ; Kwang Ik Yang ; Ji Yong Ha ; Yong Won Cho

BACKGROUND:

Obstructive sleep apnea (OSA) is linked to various health complications, including erectile dysfunction (ED), which is more prevalent in individuals with OSA. This study explored ED in Korean OSA patients and assessed the impact of continuous positive airway pressure (CPAP) therapy on ED.

METHODS:

A total of 87 male patients with OSA from four different sleep centers underwent physical measurements and completed sleep and mental health (MH) questionnaires, including the Korean version of the International index of erectile function (IIEF), before and three months after initiating CPAP therapy.

RESULTS:

After three months of CPAP therapy, the patients demonstrated a significant improvement in ED as measured on the IIEF. However, the study found no significant correlation between the duration of CPAP use and the improvement in IIEF score. It did identify the SF36 quality of life assessment as a significant factor influencing ED improvement after CPAP.

CONCLUSIONS:

ED is a prevalent issue that escalates with age and is associated with OSA. CPAP therapy has shown potential in alleviating ED symptoms, particularly in those with underlying psychological conditions, although further research is required to confirm these findings and understand the underlying mechanisms.

7,629

项与呼吸障碍相关的新闻（医药）

2024-04-08

·PRNewswire

Patient Enrolment Completed in CYP-006TK Diabetic Foot Ulcer Clinical Trial

MELBOURNE, Australia, April 7, 2024 /PRNewswire/ -- Cynata Therapeutics Limited (ASX: " CYP", "Cynata", or the "Company"), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce the completion of patient enrolment in its Phase 1 clinical trial of CYP-006TK in diabetic foot ulcers (DFU). CYP-006TK is Cynata's Cymerus™ iPSC[1]-derived MSC[2] topical wound dressing product candidate, which comprises MSCs seeded onto a novel silicon dressing. Due to reduced blood flow, patients with diabetes are at risk of developing non-healing wounds on the feet/lower limbs, which are also known as DFU. In addition to causing severe pain and discomfort, DFU pose a significant risk of infection, and if therapy is unsuccessful, amputation may be necessary. In this trial, CYP-006TK is being investigated as a potential treatment to promote wound healing in patients with DFU. The pre-specified sample size has now been reached, with a total of 30 patients with DFU randomised on a 1:1 basis to receive either: (i) CYP‑006TK treatment for four weeks, followed by standard of care treatment for the rest of the study; or (ii) standard of care treatment throughout the study. In accordance with the study protocol, patients will be followed for 24 weeks following treatment initiation, which means that the last patient visit in this trial is expected to occur around September 2024. Dr Jolanta Airey MD, Cynata's Chief Medical Officer, said: "We are delighted to have completed enrolment, and we extend our thanks to all of the investigators, study staff and patients for helping us to achieve this milestone. We recently announced very encouraging initial data from the first 16 patients enrolled in this trial after 10 weeks' follow-up, with a median percentage reduction in wound surface area of 87.6% in the active CYP-006TK group, compared to 51.1% in the control group. We now look forward to completing the follow-up period and releasing the full results from this study shortly thereafter." -ENDS- Authorised for release by Dr Kilian Kelly, CEO & Managing Director About Cynata Therapeutics (ASX: CYP) Cynata Therapeutics Limited (ASX: CYP) is an Australian clinical-stage stem cell and regenerative medicine company focused on the development of therapies based on Cymerus™, a proprietary therapeutic stem cell platform technology. Cymerus™ overcomes the challenges of other production methods by using induced pluripotent stem cells (iPSCs) and a precursor cell known as mesenchymoangioblast (MCA) to achieve economic manufacture of cell therapy products, including mesenchymal stem cells (MSCs), at commercial scale without the limitation of multiple donors. Cynata's lead product candidate CYP-001 met all clinical endpoints and demonstrated positive safety and efficacy data for the treatment of steroid-resistant acute graft-versus-host disease (GvHD) in a Phase 1 trial. A Phase 2 clinical trial in GvHD under a cleared US FDA IND, as well as trials of Cymerus products in osteoarthritis (Phase 3) and diabetic foot ulcers (DFU) are currently ongoing, while a trial in renal transplant is expected to commence in the near future. In addition, Cynata has also demonstrated utility of its Cymerus technology in preclinical models of numerous diseases, including critical limb ischaemia, idiopathic pulmonary fibrosis, asthma, heart attack, sepsis, acute respiratory distress syndrome (ARDS) and cytokine release syndrome. Cynata Therapeutics encourages all current investors to go paperless by registering their details with the designated registry service provider, Automic Group. [1] iPSC = induced pluripotent stem cell [2] MSC = mesenchymal stem (or stromal) cell SOURCE Cynata Therapeutics

临床1期细胞疗法临床结果临床2期临床3期

2024-04-08

·GBIHealth

年度收藏：跨国药企核心产品管线布局、研发进度-2023 H2（上篇）

引文跨国药企掌握着全球医药行业最强大的网络资源和决策智慧，他们用真金白银投票选择的方向有更大概率是较符合技术进步规律的（当然这既不意味着他们的决策一定正确、也不意味着这些决策能够被有效执行），通过对他们所有核心产品管线进行系统梳理并定期更新，就有助于我们系统性地了解在大药企自己的话语体系里，究竟哪些方向是在做的、有进展的、值得期待的，从而可以对判断到底什么是所谓“主流技术方向”有更全面直观的依据。本篇将为大家梳理礼来、诺和诺德、强生、默沙东、艾伯维五家企业的管线情况。在GLP-1横扫一切的强势驱动下，无论是业绩和市值，还是各自的产品布局，全球大药企都在经历深刻的变局，甚至可以说进行了颠覆性的重排，仅是下面这张摘要图与半年前相比就有不小的差异。- 左右滑动查看更多 -Lilly礼来礼来在2023年一骑绝尘成功登顶全球药企市值之冠，更夸张的是在2024年刚过两个月又从5,000多亿飚到7,000多亿，眼看就要冲着人类有史以来第一个万亿市值药企的壮举而去了。不过，这疯狂的市值还是有大幅预支未来成长之嫌，毕竟过往业绩虽然表现不俗，但也绝不是成倍的爆发式增长，且看未来是“预支”还是“透支”了。当然，礼来的业绩成长本身确实非常震撼，Tirzepatide在第一个完整销售年度豪取53亿美元、其中Q4单季24亿，在这种震古烁今的爬坡速度驱动下，礼来整体收入额一举从2022年的285亿跃升到2023年的341亿，而且仍处在继续向上跃升的过程中，2024年的业绩指引就是收入提升到410亿左右。- 左右滑动查看更多 -管线的攻城略地仍在发力：在万众瞩目的减肥线上，Tirzepatide肥胖适应症终于获批、并公布了MASH二期临床topline数据，Retatrutide和Orforglipron的多个三期临床先后启动；自免线上，Mirikizumab终于获批、并公布了CD三期临床结果，而Lebrikizumab却收到了FDA的CRL；Donanemab上市却意外地再次被推迟；肿瘤线上，Pirtobrutinib获批CLL/SLL适应症，从POINT收购来的核药PNT-2002也加入管线。- 左右滑动查看更多 -NOVO NORDISK诺和诺德诺和诺德在这波GLP-1狂潮中，市值从1,000亿飙升到接近6,000亿，与礼来呈一时瑜亮之势，在公司创立百年之际达到了可以说是从未有过的高度。看诺和诺德这十年以来的业绩成长，也确实配得上市值的提升。Semaglutide的三个品牌合计在2023年带来了近220亿美元销售额，不过近几个季度在GLP-1中的处方量市场份额已经开始走平，Tirzepatide迅速爬坡带来的竞争压力肉眼可见。- 左右滑动查看更多 -产能制约依然是严重瓶颈，特别是从2023年5月之后低剂量的供应出现明显的受限、以至于对国际市场还会实施供应量限制，从2024年1月开始逐渐增加供应能力，比起半年报时候“will remain restricted”的表述来看应该是有所缓解；产能扩建则继续加码，连续三年持续Capex翻倍的计划。- 左右滑动查看更多 -最重要的研发进展当然还属Semaglutide获批用于心血管风险保护、公布慢性肾病和HFpEF等三期临床结果，以及刚刚公布Amycretin一期的惊艳减重数据；其他值得关注的进展包括高草酸尿症RNAi疗法Nedosiran终于获批，Icosema完成三期临床，从中国药企KBP收购高血压资产等；瘦身也在持续，两个罕见病疗法Belcesiran和Eclipse先后消失在管线中。- 左右滑动查看更多 -J&J强生强生虽然业绩持续稳定，但市值近期下滑到4,000亿以下，被礼来与诺和诺德连续超车。强生医药板块的业绩在大药企中还是相当稳健，其中Ustekinumab和Daratumumab两大引擎的驱动力都非常充足，Guselkumab和Macitentan+Selexipag也表现不俗，但Ibrutinib、Infliximab、Abiraterone、Paliperidone等曾经的超重磅品种确实老态渐显。研发方面最突出的依然是在多发性骨髓瘤领域的“遮断性”优势，不过近期高歌猛进似有放缓，主要进展包括：Talquetamab获得欧盟批准；Teclistamab两周一次剂型获批；Daratumumab皮下剂型公布一线可移植MM患者的三期临床数据；Cilta-cel二线MM适应症获得欧盟积极意见；BCMA/CD3/GPRC5D三抗JNJ-5322公布一期临床数据。其他值得关注的进展包括：2019年从Taris收购来的新型膀胱内药物输送系统TAR-200/201分别公布了二期和一期数据；FcRn单抗Nipocalimab公布二期RA数据并获得FDA突破性认证；FGFR抑制剂Erdafitinib获得FDA完全批准并公布三期临床THOR2研究结果。管线新陈代谢正在进行，从收购Ambrx获得ARX-517/788等ADC资产，而RPGR AAV从管线中被拿掉。- 左右滑动查看更多 -MSD默沙东默沙东近期收入端依然表现稳健，K药仍在增长并稳住了药王地位（虽然刚上位没多久），HPV疫苗也增速不减，这两大定海神针填上了Molnupiravir急速缩水以及Sitagliptin专利悬崖带来的缺口，市值还是逼近3,000亿。研发进展中依然一大半都还是围绕K药的各种扩适应症和联用方案，近期主要进展包括：围手术期NSCLC的三期OS结果；获批1L HER2阴性胃癌和胆管癌等适应症；与mRNA-4157合作启动NSCLC辅助治疗的三期临床。其他重点值得关注的包括：与第一三共达成重大合作获得多个ADC管线，其中U3-1402已提交上市申请；HIF2α抑制剂Belzutifan获批2L RCC适应症；TIGIT单抗Vibostolimab公布与K药联用的NSCLC二期数据；肺炎疫苗V116和PAH药物Sotatercept提交上市申请；从科伦引进的TROP2 ADC、BTK C481S抑制剂Nemtabrutinib、CYP11A1抑制剂和LSD1抑制剂MK-5684Bomedemstat等启动三期临床。此外，收购Harpoon获得的DLL3/CD3/Albumin三抗加入管线，而P2X3慢性咳嗽药物Gefapixant则再次收到CRL。- 左右滑动查看更多 -Abbvie艾伯维2023年以来，Adalimumab和Ibrutinib两大超重磅受竞争者的挤压销售额开始出现大幅下滑，所幸Risankizuma、Upadacitinib、Venetoclax、Cariprazine几个新生代贡献一定的增量，整体业绩才算没有太崩坏，因此市值基本上还是稳定在2,500亿上下。眼看着业绩支撑轴在发生更迭，艾伯维将Risankizumab和Upadacitinib的峰值预期提高到170亿和100亿以上，试图再造一个Adalimumab时代的免疫帝国。- 左右滑动查看更多 -管线方面同样是在经历重心的迁移：免疫线逐渐收缩到围绕现有重磅的适应症扩展，近期包括Risankizumab公布与Ustekinumab在CD适应症的头对头三期临床结果、Upadacitinib公布白癜风二期临床结果，此外IL-1α/β双抗Lutikizumab公布化脓性汗腺炎二期临床结果，另有SCF248、IL-2、GLP-2等新机制加入管线；肿瘤线进展包括收购Immunogen并获得多个ADC资产，CD20×CD3双抗Epcoritamab获得欧盟批准并向FDA提交末线FL的上市申请，Teliso-V公布NSCLC二期临床数据，同时补充了大批新项目进入管线；神经/精神线进展较多，帕金森复方药物ABBV-951提交上市申请，偏头痛药物Atogepant和Ubrogepant分别提交预防适应症的上市申请和公布前兆适应症的三期临床数据，此外通过87亿巨额收购Cerevel补充多个AD/PD管线。- 左右滑动查看更多 -数据声明本文选取截至2023年12月31日市值超过1,000亿美元的制药企业，共11家。已上市产品包括收入贡献较大的（年销售额10亿美元以上）、尚在增长或稳定期的（获批10年以上的基本不考虑）和仍在积极开发阶段的（正在进行重要适应症扩展的临床试验）；临床在研管线以年报季报的研发进度更新章节、研发日及重要会议展示材料和公司日常信息披露等取并集，故可以理解为公司自己认为当前优先级较高的管线，而并不覆盖全体管线。主要梳理信息包括近几个季度的市值和收入利润变化（多主业公司只取制药板块）、半年内最重要的审批进展和临床数据发布、以及未来近期的重要里程碑。\ | /★联系我们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文订阅全球行业新闻

临床3期并购

2024-04-07

·梅斯医学

新冠“特效药”走下神坛！NEJM重磅：II/III期临床试验显示，P药疗效几乎与安慰剂无异！

Paxlovid，即大名鼎鼎的P药，是用于治疗COVID-19的小分子药物。自2021年12月，Paxlovid获得PDA的紧急使用授权后，该药被大众认为是抗新冠病毒的“特效药”，在病毒肆虐的时代更是一药难求。不知道大家是否服用过或者拆开来看过Paxlovid？事实上，P药是由奈玛特韦（Nirmatrelvir）和利托那韦（Ritonavir）两种抗病毒药物组合而成。其中，奈玛特韦是新冠病毒3CL蛋白酶抑制剂，能够抑制病毒的复制。利托那韦则是一种“药代动力学增强剂”，能与奈玛特韦共同作用来抑制细胞色素P450 3A4酶（CYP3A4）的代谢。值得注意的是，两个药物必须要同时服用，才能达到对新冠病毒感染的良好疗效。图源：网络2022年2月11日，我国国家药监局应急附条件批准了这款新冠口服药，用于治疗成人伴有进展为重症高风险因素的轻至中度新型冠状病毒肺炎患者。也就是说，Paxlovid的用药情形为：已经感染新冠病毒，而吃药可以预防发展为重症。其实，P药之所以被推上了“神药”位置，是因为先前公布的惊人数据——“降低89%死亡率”。具体来说，在一项关键的2-3期安全性和疗效试验中，研究者发现，在症状出现后的3天和5天后口服Paxlovid，使得新冠相关的住院或死亡风险分别降低了89%和86%。不过，这一数据有两个点需要注意。一是“短时间内服用”，即在新冠症状出现后的3-5天内尽早服用，1个疗程为5天。二是“防重症而非预防”，包括在国内的批准使用范围非常有限。最近，NEJM上最新刊登的研究更是公布了一个令人讶异的结果——Paxlovid可能是一种“昂贵的安慰剂”。为什么这么说？EPIC-SR临床试验结果显示，与安慰剂相比，P药在改善症状持续缓解的时间等主要终点方面上几乎没有差异。DOI: 10.1056/NEJMoa2309003EPIC-SR试验，即标准风险轻症新冠患者的蛋白酶抑制评估试验，是一项II/III期双盲、随机、安慰剂对照试验。研究者按照1:1的比例，将“确诊新冠感染者且在过去5天内出现症状”的成年人随机分配到治疗组或安慰剂组，每12小时一次，共持续5天。主要终点为所有目标新冠体征和症状的持续缓解的时间。其中，目标症状包括：咳嗽、气短/呼吸困难、发烧/发冷/哆嗦、肌肉/身体疼痛、腹泻、恶心、呕吐、头痛、喉咙痛、鼻塞/流鼻涕。最终纳入了1288名参与者，包括654名接受了至少一剂奈玛特韦/利托那韦的治疗和634名服用安慰剂的对照组。所有参与者均确诊感染新冠病毒，72.5%的参与者在症状出现的3天内就接受了随机化治疗。其中，超过一半（56.9%）的参与者曾接种过新冠疫苗（最常见的是mRNA疫苗）。试验流程图结果显示，对比所有目标的新冠体征和症状的持续缓解的中位时间发现，Paxlovid治疗组为12天，安慰剂组为13天，两组之间的差异并不显著。类似的情况也出现在高风险亚组（接种过疫苗且至少有一个重症风险因素）和标准风险亚组（没有重症风险因素且从未接种过疫苗/过去12个月内没有接种过），即Paxlovid的疗效几乎和安慰剂无异。Paxlovid和安慰剂的疗效对比而从预防重症的角度来看，Paxlovid也没有比对照组有效“太多”。具体来说，接受P药治疗的654名参与者中有5人因新冠入院或死亡，占比为0.8%，而安慰剂组的比例为1.6%；前者与后者仅差了0.8个百分点。不过，Paxlovid治疗组的5名住院患者中没有人入住重症监护室，但安慰剂组的10名住院患者里有3人病情加重而住进了ICU。而在入院的15名参与者中，Paxlovid治疗组的住院时间相对较短，平均5天/100人，而安慰剂组的平均住院时间几乎是前者的3.6倍。值得肯定的是，Paxlovid的疗效在高风险亚组里略有体现。治疗组和安慰剂组分别有3人和7人因新冠住院或死亡，差异为1.3%。两组对比情况当然啦，也有好消息——虽然Paxlovid疗效不理想，但该药也没有带来更多的不良反应。对比来说，参与者在接受P药治疗期间出现任何原因的不良反应的比例为25.8%，而该比例在安慰剂组为24.1%，两组之间没有统计学差异。其中，Paxlovid治疗组患者的最常见的不良反应为味觉障碍、腹泻和恶心，占比分别为6.7%、4.0%和3.1%；而安慰剂组发生这三种不良反应的对应比例为0.5%、3.0%和2.7%。治疗组和对照组的不良反应情况对比综上所述，Paxlovid并非新冠万能药。这项涵盖超1000人的II/III期临床试验显示，在新冠感染者（甚至高风险人群）中，Paxlovid对于症状缓解时间的影响与安慰剂无异。也就是说，能好的会自己好，和Paxlovid关系不大。事实上，“Paxlovid疗效不理想”已不是新闻。早在2022年的时候，NEJM便发表过一项大型真实世界疗效研究，发现：对于40-64岁相对年轻的感染者来说，Paxlovid治疗几乎不会改善新冠的住院率和死亡率，仅在65岁及以上的患者中展现出效果。而在另一项对外公布的暴露后预防的II/III期临床研究（EPIC-PEP）中，P药用于成人暴露后预防的效果同样不佳。另外，Paxlovid的使用需要遵循较多注意事项，比如：不能与降脂药物辛伐他汀、抗凝药物利伐沙班、镇静催眠药物艾司唑仑、免疫抑制剂环孢素、抗肿瘤类药物阿美替尼等等多种药物合用，需停药或换药，需受到医生指导。当然，P药价格如此高昂，要是真能吃上就当它有效吧参考资料：[1]DOI: 10.1056/NEJMoa2309003[2]Arbel R, Wolff Sagy Y, Hoshen M. Nirmatrelvir Use and Severe Covid-19 Outcomes during the Omicron Surge. N Engl J Med. 2022 Aug 24. doi: 10.1056/NEJMoa2204919. Epub ahead of print. PMID: 36001529.撰文 | Swagpp编辑 | Swagpp● 震惊！女患者没穿裤子正在结肠水疗，被男医生看到，两次告上法庭，索赔4万元！侵犯了隐私？法院如何去判？“52111”原则重磅推出!● 延寿7-8年，还能抗癌！两次登上顶刊：饮料中这种常见成分，还能增强癌症治疗的疗效！● “久坐易痴呆”的原因来了！Science首次发现：缺氧才是大脑的“常态”，但运动可使缺氧负担减轻52%！版权说明：梅斯医学（MedSci）是国内领先的医学科研与学术服务平台，致力于医疗质量的改进，为临床实践提供智慧、精准的决策支持，让医生与患者受益。欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。点击下方「阅读原文」立刻下载梅斯医学APP！

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