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Valproate: Sanofi ordered to pay €285 000 to mother whose children had birth defects. 丙戊酸钠赛诺菲公司被勒令向孩子有先天缺陷的母亲支付 28.5 万欧元。
Pub Date : 2024-09-17 DOI: 10.1136/bmj.q2034
Barbara Casassus
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引用次数: 0
A third of patients miss out on risk assessments before surgery. 三分之一的患者在手术前错过了风险评估。
Pub Date : 2024-09-17 DOI: 10.1136/bmj.q2035
Jacqui Wise
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引用次数: 0
The importance of the day of embryo transfer during in vitro fertilisation 体外受精过程中胚胎移植日的重要性
Pub Date : 2024-09-16 DOI: 10.1136/bmj.q1703
Simone Cornelisse, Liliana Ramos, Sebastiaan Mastenbroek
The timing of embryo transfer, which aligns with different stages of embryo development, is an important element of in vitro fertilisation (IVF). This article briefly describes the main phases of IVF treatment, embryo development and transfer policies, cumulative live birth rates, and the key findings of the authors’ research. In vitro fertilisation (IVF) is a well established treatment for infertility and has been responsible for the birth of more than 10 million children worldwide since 1978.1 An IVF cycle includes ovarian hyperstimulation with hormones, oocyte retrieval, and then fertilisation and embryo culture in the laboratory.23 In most laboratories worldwide, embryos are cultured in vitro for three to six days, and the embryos with the highest chance of resulting in a live birth are selected for intrauterine transfer. Surplus embryos are cryopreserved for future use if a live birth is unsuccessful after an initial transfer or more children are planned. IVF, with or without intracytoplasmic sperm injection (ICSI), involves the handling of sperm cells and oocytes (gametes) and embryos outside the human body. In IVF, thousands of sperm cells are used to inseminate oocytes in the …
胚胎移植的时机与胚胎发育的不同阶段相吻合,是体外受精(IVF)的一个重要因素。本文简要介绍了试管婴儿治疗的主要阶段、胚胎发育和移植政策、累计活产率以及作者的主要研究成果。体外受精(IVF)是一种成熟的不孕症治疗方法,自 1978 年以来,全世界已有超过 1000 万名婴儿出生。1 体外受精周期包括使用激素进行卵巢过度刺激、取卵、然后在实验室进行受精和胚胎培养23。多余的胚胎会冷冻保存,以备将来初次移植后未能成功活产或计划生育更多孩子时使用。体外受精(无论有无卵胞浆内单精子显微注射(ICSI))涉及在人体外处理精子细胞和卵细胞(配子)以及胚胎。在体外受精过程中,成千上万的精子细胞被用来对卵细胞进行人工授精。
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引用次数: 0
Cumulative live birth rate of a blastocyst versus cleavage stage embryo transfer policy during in vitro fertilisation in women with a good prognosis: multicentre randomised controlled trial 预后良好妇女体外受精过程中囊胚与卵裂期胚胎移植政策的累积活产率:多中心随机对照试验
Pub Date : 2024-09-16 DOI: 10.1136/bmj-2024-080133
Simone Cornelisse, Kathrin Fleischer, Lucette van der Westerlaken, Jan-Peter de Bruin, Carlijn Vergouw, Carolien Koks, Josien Derhaag, Jantien Visser, Jannie van Echten-Arends, Els Slappendel, Brigitte Arends, Moniek van der Zanden, Angelique van Dongen, Janneke Brink-van der Vlugt, Marcella de Hundt, Max Curfs, Harold Verhoeve, Maaike Traas-Hofmans, Yvonne Wurth, Petra Manger, Quirine Pieterse, Didi Braat, Madelon van Wely, Liliana Ramos, Sebastiaan Mastenbroek
Objectives To evaluate whether embryo transfers at blastocyst stage improve the cumulative live birth rate after oocyte retrieval, including both fresh and frozen-thawed transfers, and whether the risk of obstetric and perinatal complications is increased compared with cleavage stage embryo transfers during in vitro fertilisation (IVF) treatment. Design Multicentre randomised controlled trial. Setting 21 hospitals and clinics in the Netherlands, 18 August 2018 to 17 December 2021. Participants 1202 women with at least four embryos available on day 2 after oocyte retrieval were randomly assigned to either blastocyst stage embryo transfer (n=603) or cleavage stage embryo transfer (n=599). Interventions In the blastocyst group and cleavage group, embryo transfers were performed on day 5 and day 3, respectively, after oocyte retrieval, followed by cryopreservation of surplus embryos. Analysis was on an intention-to-treat basis, with secondary analyses as per protocol. Main outcome measures The primary outcome was the cumulative live birth rate per oocyte retrieval, including results of all frozen-thawed embryo transfers within a year after randomisation. Secondary outcomes included cumulative rates of pregnancy, pregnancy loss, and live birth after fresh embryo transfer, number of embryo transfers needed, number of frozen embryos, and obstetric and perinatal outcomes. Results The cumulative live birth rate did not differ between the blastocyst group and cleavage group (58.9% (355 of 603) v 58.4% (350 of 599; risk ratio 1.01, 95% confidence interval (CI) 0.84 to 1.22). The blastocyst group showed a higher live birth rate after fresh embryo transfer (1.26, 1.00 to 1.58), lower cumulative pregnancy loss rate (0.68, 0.51 to 0.89), and lower mean number of embryo transfers needed to result in a live birth (1.55 v 1.82; P<0.001). The incidence of moderate preterm birth (32 to <37 weeks) in singletons was higher in the blastocyst group (1.87, 1.05 to 3.34). Conclusion Blastocyst stage embryo transfers resulted in a similar cumulative live birth rate to cleavage stage embryo transfers in women with at least four embryos available during IVF treatment. Trial registration International Clinical Trial Registry Platform NTR7034. Restricted access to the study data can be arranged on request to the corresponding author. Written proposals will be assessed by the ToF study group. A data sharing agreement including terms and conditions for authorship and publication will need to be signed before data are available.
目的 评估囊胚期胚胎移植(包括新鲜和冷冻解冻移植)是否能提高卵母细胞取出后的累积活产率,以及与体外受精(IVF)治疗过程中的卵裂期胚胎移植相比,产科和围产期并发症的风险是否会增加。设计 多中心随机对照试验。地点 荷兰 21 家医院和诊所,2018 年 8 月 18 日至 2021 年 12 月 17 日。参与者 1202 名妇女在取卵后第 2 天至少有四个胚胎可用,被随机分配到囊胚期胚胎移植(n=603)或卵裂期胚胎移植(n=599)。在囊胚期组和卵裂期组,分别在取卵后第 5 天和第 3 天进行胚胎移植,然后对剩余胚胎进行冷冻保存。分析以意向治疗为基础,并根据方案进行二次分析。主要结果测量 主要结果是每次取卵的累积活产率,包括随机化后一年内所有冷冻解冻胚胎的移植结果。次要结果包括新鲜胚胎移植后的累积妊娠率、妊娠丢失率和活产率、所需胚胎移植数量、冷冻胚胎数量以及产科和围产期结果。结果 囊胚组和裂解组的累积活产率没有差异(58.9%(603 例中的 355 例)v 58.4%(599 例中的 350 例;风险比 1.01,95% 置信区间 (CI) 0.84 至 1.22)。囊胚组在新鲜胚胎移植后的活产率更高(1.26,1.00 至 1.58),累积妊娠损失率更低(0.68,0.51 至 0.89),活产所需的平均胚胎移植次数更少(1.55 对 1.82;P<0.001)。囊胚组单胎中度早产(32 至小于 37 周)的发生率更高(1.87,1.05 至 3.34)。结论 在试管婴儿治疗期间至少有四个胚胎可用的妇女中,囊胚期胚胎移植的累积活产率与卵裂期胚胎移植相似。试验注册 国际临床试验注册平台 NTR7034。如需查阅研究数据,可向通讯作者提出申请。ToF研究小组将对书面建议进行评估。在提供数据之前,需要签署一份数据共享协议,其中包括作者和出版条款和条件。
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引用次数: 0
Wellcome’s new head on the future of clinical research funding 惠康新负责人谈临床研究资金的未来
Pub Date : 2024-09-16 DOI: 10.1136/bmj.q1257
Mun-Keat Looi
After more than a decade under the stewardship of Jeremy Farrar, the Wellcome Trust has switched from having a director to a chief executive officer. So, what changes are afoot for the independent funder worth some £38bn? The BMJ asks the new man in charge, John-Arne Røttingen John-Arne Røttingen, like his predecessor, the infectious disease specialist Jeremy Farrar,1 is a doctor. He’s also a former global health ambassador for his home country of Norway and led its state funding body, the Research Council of Norway. “I’m a physician scientist. I’ve been really motivated by this sort of science—that’s why I started studying medicine,” he tells The BMJ . He studied medicine at the University of Oslo and, among other qualifications, holds an MSc from the University of Oxford. His research has covered basic science, epidemiology, clinical trials, health services research, and global health policy. Notably, he led the steering groups for the Ebola vaccine trial in Guinea and the Covid-19 WHO Solidarity trial. “Through the Ebola outbreak of West Africa [in 2014-16], I became really engaged with the need for a long term commitment on the issue of innovation and access to medicines—and how we find models for innovating where there are no commercial …
在杰里米-法拉尔(Jeremy Farrar)十多年的领导下,惠康基金会已经从董事转变为首席执行官。那么,这家价值约 380 亿英镑的独立资助机构将发生哪些变化呢?英国医学杂志》向新任负责人约翰-阿恩-罗廷根(John-Arne Røttingen John-Arne Røttingen 和他的前任、传染病专家杰里米-法拉尔(Jeremy Farrar)1 一样,都是一名医生。他还曾担任过本国挪威的全球健康大使,并领导着挪威的国家资助机构--挪威研究理事会。"我是一名医生科学家。他告诉《英国医学杂志》(The BMJ):"我对这种科学非常感兴趣,这也是我开始学医的原因。他曾在奥斯陆大学攻读医学,并拥有牛津大学的理学硕士学位。他的研究涉及基础科学、流行病学、临床试验、医疗服务研究和全球卫生政策。值得一提的是,他曾领导几内亚埃博拉疫苗试验指导小组和 Covid-19 世卫组织团结试验指导小组。"通过[2014-16年]西非埃博拉疫情的爆发,我真正意识到需要对创新和药物获取问题做出长期承诺--以及我们如何在没有商业模式的地方找到创新模式......
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引用次数: 0
Kim Suvarna: histopathologist who carried out Salisbury Novichok autopsy 金-苏瓦尔纳:对索尔兹伯里诺维乔克进行尸检的组织病理学家
Pub Date : 2024-09-16 DOI: 10.1136/bmj.q1981
John Illman
Kim Suvarna, a histopathologist at Sheffield Teaching Hospitals NHS Foundation Trust, was renowned for his 25 year old tweed jacket, bought from the local Oxfam shop, and his mantra, “Give me the short version.” Verbiage made his eyes roll. He did not suffer fools gladly, but he was as kind as he was fierce. His wife, Grace Horne, describes him as a shy man who wore his profession like a superhero’s cape. “As a doctor, he had the confidence to do anything. He had no problem standing up and lecturing 500 people. He loved imparting information.” A quirky man, he wore two wrist watches simultaneously and disregarded capital letters in emails. Kirsty Lloyd, one of his former trainees, now a consultant histopathologist in Sheffield, says, “He was all about efficiency, so perhaps the shift key was more effort than necessary.” Suvarna had a gift for and a love of teaching, an encyclopaedic memory, a fearsome intellect, and, above all else, passion and enthusiasm. He wrote more than 125 peer reviewed papers and edited several books, including Bancroft’s Theory and Practice of Histological Techniques (2018). He was the driving force behind the UK Cardiovascular Pathology Network and a contributing author to consensus statements from the Association for European Cardiovascular Pathology (AECP), of which he …
谢菲尔德教学医院 NHS 基金会信托基金会的组织病理学家 Kim Suvarna 以他那件从当地乐施会商店买来的 25 年前的斜纹软呢外套和他的口头禅 "给我简短的版本 "而闻名。他的口头禅让人眼睛发亮。他不会轻易受愚弄,但他既善良又凶狠。他的妻子格蕾丝-荷恩(Grace Horne)形容他是一个害羞的人,他的职业就像超级英雄的斗篷。"作为一名医生,他有信心做任何事情。他站在台上给 500 人讲课毫无问题。他喜欢传递信息"。他是一个古怪的人,他同时戴着两只手表,在电子邮件中无视大写字母。他以前的学员之一、现任谢菲尔德组织病理学家顾问的克尔斯蒂-劳埃德说:"他只讲求效率,所以也许按 shift 键比按必要的键更费力。苏瓦纳热爱教学,拥有百科全书式的记忆力和令人生畏的智慧,最重要的是他充满激情和热情。他撰写了超过 125 篇同行评审论文,编辑了多部著作,包括《班克罗夫特组织学技术理论与实践》(2018 年)。他是英国心血管病理网络(UK Cardiovascular Pathology Network)的推动者,也是欧洲心血管病理协会(AECP)共识声明的撰稿人,他是该协会的...
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引用次数: 0
Timing embryo transfers during assisted reproduction 把握辅助生殖过程中胚胎移植的时机
Pub Date : 2024-09-16 DOI: 10.1136/bmj.q1910
Demián Glujovsky
New evidence will help women and clinicians navigate this difficult decision In assisted reproductive technology, the timing of embryo transfer after oocyte retrieval and in vitro fertilisation is crucial. Traditionally, embryos have been transferred at the cleavage stage (two or three days post-fertilisation). However, transferring embryos at the blastocyst stage (five or six days post-fertilisation) is increasingly common. Most studies focus on outcomes from fresh embryo transfers, often overlooking the potential of surplus frozen embryos. Additionally, the effect of transfer stage on obstetric and neonatal outcomes has been underexplored. The linked study by Cornelisse and colleagues (doi:10.1136/bmj-2024-080133) therefore represents an important advance in this area.1 Their multicentre, randomised controlled trial (n=1202) compared outcomes over 12 months after embryo transfers on day 3 or day 5, analysing all embryo transfers within that timeframe. The study’s thorough approach, which assessed cumulative live birth rates—including both fresh and frozen embryo transfers from a single oocyte retrieval—as well as obstetric complications, distinguishes it from previous research. The study found no difference in cumulative live birth rates (risk ratio 1.01, 95% confidence interval (CI) 0.84 to 1.22), whereas live birth …
新证据将帮助妇女和临床医生做出这一艰难的决定 在辅助生殖技术中,卵母细胞提取和体外受精后的胚胎移植时间至关重要。传统上,胚胎移植是在胚胎裂解阶段(受精后两三天)进行的。不过,在囊胚期(受精后五六天)移植胚胎的情况越来越普遍。大多数研究侧重于新鲜胚胎移植的结果,往往忽略了多余冷冻胚胎的潜力。此外,移植阶段对产科和新生儿结局的影响也未得到充分探讨。因此,Cornelisse 及其同事的相关研究(doi:10.1136/bmj-2024-080133)代表了这一领域的重要进展。1 他们的多中心随机对照试验(n=1202)比较了第 3 天或第 5 天胚胎移植后 12 个月内的结果,分析了该时间段内的所有胚胎移植。该研究采用了全面的方法,评估了累积活产率(包括从单次卵母细胞取回中移植的新鲜胚胎和冷冻胚胎)以及产科并发症,这使其有别于以往的研究。研究发现,累积活产率没有差异(风险比 1.01,95% 置信区间 (CI) 0.84 至 1.22),而活产率...
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引用次数: 0
Barriers to investigating and reporting research misconduct: prioritising publication integrity 调查和报告研究不当行为的障碍:优先考虑出版物的完整性
Pub Date : 2024-09-16 DOI: 10.1136/bmj.q2018
Alison Avenell, Andrew A Klein, Jennifer A Byrne, Peter Wilmshurst, Mark J Bolland, Andrew Grey
Bouter’s editorial1 on the UK Research Integrity Office (UKRIO) report Barriers to investigating and reporting research misconduct 2 highlights protecting patients from consequences of research misconduct. Waiting for publishers to correct publications affected by misconduct or errors can take years. In the meantime, these papers influence clinical guidelines and patient care. Delays have been so concerning that the 2023 House of Commons’ Science, Innovation, and …
Bouter 就英国研究诚信办公室 (UKRIO) 报告《调查和报告研究不当行为的障碍》2 发表的社论1 强调了保护患者免受研究不当行为后果的影响。等待出版商纠正受不当行为或错误影响的出版物可能需要数年时间。与此同时,这些论文还会影响临床指南和患者护理。这些延误令人担忧,以至于 2023 年下议院的科学、创新和...
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引用次数: 0
One Health models are lacking an indigenous perspective 一种健康 "模式缺乏本土视角
Pub Date : 2024-09-16 DOI: 10.1136/bmj.q2015
Arthur W Blume
Indigenous peoples can help to build a more holistic approach to the health of humans and nature, writes Arthur Blume Indigenous world views have long appreciated and valued the interdependence of the natural world, and have contributed to a holistic and egalitarian frame of reference for understanding healthy relationships.1 The One Health movements emerged to integrate research and surveillance of human health with that of the natural world and have been proposed as holistic alternatives to the existing colonial model that may help to avoid zoonotic transmission of infectious diseases and health consequences from climate change.234 Some One Health oriented researchers have seen the value of including Indigenous peoples in the research,5 with many assuming that Indigenous peoples would gravitate toward One Health movements. However, none of the One …
亚瑟-布卢姆写道,土著人民可以帮助建立一种更加全面的人与自然健康的方法 土著人的世界观长期以来一直赞赏和重视自然世界的相互依存性,并为理解健康关系的全面和平等的参考框架做出了贡献。234 一些以 "一体健康 "为导向的研究人员看到了让原住民参与研究的价值,5 许多人认为原住民会倾向于 "一体健康 "运动。然而,没有一个 "一体 ...
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引用次数: 0
A new system is needed to tackle research misconduct 解决科研不端行为需要一个新系统
Pub Date : 2024-09-16 DOI: 10.1136/bmj.q2011
Andrew D Weeks
Modern evidence based medicine was built on trust: trust in researchers not to deliberately fabricate scientific research, as well as trust in peer reviewed journals to be gatekeepers of high quality research. Bouter rightly points out that trust in both has been lost.1 Not only is there increasing evidence of deliberate fabrication by researchers as the pressure to succeed grows, …
现代循证医学建立在信任之上:信任研究人员不会故意编造科学研究,信任同行评审期刊是高质量研究的守门人。Bouter 正确地指出,这两方面的信任都已丧失。1 随着成功的压力越来越大,不仅有越来越多的证据表明研究人员蓄意编造,...
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引用次数: 0
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