超声引导下辅助诊断和治疗冻结肩的研究进展

冻结肩是常见的肩部疾病,传统非可视化治疗冻结肩效果欠佳。近年来,超声引导具有动态实时定位、无辐射、便携性、低成本等优点在辅助诊断和治疗冻结肩患者中得到成功应用,不仅能提供精确的诊断,也提高了患者中长期的疗效。本文就超声引导辅助诊断和治疗冻结肩的研究进展进行综述。     

Ultrasound-guided Brachytherapy for Cervix Cancer

Radiotherapy and brachytherapy are the definitive treatments for locally advanced cervix cancer. The use of soft-tissue imaging, particularly magnetic resonance imaging, has enhanced their effectiveness and improved clinical outcomes. However, the use of magnetic resonance imaging is largely restricted to well-resourced centres in both the first and developing world and remains elusive to many less advantaged centres, particularly those in areas with a high burden of cervix cancer. Ultrasound is an accessible, affordable and accurate imaging modality that can be used throughout the brachytherapy procedure. Ultrasound is primarily used to ensure safe insertion of the applicator but can also be used to guide planning. The methods used to utilise ultrasound images for planning are described. Ultrasound is particularly useful as a verification aid to confirm applicator placement after patients are moved and transferred around the radiotherapy department. It can also be used to verify the dimensions of treatment volumes over the course of brachytherapy. There is a crucial unmet need for an accessible economical soft-tissue imaging modality in cervical brachytherapy. Ultrasound has the potential to meet this need.     

手部多发掌骨骨折术后的功能康复指导疗效评价

目的探讨手部多发掌骨骨折患者术后进行功能康复指导的临床疗效。方法 92例手部多发掌骨骨折患者依据是否早期行康复治疗分成康复组(50例)与普通组(42例)。普通组采取常规治疗,康复组在普通组治疗基础上进行功能康复指导。对比两组治疗效果及并发症发生情况。结果康复组治疗总有效率为92.0%高于普通组的76.2%,差异有统计学意义(P<0.05)。康复组并发症发生率为8.0%低于普通组的23.8%,差异有统计学意义(P<0.05)。结论手部多发掌骨骨折患者术后尽早进行康复锻炼,可有效减少并发症发生,可最大程度的恢复手部功能,对提升患者生活质量,恢复正常生活作用显著,建议临床应用。     

Dietary patterns and the risk of abnormal blood lipids among young adults: A prospective cohort study

Background and aimsThe extent to which dietary patterns influence the risk of abnormal blood lipids throughout young adulthood remains unclear. The aim was to investigate whether early young adulthood dietary patterns predict the risk of abnormal blood lipids during later young adulthood.Methods and resultsWe used data from a long running birth cohort study in Australia. Western dietary pattern rich in meats, processed foods and high-fat dairy products and prudent pattern rich in fruit, vegetables, fish, nuts, whole grains and low-fat dairy products were derived using principal component analysis at the 21-year follow-up from dietary data obtained using a food frequency questionnaire. After 9-years, fasting blood samples of all participants were collected and their total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterols and triglyceride (TG) levels were measured. Abnormal blood lipids were based on clinical cut-offs for total, LDL and HDL cholesterols, and TG and relative distributions for total:HDL and TG:HDL cholesterols ratios. Log-binomial models were used to estimate risk of each outcome in relation to dietary patterns. Greater adherence to the Western pattern predicted increased risks of high LDL (RR: 1.47; 95%CI: 1.06, 2.03) and TG (1.90; 1.25, 2.86), and high ratios of total:HDL (1.48; 1.00, 2.19) and TG:HDL (1.78; 1.18, 2.70) cholesterols in fully adjusted models. Conversely, a prudent pattern predicted reduced risks of low HDL (0.58; 0.42, 0.78) and high TG (0.66; 0.47, 0.92) and high total:HDL (0.71; 0.51, 0.98) and TG:HDL (0.61; 0.45, 0.84) cholesterols ratios.ConclusionThis is the first prospective study to show greater adherence to unhealthy Western diet predicted increased risks of abnormal blood lipids, whereas healthy prudent diet predicted lower such risks in young adults. Addressing diets in early course may improve cardiovascular health of young adults.     

Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force

ObjectivesDeliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR—The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap.MethodsThe joint Task Force consisted of 15 members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to 2 rounds of peer review.ResultsA deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation.ConclusionsThe guidance and the checklist contain a series of questions, grouped by 6 phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes.     

FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。     

A discussion of the unresolved 2016/17 plans for regulating the Polish dietary supplements market

The Polish dietary supplement market is growing steadily. However, even though these products may have an impact on health they are not as strongly regulated as pharmaceuticals. In 2016/17 the introduction of new regulations covering the marketing of dietary supplements in Poland was proposed. This article briefly describes the Polish market for dietary supplements and assesses the benefits and risks associated with its development. A range of potential legislative changes, such as a total ban on dietary supplements, a ban on using the images and recommendations of authoritative entities, increased fines for breaking the law, and other measures are under consideration. We describe the advantages (e.g., better customer protection, and the limitation of inappropriate, misleading advertising) and disadvantages (e.g., a decrease in product innovation, deterioration in product offerings, and rises in product prices) of the proposed changes. As a European Union member, Poland adopts EU law, but EU directives have only harmonized some issues relating to dietary supplement marketing, other key aspects remaining within the competence of member states, but it is noted that some proposed changes in Polish law (e.g., an advertising ban) are so strict that they are unlikely to be acceptable to the EU.     

Dietary fat intake and metabolic syndrome in adults: A systematic review

Background and aimsThe metabolic syndrome (MetS) is a cluster of coexisting cardiovascular risk factors. The role of specific dietary fats was reemphasized by dietary recommendations. This systematic review aims to assess evidence for the effect of dietary fat intake on MetS occurrence and reversion in adults.Methods and ResultsThe MEDLINE database was used to search the existing literature. We included observational studies that analyzed dietary fat intake in adults with MetS and clinical trials that compared the effects of different dietary fat diets on MetS and/or its components. Thirty articles were selected (14 observational and 16 clinical trials), and we included information of dietary fat and fatty acids as well as MetS, body mass index, cholesterol, hypertension, and diabetes in adults. SFA intake was found to be positively associated with MetS components. Most of the observational reviewed studies found beneficial associations between MUFA and PUFA (including n-3 and n-6 subtypes) intake and MetS components. Clinical trials also supported the benefits of MUFA- or PUFA-enriched diets (including low-fat diets) in reducing MetS.ConclusionsThe effects of dietary SFAs on MetS will be influenced by other specific nutrients. Replacement of SFA by MUFA and PUFA has been associated with a decrease in MetS. Dietary recommendations should emphasize on different qualities of fat intake, not only to reduce total fat intake, to obtain health benefits in adults.