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  • 文章类型: Journal Article
    目的:全面评估和比较所有可用的妊娠期安全使用药物的参考指南,目的是确定这些参考指南的科学性和可靠性。
    方法:我们搜索了PubMed,EMBase,CNKI,万方数据库,和VIP数据库,以全面识别可用的参考指南。此外,我们根据相关文献选择了103种药物,并比较了不同参考指南中每种药物的建议。
    结果:共确定了14个可用的参考指南。然而,这些参考指南均未评估原始研究的偏倚风险或现有证据的质量.7份参考指南采用专家共识法制定怀孕建议,而其余参考指南没有报告形成方法。此外,77.7%的选定药物在不同参考指南中的推荐不一致。此外,同一药物的人类和动物研究在不同的参考指南中有所不同。
    结论:我们的结果表明,目前有关怀孕期间安全使用药物的参考指南不太科学和可靠,不同参考指南关于怀孕期间药物使用的建议存在很大差异。建议差异的原因包括①大多数参考指南中的文献检索不全面,②可用的参考指南均未评估原始研究的偏倚风险或当前证据的质量,③当前参考指南制定建议的方法主观性明显,缺乏科学性。
    OBJECTIVE: To comprehensively evaluate and compare all the available reference guides for the safe use of drugs during pregnancy, with the goal of determining the scientificity and reliability of these reference guides.
    METHODS: We searched PubMed, EMbase, CNKI, Wanfang Database, and VIP database to comprehensively identify the available reference guides. Moreover, we selected 103 drugs based on relevant literatures, and compared the recommendations of each drug from different reference guides.
    RESULTS: A total of 14 available reference guides were identified. However, none of these reference guides assessed the risk of bias of original studies or the quality of current evidence. Seven reference guides adopted expert consensus method to formulate pregnancy recommendations, while the rest reference guides did not report the formation method. Moreover, 77.7% of the selected drugs had inconsistent recommendations among different reference guides. In addition, the referenced human and animal studies for the same drug differed among different reference guides.
    CONCLUSIONS: Our results indicate that current reference guides for the safe use of drugs during pregnancy are less scientific and reliable, and there are considerable discrepancies in recommendations from different reference guides concerning drug use during pregnancy. The reasons for the discrepancies in recommendations include ① the literature search in most reference guides was not comprehensive, ② none of the available reference guides assessed the risk of bias of original studies or the quality of current evidence, and ③ the method adopted by current reference guides to formulate recommendations had obvious subjectivity and lacked of scientificity.
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  • 文章类型: Journal Article
    背景:大型语言模型显示出改善放射学工作流程的希望,但是它们在结构化放射任务(例如报告和数据系统(RADS)分类)上的表现仍未得到探索。
    目的:本研究旨在评估3个大型语言模型聊天机器人-Claude-2、GPT-3.5和GPT-4-在放射学报告中分配RADS类别并评估不同提示策略的影响。
    方法:这项横断面研究使用30个放射学报告(每个RADS标准10个)比较了3个聊天机器人,使用3级提示策略:零射,几枪,和指南PDF信息提示。这些病例的基础是2018年肝脏影像学报告和数据系统(LI-RADS),2022年肺部CT(计算机断层扫描)筛查报告和数据系统(Lung-RADS)和卵巢附件报告和数据系统(O-RADS)磁共振成像,由董事会认证的放射科医生精心准备。每份报告都进行了6次评估。两名失明的评论者评估了聊天机器人在患者级RADS分类和总体评级方面的反应。使用Fleissκ评估了跨重复的协议。
    结果:克劳德-2在总体评分中获得了最高的准确性,其中少量提示和指南PDF(提示-2),在6次运行中获得57%(17/30)的平均准确率,在k-pass投票中获得50%(15/30)的准确率。没有及时的工程,所有聊天机器人都表现不佳。结构化示例提示(prompt-1)的引入提高了所有聊天机器人整体评分的准确性。提供prompt-2进一步改进了Claude-2的性能,GPT-4未复制的增强。TheinterrunagreementwassubstantialforClaude-2(k=0.66foroverallratingandk=0.69forRADScategorization),对于GPT-4来说是公平的(两者的k=0.39),对于GPT-3.5来说是公平的(总体评分k=0.21,RADS分类k=0.39)。与Lung-RADS版本2022和O-RADS相比,2018年的所有聊天机器人均显示出更高的准确性(P<0.05);在2018年LI-RADS版本中,使用prompt-2,Claude-2实现了75%(45/60)的最高总体评分准确性。
    结论:当配备结构化提示和指导PDF时,Claude-2显示了根据既定标准(如LI-RADS版本2018)将RADS类别分配给放射学病例的潜力。然而,当前一代的聊天机器人滞后于根据最新的RADS标准对案件进行准确分类。
    BACKGROUND: Large language models show promise for improving radiology workflows, but their performance on structured radiological tasks such as Reporting and Data Systems (RADS) categorization remains unexplored.
    OBJECTIVE: This study aims to evaluate 3 large language model chatbots-Claude-2, GPT-3.5, and GPT-4-on assigning RADS categories to radiology reports and assess the impact of different prompting strategies.
    METHODS: This cross-sectional study compared 3 chatbots using 30 radiology reports (10 per RADS criteria), using a 3-level prompting strategy: zero-shot, few-shot, and guideline PDF-informed prompts. The cases were grounded in Liver Imaging Reporting & Data System (LI-RADS) version 2018, Lung CT (computed tomography) Screening Reporting & Data System (Lung-RADS) version 2022, and Ovarian-Adnexal Reporting & Data System (O-RADS) magnetic resonance imaging, meticulously prepared by board-certified radiologists. Each report underwent 6 assessments. Two blinded reviewers assessed the chatbots\' response at patient-level RADS categorization and overall ratings. The agreement across repetitions was assessed using Fleiss κ.
    RESULTS: Claude-2 achieved the highest accuracy in overall ratings with few-shot prompts and guideline PDFs (prompt-2), attaining 57% (17/30) average accuracy over 6 runs and 50% (15/30) accuracy with k-pass voting. Without prompt engineering, all chatbots performed poorly. The introduction of a structured exemplar prompt (prompt-1) increased the accuracy of overall ratings for all chatbots. Providing prompt-2 further improved Claude-2\'s performance, an enhancement not replicated by GPT-4. The interrun agreement was substantial for Claude-2 (k=0.66 for overall rating and k=0.69 for RADS categorization), fair for GPT-4 (k=0.39 for both), and fair for GPT-3.5 (k=0.21 for overall rating and k=0.39 for RADS categorization). All chatbots showed significantly higher accuracy with LI-RADS version 2018 than with Lung-RADS version 2022 and O-RADS (P<.05); with prompt-2, Claude-2 achieved the highest overall rating accuracy of 75% (45/60) in LI-RADS version 2018.
    CONCLUSIONS: When equipped with structured prompts and guideline PDFs, Claude-2 demonstrated potential in assigning RADS categories to radiology cases according to established criteria such as LI-RADS version 2018. However, the current generation of chatbots lags in accurately categorizing cases based on more recent RADS criteria.
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  • 文章类型: Journal Article
    这项研究的目的是分析心理健康对2022-2023学年在大学环境中学习的初中和高中学生学习成绩的影响,在后COVID时期。这项研究是在北京进行的,中国,在600名学生的参与下,包括300名一年级学生和300名五年级学生。DASS(抑郁症,焦虑,和压力量表)和PHQ-9(患者健康问卷-9)问卷用于测量心理健康。DASS评估抑郁症的症状,焦虑,和压力,而PHQ-9专门评估抑郁症的严重程度。学业成绩采用12分量表进行评估,其中结合了各种标准,如考试成绩,课程表现,参加课外活动。该研究于2022年至2023年在该大学的五个学院进行。在研究中,与一年级学生相比,五年级学生表现出更高的心理健康水平,平均DASS评分分别为27.1和24.2。有趣的是,尽管如此,一年级学生取得了更高的学习成绩指标,平均得分为8.2分,而五年级学生为9.8分。相关分析显示压力之间存在显著关联,抑郁症,和焦虑水平与学业成绩(压力:r=-0.25,p<0.001;抑郁:r=-0.20,p=0.003;焦虑:r=-0.18,p=0.008)。这些发现强调了解决学生心理健康问题的关键重要性,尤其是在后来的学术时代。建议包括实施支持计划和为学生开发在线资源。
    The aim of this research is to analyze the impact of mental health on the academic performance of junior and senior students studying in a university setting during the 2022-2023 academic year, in the post-COVID period. The study was conducted in Beijing, China, with the participation of 600 students, including 300 first-year students and 300 fifth-year students. DASS (Depression, Anxiety, and Stress Scale) and PHQ-9 (Patient Health Questionnaire-9) questionnaires were employed to measure mental health. The DASS assesses symptoms of depression, anxiety, and stress, while the PHQ-9 specifically evaluates depression severity. Academic performance was evaluated using a 12-point scale, which incorporated various criteria such as exam scores, coursework performance, and participation in extracurricular activities. The research was conducted across five faculties of the university from 2022 to 2023. In the study, fifth-year students demonstrated a higher level of mental health compared to first-year students, with an average DASS score of 27.1 and 24.2, respectively. Interestingly, despite this, first-year students achieved higher academic performance indicators, with an average score of 8.2 compared to 9.8 in fifth-year students. Correlation analysis revealed significant associations between stress, depression, and anxiety levels with academic performance (stress: r = -0.25, p < 0.001; depression: r = -0.20, p = 0.003; anxiety: r = -0.18, p = 0.008). These findings highlight the critical importance of addressing students\' mental well-being, particularly in later academic years. Recommendations include implementing support programs and developing online resources for students.
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  • 文章类型: Journal Article
    在世界范围内广泛采用Papanicolau测试(Pap测试)的宫颈筛查策略后,宫颈癌的发病率和患病率均显着下降。但是宫颈癌仍然是最常见的女性癌症之一,报告了第四流行率,也是导致与妇女有关的主要发病率和死亡率的主要原因之一,特别是对于那些生活在低收入和中等收入国家的妇女。宫颈癌是最重要的健康问题之一,直接破坏全球医疗保健系统,部分原因不仅是由于受害者本身的疾病或幸存者的治疗相关不良事件引起的残疾增加,而且是全球患病患者死亡的主要原因,令人震惊的是,迫切需要做些什么来尽量减少灾难性疾病相关的沉重的社会经济负担。幸运的是,宫颈癌是一种可以预防的疾病,基于其与人乳头瘤病毒(HPV)感染的强烈关联(超过95%),特别是对于那些高危型HPV(HR-HPV),通过在宫颈癌发生之前检测HPV感染以及通过HPV疫苗接种有效预防其可能性很高。这就是为什么世界卫生组织(WHO)认为宫颈癌是一个公共问题,并试图通过三支柱方法(90:70:90%)加速消除宫颈癌计划的原因。包括:(1)90%的女孩在15岁时已全面接种HPV疫苗;(2)70%的女性在35岁和45岁时接受高性能检测筛查,癌前病变得到早期治疗;(3)90%的宫颈疾病女性接受适当和充分的治疗.在这里,这篇综述的重点是作为第一部分的HPV疫苗接种,包括全球建议和台湾政府的HPV疫苗接种政策。
    A significant decline in both incidence and prevalence of cervical cancers after widespread-introducing cervical screening strategy by Papanicolau test (Pap test) has been found in the world, but cervical cancer is still one of the most common female cancers, reporting the fourth prevalence and also one of the leading causes to result in main women-associated morbidity and mortality, particularly for those women living in low- and middle-income countries. Cervical cancer is one of the most important health concerns directly destroying the global health-care system, partly because of not only increasing the disability either secondary to diseases themselves of victims or mediated by treatment-related adverse events to the survivors but also acting as a leading cause of death of diseased patients worldwide, alarming the urgent need to do something to minimize the catastrophic diseases-related heavy socioeconomic burden. It is fortunate that cervical cancer is a preventable disease, based on its strong association with human papillomavirus (HPV) infection (more than 95%), particularly for those high-risk HPV (HR-HPV) and its high possibility by detecting HPV infection before the development of cervical cancer as well as an effective prevention by HPV vaccination. That is why WHO (World Health Organization) considers cervical cancer as a public problem and attempts to accelerate the elimination of cervical cancer program by three-pillar approach (90:70:90% targets), including (1) 90% of girls are fully vaccinated with HPV vaccine by 15 years of age; (2) 70% of women are screened with a high-performance test by 35 and 45 years of age and precancerous lesions are treated early; and (3) 90% of women identified with cervical diseases receive appropriate and adequate treatment. Herein, this review focuses on the HPV vaccination as Part I, including global recommendations and Taiwan government\'s policy for HPV vaccination.
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  • 文章类型: Journal Article
    中国重症监护医学学会(CSCCM)制定了中国成人重症监护病房(ICU)患者营养评估和监测的临床实践指南。本指南侧重于营养评估和代谢监测,以实现重症患者的最佳和个性化营养治疗。该指南是由重症监护医学和循证医学方法学的专家制定的,是在对该系统进行全面审查以及2000年至2023年7月发表的相关试验或研究摘要之后制定的。通过重症监护医学专家小组的讨论和检讨,共形成18项建议,并达成共识,肠外和肠内营养,和手术。这些建议基于现有证据,涵盖几个关键领域,包括筛查和评估,肠内喂养不耐受的评估和评估,营养治疗期间的代谢和营养测量和监测,与营养供应相关的器官功能评估。每个问题都根据人口进行了分析,干预,比较,和结果(PICO)原则。此外,对4个未达成共识但可能具有潜在临床和研究价值的问题进行了解释.该计划将在3-5年内使用国际指南更新方法更新本营养评估和监测指南。
    The Chinese Society of Critical Care Medicine (CSCCM) has developed clinical practice guidelines for nutrition assessment and monitoring for patients in adult intensive care units (ICUs) in China. This guideline focuses on nutrition evaluation and metabolic monitoring to achieve optimal and personalized nutrition therapy for critically ill patients. This guideline was developed by experts in critical care medicine and evidence-based medicine methodology and was developed after a thorough review of the system and a summary of relevant trials or studies published from 2000 to July 2023. A total of 18 recommendations were formed and consensus was reached through discussions and reviews by expert groups in critical care medicine, parenteral and enteral nutrition, and surgery. The recommendations are based on currently available evidence and cover several key fields, including screening and assessment, evaluation and assessment of enteral feeding intolerance, metabolic and nutritional measurement and monitoring during nutrition therapy, and organ function evaluation related to nutrition supply. Each question was analyzed according to the Population, Intervention, Comparison, and Outcome (PICO) principle. In addition, interpretations were provided for four questions that did not reach a consensus but may have potential clinical and research value. The plan is to update this nutrition assessment and monitoring guideline using the international guideline update method within 3-5 years.
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  • 文章类型: Journal Article
    细胞培养技术已经发展起来,从单细胞和单层方法转移到3D模型,比如重新聚合,球体,和类器官,通过微制造和生物打印等生物工程进行改进。这些进步,称为微生理系统(MPS),密切复制组织环境和人体生理,加强研究和生物医学用途。然而,MPS复杂性带来了标准化挑战,影响可重复性和信任度。我们提供特定于MPS的质量管理和控制标准指南,在不扼杀创新的情况下促进可靠的结果。我们的适合目的的建议为实现一致的MPS性能提供了可操作的建议。
    Cell culture technology has evolved, moving from single-cell and monolayer methods to 3D models like reaggregates, spheroids, and organoids, improved with bioengineering like microfabrication and bioprinting. These advancements, termed microphysiological systems (MPSs), closely replicate tissue environments and human physiology, enhancing research and biomedical uses. However, MPS complexity introduces standardization challenges, impacting reproducibility and trust. We offer guidelines for quality management and control criteria specific to MPSs, facilitating reliable outcomes without stifling innovation. Our fit-for-purpose recommendations provide actionable advice for achieving consistent MPS performance.
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  • 文章类型: Journal Article
    目的:全谷物最近被推广为对糖尿病预防有益。然而,全谷物对血糖有益的证据在队列研究和随机对照试验(RCT)之间似乎存在冲突.为了填补研究空白,我们进行了一项荟萃分析,以确定全谷物对糖尿病预防的影响,并提出建议.
    方法:我们搜索了PubMed,ClarivateWebofScience,和科克伦图书馆,直到2024年3月。我们使用2型糖尿病的风险比(RR)来代表队列研究的临床结果,而生物标志物,包括空腹血糖和胰岛素,HbA1C,和HOMA-IR,用于显示随机对照试验的结果。使用随机效应元回归模型和有限的三次样条模型测试了全谷物摄入量与结果之间的剂量反应关系。这项研究在PROSPERO注册,CRD42021281639。
    结果:纳入了10项前瞻性队列研究和37项随机对照试验。队列研究表明,每天摄入50克的全谷物可降低2型糖尿病的风险(RR=0.761,95%CI:0.700至0.828,I2=72.39%,P<0.001),表明全谷物与2型糖尿病发病率之间存在单调的反比关系。在RCT中,全谷物显着降低空腹血糖(平均差异(MD)=-0.103mmol/L,95%CI:-0.178至-0.028;I2=72.99%,P<0.01),对HbA1C有适度影响(MD=-0.662mmol/mol(-0.06%),95%CI:-1.335至0.010;I2=64.55%,P=0.05)和HOMA-IR(MD=-0.164,95%CI:-0.342至0.013;I2=33.38%,P=0.07)。全谷物和FBG的摄入量,HbA1C,HOMA-IR呈明显的剂量依赖性。受限制的样条曲线在150g/天之前保持平坦,然后下降。亚组分析表明,采用多种全谷类型的干预措施比采用单一类型的干预措施更有效。
    结论:我们的研究结果表明,每天摄入超过150克的全谷物成分被推荐作为预防糖尿病的人群方法。
    OBJECTIVE: Whole grains have recently been promoted as beneficial to diabetes prevention. However, the evidence for the glycemic benefits of whole grains seems to conflict between the cohort studies and randomized control trials (RCTs). To fill the research gap, we conducted a meta-analysis to determine the effects of whole grains on diabetes prevention and to inform recommendations.
    METHODS: We searched PubMed, Clarivate Web of Science, and Cochrane Library until March 2024. We used the risk ratio (RR) of type 2 diabetes to represent the clinical outcomes for cohort studies, while the biomarkers, including fasting blood glucose and insulin, HbA1C, and HOMA-IR, were utilized to show outcomes for RCTs. Dose-response relationships between whole grain intakes and outcomes were tested with random effects meta-regression models and restricted cubic splines models. This study is registered with PROSPERO, CRD42021281639.
    RESULTS: Ten prospective cohort studies and 37 RCTs were included. Cohort studies suggested a 50 g/day whole grain intake reduced the risk of type 2 diabetes (RR = 0.761, 95% CI: 0.700 to 0.828, I2 = 72.39%, P < 0.001) and indicated a monotonic inverse relationship between whole grains and type 2 diabetes rate. In RCTs, whole grains significantly reduced fasting blood glucose (Mean difference (MD) = -0.103 mmol/L, 95% CI: -0.178 to -0.028; I2 = 72.99%, P < 0.01) and had modest effects on HbA1C (MD = -0.662 mmol/mol (-0.06%), 95% CI: -1.335 to 0.010; I2 = 64.55%, P = 0.05) and HOMA-IR (MD = -0.164, 95% CI: -0.342 to 0.013; I2 = 33.38%, P = 0.07). The intake of whole grains and FBG, HbA1C, and HOMA-IR were significantly dose-dependent. The restricted spline curves remained flat up to 150 g/day and decreased afterward. Subgroup analysis showed that interventions with multiple whole-grain types were more effective than those with a single type.
    CONCLUSIONS: Our study findings suggest that a daily intake of more than 150 g of whole grain ingredients is recommended as a population approach for diabetes prevention.
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  • 文章类型: Journal Article
    这项研究的目的是评估有关中药(TCM)药物治疗的骨质疏松症指南的质量,并分析这些指南的具体建议。
    我们系统地收集了指导方针,使用评估准则研究与评估(AGREE)II工具评估准则的质量,并以患者干预-比较-结果(PICO)模型为分析框架,总结了中医药物治疗的建议。
    共包括20条指南。总体质量评价结果显示,四个指南处于A级,四个在B级,和12在C级,其质量需要在“利益相关者参与”领域提高,“发展的严谨性”,“适用性”和“编辑独立性”。分层分析表明,在“范围和目的”领域,2020年后的指南明显优于2020年之前发布的指南,“利益相关者参与”和“编辑独立性”。在“利益相关者参与”方面,有证据系统的指南明显优于没有证据系统的指南,“发展的严谨性”,“演示文稿的清晰度”和“适用性”。指南推荐对骨量减少患者进行中医药物治疗,骨质疏松和骨质疏松性骨折。推荐的中成药主要为单用或与西药合用的中成药,结果主要集中在改善骨密度(BMD)。
    The aims of this study were to evaluate the quality of osteoporosis guidelines on traditional Chinese medicine (TCM) drug therapies and to analyze the specific recommendations of these guidelines.
    We systematically collected guidelines, evaluated the quality of the guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE) II tool, and summarized the recommendations of TCM drug therapies using the Patient-Intervention-Comparator-Outcome (PICO) model as the analysis framework.
    A total of 20 guidelines were included. Overall quality evaluation results revealed that four guidelines were at level A, four at level B, and 12 at level C, whose quality needed to be improved in the domains of \"stakeholder involvement\", \"rigor of development\", \"applicability\" and \"editorial independence\". Stratified analysis suggested that the post-2020 guidelines were significantly better than those published before 2020 in the domains of \"scope and purpose\", \"stakeholder involvement\" and \"editorial independence\". Guidelines with evidence systems were significantly better than those without evidence systems in terms of \"stakeholder involvement\", \"rigor of development\", \"clarity of presentation\" and \"applicability\". The guidelines recommended TCM drug therapies for patients with osteopenia, osteoporosis and osteoporotic fracture. Recommended TCM drugs were mainly Chinese patent medicine alone or combined with Western medicine, with the outcome mainly focused on improving bone mineral density (BMD).
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  • 文章类型: Journal Article
    各种各样的术语,如“抗癫痫药,抗惊厥药,“”和“抗癫痫”历来用于治疗癫痫疾病的药物。术语很重要,因为使用不能准确反映特定治疗作用的术语可能会导致对其效果的误解和不当使用。当前的国际抗癫痫联盟(ILAE)立场文件使用Delphi方法来制定适用于目前批准用于治疗癫痫发作的药物的英语术语的建议。人们一致认为,这些药物应统称为“抗癫痫药物”。这个术语准确地反映了他们对癫痫发作的主要症状影响,并减少了医疗保健从业人员的可能性,病人,或护理人员对这些药物的真实作用有不适当的期望或不正确的理解。描述这些药物的术语“抗癫痫”并不排除对疾病过程和合并症产生有益影响的可能性,这些合并症是由癫痫的下游影响引起的。只要这些有益作用可以完全通过抑制癫痫发作活动来解释。公认的是,其他治疗方法,主要是在开发中,可以对潜在疾病或其进展发挥直接的有利作用,通过具有“抗癫痫性”或“改善疾病”的作用。需要开发一个更精确的术语来准确描述这些行动。
    A variety of terms, such as \"antiepileptic,\" \"anticonvulsant,\" and \"antiseizure\" have been historically applied to medications for the treatment of seizure disorders. Terminology is important because using terms that do not accurately reflect the action of specific treatments may result in a misunderstanding of their effects and inappropriate use. The present International League Against Epilepsy (ILAE) position paper used a Delphi approach to develop recommendations on English-language terminology applicable to pharmacological agents currently approved for treating seizure disorders. There was consensus that these medications should be collectively named \"antiseizure medications\". This term accurately reflects their primarily symptomatic effect against seizures and reduces the possibility of health care practitioners, patients, or caregivers having undue expectations or an incorrect understanding of the real action of these medications. The term \"antiseizure\" to describe these agents does not exclude the possibility of beneficial effects on the course of the disease and comorbidities that result from the downstream effects of seizures, whenever these beneficial effects can be explained solely by the suppression of seizure activity. It is acknowledged that other treatments, mostly under development, can exert direct favorable actions on the underlying disease or its progression, by having \"antiepileptogenic\" or \"disease-modifying\" effects. A more-refined terminology to describe precisely these actions needs to be developed.
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  • 文章类型: Systematic Review
    背景:传统中药(TCM)代表了丰富的经验开发的传统药物库。这些发现要求对疗效进行更严格的研究,安全,加强中药作用机制的证据基础。
    目的:系统回顾涉及中医推荐的失眠临床实践指南的质量,并总结支持推荐的证据的确定性,力量,和建议的一致性,为今后失眠指南的制定提供有价值的研究参考。
    方法:我们系统地搜索了PubMed,WebofScience,Embase,CNKI,万方,中国生物医学文献数据库,中华医学会,中国睡眠研究会,Medsci,Medlive,英国国家健康与临床卓越研究所(NICE)和国际指南合作网络(GIN)从开始到2023年3月5日的失眠临床实践指南。4名评估员利用AGREEII工具对准则的质量进行了独立评估。随后,指南建议被合并并作为证据图呈现。
    结果:解决失眠的十三个临床实践指南,包括211项建议(包括127项循证建议和84项专家共识建议),被认为有资格纳入我们的分析。评估结果显示总体质量欠佳,“范围和目的”域得分最高(58.1%),而“适用性”域得分最低(13.0%)。具体来说,据观察,74.8%(n=95)的循证建议得到了非常低或低确定性的证据的支持,与专家共识建议相反,占61.9%(n=52)。我们随后将44条建议合成为四张证据图,专注于中成药,中药处方,针灸,按摩,分别。值得注意的是,中草药和针灸显示出强大的支持,由高确定性证据证实,以血府逐瘀汤等干预措施为例,健脾汤,身体针灸,耳针,产生了可靠的建议。相反,中成药需要更多的高确定性证据,主要产生薄弱的建议。至于其他疗法,确定性水平主要分为低或极低.关于磁疗的建议,洗澡,熏蒸主要依靠专家共识,需要更多实质性的临床研究证据,因此形成了薄弱的建议。热熨烫和穴位注射的建议被弱认可,主要基于观察性研究。此外,像气功这样的干预措施,瓜莎,艾灸显示的临床研究数量相对有限,需要进一步探索以确定其功效。
    结论:我们的分析显示,所有纳入的与失眠相关的指南的质量都需要大幅改善。值得注意的是,中医(TCM)治疗的建议主要依赖于低确定性证据。这项研究代表了利用推荐映射来呈现和识别中医疗法中证据领域的现有差距的开创性努力。从而为未来的研究举措奠定了基础。必须加强支持中医治疗建议的证据,以实现更实质性的建议和更高的确定性。因此,对致力于中医的高质量临床研究存在关键和紧迫的需求,特别注重确定其长期疗效,安全,以及失眠治疗中的潜在副作用。这些努力有望建立坚实的科学基础,为失眠指南中中医治疗建议的发展提供信息。
    BACKGROUND: Traditional Chinese Medicine (TCM) represents a rich repository of empirically-developed traditional medicines. The findings call for more rigorous study into the efficacy, safety, and mechanisms of action of TCM remedies to strengthen the evidence base.
    OBJECTIVE: To systematically review the quality of insomnia clinical practice guidelines that involve TCM recommendations and to summarize the certainty of evidence supporting the recommendations, strength, and consistency of recommendations, providing valuable research references for the development of future insomnia guidelines.
    METHODS: We systematically searched PubMed, Web of Science, Embase, CNKI, Wanfang, Chinese Biomedical Literature Database, Chinese Medical Association, Chinese Sleep Research Society, Medsci, Medlive, British National Institute of Health and Clinical Excellence (NICE), and the International Guidelines Collaboration Network (GIN) for clinical practice guidelines on insomnia from inception to March 5, 2023. Four evaluators conducted independent assessments of the quality of the guidelines by employing the AGREE II tool. Subsequently, the guideline recommendations were consolidated and presented as evidence maps.
    RESULTS: Thirteen clinical practice guidelines addressing insomnia, encompassing 211 recommendations (consisting of 127 evidence-based and 84 expert consensus recommendations), were deemed eligible for inclusion in our analysis. The evaluation results revealed an overall suboptimal quality, with the \"scope and purpose\" domain achieving the highest score (58.1%), while the \"applicability\" domain garnered the lowest score (13.0%). Specifically, it was observed that 74.8% (n = 95) of the evidence-based recommendations were supported by evidence of either very low or low certainty, in contrast to the expert consensus recommendations, which accounted for 61.9% (n = 52). We subsequently synthesized 44 recommendations into four evidence maps, focusing on proprietary Chinese medicines, Chinese medicine prescriptions, acupuncture, and massage, respectively. Notably, Chinese herbal remedies and acupuncture exhibited robust support, substantiated by high-certainty evidence, exemplified by interventions such as Xuefu Zhuyu decoction, spleen decoction, body acupuncture, and ear acupuncture, resulting in solid recommendations. Conversely, proprietary Chinese medicines needed more high-certainty evidence, predominantly yielding weak recommendations. As for other therapies, the level of certainty was predominantly categorized as low or very low. Recommendations about magnetic therapy, bathing, and fumigation relied primarily on expert consensus, needing more substantive clinical research evidence, consequently forming weak recommendations. Hot ironing and acupoint injection recommendations were weakly endorsed, primarily based on observational studies. Furthermore, interventions like qigong, gua sha, and moxibustion displayed a relatively limited number of clinical studies, necessitating further exploration to ascertain their efficacy.
    CONCLUSIONS: Our analysis revealed a need for substantial improvement in the quality of all the included guidelines related to insomnia. Notably, recommendations for Traditional Chinese Medicine (TCM) treatments predominantly rely on low-certainty evidence. This study represents a pioneering effort in the utilization of recommendation mapping to both present and identify existing gaps in the evidence landscape within TCM therapies, thus setting the stage for future research initiatives. The evidence supporting TCM therapy recommendations must be fortified to achieve a more substantial level of recommendation and higher certainty. Consequently, there exists a critical and pressing demand for high-quality clinical investigations dedicated to TCM, with a specific focus on ascertaining its long-term efficacy, safety, and potential side effects in the context of insomnia treatment. These endeavors are poised to establish a robust scientific foundation to inform the development of TCM therapy recommendations within the insomnia guidelines.
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