小儿厌食中药新药临床试验设计与评价技术指南

《儿科常见疾病中药新药临床试验设计与评价技术指南》是中华中医药学会儿科分会临床评价学组制定的、指导儿科中药Ⅱ期、Ⅲ期临床试验和上市后有效性再评价方案设计的、具有病种特色的系列临床评价技术指南, 旨在推动儿科中药临床试验设计与评价水平的提高, 并为临床提供安全有效的儿童用药。采用世界卫生组织(WHO)推荐的"共识会议法"和美国国立卫生研究院(NIH)发展共识方案(GPP)有关原则, 国内全部18个国家药物临床试验机构中医儿科专业的临床儿科专家以及国内相关临床评价专家参加了急性上呼吸道感染、急性支气管炎、支气管哮喘、反复呼吸道感染、厌食、轮状病毒性肠炎、注意缺陷-多动障碍、抽动障碍、遗尿症、手足口病、湿疹11个儿科常见病种指南的起草或多次提出修改建议, 历经3年反复完善, 最终形成共识, 并由中华中医药学会儿科分会于2013年10月发布。本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了小儿厌食中药新药临床试验的设计与评价技术要点, 期望能为申办者与研究者在临床试验方案设计中提供指导。     

Practice patterns and adherence to nutrition guidelines in acute pancreatitis: An international physician survey

BackgroundThere is agreement among GI society guidelines for recommending early oral nutrition with non-liquid diet in patients with mild acute pancreatitis (AP). There is less agreement regarding administration of tube feedings (TF) in AP. Data on physicians’ adherence to nutrition guidelines and practice variations are limited.AimsTo report practice patterns in the nutritional management of different severity profiles of AP.MethodsWe conducted an anonymous electronic survey among physician members of the International Association of Pancreatology and the American Pancreatic Association. We assessed nutrition practices based on severity of AP, and asked relevant questions regarding the preferred administration strategies for enteral nutrition. Responses were compared by practice location and subspecialty.ResultsA total of 178 physicians, mostly medical pancreatologists (40.4%) and surgeons (34.8%) from Europe (43.4%) and North America (32%) responded. Overall, only 26.7% initiated oral nutrition in mild AP on day 1, 40.9% waited >48 h, and 57.3% initiated nutrition with liquid diets. Physicians reported frequently using TF in patients with moderately-severe (30–75%, depending on the amount and location of necrosis) and severe AP (75–80%). Two-thirds of physicians preferred initiating TF after 48 h, administering it post-pylorically, and using semi-elemental or polymeric formulas. Median TF duration was 11 days (IQR, 7–21). Significant variations were noted based on geographic location and physician subspecialty for several aspects of nutritional practices in both mild and non-mild AP.ConclusionAdherence to oral nutrition guideline recommendations for mild AP is low. There is significant variability in the use of TF in AP. Our study highlights opportunities for improving consistency of nutrition care in AP and identify potential areas for research.     

小儿湿疹局部用中药新药临床试验设计与评价技术指南

《儿科常见疾病中药新药临床试验设计与评价技术指南》是中华中医药学会儿科分会临床评价学组制定的、指导儿科中药Ⅱ期、Ⅲ期临床试验和上市后有效性再评价方案设计的、具有病种特色的系列临床评价技术指南,旨在推动儿科中药临床试验设计与评价水平的提高,并为临床提供安全有效的儿童用药。采用世界卫生组织(WHO)推荐的“共识会议法”和美国国立卫生研究院(NIH)发展共识方案(GPP)有关原则,国内全部18 个国家药物临床试验机构中医儿科专业的临床儿科专家以及国内相关临床评价专家参加了急性上呼吸道感染、急性支气管炎、支气管哮喘、反复呼吸道感染、厌食、轮状病毒性肠炎、注意缺陷-多动障碍、抽动障碍、遗尿症、手足口病、湿疹11 个儿科常见病种指南的起草或多次提出修改建议,历经3 年反复完善,最终形成共识,并由中华中医药学会儿科分会于2013 年10 月发布。本指南从研究背景、研究目标、总体设计、诊断标准、受试者的选择、给药方案、安全性评价、有效性评价、试验流程、数据管理与统计分析、质量保证、相关伦理学要求、试验结束后的医疗措施、资料保存等方面阐述了小儿湿疹中药新药临床试验的设计与评价技术要点,期望能为申办者与研究者在临床试验方案设计中提供指导。     

Clinical Practice Guidelines for the Medical and Surgical Management of Primary Intracerebral Hemorrhage in Korea

The purpose of this clinical practice guideline (CPG) is to provide current and comprehensive recommendations for the medical and surgical management of primary intracerebral hemorrhage (ICH). Since the release of the first Korean CPGs for stroke, evidence has been accumulated in the management of ICH, such as intracranial pressure control and minimally invasive surgery, and it needs to be reflected in the updated version. The Quality Control Committee at the Korean Society of cerebrovascular Surgeons and the Writing Group at the Clinical Research Center for Stroke (CRCS) systematically reviewed relevant literature and major published guidelines between June 2007 and June 2013. Based on the published evidence, recommendations were synthesized, and the level of evidence and the grade of the recommendation were determined using the methods adapted from CRCS. A draft guideline was scrutinized by expert peer reviewers and also discussed at an expert consensus meeting until final agreement was achieved. CPGs based on scientific evidence are presented for the medical and surgical management of patients presenting with primary ICH. This CPG describes the current pertinent recommendations and suggests Korean recommendations for the medical and surgical management of a patient with primary ICH.     

206例乳腺癌患者抗肿瘤药物应用评价分析

摘 要 目的：评价医院乳腺癌患者抗肿瘤药物的使用情况,为临床合理用药提供参考。 方法：回顾性研究206例转移性乳腺癌患者治疗方案,依据药品说明书和临床实践指南对抗肿瘤药物使用的合理性进行评价。按照实体瘤的疗效评价标准(RECIST)评价有效性;按照不良事件评价标准 (CTACE4.03)分析安全性;对患者的住院费、药费和抗肿瘤药物费用进行统计分析。 结果：疗效评价表明客观缓解率为16.0%（33/206）,疾病控制率为65.0%（134/206）,疾病进展为7.8%（16/206）,未评价的患者为27.2%（56/206）。化疗方案选择合理为80.1%（165/206）,化疗方案无依据为19.9%（41/206）,给药途径与溶媒超说明书为4.8%（10/206）,平均相对剂量强度为89.6%。不良事件多为轻度,Ⅲ级以上严重不良事件发生率为3.0%。住院费用、药物费用、抗肿瘤药费中位数分别为7 870,6 082,3 983元。 结论：抗肿瘤药物疗效与不良反应发生率均偏低,可能与多个化疗方案平均剂量低于指南标准剂量相关;需进一步改进用药剂量低、治疗方案选择缺乏依据、给药途径与溶媒用量错误等不合理用药情况。     

Considering intellectual,in addition to financial,conflicts of interest proved important in a clinical practice guideline: a descriptive study

ObjectivesThe American College of Chest Physicians Antithrombotic Guidelines ninth iteration placed restrictions on panelists with recommendations on which they disclosed a primary conflict of interest (COI). We aimed to describe panelists' financial and intellectual COI and evaluate to what extent, beyond assessing financial COI, assessing intellectual COI affected COI management.Study Design and SettingWe classified financial and intellectual COI into primary (causes voting restriction) and secondary (no restrictions). We analyzed disclosures respectively with panelists and recommendations as units of analysis.ResultsOne hundred two panelists made 4,030 disclosures for 431 recommendations. The median number (and range) of panelists per recommendation who disclosed the various categories of COI was 0 (0–5) for primary financial COI, 0 (0–4) for secondary financial COI, 0 (0–7) for primary intellectual COI, and 1 (0–6) for secondary intellectual COI. Of the 431 recommendations, 63 (15%) had at least one panelist with a primary intellectual COI but no primary financial COI.ConclusionCOI had a relatively low prevalence and a skewed distribution, many panelists with none and some with many disclosures. A substantial number of disclosures should have resulted in restrictions based on intellectual COI in the absence of financial COI.     

结合2019版NPIAP指南谈器械相关压力性损伤研究进展及医护人员防护

本文结合2019版NPIAP指南,对器械相关压力性损伤的概念、评估、发生特征及防护措施等进行详细阐述,并侧重从选择合适的器械用具、合理使用预防性敷料、保持局部皮肤清洁与湿润、减少器械使用及压迫时间等方面,总结了器械相关压力性损伤的防护建议,旨在为临床医护人员器械相关压力性损伤预防和护理提供参考依据。