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。     

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。     

彩色超声引导下针刀治疗肩胛上神经卡压综合征临床疗效观察

目的:观察彩色超声引导下针刀治疗肩胛上神经卡压综合征的临床疗效。方法:选择本院治疗的肩胛上神经卡压综合征患者60例,随机分为观察组和对照组,每组30例。对照组给予小针刀松解治疗,观察组在彩色超声引导下给予小针刀松解治疗。结果:观察组有效率96.7%,对照组有效率86.7%,观察组高于对照组,差异有统计学意义(P<0.05);治疗1周后、1个月后随访,两组VAS评分均低于治疗前,且观察组低于对照组,差异有统计学意义(P<0.05);治疗1周后、1个月后随访,两组Constant-Murley肩关节评分均高于治疗前,且观察组高于对照组,差异有统计学意义(P<0.05)。结论:彩超引导下针刀局部松解治疗肩胛上神经卡压综合征,可减轻患者的疼痛,缩短肩关节活动功能恢复的时间。     

基于依从性曲线变化规律的分阶段健康指导在维持性血液透析病人中的应用

目的:探讨基于依从性曲线变化规律的分阶段健康指导在维持性血液透析病人中的应用效果。方法:将168例行维持性血液透析治疗的慢性肾病病人根据透析时间将病人分为对照组和观察组,每组84例,对照组行常规健康指导,观察组基于依从性曲线变化规律对病人实施健康指导,比较两组病人干预前后遵医行为、自我护理能力及血液透析并发症发生率。结果:干预后观察组病人遵医行为总分及各维度评分(合理饮食、控制液体摄入、血管通路维护、日常生活管理、规律运动、定期门诊随访)较对照组明显提高(P<0.05);干预后观察组病人自我护理能力总分及相关维度评分较对照组明显提高(P<0.05);观察组病人并发症发生率低于对照组(P<0.05)。结论:基于依从性曲线变化规律的分阶段健康指导能有效提高维持性血液透析病人遵医行为及自我护理能力,从而降低病人血液透析并发症发生率。     

经皮肾镜气压弹道超声碎石在肾结石中的效果

目的 B超引导经皮肾镜气压弹道超声联合碎石治疗肾结石的临床效果。方法选择2017年9月-2018年9月医院收治的肾结石患者82例,按照抽签法的要求将其平均分成对照组(41例:B超引导经皮肾镜气压弹道超声治疗)与试验组(41例:输尿管软镜治疗),分析手术时间、住院时间、出血量、结石清除率、结石的残留率。结果试验组的手术时间、住院时间、出血量。优于对照组,数据比较有差异性,P<0.05。对照组的结石清除率高于试验组、结石的残留率低于试验组,相互比较有差异性,P<0.05。结论在肾结石实际治疗期,使用输尿管软镜钬激光碎石治疗方式。     

« S’attacher pour bien grandir » : résultats préliminaires d’un groupe thérapeutique de guidance parentale et de mise en situation centré sur l’attachement

BackgroundPreventive and therapeutic settings are very common in perinatal and early childhood mental health services. However, their theoretical basis, their methods and their efficacy are rarely described.AimsIn this paper, we present and describe the first feedback from parents about a new group therapeutic setting model that relies on parental guidance and practical experiences designed to prevent and to treat attachment-related parent–infant/child problematic issues.MethodThe group is designed to enhance the quality of parent-child attachment by promoting parents’ awareness of the nature and the importance of attachment bonds for child development and parent–child relationship, and by bringing parents and child to experience new interactions that promote child attachment security. The group is led by two psychologists, a pediatric nurse and a childcare assistant. It is designed to receive up to five families referred by a child psychiatrist after a consultation. Children are aged 1 to 3 years old. Parents and children are received for an assessment interview prior and after they complete their participation to the group, including measures of parental stress (PSI-SF), infant relational withdrawal (ADBB), parent-child relationship (PIRGAS), and child social and emotional competences and problems (BITSEA). Families attend six thematic sessions each of which addresses one of the main attachment pillars: sensitivity, reciprocity, engagement, proximity, emotional regulation and support network. Contents are delivered via slides, video clips, group discussions, practical situations and home tasks. Both parents are encouraged to participate. The feedback from the first families (n = 17) who attended the group are presented.ResultsPreliminary results on the first families who participated in this group show that all of them were satisfied about the group contents and setting. Most parents reported they have acquired new insights on their child's attachment needs and behaviors, felt more comfortable with regulating their own and their child's emotional needs and expression, and became more able to manage problematic behaviors, separation and conflict situations. Slides, video clips and experiencing practical situations and home tasks were also greatly appreciated.PerspectivesThe preliminary positive feedback from the parents supports the relevance of this new intervention model targeted on attachment issues. The group setting, the concrete materials and the active participation of parents and children promote the awareness of attachment needs and the experience of new and safer parent–child interactions.