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。     

How do peer support interventions for the self-management of chronic pain,support basic psychological needs? A systematic review and framework synthesis using self-determination theory

ObjectiveTo identify how peer support interventions, for self-management of chronic pain, support basic psychological needs from a self-determination theory (SDT) perspective, using a systematic review.MethodsTen databases were searched for studies reporting qualitative research about peer interactions in pain management interventions. ‘Best fit’ framework synthesis methodology was applied to identify strategies that support the satisfaction of competence, autonomy and motivation. These were matched to definitions of strategies provided by standardised taxonomies.Results18 studies were selected for inclusion. The synthesis resulted in a conceptual model, identifying 12 peer strategies that support psychological needs for self-management of chronic pain; 10 overlapped with existing taxonomies.ConclusionThis was the first known attempt to synthesise evidence about peer support strategies for people living with pain, using SDT as an a priori framework. The model demonstrates commonality between the motivation-promoting processes of peer support and those of other behaviour change interventions and identifies additional unique strategies provided by peers. This systematic classification of peer support strategies provides a means for future study of the efficacy and comprehensiveness of peer interventions.Practice implicationsThe model could assist healthcare professionals and support groups to optimise the potential of peer processes.     

Low percentage of patients passed the ‘Back in Action’ test battery 9 months after bone-patellar tendon-bone anterior cruciate ligament reconstruction

BackgroundAnterior cruciate ligament (ACL) reconstruction is recommended in patients who intend to return to high-level sports. However, there is only a 55–80% return to pre-injury level of sports after ACL reconstruction, with a re-injury rate up to 20%. The aim of this study was to determine the percentage of patients passing the Back in Action (BIA) test 9 months after primary bone-patellar-tendon-bone (BPTB) ACL reconstruction, and evaluate the association between passing the BIA test and patient reported outcome measurements (PROMs).MethodsPatients underwent the BIA test 9 months after BPTB ACL reconstruction. In total 103 patients were included. Passing the BIA test (PASSED-group) was defined as a normal or higher score at all sub-tests with limb symmetry index (LSI) ≥90% for the dominant leg and LSI >80% for the non-dominant leg. Patients who did not meet these criteria were defined as the FAILED-group. PROMs included the International Knee Documentation Committee, Knee injury Osteoarthritis Outcome Score and Anterior Cruciate Ligament-Return to Sport after Injury.ResultsEighteen patients (17.5%) passed the BIA test 9 months after BPTB ACL reconstruction. PROMs were not statistically significant different between the PASSED- and FAILED-group.ConclusionLow percentage of patients passed the BIA test 9 months after BPTB ACL reconstruction. Although current PROMs cut-off values were met, the BIA test results show persistent functional deficits. Therefore, the BIA test could be of additional value in the decision-making process regarding return to sport (RTS). This study highlights the need for additional rehabilitation as RTS in a condition of incomplete recovery may increase the risk of re-injury.Level of evidenceII.     

基于奥马哈理论的围手术期全程康复管理对TAVR患者心理应激、6 min步行距离及并发症的影响

目的 探讨基于奥马哈理论的围手术期全程康复管理对经导管主动脉瓣置换术（transcatheter aortic valve replacement，TAVR）患者心理应激、6 min步行距离及并发症的影响。 方法 选取我院74例TAVR患者，采用随机数字表法分为2组，各37例。对照组采取传统围术期护理，在对照组基础上，观察组采取基于奥马哈理论的围手术期全程康复管理。统计2组并发症、护理满意度及护理前后心理应激、心功能指标、健康行为（health promotionlifestyleprofile-Ⅱ，HPLP-Ⅱ）、6 min步行距离及生活质量。 结果 观察组干预后左心室舒张末期内径、跨瓣压差较对照组低，主动脉瓣面积、左心室射血分数高于对照组（P＜0.05）；观察组干预后特质焦虑（Trait Anxiety Inventory，T~AI）、状态焦虑（State Anxiety Inventory，S~AI）评分低于对照组（P＜0.05）；观察组干预后HPLP-Ⅱ量表6个维度评分高于对照组（P＜0.05）；观察组术后3个月、6个月生活质量及6 min步行距离高于对照组（P＜0.05）；2组并发症比较差异无统计学意义（P＞0.05）。 结论 基于奥马哈理论的围手术期全程康复管理应用于TAVR患者，可减轻其心理应激，提高患者健康促进生活方式水平，预防并发症发生，在改善患者心功能、运动耐力和提高患者护理满意度方面具有积极意义。