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。     

Rupture Resolution Rating System (3RS): Development and validation

Objective: Our aim was to examine the reliability and validity of the Rupture Resolution Rating System (3RS), an observer-based measure of alliance ruptures and resolution processes. Method: We used the 3RS to rate early sessions from 42 cases of cognitive behavior therapy. We compared the 3RS to a simplified version of the Structural Analysis of Social Behavior (SASB), as well as patient and therapist self-reports of ruptures and the alliance. Results: Coders achieved high rates of interrater reliability on the frequency of confrontation and withdrawal ruptures and resolution strategies (ICCs?=?.85 to .98), as well as ratings of the therapist’s contribution to ruptures and the extent to which ruptures were resolved (ICC?=?.92). Predictive validity analyses found that confrontation markers (d?=?.74), successful resolution (d?=?.67), and ratings of the therapist’s contribution to ruptures (d?=?.61) predicted dropout from therapy. Analyses of convergent validity with the SASB failed to meet predictions; however, we observed theoretically coherent relations between 3RS and SASB variables. Confrontation rupture markers were significantly associated with patient self-report of rupture (d?=?1.54) and therapist self-reported alliance (r?=??.50, p?=?.002). Conclusions: This study provides evidence that the 3RS is a reliable and useful tool for examining psychotherapy process and predicting dropout.

Clinical or methodological significance of this article: This study provides evidence of the reliability and validity of the 3RS, an observer-based measure of alliance ruptures and resolution processes. The 3RS can be used to identify problems in the therapeutic relationship that are associated with premature dropout from therapy.     

中药复方配伍的研究方法及其进展

中药复方是由2味或2味以上中药遵循中医理论组合而成的方剂。多味中药在合适的剂量配比之下,协同发挥作用,实现中医的整体调节治疗。研究中药复方的配伍对推动中药现代化发展、新药开发以及临床应用有着重要意义。近年来,研究者们在传统的"七情和合"与"君臣佐使"的基础上,运用新技术和新方法对中药复方的成分、药效活性和药代动力学性质等进行了研究,从不同角度探讨了中药复方配伍的科学内涵。同时,多种数理方法和模型的建立、网络药理学和数据挖掘方法的发展与应用,也对中药复方配伍研究提供了很大帮助。研究方法的发展虽促进了中药复方配伍的科学研究,但还需进一步建立适合中药复方配伍复杂关系的研究方法,以阐明中药复方及其成分/组分配伍的内在规律,进而构建新的现代中药复方,这也是目前中药复方配伍研究的重点任务。