Innovation in Chemistry,Manufacturing, and Controls—A Regulatory Perspective From Industry

This review describes the landscape of novel modalities such as cell and gene therapies, viruses, other novel biologics, oligomers, and emerging technologies, including modern analytics. We summarize the regulatory history and recent landmark developments in some major markets and examine specific chemistry, manufacturing, and controls (CMC) challenges, including suggestions for exploration of potential science-based approaches in support of regulatory strategy development from an industry perspective. In addition, we evaluate the economic factors contributing to patient access to innovation and discuss the impact of regulation. There is a desperate need for a consistent form of regulation where global approaches to regulatory strategies can be harmonized, and specific CMC challenges can be dealt with using the appropriate science and risk-based tools. Although these tools are well described in current guidance documents, the specifics of applicability to complex novel modalities can still result in differing regulatory advice and outcomes. The future goals for efficiently regulating innovative modalities and technologies could be aided by more regulatory harmonization, regulatory education, and industry cooperation through consortia, enabling industry to supply key information to regulators in a transparent yet well-defined manner, and utilizing mutually understood risk-benefit analyses to produce drugs with appropriate safety, efficacy, and quality characteristics.     

基于数据挖掘对治疗口疮的成方制剂的用药规律分析*

目的分析治疗口疮的成方制剂的剂型、功能主治、组方用药规律及核心组合，为临床治疗口疮的辨证用药及新药研发提供参考。方法 收集《中华人民共和国卫生部药品标准·中药成方制剂》(以下简称《中药成方制剂》)、《中华人民共和国药典：2015年版》(以下简称2015年版《中国药典》)中治疗口疮的成方制剂的名称、处方、剂型、功能与主治，录入Microsoft Excel及中医传承辅助平台(V2.5)，统计用药频次；运用Apriori算法及关联规则对处方核心组合进行统计分析(支持度为10%，置信度100%)；采用熵聚类算法统计2-3个不同成分间的关联系数(支持度为8，惩罚度为2)；根据无监督的熵层次聚类法提取内在核心组合和新方组合。结果 挖掘得出86种成方制剂及其处方，以丸剂、散剂、片剂等多见，包含药物148味，使用频次较高为冰片、甘草、大黄、黄芩等，药物四气五味以苦寒为主，主要归肺胃心脾经，治疗证型较多为热毒炽盛证、热毒攻喉证等，常用核心配伍包括“黄芩-大黄”“黄连-甘草”等，挖掘得出新方组合“珍珠-川贝母-灯心草-天花粉-没药”等4首。结论 利用数据挖掘分析治疗口疮的成方制剂的组方规律，由核心药物组合成新方，可为临床辨证使用及研发治疗口疮成方制剂、新药提供依据和参考。     

四逆散合方辨治围产期疾病验案3则

正围产期是指怀孕28周到产后1周这一分娩前后的重要时期,其间发生的疾病直接影响到胎儿的生长发育和孕妇的身心健康。因此,做好围产期保健对于保障孕妇的健康和胎儿的生长发育至关重要。四逆散出自仲景《伤寒论》,由柴胡、芍药、枳实、甘草各等份组成,具有透邪达表、宣通郁阳的作用,为治疗阳郁厥逆和肝脾不和的常用效方。笔者根据"异病     

中药方剂抗肺纤维化方治疗肺纤维化患者的临床研究

〔摘 要〕 目的：研究中药方剂抗肺纤维化方治疗肺纤维化（PF）患者的疗效。方法：选取福建中医药大学附属 第二人民医院 2020 年 3 月至 2021 年 10 月期间收治的 70 例 PF 患者，采用随机数字表法分为对照组与观察组，各 35 例。对照组患者采用常规西药治疗，观察组患者在常规西药治疗基础上采用中药方剂抗肺纤维化方治疗。比较两 组患者的临床疗效、治疗前及治疗 3 个月后中医证候积分、肺功能指标、肺纤维化指标、圣乔治呼吸疾病问卷（SGRQ）、 高分辨计算机断层扫描（HRCT）评分。结果：观察组患者治疗总有效率为 88.67 %，高于对照组的 62.86 %，差异具 有统计学意义（P ＜ 0.05）。治疗后观察组患者的乏力、呼吸气短、自汗、咳嗽评分均低于对照组，差异具有统计学 意义（P ＜ 0.05）。治疗后观察组患者的第 1 秒用力呼气容积（FEV1）、用力肺活量（FVC）、最大呼气流量（PEF） 均高于对照组，差异具有统计学意义（P ＜ 0.05）。治疗后观察组患者的透明质酸（HA）、层粘连蛋白（LN）、 Ⅲ型胶原（Ⅲ –Col）均低于对照组，差异具有统计学意义（P ＜ 0.05）。治疗后观察组患者的 SGRQ、HRCT 评分均 低于对照组，差异具有统计学意义（P ＜ 0.05）。结论：采用中药方剂抗肺纤维化方与常规西药联合治疗 PF 患者， 能进一步改善患者临床症状，降低肺纤维化程度，增强肺功能，提高临床疗效。     

民间验方生存发展困境与保护策略

目的：探讨我国民间验方开发利用过程中存在的问题及其生存发展的困境，为合理获取和传承民间验方提出相关的建议和对策。方法：比较现行法律法规在保护民间验方上存在的不足与缺陷，借鉴泰国保护传统医药知识的做法和经验。结果：针对我国民间验方的实际情况，建议完善相关法律法规，建立民间验方保护名录。结论：建立民间验方保护名录，实行保密登记制度，可以对提出申请的民间验方中核心的信息进行保护，促进传统医药知识的传承与发展。     

In Utero Exposure to Opioids: An Observational Study of Mothers Involved in the Child Welfare System

Background: Women are underrepresented in the current substance abuse research; however, women are a particularly vulnerable population when it comes to opioid use and abuse. Pregnant women are even more so, because of the potential that exists for in utero exposure (IUE) to substances. Objectives: To identify trends in IUE to opioids in order to ensure that resources are allocated effectively to address the current opioid epidemic and to assist the populations most affected by it. Methods: This study draws on 15 years' worth of clinical assessment data collected from 3598 child welfare-involved mothers to assess for trends in IUE to substances over time. Data from the last 5 year period (N = 852) are then analyzed to identify recent demographic correlates associated with IUE to opioid substances. Results: A substantial increase in the rates of IUE to opioids over the past 15 years is observed among child welfare-involved mothers. Moreover, we find that race is a significant correlate of IUE to opioids. Conclusion: Study findings are consistent with other recent research that demonstrates racial differences in the populations that are most affected by the opioid epidemic; however, more research is needed to determine how these racial differences in rates of IUE to opioids affect child welfare outcomes.