生物等效性试验动态现场核查的可行性探讨

生物等效性（BE）试验作为药物临床试验的一种方式,大量应用于我国仿制药一致性评价。随着我国药物临床试验开展数量逐年递增,保证其过程规范性、数据可靠性变得尤为重要。同时,对于监管部门来说,降低试验风险、提高检查效率和质量,是一直以来研究探讨的方向。本文对生物等效性试验动态现场核查的法规基础、优势和困难、核查的关键要点进行梳理,探讨开展生物等效性试验动态现场核查的可行性,并就目前存在的问题与挑战进行展望,提出继续优化药物临床试验的监管建议。     

Perception of the Food and Drug Administration Electronic Cigarette Flavor Enforcement Policy on Twitter: Observational Study

BackgroundOn January 2, 2020, the US Food and Drug Administration (FDA) released the electronic cigarette (e-cigarette) flavor enforcement policy to prohibit the sale of all flavored cartridge–based e-cigarettes, except for menthol and tobacco flavors.ObjectiveThis research aimed to examine the public perception of this FDA flavor enforcement policy and its impact on the public perception of e-cigarettes on Twitter.MethodsA total of 2,341,660 e-cigarette–related tweets and 190,490 FDA flavor enforcement policy–related tweets in the United States were collected from Twitter before (between June 13 and August 22, 2019) and after (between January 2 and March 30, 2020) the announcement of the FDA flavor enforcement policy. Sentiment analysis was conducted to detect the changes in the public perceptions of the policy and e-cigarettes on Twitter. Topic modeling was used for finding frequently discussed topics about e-cigarettes.ResultsThe proportion of negative sentiment tweets about e-cigarettes significantly increased after the announcement of the FDA flavor enforcement policy compared with before the announcement of the policy. In contrast, the overall sentiment toward the FDA flavor enforcement policy became less negative. The FDA flavor enforcement policy was the most popular topic associated with e-cigarettes after the announcement of the FDA flavor enforcement policy. Twitter users who discussed about e-cigarettes started to talk about other alternative ways of getting e-cigarettes after the FDA flavor enforcement policy.ConclusionsTwitter users’ perceptions of e-cigarettes became more negative after the announcement of the FDA flavor enforcement policy.     

Kaposi肉瘤治疗的研究进展

Kaposi肉瘤的治疗应依据不同临床类型,制定个体化方案.常用治疗方法有电化学疗法、放疗、物理治疗(如硝酸银、液氮冷冻、弹力长筒袜)和皮损内注射等,适用于经典型Kaposi肉瘤及其他类型Kaposi肉瘤的皮肤损害.常用治疗药物有足叶乙甙、紫杉醇、阿霉素、雷帕霉素、吉西他滨等,适用于各型Kaposi肉瘤.Kaposi肉瘤的治疗尚缺乏标准化指南,以上治疗远期疗效欠佳.目前,新治疗靶标的研究主要集中在阻止成瘤过程、炎症调控、阻止病毒复制、细胞周期的调控等方面.     

Comparative study of portacaval and mesocaval interposition shunts

Portacaval and mesocaval interposition shunts using vascular prosthetic grafts were compared in 37 cirrhotic patients without portal vein thrombosis who were operated on for previous or active variceal hemorrhage. Operative indications and severity of liver disease were similar in the two groups of patients having one or the other procedure. The major difference in results was that none of the 23 patients with portacaval H-graft shunts had rebleeding, while 4 of 14 had rebleeding from varices after mesocaval interposition shunting. This contributed to the higher operative mortality associated with the latter procedure. The index of operative difficulty, as judged by blood loss and length of operation, and postshunt encephalopathy rates were similar for both procedures. Thus, while the mesocaval interposition shunt offers none of the reported theoretical advantages over portacaval H-graft shunt, it does place patients at greater risk of postoperative variceal rehemorrhage. It is concluded that the portacaval interposition shunt, because of its effectiveness and technical expediency, may be the operation of choice in cirrhotic patients with bleeding varices who are not otherwise candidates for other procedures which reduce portal flow less drastically.