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。     

Profiling of the microbiota in the remaining sports drink and orange juice in plastic bottles after direct drinking

ObjectivesThe survival of bacteria in the sports drink and orange juice remaining in and at the mouth of bottles after direct drinking was examined after immediately drinking and incubation at 37 °C for 24 h.MethodsNine healthy participants were asked to drink approximately 100 mL of a plastic bottled sports drink or orange juice. The samples were cultured anaerobically at 37 °C for 7 days. Genomic DNA was extracted from the resulting individual colonies, and bacterial species were identified using 16 S rRNA gene sequencing.ResultsThe mean amount of bacteria in the remaining sports drink and orange juice, immediately after drinking, were (1.6 ± 2.3) × 10³ colony-forming units (CFU)/mL and (2.9 ± 3.3) × 10³ CFU/mL, respectively. Additionally, bacteria recovered from the mouths of the sports drink and orange juice bottles were (2.5 ± 5.5) × 10⁴ CFU/mL and (5.8 ± 2.4) × 10³ CFU/mL, respectively. Oral bacteria, such as Streptococcus, Actinomyces, Neisseria, and Rothia were found to be transferred in the sports drink and orange juice, and the bacteria were scarcely detected after incubation at 37 °C for 24 h.ConclusionsThe bacterial levels differed significantly from the previously reported levels in bottled tea 24 h after drinking, suggesting that remaining drinks with low pH levels can be preserved for a longer period.     

桃仁的本草考证

对中药的本草考证,是推动经典名方开发与上市的前期工作。查阅现代文献发现,近年对桃仁的研究大多集中在药理成分、药代动力学、医案等方面,鲜有从古籍文献出发对桃仁的基原、炮制、性味归经及功效主治等方面进行研究。经考证发现,桃仁的常用名有"桃仁""桃核仁",产地较广;从品种而言,桃仁的植物来源古今变化不大,清代以前,桃仁的植物来源为山桃或毛桃的种子,近代以来桃或山桃的种子成为主流,不同著作关于桃仁植物来源的拉丁学名有所不同,笔者认为桃Amygdalus persica,山桃A. davidiana拉丁学名较为合理。桃仁行血,宜连皮、尖,生用;桃仁润燥,宜去皮、尖,炒黄。桃核承气汤和桃红四物汤原方中桃仁的炮制方法应当皆为"去皮、尖,炒黄",身痛逐瘀汤中桃仁的炮制方法则应为"连皮、尖,生用"。桃仁主治闭经、瘕邪、小虫、胸痹、咳喘、便秘等多个病证,血虚者、血燥者、孕妇等群体慎用或勿用。现代临床应用仅是对古籍记载的部分继承,提示桃仁还有许多功效可供考证研究,值得进一步深入挖掘以扩大临床应用。古籍关于桃仁的性味归经、品质评定与现代《中华人民共和国药典》内容较一致。因桃仁外观与杏仁相似,尤以粉碎后难以区分,需耗费大量时间和财力予以鉴别,建议医疗机构采购桃仁时尽量采购未经粉碎的桃仁,药房根据临床需求再进行加工炮制。     

蒙药经典方扎冲十三味丸的方解、方源、药理与临床应用

目的:对蒙药经典方扎冲十三味丸(GRD-13)进行基原考证、方解分析、综述药理与机制、临床应用,为该经典方的深一步研究与利用提供科学依据。方法:采用查阅文献研究与考证方法进行文献综述。结果:蒙药扎冲十三味丸出自《哲对宁诺尔》(《至高要方》),属传统蒙药经典方。该方由沉香10 g、麝香7.5 g、木香15 g、禹粮土7.5 g、制草乌30 g、甘草10 g、诃子60 g、制珊瑚7.5 g、制珍珠8 g、石菖蒲45 g、丁香5 g、煅磁石5 g、肉豆蔻5 g,共13味单味药组成。蒙医在使用过程中,因临床用药经验和用药方法有所不同而出现有单味药在处方中的入药量改变。蒙药扎冲十三味丸具有愈白脉损伤、杀黏、镇静安神功效,由蒙医主治白脉病、萨病、黏性刺痛、瘟疫、疽炭、白喉、吾亚曼病、转筋、亚玛症、协日乌素病、丹毒、高血压等疾病,临床疗效确切。结论:蒙药扎冲十三味丸出自《哲对宁诺尔》(《至高要方》),属传统蒙医经典方,对脑梗死等脑血管疾病疗效显著,具有进一步探索研究价值。     

苦味药材性状分析

苦味是中药药性理论的重要组成部分。不同的物质组成影响着药材性状,也影响着药材性味。选取《中华本草》所载1 728种寒热药性明确的中药,运用数学统计方法,研究了中药苦味与药材性状的关系,认为药材质地、气味、味道、外观颜色共同影响着中药苦味。药材性状质脆、味苦或味涩越多的中药,药材性味越偏向苦味;药材性状气香、味甘、味咸、味辛和白色越多的中药,药材性味越远离苦味。     

Clinicopathological features of mycosis fungoides in patients exposed to Agent Orange during the Vietnam War

There are no reports on the clinicopathological features of mycosis fungoides (MF) among veterans exposed to Agent Orange, one of the herbicides used during the Vietnam War. To evaluate the clinical, histopathological and genotypic findings of Vietnam War veterans with MF and a positive history of exposure to Agent Orange, we performed a comparative clinicopathological study between MF patients with a history of Agent Orange exposure and those without a history of Agent Orange exposure. Twelve Vietnam War veterans with MF were identified. The mean interval from Agent Orange exposure to diagnosis was 24.5 years (range, 9–35). Skin lesions were significantly present on exposed and unexposed areas. Most patients (75%) experienced pruritus (mean visual analog scale score of 6.7). MF was manifested by plaques in 10 patients and by lichenification in five. Histopathological features of most cases were consistent with MF. Biopsy specimens also demonstrated irregular acanthosis (66.7%). In the comparative study, MF patients with a history of Agent Orange exposure differed significantly from those without exposure to Agent Orange in demographic and clinical characteristics. In addition, patients with exposure had an increased tendency for lesions in the exposed area. Notably, our patients showed a higher frequency (33.3%) of mycosis fungoides palmaris et plantaris than in previous studies. Histologically, irregular acanthosis was more frequently observed than ordinary MF. Our results indicate that dermatologists should pay close attention to these clinicopathological differences. Careful assessment of history of exposure to defoliants is warranted in some cases suspicious for MF.     

Legal liability for Agent Orange-related illnesses: a reassessment of the 2005 VAVA case and prospects for new litigation

Attempts through the US courts to hold the corporations responsible for the production of dioxin-contaminated herbicides used by the US military in the 1960s and early 1970s liable for their ongoing health consequences have failed. This article scrutinizes the most recent judgement – that of the United States District Court for the Eastern District of New York handed down in 2005 following a lawsuit brought by the Vietnam Association of Victims of Agent Orange/dioxin (VAVA). It is argued that despite this judgement there is the potential to bring a further legal case, with some prospect of success, on the basis of: (i) debatable legal judgements in the 2005 decision; (ii) new scientific evidence on the health effects of exposure to Agent Orange; and (iii) cases brought in other jurisdictions. The article concludes by noting the underfunding of ongoing remediation efforts, especially for the provision of assistance to affected individuals, and argues that it is desirable to oblige the producers of the herbicides to contribute financially to these efforts.     

论甘草之缓

甘草味甘性平,在中药中有"国老"之誉,五行为土,借甘以缓肝之急、缓中健脾、缓肺气之急、缓心之急、缓肾之急、缓百药辛烈之性,作用广泛又不失平和之性。但临床仍需辨证论治为基础,以求熟用其甘缓之功。