市场导向下的药企间仿制药一致性评价横向合作的现状分析及对策

中国仿制药占上市化学药品的绝大部分,由于仿制药的质量参差不齐,直接影响到人民群众用药的安全性和有效性。现阶段,我国提出要全面提高仿制药质量,将仿制药分期分批与被仿制药进行质量一致性评价,对于整个医药行业是一次重要的战略机遇。在市场导向下,以企业作为主体通过横向合作的方式,引导企业参与生物等效性(BE)研究平台的建设,通过企业联合建立仿制药一致性评价的参比制剂及研究信息共享机制;同时通过政府引导资源配置,适度倾斜照顾中西部地区企业,解决中西部地区药企面临的实际问题,实现医药行业的区域均衡发展,使之成为促进医药行业的供给侧结构改革的重要抓手。     

Topical cannabis‐based medicines – A novel paradigm and treatment for non‐uremic calciphylaxis leg ulcers: An open label trial

Non‐Uremic Calciphylaxis (NUC) is a rare condition that often manifests as intractable and painful integumentary wounds, afflicting patients with a high burden of co‐morbidity. The Endocannabinoid System (ECS) is a ubiquitous signalling system that is theorised to be dysregulated within wound beds and associated peri‐wound tissues. Preclinical research has shown that the dominant chemical classes derived from the cannabis plant, cannabinoids, terpenes, and flavonoids, interact with the integumentary ECS to promote wound closure and analgesia. This is a prospective open label cohort study involving two elderly Caucasian females with recalcitrant NUC leg ulcers of greater than 6 months duration. Topical Cannabis‐Based Medicines (TCBM) composed of cannabinoids, terpenes, and flavonoids were applied daily to both the wound bed and peri‐wound tissues until complete wound closure was achieved. Wounds were photographed regularly, and the digital images were subjected to planimetric analysis to objectively quantify the degree of granulation and epithelization. Analgesic utilisation, as a surrogate/proxy for pain scores, was also tracked. The cohort had a mean M3 multimorbidity index score of 3.31. Complete wound closure was achieved in a mean of 76.3 days. Additionally, no analgesics were required after a mean of 63 days. The treatments were well tolerated with no adverse reactions. The positive results demonstrated in very challenging wounds such as NUC, among highly complex patients, suggest that TCBM may have an even broader role within integumentary and wound management. This treatment paradigm warrants being trialled in other wound types and classes, and ultimately should be subjected to randomised controlled trials.     

中西医结合治疗冠心病劳力型心绞痛60例疗效分析

目的：比较分析中西医结合治疗与单纯西药治疗冠心病劳力型心绞痛的疗效,以为今后临床本病的治疗提供参考。方法114例冠心病合并劳力型心绞痛患者,随机分为中西医结合治疗组(观察组,60例)以及西药治疗组(对照组,54例),对照组给予单硝酸异山梨酯片治疗,观察组在对照组基础上联合自制中药汤剂治疗。观察两组疗效。结果观察组显效34例,有效18例,无效8例,总有效率为86.7%,对照组患者显效18例,有效20例,无效为16例,总有效率为70.4%,观察组总有效率明显高于对照组,差异具有统计学意义(P<0.05)。两组均有个别患者有副作用,经对应调节后副作用均消失,所有患者均坚持全程服药。结论中西医结合治疗冠心痛劳力型心绞痛疗效显著,值得临床应用推广。     

Clinical trials in children

Safety and efficacy data on many medicines used in children are surprisingly scarce. As a result children are sometimes given ineffective medicines or medicines with unknown harmful side effects. Better and more relevant clinical trials in children are needed to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies. Clinical trials provide reliable evidence of treatment effects by rigorous controlled testing of interventions on human subjects. Paediatric trials are more challenging to conduct than trials in adults because of the paucity of funding, uniqueness of children and particular ethical concerns. Although current regulations and initiatives are improving the scope, quantity and quality of trials in children, there are still deficiencies that need to be addressed to accelerate radically equitable access to evidence-based therapies in children.     

中药品质综合量化评控体系——标准评控力金字塔

中药品质评控是制约中药现代化发展的重要瓶颈问题。现有中药质控标准多为单一、定性的指标,缺少定量化和系统化评判,并且与临床安全性和有效性以及用量和用法等关联不密切。为此,笔者首次提出并构建了中药品质综合量化评控方法体系——标准评控力金字塔,并结合相关研究实例进行阐释,以期推动以临床为导向的中药整合创新研究,为提振中药品质及临床疗效提供前瞻性的管控策略与技术示例。     

胃食管反流病的常用方剂及药对规律

目的 总结胃食管反流病(GERD)的常用方剂及药对规律.方法 检索1994-2014年中医药治疗GERD的相关文献,提取辨证分型、用药等信息,建立Microsoft Excel 2003数据库,采用Crosstabs方法分析各证型、方剂、药对出现频次.结果 共纳入文献350篇,常见6种基本证型,依次为肝胃不和证、脾虚湿热证、肝胃郁热证、痰气交阻证、中虚气逆证、脾胃虚寒证;共使用方剂109个,中药143种.GERD肝胃不和证治疗以柴胡疏肝散为主;脾虚湿热证以半夏泻心汤居多;肝胃郁热证常用左金丸;痰气交阻证以半夏厚朴汤为主;中虚气逆证以旋覆代赭汤为主;脾胃虚寒证黄芪建中汤多见.文献中高频使用的药对组合是半夏-黄连、黄芩-黄连、芍药-甘草、柴胡-白芍等共19对.结论 中医药治疗GERD重视辨证论治的思想,多在主方、主药的基础上,综合考虑本证型病机特点,适当配伍其他类药物,或使其兼顾病机更加广泛,提高主药治疗效果,或防止主药作用太过,佐制其潜在副作用.     

化痰祛瘀方加减联合硫唑嘌呤片治疗白塞病27例临床观察

目的：观察化痰祛瘀方加减联合硫唑嘌呤片治疗白塞病的临床疗效。方法将50例白塞病患者随机分为2组。治疗组27例予化痰祛瘀方加减联合硫唑嘌呤片治疗,对照组23例予硫唑嘌呤片治疗,2组均治疗2个月。比较2组临床疗效及治疗前后C反应蛋白（ CRP）、免疫球蛋白（ Ig） A变化。结果2组总有效率比较差异有统计学意义（P＜0．05）,治疗组疗效优于对照组。2组治疗后CRP及IgA均较本组治疗前降低（P＜0．01）,且治疗组降低更明显（P＜0．05）。结论化痰祛瘀方加减联合硫唑嘌呤片治疗白塞病疗效显著,可提高免疫力。