“一带一路”医疗援外项目卫生人员不同培养方式结果分析

目的探讨援外医疗救助"爱心行"项目中,针对柬埔寨医务人员不同培养形式初步结果。方法 2017年12月-2019年3月,横断面调查方法。近5年卫生人力资源培养相关文献查询,参加"爱心行"项目中国柬埔寨政府多部门,中国援外医疗队员,柬埔寨西部大学教授,参加培养柬埔寨卫生管理及医疗卫生人员等为访谈对象。半结构式访谈收集培养时间、内容类型及过程,分析比较长短期不同培训形式优缺点及初步结果。结果 7种形式共培养柬埔寨医生167人,来自柬埔寨4个省及金边市。其中硕士1名;长期进修(3月及以上)2名,会议及培训40名,与柬大学联合短期培训24名学员,来华现场培训实习5名,中国援外医疗队现场带教33人,中国流动医疗车现场带教培训70名。培训内容包括项目管理组织,筛查技能,心脏B超检查,Intensive Care Unit(ICU),心导管,经皮介入治疗结构性心脏病及车载心电图机,X线,生化分析仪使用等。结论援外项目应长短期培养相结合,多种培养形式有利于兼顾项目实施现场需求及长期项目影响。     

Randomized Clinical Trials of Traditional Chinese Medicines for Treating Ulcerative Colitis: A Scoping Review

Objective: Traditional Chinese medicines (TCMs) are efficacious against ulcerative colitis (UC). In recent years, the number of randomized clinical trials (RCTs) of TCM has increased. Thus, it is very important to summarize the basic characteristics, quality, and types of TCM interventions in published RCTs. This scoping review was performed to systematically identify and describe the current situations about RCTs of TCMs for treating UC. Hope to express the focus and specifics of nowadays research in TCM interventions in RCTs and evaluate their common disadvantages exposed to help advance in TCM researching. Materials and Methods: Ascoping review was conducted according to the PRISMA extension for scoping reviews. We searched two English databases and four Chinese databases from the date of establishment of each database to January 2020. Data from RCTs focusing on any TCM treatment for patients with UC were extracted and evaluated. Selection and characterization were performed by two independent reviewers using predefined forms. All discrepancies were resolved by consensus discussion with a third reviewer. Microsoft Excel 2010 was used to extract the following data from the included studies: (1) basic information of the included studies including research ID, article title, publication language, journal, year of publication, and funding information; (2) patient information including gender, age, disease course, disease stage, severity, sample size; and (3) information on intervention measures, types of intervention measures, drug dosage forms, and treatment courses. Results: The search identified 2225 RCTs published between 1987 and 2020. These studies covered 36 provinces in China. The time frame of the RCTs was <28 days in approximately one-third of the RCTs (647, 29.08%). Only one RCT was published in English. Nearly three-quarters of RCTs (1665, 74.83%) did not report the severity of the disease. Three types of interventions were included in the RCTs: pharmacotherapy (2028, 91.15%), nonpharmacotherapy (57, 2.56%), and a combination of the two (140, 6.29%). The administration modes of the intervention groups were evaluated. Drug therapy involved 12 types of TCM dosage forms, which were decoctions, troches, powders, capsules, granules, pills, suppositories, ointments, injections, gels, oral liquids, and substitute tea according to the frequency of use. Nondrug intervention measures involved 10 treatment options, namely, acupuncture, moxibustion, hemospasia, auricular point, acupoint catgut embedding, acupoint injection, scrapping, tuina, acupoint application, and five?tone therapy according to the frequency of use. Most studies included in this review were low in quality. This underscores the need for improvement in the quality of trial methodology in TCM RCTs.     

不同剂型桂枝葛根汤治疗颈性眩晕的疗效比较

摘 要 目的：观察不同剂型桂枝葛根汤治疗颈性眩晕的疗效差异,并初步探讨其作用机制。方法：96例颈椎病患者随机分为饮片组、配方颗粒组和葛根定眩胶囊组各32例,分别采用桂枝葛根汤饮片、配方颗粒和葛根定眩胶囊治疗14 d,比较3组患者的疗效和治疗前后血流动力学指标变化,酶联免疫法测定3组患者治疗前后IL-6及IL 1β的表达。结果：3组总有效率比较,差异无统计学意义（P＞0.05）。治疗后3 组患者眩晕和头痛评分均较治疗前明显改善（P＜0.01）,饮片组眩晕评分优于胶囊组（P＜0.05）。治疗后3组患者基底动脉和双侧椎动脉的Vs和Vm均较治疗前明显增加（P＜0.01),且配方颗粒组和胶囊组椎动脉的Vm低于饮片组（P＜0.05或P＜0.01）。治疗后,饮片组和配方颗粒组血清IL 6水平较治疗前明显降低(P<0.05),饮片组和胶囊组血清IL-1β水平较治疗前明显降低(P<0.05);胶囊组血清IL-6水平显著高于其他两组(P<0.05),饮片组血清IL 1β水平显著低于配方颗粒组和胶囊组(P<0.05)。结论：桂枝葛根汤三种剂型治疗颈性眩晕的总有效率相当,部分疗效指标饮片相比配方颗粒和胶囊更优。此作用可能与增加脑血流及抑制相关炎症因子IL-6及IL-1β的表达有一定关联。     

10 years EU regulation of pediatric medicines – impact on cardiovascular drug formulations

Introduction: Child-appropriate drug formulations are mandatory for an efficient and safe drug therapy in children. Since the implementation of supportive legislations development of novel drug formulations has significantly been enforced despite the fact that children are a heterogeneous group of patients with varying needs according to age, maturation and disease.

Areas covered: In this review, recent advances and current strategies are evaluated how to overcome the specific hurdles in pediatric drug development. For cardiovascular diseases as an example, EMA’s decisions on pediatric investigation plans (PIPs) have been evaluated. New developments with innovative platform technologies such as mini-tablets and orodispersible preparations have been identified indicating a clear shift from liquid preparations to small-sized solid (multiparticulate) or orodispersible dosage forms. Reasons for this shift of paradigm are discussed.

Expert opinion: Innovative platform technologies for solid drug dosage forms such as mini-tablets, orodispersible tablets or film preparations will continue to conquer the pharmaceutical market. Still, there are some major issues to be resolved, e.g. how to ensure quality of the new dosage forms and dose accuracy in flexible dosing, but the governmental incentives will continue to accelerate development of pediatric medicines and will bridge the still existing gaps in the near future.     

三氧化二砷新剂型的研究进展

三氧化二砷是急性早幼粒细胞白血病的一线用药,对多种实体瘤也具有抑制作用。然而,三氧化二砷肾脏清除速率快,无组织特异性分布,靶向性较差,易产生心、肝和肾等毒性作用,限制了其在实体瘤的临床应用。近年来,科学家开发大量三氧化二砷新剂型以提高其疗效,降低其不良反应,包括脂质体、微球、纳米粒、乳剂和悬浮剂等。本文对三氧化二砷的新剂型研究进展进行梳理,以期为三氧化二砷新剂型的合理开发和应用提供新思路。     

速释口服固体制剂人体生物等效性试验豁免药学研究的要求

随着科学认知的不断深入,为缩短药品的批准上市时间,不同药品监管机构相继出台了人体生物等效性豁免的相关法规及技术文件,旨在通过体外研究来替代体内试验。总结和比较国内外相关指导原则对速释口服固体剂型的仿制药药学研究的要求,重点关注存在的差异之处,探讨背后的科学原因,并在最终经国际人用药品注册技术协调委员会协调一致的过程中得到思考和启示,以期增加仿制药被豁免体内试验的成功率、进而降低仿制药的开发成本,但同时亦能保证其质量和疗效与参比制剂一致,真正实现其临床可替代性。     

膝关节外翻畸形股骨侧形态学参数分析

目的探讨膝关节外翻畸形股骨侧形态结构改变特点,并分析各参数的异常分布。方法收集2010年1月至2012年12月北京积水潭医院矫形骨科收治的68例(68膝)膝关节外翻畸形患者的影像学资料,包括下肢全长X线片和膝关节CT容积性数据。在下肢全长X线片上测量解剖学股胫角(aFTA)和解剖学股骨远端外侧角(aLDFA),将DICOM格式的CT容积性数据导入MIMICS17.0软件,测量股骨远髁角(DCA)和股骨后髁角(PCA)。分析膝关节外翻畸形股骨侧各参数异常的构成比,并绘制散点图分析各参数的线性相关性。结果股骨侧形态学参数测量结果:aFTA为(18.42±6.42)°,aLDFA为(74.71±4.63)°,DCA为(6.64±1.36)°,PCA为(4.51±1.82)°,其中DCA异常人数占比最高(95.59%)。DCA、PCA和aLDFA均存在异常的人数占比为51.47%。DCA与PCA和aLDFA之间均不存在线性相关。结论股骨外侧髁远端形态结构异常是膝关节外翻畸形股骨侧骨组织异常的主要来源。约1/2的患者同时存在股骨外侧髁远端、后方和股骨干骺端形态结构异常。     

胰岛素非注射制剂研究现状及展望

当前改进胰岛素治疗的关键，在于力求找到代替给患者带来痛苦和麻烦的皮下注射胰岛素的方法，即模拟生理性胰岛素分泌，恢复正常代谢环境，并由此降低糖尿病并发症的危险性。国内外有许多研究者业已扩展了许多胰岛素给药途径，包括鼻黏膜、口颊黏膜、直肠、眼、阴道内、肺、皮肤和胃肠道。我们复习了本领域的大量论文和报告，对各给药途径的进展、优点和缺点作出分析，所得出的结论是：探索各种胰岛素给药途径的视野广阔，前进道路上仍不乏困难。     

中药"显效理论"或有助于阐释并弘扬中药特色优势

该文归纳出中药"显效理论",即中药通过"众多显效形式(显效型)的单靶点叠加作用、多靶点协同作用及毒性分散效应"发挥药效并削弱自身毒性。一味中药可含有约1 000种成分,一种成分口服进入体内后又可产生约100种代谢产物。无数化学成分及其无数体内代谢产物中的众多显效形式可共同发挥"集团军式作用"。在药物分子少、靶点分子多的情况下,中药不同种的显效型分子可相继与靶点分子结合,发生叠加作用,当"靶点充分占位"时药效始启动。既有浓度上的叠加作用又有时间段先后的叠加作用,这使得药效得以持久。显效型呈现药效叠加和毒性分散,源于不同显效形式分子结构之间药效基团相同而毒性基团不完全相同。"毒性分散效应"适于对无毒中药而不适于对有毒中药的解释。显效理论揭示中药可以众多化学成分及众多代谢产物参与发挥药效过程,包括叠加作用、协同作用及毒性分散效应,可有助于阐释和弘扬中药特色优势。今后需研究/确证的问题:中药药效物质基础及其作用机制是怎样构成的?多数中药为什么毒性小?体现中药特色优势的中药"显效理论"如何在新药研发中应用?