安阳市实施基本药物制度的探索与实践

安阳市自实行基本药物制度试点以来,取得了一些成效和经验,但同时也暴露出一些问题。通过对安阳市基本药物制度在实施过程中出现的问题进行分析,探讨基本药物制度实施的难点问题及解决方法。基本药物制度需要大力改进和完善,以满足人民群众基本医疗用药需求。     

国家基本药物遴选的方法遴选

目的 2009—2011年我国初步建立基本药物制度,对广大公立医院的药品管理和运作影响巨大,但是目前相关的方法体系研究却很少;药物遴选是新医改向纵深推进中实施国家药物政策的起点、重点、难点,旨在系统评价和分析各种方法,完善基本药物的遴选。方法基于＂结构—过程—结果＂的指标体系,设计了评分模型,定量比较。结果量化排序为：背包模型法、专家委员会、循证评价法、层次分析法、专家库抽组、经济学方法。结论总结了每种方法的特点,并给出了各种方法使用的特定条件和建议。     

八桂民族药防治肝纤维化研究的进展

文章列举当前研究和有代表性的八桂民族药白花丹、排钱草、半枝莲、桂莪术和桂郁金在抗肝纤维化的进展,侧重反映广西地方学者在研究上述八桂民族药方面的最新成果。详述了白花丹在防治肝纤维化等方面的研究近况,并阐述了排钱草提取物抗肝纤维化作用;半枝莲提取物对肝损伤的保护功能;桂莪术对肝组织病变的减轻作用;桂郁金提取物具有抑制HSC-LX2细胞增殖、诱导细胞发生凋亡的能力。通过对上述八桂民族药的综述拟说明其抗肝纤维化的研究价值及意义。     

加快编制《全国中药饮片炮制规范》,规范统一饮片炮制国家标准

近年来,中药饮片的重要性日益彰显,面临着新的发展形势和机遇.笔者结合工作实际,深入分析加快编制《全国中药饮片炮制规范》的重大意义,提出编制总体目标及工作任务,并强调要正确处理好影响编制《全国中药饮片炮制规范》的几个重要关系,统一饮片炮制国家标准,着力解决好当前中药饮片产业发展面临的现实问题.     

第四次全国中药资源普查试点外业调查情况简报△

第四次全国中药资源普查试点工作从2009年开始筹备,2011~2012年先后分3批在全国22个省(区、市)启动了655个县的中药资源普查试点。共有8 000多名来自不同学科的专业技术人员组成普查队,按照全国统一普查技术规范和进度要求,开展了广泛深入的外业实地调查,获得了大量普查基础数据。前期启动的10个省(区、市)已完成70%以上的普查试点任务。据统计,截至到2013年5月底,全国中药资源普查数据库收集到资源调查样方套3万个,涉及药用物种9 000种,其中普查重点品种429种,采集标本47 665份、药材样品2 944份,拍摄药用植物形态及生态照片54万张,收集民间和民族传统医药知识500条。     

Immunogenicity,safety and reactogenicity of the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in 2–17-year-old children with asplenia or splenic dysfunction: A phase 3 study

BackgroundImmunization with pneumococcal vaccines is an important prophylactic strategy for children with asplenia or splenic dysfunction, who are at high risk of bacterial infections (including S. pneumoniae). This study aimed to assess immunogenicity and safety of pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, GSK) in this at-risk population.MethodsThis phase III, multi-centre, open-label, controlled study, in which at-risk children with asplenia or splenic dysfunction were enrolled (age strata: 2–4, 5–10 and 11–17 years), was conducted in Poland and the Russian Federation. For the 2–4 years at-risk group, healthy age-matched children were enrolled as control. Unprimed children (not previously vaccinated with any pneumococcal vaccine) received 2 PHiD-CV doses (≥2 months apart) and pneumococcal vaccine-primed children received 1 dose. Immune responses were assessed pre-vaccination and one month post-each dose. Solicited and unsolicited adverse events (AEs) were recorded for 4 and 31 days post-vaccination, respectively, and serious AEs (SAEs) throughout the study.ResultsOf 52 vaccinated children (18 at-risk primed, 28 at-risk unprimed and 6 control unprimed), 45 (18, 23 and 4, respectively) were included in the according-to-protocol cohort for immunogenicity. Post-vaccination (post-dose 1 in primed and post-dose 2 in unprimed children), for each vaccine pneumococcal serotype and vaccine-related serotype 6A all at-risk children had antibody concentrations ≥0.2 µg/mL, and for vaccine-related serotype 19A at least 94.4%. Increases in antibody geometric mean concentrations were observed. For most serotypes, all at-risk children had post-vaccination opsonophagocytic activity (OPA) titers ≥8 and increases in OPA geometric mean titers were observed. No safety concerns were raised. One non-fatal SAE (respiratory tract infection, considered not vaccine-related) was reported by one at-risk unprimed child.ConclusionPHiD-CV was immunogenic and well tolerated in 2–17-year-old children with asplenia or splenic dysfunction.Clinical Trial Registry: www.clinicaltrials.gov, NCT01746108.     

2021年国家药品抽检中成药质量分析

国家药品抽检是目前我国对上市后药品监管的重要手段,自2008年实施以来,在药品监管、质量控制水平提升及质量评价等方面发挥了重要作用。2021年,国家药品评价抽检中成药品种46个,通过认真梳理各品种质量分析报告,对标准检验及探索性研究发现的主要问题进行归纳,对报告反映的中成药整体质量状况进行总结、分析,全面了解市场上相关药品的质量现状,并提出相应建议,为中成药的质量进一步提升提供参考。     

Associations between dietary patterns and screen time among Korean adolescents

Data are limited on the association between dietary patterns and screen time among Korean adolescents. The present study identified dietary patterns of 691 adolescents, aged 13-18 years, who had participated in the Third Korean National Health and Nutrition Examination Survey (KNHANES III) and analyzed their associations with screen time. Screen time was defined as the time spent watching TV, using a computer, or playing video games was calculated as a sum of all these times. Dietary patterns and their factor scores were derived from a food frequency questionnaire using the factor analysis method. To analyze the association between dietary patterns and screen time, we conducted multiple linear regression analysis. We also performed multiple logistic regression analysis to estimate odds ratios (OR) of excessive screen time (2 hours or longer per day) and 95% confidence intervals (CI). We identified 2 dietary patterns labeled "the Korean healthy dietary pattern" and "the Western diet and fast foods pattern". The former included mixed grains, legumes, potatoes, red meat, eggs, fish, dairy products, fruits, vegetables, seaweeds, and mushrooms, whereas the latter included noodles, bread, red meat, poultry, fast foods, snack, and soft drinks. After controlling for potential confounding factors, factor scores for the Korean healthy dietary pattern were inversely associated (P-value for trend < 0.01) and those for the Western diet and fast foods pattern were positively associated with the screen time (P-value for trend < 0.01). Adolescents in the top tertile of the scores for the Korean healthy dietary pattern had a multivariable-adjusted OR [95% CI] of 0.44 (0.25-0.75) for excessive screen time compared with those in the lowest tertile. On the basis of these findings, adolescents who have excessive screen time may need to be encouraged to consume a more healthy diet.     

专利保护和公共健康:国家药物政策中的冲突与协调

药物专利保护能够有效地激励科技创新,然而,产业资本寻求利益最大化导致了产业资本诉求与公共健康问题无法避免的利益冲突,专利保护对于药物可及性的影响十分明显,两者的冲突只能进一步协调而不可能完全消失.在一个合理的专利制度体系下,会不断激励药物研发创新、改善人类生活质量.国家药物政策的一个重要作用就是通过协调机制增强药物的可及性.     

全民医保单一保险人与多元保险人模式比较

采用文献研究法,从人群覆盖、筹资政策、给付项目、保障待遇、基金管理和定点管理六个方面,分析单一保险人和多元保险人的含义、特征和优缺点。我国全民医保一体化的方向是实行单一保险人模式,有助于实现公平可及的全民医保覆盖、有效控制医疗费用过快增长;但也可能面临着医疗品质下降的风险。对此建议我国在全民医保一体化改革中实行强制参保,建立以扩充保费基数为基础的多元筹资体系,实施总额控制下的多元复合式支付方式。