A phase II,single-center,randomized, double-blind,parallel control clinical study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine

BackgroundThis was a single-center, randomized, double-blind, parallel control study evaluating the immunogenicity and safety of a two-dose schedule of serogroups ACYW meningococcal polysaccharide conjugate vaccine with tetanus toxoid (TT) conjugate protein, in infants and toddlers of 3–35 months old.Method720 participants were stratified according to the age of 3–5 months old, 6–11 months old, and 12–35 months old and randomly assigned with an equal ratio to two different dose groups, i.e., 40- and 20-μg doses. Blood samples were taken from all participants before the first vaccination and 30 days after the full-course vaccination to detect the serogroups ACYW meningococcal antibodies. All adverse events occurred within 30 days after vaccination of each dose, and serious adverse events occurred within six months after full-course vaccination were collected for safety evaluation. This study was registered at the China drug trial registration with the identifier CTR 20182031.ResultsAfter 30 days of full-course vaccination, 92.78 % (95 % CI: 85.70 %-100.00 %) showed the immune response against all serogroups in both high-dose and low-dose groups by rabbit serum bactericidal antibody assay (rSBA) and the geometric mean titer (GMT) of all serogroups showed a high level (74.6–505.8, 95 % CI: 56.4–615.7). However, no significant difference between different dose groups was observed (P > 0.05). The common local and systemic adverse events in both groups were redness (3 %-7%), and fever (26 %-65 %), respectively. In addition, the grade 3 adverse event related to the vaccine was fever (1.67 %-12.50 %). No serious adverse event was reported to be associate with the vaccination.ConclusionThe serogroups ACYW meningococcal polysaccharide conjugate vaccine was safe and effective in the population aged 3–35 months. The vaccine efficacy and safety of the 20-μg dose group were not less than that of the 40-μg dose group.     

1972—2016年江苏省启东市胃癌死亡流行特征分析

目的分析江苏省启东市1972—2016年胃癌死亡流行特征。方法收集启东市1972—2016年恶性肿瘤死亡登记数据库及历年人口资料, 计算死亡率、中国人口标化率(中标率)、世界人口标化率(世标率)、35～64岁截缩率、0～74岁累积死亡率、累积死亡风险、变化百分比、死亡率年均变化百分比。结果 1972—2016年启东市胃癌死亡例数为15 863例, 占全部恶性肿瘤死亡例数的16.04%, 胃癌死亡率为31.37/10万, 中标率为12.97/10万, 世标率为21.39/10万, 35～64岁截缩死亡率为28.86/10万, 0～74岁累积死亡率为2.54%, 胃癌死亡累积风险为2.51%。男性死亡10 114例, 男性死亡率、中标率、世标率分别为40.53/10万、17.98/10万和30.13/10万;女性死亡5 749例, 女性死亡率、中标率、世标率分别为22.45/10万、8.52/10万和13.92/10万。25岁以下各年龄组的死亡率<1/10万, 死亡率随年龄的增长而升高, 50～岁组达到并超过人群的平均死亡率水平, 80～岁组达到死亡高峰。1972—2016年间胃癌死...     

从《温病条辨》探析吴鞠通儿科用药特点

吴鞠通著《温病条辨》倡三焦辨证,形成了以卫气营血、三焦为核心的温病辨证体系,其中卷六《解儿难》结合温病理论阐释了其对儿科疾病和治疗用药的独特见解。吴鞠通解小儿“纯阳”为“稚阳未充,稚阴未长”,其易于感邪、易于传变,治疗用药需谨慎。本文结合吴鞠通对小儿生理病理特点的认识,从谨慎选药、慎用苦寒、多甘少酸、巧用辛温、善用辛凉、重视脾胃、辅以食疗七个方面阐释吴鞠通儿科方面的用药特点,以期为儿科临床用药提供参考。     

我国高血压合理用药文献研究计量学分析

目的 了解我国医院高血压合理用药文献的研究趋势和热点，为提出促进高血压合理用药的相关措施提供参考。方法 检索2010—2017年中国知网数据库、万方数据库、维普数据库收录的高血压合理用药的相关文献，运用书目信息共现分析系统（BICOMB）2.0提取关键词、年份及相应文献量、期刊、作者及机构等参量进行文献计量学分析，并构建高频关键词词篇矩阵；将该词篇矩阵导入SPSS21.0软件进行系统聚类分析；利用图形聚类工具包（gCLUTO）1.0版对词篇矩阵进行词篇共现分析和双聚类可视化分析。结果 从知网、万方、维普三大数据库共检索到高血压合理用药相关文献1 010篇；从年发文量来看，高血压合理用药问题一直是研究热点；从期刊分布来看，高血压合理用药相关文献分布于262种期刊，高血压合理用药问题受到期刊界的广泛关注；从发文作者来看，我国还未形成高血压合理用药研究的核心力量；从单位分布来看，发文机构分散，多数为医院；高频关键词聚焦于“抗高血压药物/降压药、合理用药、高血压、用药分析”等。结论 我国目前对于高血压合理用药的研究多为对单个医院高血压患者用药合理性评价或是对抗高血压药物临床应用的分析，该领域的研究仍需从简单定性分析转向多地区、多层次、大样本的定量分析，以更好地促进高血压合理用药。     

Participation profiles in domestic life and peer relations as experienced by adolescents with and without impairments and long-term health conditions

Purpose: To investigate how individual and environmental factors relate to self-reported participation profiles in adolescents with and without impairments or long-term health conditions. Methods: A person-oriented approach (hierarchical cluster analysis) was used to identify cluster groups of individuals sharing participation patterns in the outcome variables frequency perceived importance in domestic life and peer relations. Cluster groups were compared using one-way analysis of variance (ANOVA). Results: A nine-cluster solution was chosen. All clusters included adolescents with impairment and long-term health conditions. Perceived importance of peer relations was more important than frequent attendance in domestic-life activities. Frequency of participation in dialogues and family interaction patterns seemed to affect the participation profiles more than factors related to body functions. Conclusion: Type of impairment or long-term health condition is a weaker determinant of membership in clusters depicting frequency and perceived importance in domestic life or peer relations than dialogue and family environment.     

New era of research on cancer‐associated glycosphingolipids

Cancer‐associated glycosphingolipids have been used as markers for diagnosis and targets for immunotherapy of malignant tumors. Recent progress in the analysis of their implications in the malignant properties of cancer cells revealed that cancer‐associated glycosphingolipids are not only tumor markers, but also functional molecules regulating various signals introduced by membrane microdomains, lipid rafts. In particular, a novel approach, enzyme‐mediated activation of radical sources combined with mass spectrometry, has enabled us to clarify the mechanisms by which cancer‐associated glycosphingolipids regulate cell signals based on the interaction with membrane molecules and formation of molecular complexes on the cell surface. Novel findings obtained from these approaches are now providing us with insights into the development of new anticancer therapies targeting membrane molecular complexes consisting of cancer‐associated glycolipids and their associated membrane molecules. Thus, a new era of cancer‐associated glycosphingolipids has now begun.     

东北苦菜UPLC指纹图谱建立及化学模式识别

目的建立东北苦菜Ixeris vesicolor DC.UPLC指纹图谱,并进行化学模式识别。方法东北苦菜甲醇提取物的分析采用CORTECS C18色谱柱(2.1 mm×150 mm,1.6μm);流动相0.1%磷酸水⁃乙腈,梯度洗脱;体积流量0.1 mL/min;检测波长(1~15 min,327 nm;15~50 min,360 nm);柱温35℃;进样量2μL。采用相似度分析和化学模式识别技术相结合的方法对其进行质量评价。结果10批样品指纹图谱中有19个共有峰,相似度均大于0.953。通过聚类分析将样品分成2类,主成分分析结果支持聚类分析结果,采用正交偏最小二乘法⁃判别分析筛选出了导致不同批次药材质量差异的3个共有峰,指认出2号峰(绿原酸)和12号峰(木犀草素)。结论该方法稳定可靠,可系统、全面地评价东北苦菜的药材质量。     

不同产地当归藤HPLC指纹图谱

目的建立不同产地当归藤HPLC指纹图谱。方法当归藤85%甲醇提取物的分析采用Phenomenex C18色谱柱(4.6 mm×250 mm,5μm);流动相乙腈⁃0.1%磷酸水,梯度洗脱;体积流量0.8 mL/min;柱温30℃;检测波长225 nm。对结果进行聚类分析和主成分分析。结果12批样品指纹图谱中有12个共有峰,相似度均大于0.940,并指认了没食子酸,儿茶素;聚类分析将12批样品分为2类。结论该方法准确稳定,重复性好,可用于当归藤药材的质量控制。     

基于化学模式识别技术提升参威骨痹片的质量标准并监测其生产中质控指标的转移率变化

目的:提升参威骨痹片的质量标准,初步探索其质量控制指标成分在批间含量差异较大的原因。方法:采用HPLC建立参威骨痹片的指纹图谱,以Diamonsil C18(4. 6 mm×250 mm,5μm)为色谱柱,流动相乙腈(A)-0. 1%磷酸水溶液(B)梯度洗脱(0～5 min,10%A;5～15 min,10%～12%A;15～30 min,12%～26%A;30～43 min,26%～31%A,43～50 min,31%～40%A,50～70 min,40%～55%A;70～84 min,55%～72. 5%A),检测波长230 nm。以共有峰为自变量绘制正交偏最小二乘法-判别分析-变量重要性投影(OPLS-DA-VIP)图,将共有峰对该制剂各批次间指纹图谱差异的贡献度量化,寻找差异较大的色谱峰,结合相关文献,筛选出与参威骨痹片临床适应症相关的成分并进行其含量测定的专属性试验,最终选定质控指标。通过HPLC-二极管阵列检测器(DAD)同时对本品及其生产过程中间体中质控指标进行测定,检测波长236,276,230,322 nm,其他条件同HPLC指纹图谱检测方法。结果:HPLC指纹图谱共标定了26个共有峰,各批次样品指纹图谱与对照指纹图谱的相似度均≥0. 950。优选出马钱苷酸、龙胆苦苷、芍药苷、蛇床子素为参威骨痹片的质控指标,四者的平均质量分数分别为161. 02,401. 80,255. 54,80. 68μg·g-1。结论:所建立的指纹图谱及多指标定量分析方法稳定、可靠,可用于参威骨痹片的质量控制。原料药批间质控指标成分含量差异和生产过程中间体的质控方法不够完善是引起该制剂批间质控指标成分含量差异较大的主要原因。