乙肝疫苗苦参素拉米夫定联合治疗慢性乙型肝炎的临床研究

目的探讨乙肝疫苗苦参素拉米夫定联合治疗慢性乙型肝炎的临床疗效。方法随机选择62例慢性乙型肝炎患者分为治疗组31例,苦参素0.2tidpo。疗程7～9个月,乙肝疫苗60ug,每15天1次,皮下注射,疗程12个月,拉米夫定0.1qdpo.疗程12个月。对照组31例单用拉米夫定0.1qdpo。疗程12个月。疗程中定期检测血常规、谷丙转氨酶(ALT)、HBeAg、抗-HBe、HBV、DNA。结果全部患者完成1年治疗。治疗组ALT复常率,HBeAg/抗-HBe血清转换率、HBVDNA阴转率明显高于对照组(分别为80.6%和51.6%,P<0.05;45.2%和19.4%,P<0.05;77.4%和51.6%,P<0.05)。结论乙肝疫苗、苦参素、拉米夫定联合治疗慢性乙型肝炎疗效优于单用拉米夫定。     

Adjuvant Immune Enhancement of Subunit Vaccine Encoding pSCPI of Streptococcus iniae in Channel Catfish (Ictalurus punctatus)

Channel catfish (Ictalurus punctatus) is an important agricultural fish that has been plagued by Streptococcus iniae (S. iniae) infections in recent years, some of them severe. C5a peptidase is an important virulent factor of S. iniae. In this study, the subunit vaccine containing the truncated part of C5a peptidase (pSCPI) was mixed with aluminum hydroxide gel (AH), propolis adjuvant (PA), and Freund’s Incomplete Adjuvant (FIA). The immunogenicity of the pSCPI was detected by Western-blot in vitro. The relative percent survival (RPS), lysozyme activity, antibody titers, and the expression of the related immune genes were monitored in vivo to evaluate the immune effects of the three different adjuvants. The results showed that pSCPI exerted moderate immune protection (RPS = 46.43%), whereas each of the three adjuvants improved the immune protection of pSCPI. The immunoprotection of pSCPI + AH, pSCPI + PA, and pSCPI + FIA was characterized by RPS values of 67.86%, 75.00% and, 85.71%, respectively. Further, each of the three different adjuvanted pSCPIs stimulated higher levels of lysozyme activity and antibody titers than the unadjuvanted pSCPI and/or PBS buffer. In addition, pSCPI + FIA and pSCPI + PA induced expression of the related immune genes under investigation, which was substantially higher than the levels stimulated by PBS. pSCPI + AH significantly stimulated the induction of MHC II β, CD4-L2, and IFN-γ, while it induced slightly higher production of TNF-α and even led to a decrease in the levels of IL-1β, MHC I α, and CD8 α. Therefore, we conclude that compared with the other two adjuvants, FIA combined with pSCPI is a more promising candidate adjuvant against S. iniae in channel catfish.     

国产甲型H1N1流感病毒裂解疫苗的安全性及免疫原性

目的观察国产甲型H1N1流感病毒裂解疫苗的安全性及免疫原性。方法按照随机、对照、盲法的原则,0、21d程序选择老年组、少年组和少儿组各220人,按1︰1比例随机接种15μg、30μg甲型H1N1流感疫苗;成年组330人,按1︰1︰1比例随机接种15μg、30μg甲型H1N1流感疫苗和安慰剂对照(PBS);0、28d程序只选择成年组220人,按1︰1比例随机接种15μg、30μg甲型H1N1流感疫苗。观察各组接种后的总体不良反应率、全身和局部不良反应率以及免疫后HI抗体阳转率、保护率、GMT水平和平均增长倍数。结果1210名观察对象总体不良反应发生率为21.82%,均以1级不良反应为主,未观察到3级及3级以上不良反应、其他异常反应和严重不良事件。30μg剂量组免疫后HI抗体阳转率和保护率与15μg剂量组比较,差异无统计学意义。两接种程序同一剂量组内第1针免疫后HI抗体阳转率、保护率、免疫后GMT及增长倍数各指标比较,差异均无统计学意义。结论国产甲型H1N1流感病毒裂解疫苗具有良好的安全性和免疫原性,按照0、21d程序各接种1针15μg甲型H1N1流感疫苗,即可在12～60岁人群中产生良好的免疫效果。     

Sabin株脊髓灰质炎灭活疫苗纯化工艺的建立

目的建立Sabin株脊髓灰质炎灭活疫苗(IPV)纯化工艺。方法采用Sepharose CL-6B凝胶过滤和DEAE-Sepharose Fast Flow离子交换层析两步纯化法纯化脊髓灰质炎病毒,进行各项检定后再经除菌过滤和灭活。结果Ⅰ、Ⅱ、Ⅲ型病毒纯化后的蛋白去除率均不低于98.81%,病毒滴度分别为8.75、8.50和8.63lgCCID50/ml,DNA残留量均<100pg/ml。除菌过滤和灭活后,D抗原含量略有下降。结论已建立了Sabin株IPV的纯化工艺,纯化后制备出了高纯度的Sabin株IPV。     

国产治疗用卡介苗预防浅表性膀胱癌术后复发及不良反应的观察

目的观察我国治疗用卡介苗(CT-BCG)预防浅表性膀胱癌术后复发情况及其不良反应。方法对117例浅表性膀胱癌患者术后给予CT-BCG治疗,另对53例患者采用丝裂霉素C(MI-C)治疗,作为对照。CT-BCG组每次用药120mg,MI-C组40mg。用导管灌注膀胱,2h后自行排出。术后2或3周开始,不同时间用药1次,直至1年。观察两组的复发情况及不良反应发生率。结果CT-BCG组复发率为18.8%,MI-C组为13.2%,二者差异无统计学意义;不良反应主要为膀胱炎症状(尿痛、尿频、血尿等)及低热,MI-C组无低热患者,且膀胱炎症状也较CT-BCG组轻。结论CT-BCG预防浅表性膀胱癌术后复发药效良好,无严重不良反应发生。     

Stability of a soybean seed‐derived vaccine antigen following long‐term storage,processing and transport in the absence of a cold chain

BACKGROUND: Soybean seeds are rich in natural protein and are favorable environments for targeted protein expression. Soybeans represent an ideal platform for the production of novel vaccines that, in theory, do not require a cold chain. This study investigated the stability of a soybean‐derived antigen following long‐term storage, formulation, and shipment overseas in the absence of refrigeration. RESULTS: Transgenic seeds can be stored for more than 4 years at ambient temperature with no detectable loss of FanC antigen stability. Conventional processing methods utilizing heat, mechanical extraction and solvent extraction resulted in practical formulations that could be lyophilized, stored as dried milk powder and rehydrated in water without loss of FanC antigen stability. Overseas shipment of transgenic seed powder and soymilk formulations in the absence of a cold chain had no adverse effects on formulations or the FanC antigen. CONCLUSION: The feasibility of long‐term storage, processing and shipment of transgenic soy products in the absence of a cold chain was demonstrated. Soybeans represent a practical platform for development of novel vaccines to potentially address the worldwide need for vaccines that are cost‐effective, easy to formulate and can be manufactured, stored and transported without refrigeration. Copyright © 2009 Society of Chemical Industry     

Preparation and characterization of poly(lactic‐co‐glycolic acid) microparticles containing DNA molecules encoding a malaria vaccine candidate

BACKGROUND: A novel ultrasonic atomization approach for the formulation of biodegradable poly(lactic‐co‐glycolic acid) (PLGA) microparticles of a malaria DNA vaccine is presented. A 40 kHz ultrasonic atomization device was used to create the microparticles from a feedstock containing 5 volumes of 0.5% w/v PLGA in acetone and 1 volume of condensed DNA which was fed at a flow rate of 18 ml h^?1. The plasmid DNA vectors encoding a malaria protein were condensed with a cationic polymer before atomization. RESULTS: High levels of gene expression in vitro were observed in COS‐7 cells transfected with condensed DNA at a nitrogen to phosphate (N/P) ratio of 10. At this N/P ratio, the condensed DNA exhibited a monodispersed nanoparticle size (Z‐average diameter of 60.8 nm) and a highly positive zeta potential of 38.8 mV. The microparticle formulations of malaria DNA vaccine were quality assessed and it was shown that the microparticles displayed high encapsulation efficiencies between 82–96% and a narrow size distribution in the range of 0.8–1.9 µm. In vitro release profile revealed that approximately 82% of the DNA was released within 30 days via a predominantly diffusion controlled mass transfer system. CONCLUSIONS: This ultrasonic atomization technique showed excellent particle size reproducibility and displayed potential as an industrially viable approach for the formulation of controlled release particles. Copyright © 2009 Society of Chemical Industry     

Automating procedures for processing, cryopreservation, storage, and manipulation of human peripheral blood mononuclear cells

Cell-mediated immune responses have been found to play a crucial role in the protection from, or amelioration of, many human diseases. There are many vaccine trials being conducted where the most important immune assessment consists of measuring T cell responses. The most readily accessible source of T cells is the peripheral blood. Thus, collection, processing, cryopreservation, storage, and manipulation of human peripheral blood mononuclear cells (PBMCs) are all key steps for assessment of vaccine and disease-induced immune responses. Automation of these procedures is not currently practiced widely. This article reviews current practices and explores the need for automation.     

要重视对现金流量的分析

与利润或销售量相比,现金流量则更为重要,因为它是企业未来财政健康的生命线.但过去并未引起企业家们的重视.一则分析现金流量的BCG模型本身存在着一些缺点.如不论产品性质一律以销售年增长率为准.二则引进我国时名词翻译得不够贴切,不易为中国人所理解,如Matrix译为矩阵,使人误以为是深奥的运筹学.加上我国行业组织对有关数字不作统计或统计了不公布,也造成此方法不易推行.本文对BCG模型本身和名词翻译作了一些修改的建议,也试图对如何正确理解和实施该模型作了一些说明.     

MEMS微针的最新研究进展

介绍了MEMS微针技术在微针制备工艺、力学和流体性能模拟以及透皮给药方面研究的近况。描述了硅、金属和聚合物材料的微针制备工艺,分析了这些材料在MEMS微针应用上的优缺点。比如硅微针制备工艺成熟但是硅的质地太脆;金属微针机械强度高却不易载药;聚合物微针易于批量化复制但是机械强度差。进一步阐述了微针研究取得的进展,总结了微针技术发展需要解决的关键问题。微针制备工艺已经日趋成熟,微针将朝着可复制化、批量化方向发展,微针经皮给药将逐渐从动物实验转移到人体实验,以实现微针研究的最终目的——临床给药。