流行性感冒病毒裂解疫苗在18岁以上健康人群中应用的安全性及免疫原性研究

目的 评价流感病毒裂解疫苗安尔来福(R)的免疫原性及安全性.方法 2010年8-9月在沈阳市开展开放式临床试验,选择18～60岁及＞60岁健康成年人接种安尔来福(R)进行安全性观察,并采集受试者免疫前及免疫后21 d 血清标本,采用血凝抑制试验(HI)进行流感病毒裂解疫苗甲型H1N1、甲型H3N2及乙型3个型别抗体检测.结果 130名观察对象完成疫苗接种并进行安全性观察,其中120人完成免疫前及免疫后采血.总体不良反应发生率为2.3%(3/130),均为全身不良反应,未出现严重不良反应.接种疫苗后21 d,成年组甲型H1N1、甲型H3N2及乙型3个型别抗体阳转率分别为82.5%、93.7%、92.1%,GMT增长倍数分别为20.2、32.0、11.4,保护率分别为92.1%、98.4%、98.4%;老年组3个型别抗体阳转率分别为89.5%、91.2%、87.7%,GMT增长倍数分别为23.9、39.8、15.1,保护率分别为93.0%、94.7%、96.5%.结论 疫苗安尔来福(R)接种后甲型H1N1、甲型H3N2及乙型3个型别抗体各项指标均超过欧盟标准,表明其免疫原性及安全性良好.

Abstract：

Objective To evaluate the safety and immunogenicity of split influenza vaccine (Anflu(R) ). Methods An open-labeled clinical trial was carried out in adults aged 18-60 years and elders aged over 60 years from August to September, 2010 in Shenyang, Liaoning province. One dose of split influenza vaccine was administered and adverse events were observed. Serum samples were obtained prior to vaccination and 21 days post vaccination. A/H1N1, A/H3N2 and B antibodies against influenza virus were measured using micro-hemagglutination inhibition (HI) assay. Results A total of 130 subjects were recruited and 120 paired serum samples were obtained. The overall rate of adverse events was 2.3% (3/130) and all of them with systemic reaction. No single serious adverse event was reported. 21 days after the vaccination, the sero-conversion rates of A/H1N1, A/H3N2 and B antibodies against influenza virus among adults were 82.5%, 93.7% and 92.1%, respectively. The Geometric Mean Titer (GMT) ratios were 20.2, 32.0 and 11.4, while the sero-protection rates were 92.1%, 98.4% and 98.4%, respectively. The sero-conversion rates of antibodies among elders were 89.5%, 91.2% and 87.7%, with the GMT ratios as 23.9, 39.8 and 15.1, respectively. The seroprotection rates were 93.0%, 94.7% and 96.5%,respectively. Conclusion All indexes ofA/H1N1,A/H3N2 and B antibodies exceeded the licensure criteria established by the EU Committee for Medicinal Products for Human Use,proving the trial vaccine Anflu(R) with good safety and immunogenicity.     

丹参酮ⅡA磺酸钠治疗糖尿病周围神经病变33例观察

目的：探讨丹参酮ⅡA磺酸钠注射液治疗糖尿病周围神经病变的临床效果。方法：66例糖尿病周围神经病变患者随机分为实验组和对照组,每组33例,在常规用药控制血糖水平的基础上,对照组单用甲钴胺注射液,治疗组再加用丹参酮ⅡA磺酸钠注射液,两组疗程均为3周。观察两组的临床疗效,并检测两组患者的神经传导速度。结果：治疗组总有效率为81.8%,明显高于对照组的72.7%,差异具有统计学意义(P＜0.05);实验组神经传导速度的改善情况明显优于对照组,差异具有统计学意义(P＜0.05)。结论：丹参酮ⅡA磺酸钠联合甲钴胺用于糖尿病周围神经病变是一种疗效较好的治疗方法。     

康宁克通A,利多卡因复合用于胶原酶盘外溶解术

目的：观察康宁克通Ａ、利多卡因复合用于胶原酶盘外溶解术的作用。方法：随机将７０例患腰椎间盘突出症,经骶裂孔（硬膜外）前间隙置管注入胶原酶行盘外溶解术的患者分为三组,１、单纯胶原酶组（Ｃ组）,２、胶原酶,利多卡因组（Ｃ＋Ｌ组）;３、胶原酶,康宁克通Ａ、利多卡因组（Ｃ＋Ｋ＋Ｌ组）。