Vaccination antigrippe A (H1N1) : analyse rétrospective 2009

The occurrence of the influenza A (H1N1) pandemic was the opportunity to set an appropriate vaccination campaign, effective and well tolerated within the shortest period of time. Thanks to a strong experience in the development of seasonal influenza vaccines and recent experimental knowledge on potential vaccines against H5N1 strain, pharmaceutical companies developed a new vaccine suited for the pandemic A H1N1 California July 2009 strain. This vaccine was produced with and without adjuvant, taking into account safety controls and evolution of scientific knowledge. Nevertheless, this campaign got a poor reception from the general and medical population due to the concomitant spread of the pandemics, an insufficient communication program, organization that was felt as unsuited, too complex and not well understood. Despite that, effectiveness and tolerance of the vaccination campaign have been observed with may be a positive effect on the epidemic.     

Caractéristiques des infections respiratoires basses chez les sujets âgés

Pneumonia is more frequent among the elderly and is associated with higher rates of hospitalization and death. The diagnosis of pneumonia in the elderly is a clinical challenge because of its non-typical symptoms and because of a poor diagnostic yield of microbiological analysis. Ageing is associated with specific pathogenesis, modifications in lung performance and modifications in oropharyngeal flora. The management relies on empirical therapy, which takes into account the severity of the infectious episode, the presence of additional risk factors, co-morbidities and institutionalization.     

贵州省新型甲型HIN1(2009)流感病毒HA-1基因分析

目的 建立并完善贵州省新型甲型H1N1流感病毒基因分析检测技术平台,了解贵州省新型甲型H1N1(2009)流感病毒HA1片断与WHO公布的流行株有否发生变异.方法 收集16株新型甲型H1N1流感病毒毒株,提取病毒核酸RNA,通过RT-PCR扩增HA1片断,用电泳观察PCR产物目的条带大小,经过纯化、测序,用Biodeit、MEGA4相关软件进行序列比对,同源性及差异性分析,构建系统发育树.结果 贵州省(2009)代表株与中俄代表株A/Habarovak/01/2009 (H1N1)和墨西哥第一株甲型H1N1流感A/Mexio City/001/2009(H1N1)同属一个谱系,亲缘关系较近,同源性在93.2％～95.8％之间.结论 贵州省(2009)代表株与WHO公布的流行株在核苷酸水平上有一定程度的变异.     

L’histoire des Annales pharmaceutiques françaises. 1809–2009

The Annales pharmaceutiques françaises is 200 years old. Initially, in 1809, the Bulletin de pharmacie was the organ of the Société de pharmacie de Paris. The journal was one of the dynamic events stimulated by the law of Germinal in year XI of the French revolution (1803). Its readership increased tremendously, rapidly making it the first regular journal in the pharmaceutical world. In 1984 it became the Journal de pharmacie et chimie published for a century. It was in 1943 that the journal took on its current name of the Annales pharmaceutiques françaises. The journal is now the official organ of the French National Academy of Pharmacy. The six annual issues are supplemented by an internet diffusion allowing readers access in all French-speaking countries.     

上海地区在校中学生接种甲型H1N1流感疫苗前后抗体水平监测分析

 目的  了解上海地区在校中学生接种甲型H1N1流感疫苗前后的抗体水平;观察甲型H1N1流感疫苗对该人群的免疫保护作用。 方法    应用常规微量血凝抑制试验（micro-hemagglutination inhibition test, HIT）对上海地区在校中学生分3个时间段进行甲型H1N1流感病毒抗体的血清学监测,3个时间段的抗体阳性率比较采用Pearson χ2 检验进行分析。 结果  2009年甲型H1N1流感流行前上海地区在校中学生的血清抗体阳性率仅为1.3%。经过一段时间流行后,血清抗体阳性率升至8.5%。接种甲型H1N1流感疫苗后,血清抗体阳性率升至87.3%。经Pearson χ² 检验分析,3个时间段在校中学生的血清甲型H1N1流感抗体阳性率差异有统计学意义（χ²=243.7,P<0.05）。 结论  在甲型H1N1流感流行前,上海地区在校中学生对其几乎没有免疫力,接种甲型H1N1流感疫苗能为该人群提供较好的免疫保护作用。     

Oseltamivir-resistant pandemic A(H1N1) 2009 influenza viruses detected through enhanced surveillance in the Netherlands, 2009–2010

Enhanced surveillance of infections due to the pandemic A(H1N1) influenza virus, which included monitoring for antiviral resistance, was carried out in the Netherlands from late April 2009 through late May 2010. More than 1100 instances of infection with the pandemic A(H1N1) influenza virus from 2009 and 2010 [A(H1N1) 2009] distributed across this period were analyzed. Of these, 19 cases of oseltamivir-resistant virus harboring the H275Y mutation in the neuraminidase (NA) were detected. The mean 50% inhibitory concentration (IC₅₀) levels for oseltamivir- and zanamivir-susceptible A(H1N1) 2009 viruses were 1.4-fold and 2-fold, respectively, lower than for the seasonal A(H1N1) influenza viruses from 2007/2008; for oseltamivir-resistant A(H1N1) 2009 virus the IC₅₀ was 2.9-fold lower. Eighteen of the 19 patients with oseltamivir-resistant virus showed prolonged shedding of the virus and developed resistance while on oseltamivir therapy. Sixteen of these 18 patients had an immunodeficiency, of whom 11 had a hematologic disorder. The two other patients had another underlying disease. Six of the patients who had an underlying disease died; of these, five had received cytostatic or immunosuppressive therapy. No indications for onward transmission of resistant viruses were found. This study showed that the main association for the emergence of cases of oseltamivir-resistant A(H1N1) 2009 virus was receiving antiviral therapy and having drug-induced immunosuppression or an hematologic disorder. Except for a single case of a resistant virus not linked to oseltamivir therapy, the absence of detection of resistant variants in community specimens and in specimens from contacts of cases with resistant virus suggested that the spread of resistant A(H1N1) 2009 virus was limited. Containment may have been the cumulative result of impaired NA function, successful isolation of the patients, and prophylactic measures to limit exposure.     

Validation of pharmaceutical quality of a [6,6-(2)H(2)]-glucose parenteral solution used for insulin-resistance measurement during human clinical trials

Introduction

Deuterated glucose ([6,6-²H₂]-glucose) is a stable isotopic tracer administered parenterally in healthy volunteers, obese or diabetic patients in clinical trial to study glucose metabolism during euglycemic hyperinsulinemic clamps. In accordance with the Health Authorities on drug safety, we evaluated the pharmaceutical quality of this preparation for biomedical research with a stability study.

Methods

After pharmaceutical qualification of the raw material, the [6,6-²H₂]-glucose was dissolved in water for injection, then sterile, filtered under positive pressure of nitrogen and then autoclaved. Two batch products (500 mg/10 mL and 2 g/15 mL) were sampled to evaluate glucose alteration, isotope shift, limpidity, apyrogenicity and sterility at regular intervals for 2 years. Deuterated glucose solutions were stored in the dark, at +2 °C + 8 °C, in type II glass bottles.

Results

Neither significant decrease of glucose concentration nor pH variation were observed for 2 years. The 5-hydroxymethylfurfural concentration was below the human harmful levels, attesting a non-generation of metabolites during autoclaving. Isotopic enrichment higher than 99% reflected the stability of deuterated label on the 6-carbon of glucose molecules. The non-visible particle concentration below the minimal permissible concentration tolerated by the European Pharmacopoeia and the absence of bacterial endotoxin and bacterial growth attested limpidity, apyrogenicity and sterility of the [6,6-²H₂]-glucose solutions.

Conclusion

After the 2-year study, 500 mg/10 mL and 2 g/15 mL deuterated glucose solutions stored in the dark at +2 °C + 8 °C were stable in aqueous solution, allowing to ensure safety administration for human clinical trials using euglycemic hyperinsulinemic clamps.