Fourteen years of the Pregnancy Registry on maternal immunisation with a reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap) vaccine

BackgroundGSK initiated a Pregnancy Registry in the United States (US) for the reduced-antigen-content tetanus-diphtheria-acellular pertussis (Tdap; Boostrix, GSK) vaccine with the aim to detect and describe pregnancy outcomes in women vaccinated with Boostrix 28 days before estimated conception or during pregnancy.MethodsVoluntary reports of pregnancy exposure to Boostrix received from spontaneous and post-marketing surveillance sources in the US were assessed. Reports were classified as prospective or retrospective based on the knowledge of pregnancy outcomes at the time of reporting. For completeness, reports of exposure to Boostrix or to the Tdap-inactivated poliovirus vaccine (Boostrix-IPV, GSK) reported to the global safety database from countries outside the US were also evaluated.ResultsFrom May 2005 to August 2019, 1517 (1455 prospective and 62 retrospective) pregnancy reports were received in the Boostrix US Pregnancy Registry. Of the prospective reports, 250 had known outcomes: 244 live infants with no apparent birth defects (BDs), three live infants with BDs, and three spontaneous abortions with no apparent BDs. Of the retrospective reports, 55 had known outcomes: 33 live infants with no apparent BDs, 16 live infants with BDs, one spontaneous abortion with no apparent BDs, four stillbirths with no apparent BDs, and one stillbirth with BDs. Cumulatively, 1321 pregnancy reports (1006 for Boostrix; 315 for Boostrix-IPV) were received from countries outside the US. Of these, 163 prospective reports and 551 retrospective reports had known outcomes. Results were in line with those from the Boostrix US Pregnancy Registry.ConclusionsData currently available from the Boostrix US Pregnancy Registry and from countries outside the US suggested that exposure to Boostrix or Boostrix-IPV during pregnancy does not raise safety concerns related to adverse pregnancy outcomes or BDs.     

中药饮片保质期与有效期文献计量学分析

目的：对中药保质期或有效期进行系统的调研，探讨中药饮片设定保质期或有效期的依据及其必要性，为提高中药饮片质量、保障临床用药安全提供技术支撑，为药品监管部门制定有关法规提供科学依据。方法：以国家知识基础设施数据库（CNKI）为数据来源，采用文献计量学研究方法，选用检索词为“中药材”并“有效期”“饮片”并“有效期”，“饮片”并“保质期”“中药材”并“保质期”“中药材”并“效期”和“饮片”并“效期”，利用CNKI平台工具以及Excel统计工具进行统计分析。结果：经数据库检索、筛选，获取中药材、饮片保质期或有效期或效期的相关有效文献共85篇，其中关于中药、饮片保质期的相关文献26篇，中药、饮片有效期或效期的相关文献59篇；在59篇关于中药有效期的文献中，74.58%的文献对于中药是否应该制定有效期、如何制定有效期等展开了讨论，25.42%的文献为中药有效期研究的实验性文献。结论：本文从中药材、饮片保质期与有效期的现状，质量评价指标，研究方法，饮片分类、保质期制定的必要性，及其存在的问题和建议等方面进行了梳理和归纳，为中药饮片保质期制定，提供了详实的文献依据。     

Safety evaluation of adverse events following vaccination with Havrix,Engerix-B or Twinrix during pregnancy

BackgroundVaccination of pregnant women against hepatitis A virus (HAV) or hepatitis B virus (HBV) may benefit the mother and the fetus but is not routinely recommended. However, the risk associated with vaccination should be weighed against the risk of HAV or HBV infection. Data on safety profiles after hepatitis A, B or combined AB immunization during pregnancy are limited.MethodsWe searched the GSK Worldwide Safety Database for adverse events (AEs) following immunization of pregnant women with HAV (Havrix, GSK), HBV (Engerix-B, GSK) or the combined hepatitis AB (Twinrix, GSK) vaccine since market authorization through 31 January 2018, covering at least 25 years. AE reports (spontaneous, post-marketing surveillance and clinical trial cases) in the GSK Worldwide Safety Database were identified using a systematic search and were reviewed by clinicians to ascertain pregnancy status at time of vaccination and characterize adverse pregnancy outcomes, including pregnancy-related AEs and AEs in infants regardless of the causality assessment.ResultsOverall, 613, 700 and 363 pregnancies with exposure to Havrix, Engerix-B and Twinrix, respectively, were reported. Of these, 378, 339 and 194 were analyzed. The most frequently identified pregnancy outcomes were live infants (288, 223 and 151), spontaneous abortions (43, 57 and 26) and elective terminations (25, 24 and 9). A total of 19, 29 and 10 cases of congenital anomalies were reported. Of these, 17, 20 and 7 were major birth defects. The most commonly reported pregnancy-related AE and AE in infants were premature delivery (28) and jaundice (11), respectively. No maternal deaths were reported. Congenital anomalies were reported in all recorded infant deaths.ConclusionsThis review did not indicate any concerning pattern of adverse pregnancy outcomes following exposure to any of the 3 vaccines during pregnancy.     

从外观性状识别酸枣仁伪品

探讨酸枣仁及其常见伪品的性状鉴别,确保临床用药的安全、有效。取酸枣仁及其常见伪品,对外观性状进行比对讨论发现酸枣仁及其伪品在外观性状有明显区别。性状鉴别方法能有效地识别酸枣仁及其伪品。     

Long-term Cardiovascular Risk in Astronauts: Comparing NASA Mission Astronauts With a Healthy Cohort From the Cooper Center Longitudinal Study

ObjectiveTo determine the long-term cardiovascular disease risk of astronauts with spaceflight exposure compared with a well-matched cohort.MethodsNational Aeronautics and Space Administration (NASA) astronauts are selected into their profession based upon education, unique skills, and health and are exposed to cardiovascular disease risk factors during spaceflight. The Cooper Center Longitudinal Study (CCLS) is a generally healthy cohort from a preventive medicine clinic in Dallas, Texas. Using a matched cohort design, astronauts who were selected beginning April 1, 1959, (and each subsequent selection class through 2009) and exposed to spaceflight were matched to CCLS participants who met astronaut selection criteria; 1514 CCLS participants matched to 303 astronauts in a 5-to-1 ratio on sex, date of birth, and age. The outcome of cardiovascular mortality through December 31, 2016, was determined by death certificate or National Death Index.ResultsThere were 11 deaths caused by cardiovascular disease (CVD) among astronauts and 46 among CCLS participants. There was no evidence of increased mortality risk in astronauts (hazard ratio [HR]=1.10; 95% confidence interval [CI], 0.50 to 2.45) with adjustment for baseline cardiovascular covariates. However, the secondary outcome of CVD events showed an increased adjusted risk in astronauts (HR=2.41; 95% CI, 1.26 to 4.63).ConclusionNo increased risk of CVD mortality was observed in astronauts with spaceflight exposure compared with a well-matched cohort, but there was evidence of increased total CVD events. Given that the duration of spaceflight will increase, particularly on missions to Mars, continued surveillance and mitigation of CVD risk is needed to ensure the safety of those who venture into space.     

消毒后备用湿化瓶的干燥方法及存放时间探讨

氧气湿化瓶是输氧装置的一部分,使用率高,是一个极易带菌的感染源,其造成的医院内感染已被临床所证实[1],但其保存方法在护理操作中尚未规范化[2]。根据《医院感染管理规范》要求,氧气湿化瓶及其管道,用毕应终末消毒,干燥保存[3]。由于氧气湿化瓶及其管道是塑料制品,不能采用高     

恩替卡韦分散片的稳定性研究

目的研究恩替卡韦分散片在加速试验和长期试验条件下的稳定性并测算其有效期。方法在模拟市售包装条件下,通过加速试验和室温贮存18个月,参照《中国药典》附录对其性状、鉴别、分散均匀性、溶出度、有关物质、微生物限度检查及含量测定等项指标进行定期考察。结果在考察期内,各项指标均符合规定。结论本品在温度40℃、相对湿度75%条件下放置6个月或常温、相对湿度60%条件下放置18个月,药物制剂稳定,故其有效期定为18个月。     

脑梗死患者出生日期的运气规律探析

目的探讨脑梗死患者出生日期的五运六气分布特点。方法对3 222例脑梗死患者出生日期的天干、岁运、主气、客气等运气要素进行描述性统计分析,并通过卡方检验判断其间差异性。结果脑梗死患者出生时的天干、主气分布具有一定的差异性,且差异具有统计学意义(P0.05),其中出生在乙年(金运不及)者罹患率最高,己年(土运不及)者最低;出生在四之气(主气太阴湿土)者罹患率最高,终之气(主气太阳寒水)者最低。脑梗死患者出生时的岁运、客气分布差异没有统计学意义(P0.05)。结论出生时天干、主气的运气特征对后天脑梗死的罹患存在一定影响。     

34组相同成分与给药途径的国产与外资药品说明书“修改日期”项的差异分析

目的:为医疗机构管理药品及药品说明书提供参考。方法:收集我院2012年12月使用中的相同成分与给药途径的国产和外资药品说明书34组,依据2010年版《中国药典·临床用药须知》对药品说明书"修改日期"项的修改次数和修改年份进行统计分析。结果:34组药品说明书中有口服剂型25组(包括心血管系统药物8组)、注射剂型9组,其中国产药品说明书修改次数达33次,外资药品说明书113次;2011-2012年发生修改的国产药品说明书有8种,外资药品说明书有17种。口服剂型中,修改次数≤1的国产药品说明书有18种,外资药品说明书有8种;国产药品说明书修改次数达26次,外资药品说明书76次;2011-2012年发生修改的国产药品说明书有5种,外资药品说明书有12种。心血管系统药物中,修改次数≤1的国产药品说明书有4种,外资药品说明书有1种;国产药品说明书修改次数达11次,外资药品说明书27次;2011-2012年发生修改的国产药品说明书有2种,外资药品说明书有6种。结论:外资药品说明书的修改明显比国产药品说明书频繁。