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。     

“姜红大枣汤”在人工流产术中的应用效果观察

目的 探讨“姜红大枣汤”在人工流产术中的应用效果和意义。方法 随机选择50例术前口服温热“姜红大枣汤”治疗的人工流产病人为治疗组，44例采用常规人工流产术病人为常规治疗组，观察术前和术中血压、心率变化；术中、术后疼痛程度；人工流产综合征发生率；平均手术时间及阴道流血量。结果 治疗组中的血压、心率变化波动幅度小，疼痛减轻程度高，人流综合征的发生率低，与常规治疗组相比差异有显著性意义（P ＜ 0.05），两组平均手术时间和术中出血量比较差异无显著意义（P ＞ 0.05）。结论 口服“姜红大枣汤”预防和辅助治疗人流综合征效果显著，简便易行，无不良反应，病人易接受。     

胃肠激素检测在小于胎龄儿变化中临床意义

应用放射免疫法对68例小于胎龄儿(其中早产36例;足月32例)生后喂奶前及第7日空腹血中生长抑素(soma-tostatin,SS)、胃动素(motilin,MOT)、胃泌素(gastrin,Gas)浓度进行测定,并以30例足月新生儿作为对照组。结果小于胎龄儿组生后喂奶前及第7日空腹血浆胃动素、胃泌素均明显低于对照组,而生长抑素浓度明显高于对照组.并且与胎龄、开始喂养时间及当日进奶等因素相关。结论小于胎龄儿消化道机能适应胃肠道营养,在严密观察下应用合理的喂养方式早日开始胃肠道营养,将能促进小于胎龄儿胃肠道的发育和成熟。     

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。     

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。     

2型糖尿病与无症状性颅内动脉狭窄的相关性研究

目的探讨年龄、糖尿病病程与2型糖尿病患者无症状性颅内动脉狭窄的相关性.方法用经颅多普勒超声(TCD)评价无中风及中风史的347例住院2型糖尿病患者无症状性颅内动脉狭窄及其严重程度,SPSS统计软件分析年龄、糖尿病病程与其相关性.结果颅内动脉狭窄患病率为31.1%(108/347),大脑中动脉(MCA)狭窄率(20.32%)及狭窄频数最高(38.1%);狭窄组患者年龄(63.12±10.58)岁明显高于非狭窄组(58.29±11.99)岁,病程也比非狭窄组长;Logistic回归分析显示年龄(OR 1.161,95%可信区间1.031～1.308)、糖尿病病程(OR 1.802,95%可信区间1.368～2.374)是无症状性颅内动脉狭窄的独立危险因素.Spearman等级分析提示血管狭窄严重程度与年龄、病程相关(分别为r=0.196,P<0.000和r=0.227,P<0.000).结论年龄和病程增长是2型糖尿病无症状性颅内动脉狭窄的独立危险因素,而且和动脉狭窄严重程度密切相关.     

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