Immunogenicity and Safety of Two Different Haemophilus influenzae Type b Conjugate Vaccines in Korean Infants

The incidence of invasive diseases, including meningitis caused by Haemophilus influenzae type b (Hib) was markedly decreased after routine immunization of Hib vaccine through diverse schedules in many countries. The purpose of this study was to evaluate the immunogenicity and safety of Hib conjugate vaccines in Korean children before the implementation of a national immunization program against Hib in Korea. A multicenter controlled trial was performed on two different Hib vaccines in Korean children. A total of 319 infants were enrolled: 199 infants were immunized with the Hib polysaccharide conjugated to the tetanus toxoid (PRP-T) and 120 infants with the Hib polysaccharide conjugated to the outer-membrane protein of Neisseria meningitides (PRP-OMP). Immunogenicity was evaluated by enzyme-linked immunosorbent assay (ELISA) and serum bactericidal assay. Both vaccines showed good immunologic responses after primary immunization. After 2 doses of PRP-T or PRP-OMP, 78.9% and 91.7% of infants achieved an antibody level of ≥1.0 µg/mL, respectively. Both vaccines were safe and well-tolerated. No serious adverse events were observed. Thus, Hib conjugate vaccines appear to be safe and show good immunogenicity in Korean infants. These results will be important reference data for the implementation of Hib vaccine in the national immunization program of Korea.     

道路交通安全执法对医院质控的启示

道路交通安全执法对机动车的管理井然有序,而行人违规过马路现象却比比皆是。医院质控也常常出现类似的现象。文章比较了道路交通安全执法对机动车管理与行人管理的异同,认为道路交通安全执法与医院质控虽然属于不同的领域,但拥有相同或相似的功能和流程,可以作为跨行业功能性标杆来学习。道路交通安全执法对医院质控的启示为:（1）医院质控必须遵循结构质量—过程质量—结果质量（SPO）三维质量评价模型,且有机协同;（2）有效的质量控制必须符合热炉法则;（3）质控工作的重心应放在监控和改进上,即“有时去应急,常常去改进,总是去监控”;（4）遵循规章制度的自律文化的养成是良好质控的保证。     

1例用药错误事件的分析与改进

采用根本原因分析及行动法对1例儿科用药错误事件进行分析,确定根本原因,从人员、环境、制度等方面提出针对性改进措施。采取措施后,类似不良事件未再发生。建议医疗机构加强关键环节的有效沟通,鼓励患者参与医疗安全管理,营造病区安静环境,严格执行查对制度,正确识别患者身份,优化护理人力资源配置,以保证患者用药安全。     

一例促皮质素静脉外渗至局部皮肤坏死的案例解析与改进

对1例癫痫性痉挛患儿采用促皮质素静脉给药时发生静脉外渗至局部皮肤坏死的案例进行解析。针对事件发生原因,制定并采取措施:静脉穿刺难度事前评估,优化临床监护,加强相关知识培训,以肌肉注射代替静脉滴注等,避免了此类事件的再次发生,提升了临床合理用药水平,确保了患者安全。     

Immunogenicity and safety of two novel human papillomavirus 4- and 9-valent vaccines in Chinese women aged 20–45 years: A randomized,blinded, controlled with Gardasil (type 6/11/16/18), phase III non-inferiority clinical trial

BackgroundHuman papillomavirus (HPV) infections were the main cause of anogenital cancers and warts. HPV 6/11/16/18 vaccines provide protection against the high-risk types of HPV responsible for 70% of cervical cancers and 90% of genital warts. This randomized, blinded, non-inferiority phase III trial was to determine whether immunogenicity and tolerability would be non-inferior among women after receiving two novel 4- and 9-valent HPV vaccines (4vHPV, HPV 6/11/16/18; 9vHPV, HPV 6/11/16/18/31/33/45/52/58) compared with those receiving Gardasil 4 (4-valent).Methods1680 females between 20 and 45 years were randomized in a 2:1:1 ratio to 20–26, 27–35, or 36–45 y groups. Subjects then equally assigned to receive 4vHPV, 9vHPV or Gardasil 4 (control) vaccine at months 0, 2, and 6. End points included non-inferiority of HPV-6/11/16/18 antibodies for 4vHPV versus control, and 9vHPV versus control and safety. The immunogenicity non-inferiority was pre-defined as the lower bound of 95% confidence interval (CI) of seroconversion rate (SCR) difference > ?10% and the lower bound of 95% CI of geometric mean antibody titer (GMT) ratio > 0.5.ResultsAmong the three vaccine groups, more than 99% of the participants seroconverted to all 4 HPV types. The pre-specified statistical non-inferiority criterion for the immunogenicity hypothesis was met: all the lower bounds of 95% CIs on SCR differences exceeded ?10% for each vaccine HPV type and the corresponding lower bounds of 95% CIs for GMT ratios > 0.5. Across vaccination groups, the most common vaccination reaction were injection-site adverse events (AEs), including pain, swelling, and redness. General and serious AEs were similar in the three groups. There were no deaths.ConclusionsThis study demonstrated that the novel 4- and 9-valent HPV vaccination was highly immunogenic and generally well tolerated, both of which were non-inferior to Gardasil 4 in immunogenicity and safety.     

国产重组人促卵泡激素在辅助生殖技术控制性超促排卵的临床应用

目的评价国产重组人促卵泡激素(recombinant human follicle-stimulating hormone,rhFSH)用于辅助生殖技术(assisted reproductive technology,ART)控制性超促排卵(controlled ovarian hyperstimulation,COH)的有效性及安全性。方法本试验采用多中心、随机、双盲、阳性平行对照、非劣效研究方法,于2017年7月至2019年6月间选取6家生殖医学中心纳入卵巢储备正常的不孕女性进行ART的COH治疗。受试者随机分为试验组(国产rhFSH,n=134)和对照组(进口rhFSH,n=133),研究过程中因各种因素排除受试者共8例,试验组7例,对照组1例,最终依照研究方案完成试验的受试者试验组127例,对照组132例。比较两组受试者COH周期中获得的卵母细胞总数、rhFSH用药情况、卵母细胞受精率、优质胚胎数、临床妊娠率、活产率、新生儿情况及不良反应发生率等指标。结果试验组和对照组在COH周期中获得的卵母细胞总数分别为(13.0±5.8)枚和(12.9±5.7)枚,差异无统计学意义(P>0.05);在82例卵胞质内单精子显微注射(intracytoplasmic sperm injection,ICSI)受试者中,试验组(39例)获得MII卵母细胞数[(9.9±3.9)枚]显著高于对照组(43例)[(7.5±3.0)枚,P=0.003];卵母细胞受精率试验组[63.82%(1048/1642)]显著高于对照组[56.19%(958/1705),P<0.001]。rhFSH用药时间和总量、优质胚胎数、临床妊娠率、早产率、活产率、新生儿异常发生率、新生儿体质量、Apgar评分等两组间差异无统计学意义(P均>0.05);治疗期间卵巢过度刺激综合征(ovarian hyperstimulation syndrome,OHSS)和其他不良反应发生率差异无统计学意义(P均>0.05),且均为进口rhFSH已知的不良反应。结论在卵巢储备正常的不孕女性中使用相同卵巢刺激治疗方案,国产rhFSH有效性及安全性与进口rhFSH相当。     

甘露醇联合吡拉西坦治疗脑出血致脑水肿的疗效及其安全性分析

目的分析甘露醇联合吡拉西坦治疗脑出血致脑水肿患者的疗效及其安全性。方法选择2019年9月-2020年5月在沈阳市第五人民医院接受治疗的脑出血致脑水肿患者118例,按随机数字表法分为观察组和对照组各59例,两组入院后均实施常规治疗,在此基础上对照组予以甘露醇治疗、观察组给予甘露醇联合吡拉西坦治疗,比较两组的疗效、药物安全性,以及治疗前和治疗20d后神经功能和神经肽Y水平。结果观察组总有效率为98.31%,高于对照组的86.44%,差异有统计学意义(P<0.05)。治疗后两组美国国立卫生研究院卒中量表评分及神经肽Y水平均较治疗前下降,且观察组较对照组更低,差异有统计学意义(P<0.05)。观察组不良反应总发生率为8.47%,高于对照组的5.08%,但差异无统计学意义(P>0.05)。结论甘露醇联合吡拉西坦治疗脑出血致脑水肿的疗效较单独应用甘露醇更好,而且能够改善患者神经功能,安全性较高,值得推广。     

值班和交接班制度问题分析与改进建议

值班和交接班制度是诊疗过程连续性的重要保障。若落实不到位,可能发生患者伤害的不良后果。采用案例分析结合问卷调查方式,阐述值班和交接班制度存在问题,包括值班人员不在岗,值班人员资质不符,医院总值班能力不足,交接班记录不完整等。提出针对性改进建议:加强医务人员依法执业培训;严格管理值班医师资质;健全医疗值班体系;规范记录交接班内容等。     

关于方舱医院安全防控的工作思考

为有效解决新型冠状病毒肺炎确诊轻症患者的隔离救治问题,在武汉建设了16家方舱医院,这对于全面推进武汉市疫情防控工作发挥了积极作用。由于方舱医院是由会展中心、体育场馆内等场所临时改造而成,存在木质易燃材料众多、供电线路暴露等情况,其消防、治安、饮食等方面的安全防控压力巨大。全面加强方舱医院安全防控工作,对积极开展医疗救治工作具有重要意义。通过对方舱医院安全防控工作的梳理,总结提炼方舱医院安全防控工作的经验,并提出思考。