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1.
目的 评估人乳头状瘤病毒(HPV)疫苗在亚洲人群中接种后的免疫原性和安全性。方法 本研究分别检索英文数据库(PubMed、Embase、Web of Science、Clinical Trails、Cochrane library)和中文数据库(中国知网、万方、维普),自建库至2022年4月,关于亚洲人群进行的HPV疫苗安全性和免疫原性临床试验文献。采用主题词与自由词灵活搭配检索并结合纳排标准筛选文献,对最终纳入文献进行质量评价并提取资料,应用Meta分析合并评估。结果 最终纳入16篇随机对照试验(RCT)研究,累计研究对象25 485人。Meta分析表明对于HPV疫苗免疫原性,HPV16型特异性血清转化率合并效应值RR为43.74(16.51~115.85),HPV18型特异性血清转化率合并效应值RR为45.72(8.78~238.13)。对于HPV疫苗安全性,二价与四价HPV疫苗接种局部不良事件风险试验组高于对照组,RR为1.52(1.34~1.73)和1.38(1.20~1.59)。二价HPV疫苗与四价HPV疫苗试验组发生全身性不良事件的风险也高于对照组,RR分别为1.21(1....  相似文献   

2.
分析SARS的临床特征,为SARS的诊疗技术和疾病监测的完善提供循证依据。方法以规定检索词在常用中、英文数据库中检索并严格按照纳入与排除的标准纳入文献。将纳入文献的研究病例汇集后分析患者症状、体征、常见实验室检查、影像学改变及其并发症等临床特征发生的概率。结果经过严格筛选共纳入文献93篇,其中英文文献19篇,中文文献7...  相似文献   

3.
目的评价降压0号治疗原发性高血压的有效性和安全性。方法制定严格的纳入和排除标准,全面检索相关数据库(CBMDISC,CNKI,维普,万方,Cochrane Library,MEDLINE,OVID,PubMed Central),并配合数据库外检索保证文献的查全率。由两名独立的摘录员对原始研究进行质量评价和信息摘录。利用Rev Man 4.2软件进行Meta分析,根据各原始研究间异质性大小选择随机/固定效应模型,并进行敏感性分析和亚组分析。结果共检索到相关文献649篇,经评价后19个研究包含2 434例患者符合研究的纳入标准,其中4篇为中等质量的研究,其余均为低质量的研究。有效性结果:降压0号组与常规药物组合并总有效率之比及其95%可信区间为1.02(0.98,1.05),两组差异无统计学意义(P=0.39);安全性结果:降压0号组与常规药物组合并不良事件发生率之差及其95%可信区间为-0.01(-0.03,0.02),两组差异无统计学意义(P=0.65)。结论根据目前研究证据,降压0号与其他常规降压药物相比疗效相近、不良事件的发生情况与其他常规降压药差异不明显,有较为可靠的疗效和安全性。为得到更加可靠的结论,开展更多设计严谨,大样本、多中心的随机对照实验进行验证和补充是必要的。  相似文献   

4.
目的依据国际认可的药物抑菌活性检测实验的实验方法对现有的中药抑杀幽门螺杆菌体外实验相关文献的实验方法及文献质量进行系统评价。方法通过检索中国生物医学文献数据库、中国期刊全文数据库、中国博士学位论文全文数据库、中国优秀硕士学位论文全文数据库、中国重要会议论文全文数据库、中国重要报纸全文数据库及万方数据库自1978年以来有关中药对于幽门螺杆菌体外抑杀实验的相关文献对符合纳入标准的文献进行系统评价。结果检索到相关文献33篇,全部符合纳入与排除标准的文献为22篇,运用抑菌环法及菌液稀释法有5篇,只采用菌液稀释法的有13篇,只采用抑菌环实验的有3篇,而无一篇采用国际认可的微量菌液稀释法。  相似文献   

5.
目的探讨阿司匹林联合波立维治疗急性心肌梗死的临床疗效,为急性心肌梗死的临床救治提供科学依据。方法计算机检索中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方数据库、维普系列数据库、The Cochrane Library、PubMed数据库、SpringerLink全文数据库、EBSCO全文数据库、泉方MEDLINE文献服务等数据库,检索文献发表时间为2000年1月至2017年12月,关键词包括"阿司匹林"、"波利维"、"急性心肌梗死"及其自由词的随机对照试验相关文献,共137篇,在尽可能全面地收集相关临床试验数据资料的基础上,根据纳入和排除标准,严格评价文献质量,采用RevMan 5.3对符合纳入标准的研究结果进行Meta分析。结果符合纳入标准的文献共10篇,其中只涉及治疗效果的文献4篇,只涉及不良心脏事件和不良反应的3篇,两者均涉及的3篇。总样本量1 437例,其中实验组720例,对照组717例。阿司匹林联合波立维治疗急性心肌梗死的有效率高于对照组,OR值(95%CI)为4.50(2.98,6.79),阿司匹林联合波立维可以降低不良心脏事件和不良反应的发生[OR(95%CI)为0.31(0.19,0.50)]。结论阿司匹林联合波立维治疗急性心肌梗死具有显著的疗效,可以提高治疗有效率,改善患者的预后。  相似文献   

6.
目的系统评价预防性人乳头状瘤病毒(HPV)疫苗接种预防宫颈癌的不良反应。方法应用计算机全面检索PubMed并辅以手工检索,查找近10年关于预防性HPV疫苗预防宫颈癌的随机对照研究(RCT)的文献,按照纳入和排除标准对数据进行提取并建立Excel表,采用Rev Man5. 3软件进行Meta分析。结果最终共纳入13篇RCT文献,HPV疫苗接种局部注射的不良反应发生率大于对照组; HPV疫苗组和对照组全身不良反应、严重不良反应、自然流产率和死亡率无明显差异。结论疫苗组注射部位相关不良事件包括局部红肿、疼痛及麻木,但是大多数不良反应比较短暂,多为轻度。接种HPV疫苗后系统不良反应最常见的为头痛、眩晕、体温升高、疲乏、肌痛等。严重不良反应发生率及疫苗相关自然流产率,死亡率在疫苗组和对照组保持均衡。  相似文献   

7.
目的 探讨医学营养干预对妊娠期糖尿病临床结局的影响。方法 计算机检索2005年1月至2015年1月Pubmed、EMBASE、OVID,Cochrane 图书馆、中国知网及万方数据库知识服务平台等数据库中探讨医学营养干预对妊娠期糖尿病临床结局影响的文献,同时进行手工检索和参考文献回溯。根据纳入及排除标准,对检索到的文献进行严格筛选。依据干预措施是否涉及胰岛素,所有纳入文献被分成两组(单纯营养干预组和多重干预组)进行分析。采用Cochrane手册推荐的偏倚风险评估工具对所纳入文献的偏倚风险进行评价。两组人员  相似文献   

8.
目的:运用meta分析的方法探究女性不孕症与解脲支原体(Uu)和沙眼衣原体(Ct)感染之间的关系。方法:拟定严格的文献纳入标准和排除标准,检索中国知网以及维普、万方、中国生物医学文献数据库等中文数据库和PubMed等外文数据库,时间限定在2000~2014年。由两名研究者独立对检索后的文献进行质量评价,然后采用RevMan5.3软件对筛选出的文献进行数据定量分析。结果 :1共检索出相关文献181篇,其中中文文献132篇,英文文献49篇,仔细阅读相关文献的题目和摘要,对相关度高的文献详细阅读全文,严格依照以上的纳入和排除标准,最终共筛选出中文相关文献13篇,英文文献0篇,共纳入13个符合要求的研究,包含3760例患者;2将上述筛选后的文献进行meta分析,得出单纯Uu感染、单纯Ct感染以及两者混合感染合并后的OR分别为6.41(95%CI:4.85~8.47)、6.76(95%CI:5.33~8.58)、10.74(95%CI:6.87~16.81),各组与其相应对照组之间不孕症患病率差异均具有统计学意义。结论 :单纯的Uu或是Ct感染与女性不孕症相关,当两者混合感染时,女性患不孕症的危险度会更高,因此,在检测女性不孕症病因时,应该注重对Uu和Ct感染的检测。  相似文献   

9.
目的分析中文期刊发表的关于艾滋病评价方面的中文文献的现状、特点及发展方向。方法由两名研究人员讨论确定检索词,以中国知网(China national knowledge internet,CNKI)为基础进行检索,然后根据纳入和排除标准对检索到的文献进行筛选。对筛选过后的文献从发表年份和数量、题录类型、发表期刊、评价主题及基金资助情况进行分析。结果筛选出符合纳入标准的903篇文献,发表文献数量总体上呈上升趋势;刊登此类文献最多的杂志是《中国健康教育》;有307篇文献(33.40%)获得了基金资助,其中有144项为国际合作项目基金;有43.74%的文献的评价主题/对象是关于艾滋病宣传教育评价的,而对艾滋病其他方面的评价涉及较少。结论国内应加大对艾滋病评价工作的投入,注意艾滋病各领域评价工作的均衡发展。  相似文献   

10.
目的 评价国内外已发表的新型冠状病毒肺炎(COVID-19)疫苗有效性和安全性的系统综述(SR)和Meta分析(MA)的方法学质量。方法 系统检索Medline、Embase、Cochrane Library、Web of Science、中国知网、万方数据知识服务平台、维普网、SinoMed等中英文数据库,检索时间截至2021年12月10日。双人独立筛选文献、提取信息,使用SR评价工具第2版(AMSTAR-2),从16个方面评价SR/MA的方法学质量。结果 共纳入22篇SR/MA,3篇(13.6%)的总体质量为低、19篇(86.4%)的总体质量为极低。问题主要体现在研究问题和纳入标准未明确PICO(Participants,intervention,control,outcome)、未提前制定研究方案、未提供排除文献的清单及排除理由、未考虑纳入研究的偏倚风险对SR/MA或证据整合的潜在影响、未解释或讨论纳入研究的偏倚风险、未评估发表偏倚及讨论其对SR/MA的影响等方面。结论 COVID-19疫苗有效性和安全性的SR/MA存在不同程度的方法学缺陷,需要进一步提高其方法学质量。  相似文献   

11.
《Vaccine》2023,41(21):3328-3336
AbstractThe COVID-19 vaccination program implementation in Ontario, Canada has spanned multiple years and is ongoing. To meet the challenges of the program, Ontario developed and implemented a new electronic COVID-19 immunization registry, COVaxON, which captures individual-level data on all doses administered in the province enabling comprehensive coverage assessment. However, the need for ongoing COVID-19 vaccine coverage assessments over a multi-year vaccination program posed challenges necessitating methodological changes. This paper describes Ontario’s COVID-19 immunization registry, the methods implemented over time to allow for the ongoing assessment of vaccine coverage by age, and the impact of those methodological changes.Throughout the course of the vaccination program, four different methodological approaches were used to calculate age-specific coverage estimates using vaccination data (numerator) obtained from COVaxON. Age-specific numerators were initially calculated using age at time of first dose (method A), but were updated to the age at coverage assessment (method B). Database enhancements allowed for the exclusion of deceased individuals from the numerator (method C). Population data (denominator) was updated to 2022 projections from the 2021 national census following their availability (method D). The impact was most evident in older age groups where vaccine uptake was high. For example, coverage estimates for individuals aged 70–79 years of age for at least one dose decreased from 104.9 % (method B) to 95.0 % (method D). Thus, methodological changes improved estimates such that none exceeded 100 %.Ontario’s COVID-19 immunization registry has been transformational for vaccine program surveillance. The implementation of a single registry for COVID-19 vaccines was essential for comprehensive near real-time coverage assessment, and enabled new uses of the data to support additional components of vaccine program surveillance. The province is well positioned to build on what has been achieved as a result of the COVID-19 pandemic and expand the registry to other routine vaccination programs.  相似文献   

12.
《Vaccine》2019,37(48):7138-7146
BackgroundProduct labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.PurposeTo develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.MethodsWe conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) meeting, followed by a Delphi survey, and then a consensus workshop with a subset of Delphi participants. We developed a methodological tool to analyse data for consensus.Principal resultsStakeholders (N = 14) at the NGT meeting drafted product label statements for evaluation in the Delphi survey. Survey participants (N = 41) provided feedback on statements for five hypothetical vaccines. Workshop participants (N = 27) initiated discussions that demonstrated a lack of awareness that the regulatory purpose of product labels is to provide a scientific summary of product-specific pre-clinical and clinical trial data. Each stage of this project built on earlier stages until we achieved strong consensus on the language, structure, and types of data that stakeholders wanted to include in inactivated influenza vaccine (IIV) and tetanus-diphtheria-acellular pertussis (Tdap) vaccine product labels in Canada.ConclusionsThe revised statements for IIV and Tdap aligned with workshop participants’ goals that the product label be evidence-based, with a consistent structure and language that is easily understood by healthcare providers. Emergent methods uncovered stakeholder concerns about the regulatory purpose, content, and evidence used in product labels. Involving healthcare providers in the development and regular updating of product information could prevent interpretations of that information that contribute to vaccine hesitancy.  相似文献   

13.
目的 对新疫苗纳入国家免疫规划涉及的决策要素相关的文献进行系统梳理。方法 通过8个中英文文献数据库检索国内外相关文献,归纳各国进行免疫决策时的评价维度及核心指标等。结果 纳入41篇文献,内容以案例研究为主,实证研究较少。各文献基本遵循疾病、疫苗、卫生系统的评价框架,但有不同程度的延伸。疾病死亡率、疫苗安全性及有效性、成本效果评价等为高频评价指标。本研究梳理出基于“疾病-疫苗-能力-效益评价”的4维度13个要素43个指标的评价体系。结论 国内外关于疫苗决策的研究处于发展阶段,我国应增强疫苗纳入免疫规划的评价框架的可操作性及广度,注重本土的流行病学、卫生经济学数据收集,进一步发挥国家免疫规划技术工作组在疫苗循证决策中的作用。  相似文献   

14.
目的对比分析精神卫生领域患者安全中外研究主题,以期对我国该领域研究发展提供参考。 方法检索中国知网(CNKI)、万方和PubMed数据库,获取精神卫生领域患者安全中外文文献,采用VOSviewer软件并借助Excel 2016软件对纳入文献的发表年份、来源期刊、作者及合作网络、关键词等进行计量学分析。结果最终纳入810篇中文文献,1 427篇外文文献。中文文献包含老年、安全隐患及应对措施、住院安全及风险控制、精神分裂患者、不良事件管理5个主题;外文文献包含医务人员临床工作及沟通能力,老年,儿童、青少年及成人住院与出院患者自伤、自杀,住院患者安全4个主题。结论精神卫生领域中外文文献共同研究热点为老年及住院患者安全。外文文献主题涉及较宽泛,全方位探索了针对性干预方式;而中文文献研究内容较笼统,研究结果缺乏针对性,有较大发展空间。  相似文献   

15.
《Vaccine》2021,39(14):1897-1909
BackgroundCompeting priorities make using a transparent and evidence-based approach important when deciding to recommend new vaccines. We conducted a literature review to document the processes and frameworks for national decision-making on new vaccine introductions and explored which key features have evolved since 2010.MethodsWe searched literature published on policymaking related to vaccine introduction from March 2010 to August 2020 in six databases. We screened articles for eligibility with the following exclusion criteria: non-human or hypothetical vaccines, the sole focus on economic evaluation or decision to adopt rather than policy decision-making. We employed nine broad categories of criteria from the 2012 review for categorization and abstracted data on the country, income level, vaccine, and other relevant criteria.ResultsOf the 3808 unique references screened, 116 met eligibility criteria and were classified as: a) framework of vaccine adoption decision-making (27), b) studies that analyse empirical data on or examples of vaccine adoption decision-making (45), c) theoretical and empirical articles that provide insights into the vaccine policymaking process (44 + 17 already included in the previous categories). Commonly reported criteria for decision-making were the burden of disease; vaccine efficacy/effectiveness, safety; impact on health and non-health outcomes; economic evaluation and cost-effectiveness of alternative interventions. Programmatic and acceptability aspects were not as often considered. Most (50; 82%) of the 61 articles describing the process of vaccine introduction policymaking highlighted the role of country, regional, or global evidence-informed recommendations and a robust national governance as enabling factors for vaccine adoption.ConclusionsThe literature on vaccine adoption decision-making has expanded since 2010. We found that policymakers and expert advisory committee members (e.g., National Immunization Technical Advisory Group [NITAG]) increasingly value the interventions based on economic evaluations. The results of this review could guide discussions on evidence-informed immunization decision-making among country, sub-regional, and regional stakeholders.  相似文献   

16.
《Vaccine》2022,40(5):742-751
BackgroundYellow fever (YF) vaccines are highly effective and have a well-established safety profile despite the risk of rare serious adverse events (SAEs), vaccine-associated neurotropic (YEL-AND) and viscerotropic disease (YEL-AVD). This study aimed to describe US civilian YF vaccine usage, the population characteristics and pre-existing immunosuppressive medical conditions among those vaccinated, and to provide updated risk estimates of neurotropic and viscerotropic disease post-vaccination.MethodsA retrospective cohort study was conducted using de-identified patient information from Optum Electronic Healthcare Record (EHR) (2007–2019), Optum Clinformatics Data Mart (CDM) (2004–2019) and IBM MarketScan (2007–2019) databases. YF vaccine recipients were identified using relevant vaccination and procedural codes. Demographic characteristics and pre-existing medical conditions were described. Incidence proportions with 95% confidence intervals (CI) of neurotropic and viscerotropic diseases occurring ≤ 30 days post-vaccination, after exclusion of unlikely cases based on current clinical guidelines of YEL-AND and YEL-AVD, were calculated.ResultsA total of 92,205, 46,539 and 125,235 YF vaccine recipients were retrieved from Optum EHR, Optum CDM and IBM MarketScan databases, respectively. The majority of vaccine recipients were aged < 60 years (highest proportion aged 18–29 years) with a higher proportion of females overall. Few vaccine recipients (<1%) had conditions predisposing them to immunosuppression. Four non-fatal cases of neurotropic disease and zero cases of viscerotropic disease were identified. The incidence proportion of post-vaccination neurotropic disease was 1.41 (95% CI: 0.15–6.61) and 3.04 (95% CI: 0.86–8.11) per 100,000 vaccine recipients in Optum EHR and IBM MarketScan, respectively, with no events identified in Optum CDM.ConclusionsThis study provides updated insights into current YF vaccine usage in US civilian recipients and supports the safety profile of YF vaccines in US practice. The low frequency of pre-existing immunosuppressive medical conditions among vaccine recipients suggests good adherence to vaccination guidelines by healthcare practitioners. The risk of developing neurotropic and viscerotropic disease post-vaccination remains rare.  相似文献   

17.
《Vaccine》2021,39(40):5891-5908
BackgroundRapid assessment of COVID-19 vaccine safety during pregnancy is urgently needed.MethodsWe conducted a rapid systematic review, to evaluate the safety of COVID-19 vaccines selected by the COVID-19 Vaccines Global Access-Maternal Immunization Working Group in August 2020, including their components and their technological platforms used in other vaccines for pregnant persons. We searched literature databases, COVID-19 vaccine pregnancy registries, and explored reference lists from the inception date to February 2021 without language restriction. Pairs of reviewers independently selected studies through COVIDENCE, and performed the data extraction and the risk of bias assessment. Discrepancies were resolved by consensus. Registered on PROSPERO (CRD42021234185).ResultsWe retrieved 6757 records and 12 COVID-19 pregnancy registries from the search strategy; 38 clinical and non-clinical studies (involving 2,398,855 pregnant persons and 56 pregnant animals) were included. Most studies (89%) were conducted in high-income countries and were cohort studies (57%). Most studies (76%) compared vaccine exposures with no exposure during the three trimesters of pregnancy. The most frequent exposure was to AS03 adjuvant, in the context of A/H1N1 pandemic influenza vaccines, (n = 24) and aluminum-based adjuvants (n = 11). Only one study reported exposure to messenger RNA in lipid nanoparticles COVID-19 vaccines. Except for one preliminary report about A/H1N1 influenza vaccination (adjuvant AS03), corrected by the authors in a more thorough analysis, all studies concluded that there were no safety concerns.ConclusionThis rapid review found no evidence of pregnancy-associated safety concerns of COVID-19 vaccines or of their components or platforms when used in other vaccines. However, the need for further data on several vaccine platforms and components is warranted, given their novelty. Our findings support current WHO guidelines recommending that pregnant persons may consider receiving COVID-19 vaccines, particularly if they are at high risk of exposure or have comorbidities that enhance the risk of severe disease.  相似文献   

18.
目的 系统评价红外耳温计测量老年人体温的准确性。方法 计算机检索PubMed、Cochrane图书馆、Embase、中国期刊全文数据库(CNKI)、维普中文科技期刊数据库以及万方数据库中1988-2019年关于红外耳温计测量老年人体温准确性的文献,正在进行的研究通过ClinicalTrials.gov进行搜索。严格按照纳入和排除标准筛选文献,提取资料,评价纳入研究的偏倚风险,使用Stata12.0软件进行统计分析。结果 最终纳入8篇文献,其中3篇有体温正常组和发热组患者体温均数和标准差,1篇有发热组耳温与腋温数据的比较,4篇仅有正常组耳温与腋温数据的比较;5篇文献比较了左耳与右耳耳温的数据。Meta分析结果显示,耳温与腋温比较,体温正常组、发热组差异均无统计学意义(均P>0.05);左耳与右耳耳温比较,差异无统计学意义(P>0.05)。结论 红外耳温计准确性良好,可作为确定老年人初始温度的最佳筛选工具。  相似文献   

19.
ObjectivesTo conduct a systematic review of the methods used to determine when and how to update clinical practice guidelines (CPGs) and develop a procedure for updating CPGs.Study Design and SettingWe searched MEDLINE, Embase, and the Cochrane Methodology Register for methodological publications on updating CPGs. Guideline development manuals were obtained from the Web sites of guideline-developing organizations. Using the information obtained from these records, a procedure for updating CPGs was developed.ResultsA total of 5,116 journal articles were screened, and seven articles met the criteria for inclusion. Forty-seven manuals were included; of these, eight included details about the methods used to update the guidelines. Most of the included publications focused on assessing whether the CPGs needed updating and not on how to update them. The developed procedure includes a systematic monitoring system and a scheduled process for updating the CPGs, which includes guidance on how to determine the type and scope of an update.ConclusionPartial updating often makes more sense than updating the whole CPG because topics and recommendations differ in terms of the need for updating. Guideline developers should implement a systematic updating procedure that includes an ongoing monitoring system that is appropriate for the nature of the guideline topics and the capabilities of the developers.  相似文献   

20.
《Vaccine》2023,41(27):3960-3963
BackgroundFollowing the authorization and recommendations for use of the U.S. COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC)’s Immunization Safety Office (ISO) responded to inquiries and questions from public health officials, healthcare providers, and the general public on COVID-19 vaccine safety.MethodsWe describe COVID-19 vaccine safety inquiries, by topic, received and addressed by ISO from December 1, 2020–August 31, 2022.ResultsOf the 1978 COVID-19 vaccine-related inquiries received, 1655 specifically involved vaccine safety topics. The most frequently asked-about topics included deaths following vaccination, myocarditis, pregnancy, and reproductive health outcomes, understanding or interpreting data from the Vaccine Adverse Event Reporting System (VAERS), and thrombosis with thrombocytopenia syndrome.ConclusionsInquiries about vaccine safety generally reflect issues that receive media attention. ISO will continue to monitor vaccine safety inquiries and provide accurate and timely information to healthcare providers, public health officials, and the general public.  相似文献   

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