...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>BMC Family Practice >The safety and efficacy of the tetanus vaccine intramuscularly versus subcutaneously in anticoagulated patients: a randomized clinical trial
【24h】

The safety and efficacy of the tetanus vaccine intramuscularly versus subcutaneously in anticoagulated patients: a randomized clinical trial

机译：肌内和皮下注射破伤风疫苗在抗凝患者中的安全性和有效性：一项随机临床试验

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

Background In patients treated with oral anticoagulants, subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding, although the effectiveness of the vaccine has only been proven for intramuscular injection. The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants. Methods/design We present a prospective, double blinded, clinical trial comparing two groups of patients with oral anticoagulants: one group was administered tetanus-diphtheria vaccine by intramuscular injection, while the other was administered the same vaccine by subcutaneous injection. Allocation to each group was randomized and the duration of the study was six years. Study population: all patients treated with oral anticoagulants, who had been administered with at least one dose of vaccine, at 15 Health Centres in Vigo (Spain), and who agreed to participate in the study. The sample size was 115 patients in each group. The main variables for the safety analysis were the measurement of the brachial diameter, the appearance of basic injuries at the vaccine administration site, the appearance of pain and systemic reactions. The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies. An Intention-to-treat analysis will be performed. Details will be classified according to the administration route, while within each group a 3-tiered stratification will be defined by the administered number of doses. As a measure of association, relative risk will be estimated; the reduction of relative risk will also measured. For safety and to control the confounder effect, a logistic regression analysis will be carried out. As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated. CONSORT 2010 guidelines were applied for reporting parallel group randomised trials. Discussion The most significant difficulties on the project are related to the large number of participating centres, required to obtain a viable study population sample size, and the coordination given the scattering of the centres and researchers. Trial registration ISRCTN69942081 .
机译：背景技术在口服抗凝剂治疗的患者中，通常建议皮下注射抗破伤风疫苗以减少出血的风险，尽管该疫苗的有效性仅在肌肉注射中得到证实。这项研究的目的是比较肌肉注射和皮下注射破伤风-白喉疫苗在口服抗凝剂治疗患者中的安全性和有效性。方法/设计我们提供了一项前瞻性，双盲的临床试验，对两组口服抗凝药的患者进行了比较：一组通过肌肉注射注射破伤风-白喉疫苗，而另一组通过皮下注射注射相同的疫苗。每个组的分配是随机的，研究时间为六年。研究人群：在西班牙维哥的15个卫生院接受口服抗凝剂治疗的所有患者，至少已注射了一剂疫苗，并同意参加该研究。每组样本量为115名患者。安全性分析的主要变量是肱动脉直径的测量，疫苗接种部位基本损伤的出现，疼痛和全身反应的出现。用于功效分析的变量是抗破伤风类毒素抗体滴度的显着增加。将进行意向治疗分析。详细信息将根据给药途径进行分类，而在每组中，将根据给药剂量确定3层分层。作为一种关联度量，将估计相对风险;相对风险的降低也将得到衡量。为了安全和控制混杂因素，将进行逻辑回归分析。作为影响的衡量标准，将估计相对于要治疗的患者总数和所需治疗人数的绝对风险降低。 CONSORT 2010指南适用于报告平行组随机试验。讨论该项目上最重大的困难与大量参与中心有关，要获得可行的研究人群样本量就需要这样做，并且要考虑到各中心和研究人员分散的协调性。试用注册ISRCTN69942081。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号