Avoidance of Nitrous Oxide for Patients Undergoing Major Surgery: A Randomized Controlled Trial

Background: Nitrous oxide is widely used in anesthesia, often administered at an inspired concentration around 70%. Although nitrous oxide interferes with vitamin B12, folate metabolism, and deoxyribonucleic acid synthesis and prevents the use of high inspired oxygen concentrations, the consequences of these effects are unclear.

Methods: Patients having major surgery expected to last at least 2 h were randomly assigned to nitrous oxide-free (80% oxygen, 20% nitrogen) or nitrous oxide-based (70% N2O, 30% oxygen) anesthesia. Patients and observers were blind to group identity. The primary endpoint was duration of hospital stay. Secondary endpoints included duration of intensive care stay and postoperative complications; the latter included severe nausea and vomiting, and the following major complications: pneumonia, pneumothorax, pulmonary embolism, wound infection, myocardial infarction, venous thromboembolism, stroke, awareness, and death within 30 days of surgery.

Results: Of 3,187 eligible patients, 2,050 consenting patients were recruited. Patients in the nitrous oxide-free group had significantly lower rates of major complications (odds ratio, 0.71; 95% confidence interval, 0.56-0.89; P = 0.003) and severe nausea and vomiting (odds ratio, 0.40; 95% confidence interval, 0.31-0.51; P < 0.001), but median duration of hospital stay did not differ substantially between groups (7.0 vs. 7.1 days; P = 0.06). Among patients admitted to the intensive care unit postoperatively, those in the nitrous oxide-free group were more likely to be discharged from the unit on any given day than those in the nitrous oxide group (hazard ratio, 1.35; 95% confidence interval, 1.05-1.73; P = 0.02).     

Sumatriptan nasal spray in the acute treatment of migraine in adolescents and children

About 4-10% of children and adolescents suffer from migraine. In the last few years, several studies have been performed to assess the efficacy and safety of triptans for the acute treatment of migraine in children and adolescents. Only sumatriptan nasal spray has been approved for the treatment of acute migraine with or without aura in adolescents aged 12-17 years in Europe. This review describes the results of the studies with sumatriptan nasal spray that have been performed in children and adolescents, including a study performed in the Netherlands.     

The immune response of healthy adults to a reduced dose of hepatitis B vaccine

Three hundred thirty-six medical personnel from hemodialysis centers were treated with three doses, 20 μg each, of the Merck hepatitis B vaccine (at 0, 1, and 6 months). Within 1 month after the first injection, 41% converted to anti-HBs positivity; after the second injection the conversion rate rose to 80–90%; and after the booster, to 96–98%. The later rate remained unchanged during the 18-month follow-up period. Only 2.8% of those vaccinated did not respond to the vaccine. The patterns of immune responses to 20-μg doses were found to be exactly the same as to 40-μg doses. It is suggested that reduced doses of vaccine should be as efficacious as the larger ones.     

192例恶性肿瘤患者应用重组人肿瘤坏死因子-α免疫功能与疗效的相关性分析

目的：观察重组人肿瘤坏死因子—α(rh—TNFα)静脉输注对恶性肿瘤患者细胞免疫功能的增强作用及影响因素，并分析其与rh—TNFα抗肿瘤作用的相关性。方法：选择具有明确病理诊断的复治或拒绝放、化疗的乳腺癌、恶性淋巴瘤、肾癌和恶性黑色素瘤患者，静脉输注rh—TNFα，100万U／m^2，每日1次，每周连续5日，连用4周为1个疗程。采用免疫荧光直标染色法染色，以流式细胞仪检测治疗前后患者外周血T细胞亚群、NK细胞变化，同时评价抗肿瘤治疗的疗效。治疗前后细胞免疫功能比较采用配对t检验，免疫功能变化与抗肿瘤客观疗效的相关性采用多因素Logistic回归分析。结果：rh—TNFα给药后可提高患者外周血NK细胞和T细胞亚群数量，但CD4／CD8比值变化不明显，NK细胞和T细胞亚群的变化与rh—TNFα的抗肿瘤客观疗效的相关性不显著。结论：rh—TNFα具有一定的改善肿瘤患者细胞免疫功能的作用，但这种免疫增强作用可能不是其抗肿瘤疗效的最主要机制。     

临床试验数据采集与报告文件设计制作的技术规程

临床试验数据采集与报告文件的设计和制作对保证试验数据的质量与完整性至关重要。参照临床试验数据管理规范 (GCP)并结合具体实践经验制订本规程。设计规程包括与方案设计同步、文件格式、问题和提示、冗余数据、数据记录指南、标准化、版本管理与培训 ;印制规程包括审批、印制说明书以及厂商选择。     

临床试验的数据和安全监察

临床试验数据和安全监察的目的是保证受试者的安全 ,数据的有效性 ,以及当明显的受益或风险被证实时 ,或试验不可能成功获得结论时 ,适时中止试验。所有的临床试验都应制定数据和安全监察计划 ;必要时需要建立数据和安全监察委员会。数据和安全监察的方法和强度应该与临床试验的风险以及试验规模和复杂程度相当。监察范围涉及试验实施的质量 ,以及安全性和有效性的数据。监察类型包括对试验主要结局指标等监察项目进行连续地累积性评估和中期分析。