Tseng Hung-Fu, Tan Hsiu-Fen, Chang Chen-Kang
Department of Healthcare Administration, Fooyin University, Taiwan, Republic of China.
Am J Infect Control. 2003 May;31(3):151-6. doi: 10.1067/mic.2003.58.
Varicella vaccine was first available in Taiwan in 1997. The aims of this study were to investigate varicella vaccine safety and occurrence of breakthrough in Taiwan during the first 3 years. The adverse events, incidence of breakthrough, and factors associated with breakthrough were analyzed.
A personal interview using a structured questionnaire was conducted for the parents of 1248 children less than 12 years old who were vaccinated between 1998 and 2000. Incidence of adverse events and breakthrough were presented and factors associated with breakthrough were estimated by logistic regression.
There were 27 (2.16%) breakthrough cases occurring during the maximum follow up period of 31 months, including 22 very mild or mild cases, 3 moderately severe cases, and 2 severe cases. Compared with those who did not have confirmed history of varicella exposure after vaccination, children with such exposure were approximately 28 times as likely to have breakthrough varicella develop (adjusted odds ratio = 27.75, 95% confidence interval: 6.12-125.78, P =.00). There were 91 (7.3%) reported cases of adverse events, including rash, fever, and pain or swelling, occurring within 2 weeks of vaccination.
Although rare adverse events cannot be well-quantified in this study, the results suggest that, at least in the short term, varicella vaccine is well-tolerated and effective in Taiwan. Long-term monitoring program is necessary to ensure the safety of this vaccine.
水痘疫苗于1997年首次在台湾上市。本研究的目的是调查台湾地区头3年水痘疫苗的安全性及突破性病例的发生情况。分析了不良事件、突破性病例的发生率以及与突破性病例相关的因素。
对1998年至2000年间接种疫苗的1248名12岁以下儿童的家长进行了结构化问卷调查的个人访谈。报告了不良事件和突破性病例的发生率，并通过逻辑回归估计了与突破性病例相关的因素。
在最长31个月的随访期内，共出现27例（2.16%）突破性病例，其中22例为非常轻微或轻度病例，3例为中度严重病例，2例为严重病例。与接种疫苗后没有确诊水痘暴露史的儿童相比，有此类暴露史的儿童发生突破性水痘的可能性约为前者的28倍（调整后的优势比=27.75，95%置信区间：6.12-125.78，P=0.00）。有91例（7.3%）报告的不良事件发生在接种疫苗后2周内，包括皮疹、发热以及疼痛或肿胀。
尽管本研究无法很好地量化罕见不良事件，但结果表明，至少在短期内，水痘疫苗在台湾耐受性良好且有效。需要长期监测计划以确保该疫苗的安全性。
