Safety of human papillomavirus vaccines in healthy young women: a meta-analysis of 24 controlled studies.
Safety of human papillomavirus vaccines in healthy young women: a meta-analysis of 24 controlled studies.
复制标题
DOI：
10.1186/s40780-017-0087-6
复制
发表时间：
2017
影响因子：
1
通讯作者：
Mihara K
中科院分区：
文献类型：
--
作者：
Ogawa Y;Takei H;Ogawa R;Mihara K
人类乳头瘤病毒（HPV）疫苗已被证明对根除HPV和预防宫颈癌有效。然而，由于担心与疫苗有关的不良反应，在过去几年中，日本接受HPV疫苗接种的妇女人数有所减少。我们通过荟萃分析分别评估了三种HPV疫苗在年轻女性中的安全性，以及HPV疫苗与其他疫苗不良反应风险的差异。主要文献检索自MEDLINE、Cochrane中央对照试验注册库和日本中央医学文献。前瞻性对照研究包括接受二价、四价或9价HPV （2vHPV、4vHPV或9vHPV）疫苗的健康女性。主要的安全性指标是征求的局部和全身症状的发生率，以及未经征求的症状。当两个或两个以上的研究发现相同的分析时，应用荟萃分析。本研究共纳入22篇文献的24项对照研究。在24项研究中，16项是安慰剂对照，8项是活性对照（不同的HPV疫苗或肝炎疫苗）。参与者的平均年龄从12岁到37岁不等。与安慰剂相比，注射HPV疫苗（2vHPV和4vHPV）后，引起局部症状的发生率显著增加，但HPV疫苗之间没有差异[2vHPV的风险比（RR）： 1.25, 95%可信区间（CI）： 1.09至1.43,4vHPV的风险比（RR）： 1.16, 95% CI: 1.11至1.20]。HPV疫苗和安慰剂引起的系统性症状的发生率没有差异（RR: 1.04, 95% CI: 0.99至1.09）。与安慰剂相比，2vHPV疫苗的主动症状发生率显著高于安慰剂（RR: 1.28, 95% CI: 1.01至1.63），但在2vHPV疫苗和乙肝疫苗之间无显著差异。与安慰剂或其他疫苗（甲型肝炎和乙型肝炎疫苗）相比，HPV疫苗在任何注射部位出现症状的风险都明显更高，并且在接种2vHPV疫苗和接种4vHPV疫苗之间，征求的局部症状的发生率没有差异。然而，大多数不良反应是短暂的。
Human papillomavirus (HPV) vaccines have been shown to be effective for the eradication of HPV and prevention of cervical cancer. However, the number of women who receive HPV vaccinations has decreased over the last several years in Japan, due to concerns about adverse reactions associated with the vaccines. We evaluated the safety of three types of HPV vaccines separately in young women and the difference in the risk of adverse reactions between HPV and other vaccines by conducting a meta-analysis. Primary literature was retrieved from MEDLINE, the Cochrane Central Register of Controlled Trials, and Japana Centra Revuo Medicina. Prospective controlled studies with participants consisting exclusively of healthy women who received bivalent, quadrivalent, or 9-valent HPV (2vHPV, 4vHPV or 9vHPV) vaccines were included. Primary safety outcome was the incidence of solicited local and systemic symptoms, and unsolicited symptoms. When two or more studies were found for the same analysis, a meta-analysis was applied. A total of 24 controlled studies from 22 articles were included in our study. Of the 24 studies, 16 were placebo-controlled and eight were active-controlled (different HPV vaccine or hepatitis vaccine). Average ages of the participants ranged from 12 to 37 years. A significantly higher incidence of solicited local symptoms was observed following injection of HPV vaccines (2vHPV and 4vHPV) compared to placebo, but there was no difference between HPV vaccines [risk ratio (RR) for 2vHPV: 1.25, 95% confidence interval (CI): 1.09 to 1.43, RR for 4vHPV: 1.16, 95% CI: 1.11 to 1.20]. The incidence of solicited systemic symptoms was not different between HPV vaccines and placebo (RR: 1.04, 95% CI: 0.99 to 1.09). The incidence of unsolicited symptoms was significantly higher for 2vHPV vaccine compared to placebo (RR: 1.28, 95% CI: 1.01 to 1.63), but was not significantly different between 2vHPV and hepatitis B vaccines. HPV vaccines had significantly higher risk of any injection site symptom compared to placebo or other vaccines (hepatitis A and B vaccines), and the incidence of solicited local symptoms was no difference between 2vHPV vaccination and 4vHPV vaccination. However, the most adverse reactions were transient.