Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review & meta-analysis.
Efficacy and safety of prophylactic vaccines against cervical HPV infection and diseases among women: a systematic review & meta-analysis.
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DOI：
10.1186/1471-2334-11-13
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发表时间：
2011-01-12
影响因子：
3.7
通讯作者：
Giuliano AR
中科院分区：
文献类型：
--
作者：
Lu B;Kumar A;Castellsagué X;Giuliano AR
我们进行了系统回顾和荟萃分析，以评估预防性HPV疫苗对妇女宫颈癌前体事件的有效性和安全性。从MEDLINE、科克伦对照试验中心登记处、会议摘要和已确定研究的参考文献中确定HPV疫苗的随机对照试验，并由两名独立评审员进行评估。使用固定效应模型合成疗效数据，并使用I2统计量评价异质性。纳入了7项独特的试验，共招募了44，142名女性。在符合方案人群（PPP）中，HPV-16和HPV 18相关CIN 2+的固定效应相对风险（RR）和95%置信区间分别为0.04（0.01-0.11）和0.10（0.03-0.38）。意向治疗人群（ITT）中相应的RR为0.47（0.36-0.61）和0.16（0.08-0.34）。对抗CIN 1+的效力在规模上相似，有利于疫苗。总体而言，疫苗对PPP队列（RR分别为0.06 [0.04-0.09]和0.05 [0.03-0.09]）和ITT队列（RR分别为0.15 [0.10-0.23]和0.24 [0.14-0.42]）中HPV 16和18的6个月持续感染高度有效。对与非疫苗致癌HPV类型相关的CIN 2+和6个月持续感染的预防作用有限。严重不良事件（RR：1.00，0.91-1.09）或疫苗相关严重不良事件（RR：1.82; 0.79-4.20）的风险在疫苗组和对照组之间没有显著差异。关于异常妊娠结局的数据报告不足。预防性HPV疫苗是安全的，耐受性好，在预防年轻女性中与疫苗HPV类型相关的持续感染和宫颈疾病方面非常有效。然而，长期疗效和安全性需要在未来的试验中解决。
We conducted a systematic review and meta-analysis to assess efficacy and safety of prophylactic HPV vaccines against cervical cancer precursor events in women. Randomized-controlled trials of HPV vaccines were identified from MEDLINE, Cochrane Central Register of Controlled Trials, conference abstracts and references of identified studies, and assessed by two independent reviewers. Efficacy data were synthesized using fixed-effect models, and evaluated for heterogeneity using I2 statistic. Seven unique trials enrolling 44,142 females were included. The fixed-effect Relative Risk (RR) and 95% confidence intervals were 0.04 (0.01-0.11) and 0.10 (0.03-0.38) for HPV-16 and HPV 18-related CIN2+ in the per-protocol populations (PPP). The corresponding RR was 0.47 (0.36-0.61) and 0.16 (0.08-0.34) in the intention-to-treat populations (ITT). Efficacy against CIN1+ was similar in scale in favor of vaccine. Overall vaccines were highly efficacious against 6-month persistent infection with HPV 16 and 18, both in the PPP cohort (RR: 0.06 [0.04-0.09] and 0.05 [0.03-0.09], respectively), and the ITT cohorts (RR: 0.15 [0.10-0.23] and 0.24 [0.14-0.42], respectively). There was limited prophylactic effect against CIN2+ and 6-month persistent infections associated with non-vaccine oncogenic HPV types. The risk of serious adverse events (RR: 1.00, 0.91-1.09) or vaccine-related serious adverse events (RR: 1.82; 0.79-4.20) did not differ significantly between vaccine and control groups. Data on abnormal pregnancy outcomes were underreported. Prophylactic HPV vaccines are safe, well tolerated, and highly efficacious in preventing persistent infections and cervical diseases associated with vaccine-HPV types among young females. However, long-term efficacy and safety needs to be addressed in future trials.
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DOI：
10.1111/j.1471-0528.2002.01053.x
发表时间：
2002-01-01
影响因子：
5.8
作者：
Collins, S;Mazloomzadeh, S;Woodman, CBJ
通讯作者：
Woodman, CBJ
影响因子：
7.2
作者：
Mao, C;Koutsky, LA;Barr, E
通讯作者：
Barr, E
影响因子：
5.5
作者：
Rowhani-Rahbar, Ali;Mao, Constance;Koutsky, Laura A.
通讯作者：
Koutsky, Laura A.
影响因子：
14.6
作者：
Rambout, Lisa;Hopkins, Laura;Fergusson, Dean
通讯作者：
Fergusson, Dean
影响因子：
105.7
作者：
Higgins, JPT;Thompson, SG;Altman, DG
通讯作者：
Altman, DG