目的:建立用气相色谱法测定人类乳头瘤病毒(HPV)疫苗中3-O-脱酰基-4′-单磷酰脂质A(MPL)的含量。方法:HPV疫苗中的MPL经过与氢氧化钠-甲醇的皂化反应,以己烷进行萃取,以三氟醋酐进行衍生化,再经HP-5色谱柱(30 m×0.32 mm, 0.25μm)...
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目的:建立用气相色谱法测定人类乳头瘤病毒(HPV)疫苗中3-O-脱酰基-4′-单磷酰脂质A(MPL)的含量。方法:HPV疫苗中的MPL经过与氢氧化钠-甲醇的皂化反应,以己烷进行萃取,以三氟醋酐进行衍生化,再经HP-5色谱柱(30 m×0.32 mm, 0.25μm)分离,火焰离子检测器(FID)检测,用MPL对照品和内标十五烷酸(pentadecanoic acid)进行内标法定量测定HPV疫苗中MPL含量。结果:MPL质量浓度在15~150μg·mL^(-1)范围内线性关系良好(r=0.999),精密度RSD为0.24%,重复性RSD为1.0%,稳定性RSD为0.37%,平均回收率为100.1%~100.5%(RSD小于2.0%)。12个批次的HPV疫苗中MPL含量范围为93.4~103.2μg·mL^(-1),符合质控要求。结论:本法准确可靠,特异性强,可对HPV疫苗中MPL进行检测。
接种人类乳头瘤病毒(human papilloma virus,HPV)疫苗可预防HPV感染和HPV相关癌症。目前大多数国家采用2剂次HPV疫苗接种方案,但越来越多的研究发现接种单剂次HPV疫苗具有潜在的保护效果。鉴于宫颈癌的巨大全球疾病负担及因HPV疫苗供应紧张而造成国家或地区间的供应日益严重不平等现象,世界卫生组织免疫策略咨询专家组(Strategic Advisory Group of Experts on Immunization,SAGE)在2022年4月相关会议上表明,单剂次HPV疫苗与2剂次或3剂次疫苗接种方案的保护作用相当。本文就HPV疫苗接种现状和单剂次HPV疫苗保护作用的相关研究进行综述,并分析未来实施单剂HPV疫苗接种策略的机遇和挑战。
Background: To perform a systemic review and meta-analysis of randomized controlled trials to assess the efficacy of HPV vaccine in preventing cervical cancer. Methods: A systemic search was carried out on electronic ...
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Background: To perform a systemic review and meta-analysis of randomized controlled trials to assess the efficacy of HPV vaccine in preventing cervical cancer. Methods: A systemic search was carried out on electronic databases (Medline and Cochrane library) and randomized clinical trials of prophylactic HPV vaccination were identified. Additional searc h was carried out from Google scholar, reviews and from references of identified studies. The primary outcome of interest was cervical intraepithelial neoplasia grade 2 + and the secondary outcome was persistent cervical lesions, both associated with HPV type 16 and 18. The efficacy analysis was based on the fixed effect model with I2 used for the evaluation of heterogeneity in studies. Results: From 162 studies, 8 studies fulfilled the eligibility criteria （5- RCTs and 3-follow up of the initial studies). The relative risk (RR) of having persistent infection in vaccinated women with HPV 16 and 18 was 0.14(95%CI: 0.09-0.21) and 0.23(95% CI: 0.13-0.39) respectively. The corresponding RR for CIN2+ associated with HPV 16 in vaccinated women was 0.50(95%CI:0.38-0.65) and with HPV 18 was 0.16(95%CI: 0.08-0.34). The meta-analysis covering CIN2+ associated with both HPV 16/18 was also calculated which showed the RR of 0.52(95%CI: 0.42-0.64) for having CIN2+ in vaccinated women. Conclusion: HPV vaccines available are highly effective in reducing the persistent infections and to some extent the cervical neoplasia associated with vaccine type HPV, irrespective of the HPV status at baseline.
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