Department of Medicine, Tuen Mun and Pok Oi Hospital, New Territories, Hong Kong, SAR China.
Ann Rheum Dis. 2013 May;72(5):659-64. doi: 10.1136/annrheumdis-2012-201393. Epub 2012 May 15.
To evaluate the immunogenicity and safety of GARDASIL, a quadrivalent human papillomavirus (HPV) vaccine, in patients with systemic lupus erythematosus (SLE).
Women with SLE aged 18-35 years who had stable disease were recruited to receive GARDASIL vaccination and an equal number of age-matched healthy women were also vaccinated. Seroconversion rates of antibodies to HPV serotypes 6, 11, 16 and 18 at months 7 and 12 and adverse events (AEs) were compared between patients and controls. The rate of disease flares in SLE participants was compared with matched SLE controls.
50 patients with SLE and 50 healthy controls were studied. The mean age and disease duration of the patients was 25.8±3.9 years and 6.6±4.5 years, respectively. At month 12 the seroconversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. In patients with SLE there were no significant changes in the titres of anti-dsDNA, complements, anti-C1q and SLE Disease Activity Index scores from baseline to months 2, 7 and 12. There was one mild/moderate SLE flare at months 0-2, two mild/moderate flares at months 3-6 and six mild/moderate and two severe flares at months 7-12. Disease flares in patients with SLE occurred at a similar frequency to that of 50 matched SLE controls (0.22/patient/year vs 0.20/patient/year, p=0.81). Injection site reaction was the commonest AE (5%), and the incidence of AEs was comparable between patients with SLE and controls.
The quadrivalent HPV vaccine is well tolerated and reasonably effective in patients with stable SLE and does not induce an increase in lupus activity or flares.
评估 Gardasil （一种四价人乳头瘤病毒[HPV]疫苗）在系统性红斑狼疮（SLE）患者中的免疫原性和安全性。
招募年龄在 18-35 岁之间、疾病稳定的女性 SLE 患者接受 Gardasil 疫苗接种，同时招募相同数量的年龄匹配的健康女性作为对照组。比较患者和对照组在接种后第 7 个月和第 12 个月时 HPV 血清型 6、11、16 和 18 抗体的血清转化率以及不良反应（AE）。比较 SLE 患者组的疾病发作率与匹配的 SLE 对照组。
共纳入 50 例 SLE 患者和 50 例健康对照者。患者的平均年龄和疾病病程分别为 25.8±3.9 岁和 6.6±4.5 年。在第 12 个月时，患者和对照组中 HPV 血清型 6、11、16 和 18 的抗体血清转化率分别为 82%、89%、95%、76%和 98%、98%、98%、80%。SLE 患者的抗 dsDNA、补体、抗 C1q 和 SLE 疾病活动指数评分自基线至第 2、7 和 12 个月时无显著变化。在第 0-2 个月时有 1 例轻度/中度 SLE 发作，第 3-6 个月时有 2 例轻度/中度发作，第 7-12 个月时有 6 例轻度/中度和 2 例重度发作。SLE 患者的疾病发作频率与 50 例匹配的 SLE 对照组相似（0.22/患者/年与 0.20/患者/年，p=0.81）。注射部位反应是最常见的 AE（5%），SLE 患者与对照组的 AE 发生率相当。
四价 HPV 疫苗在病情稳定的 SLE 患者中耐受性良好，且具有一定的有效性，不会引起狼疮活动或发作增加。
