Garland Suzanne M, Steben Marc, Sings Heather L, James Margaret, Lu Shuang, Railkar Radha, Barr Eliav, Haupt Richard M, Joura Elmar A
Microbiology and Infectious Diseases Department, Royal Women's Hospital, 132 Grattan Street, Carlton, Victoria 3053, Australia.
J Infect Dis. 2009 Mar 15;199(6):805-14. doi: 10.1086/597071.
The placebo arm of human papillomavirus (HPV) vaccine trials helps define the natural history of genital warts (GW).
Women enrolled in the placebo arm (n = 8800) of 2 randomized trials of a quadrivalent vaccine were examined for the presence of GW for up to 9 visits over approximately 4 years. A comprehensive examination of the perianal area, vulva, and vagina prompted biopsy. Biopsy samples were analyzed by a blinded panel of up to 4 histopathologists and tested for 14 HPV genotypes (6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) by use of a polymerase chain reaction-based assay. Risk factors for the development of GW were assessed.
Women were followed up for an average of 3.6 years (range, 0-4.9 years). Overall, 298 (3.4%) of 8800 participants developed GW related to HPV-6 or HPV-11 (incidence rate, 0.87 cases per 100 person-years-at-risk). In total, 520 distinct lesions were diagnosed as GW. HPV DNA was detected in 472 (90.8%) lesions, with HPV-6 and HPV-11 detected in 447 (86.0%) of these lesions (94.7% of 472 HPV DNA-positive lesions). We found high-risk HPV types in 161 (31.0%) of 520 lesions. Risk factors for HPV-6- and HPV-11-related GW included infection at baseline, acquisition of new sex partners, a higher number of sex partners, and DNA positivity at baseline for a high-risk HPV type.
We confirm the major role played by HPV-6 and HPV-11 in GW, as well as associated risk factors. A vaccine that includes these types of HPV could substantially reduce the overall burden of HPV disease.
人乳头瘤病毒（HPV）疫苗试验中的安慰剂组有助于明确尖锐湿疣（GW）的自然病史。
在一项四价疫苗的两项随机试验的安慰剂组（n = 8800）中，对女性进行了长达约4年的检查，最多检查9次以确定是否存在GW。对肛周区域、外阴和阴道进行全面检查并进行活检。活检样本由多达4名组织病理学家组成的盲法小组进行分析，并使用基于聚合酶链反应的检测方法检测14种HPV基因型（6、11、16、18、31、33、35、39、45、51、52、56、58和59）。评估了GW发生的危险因素。
女性平均随访3.6年（范围0 - 4.9年）。总体而言，8800名参与者中有298名（3.4%）发生了与HPV - 6或HPV - 11相关的GW（发病率为每100人年危险人群中0.87例）。总共诊断出520个不同的病变为GW。472个（90.8%）病变中检测到HPV DNA，其中447个（86.0%）病变检测到HPV - 6和HPV - 11（占472个HPV DNA阳性病变的94.7%）。在520个病变中的161个（31.0%）中发现了高危HPV类型。与HPV - 6和HPV - 11相关的GW的危险因素包括基线感染、获得新的性伴侣、性伴侣数量较多以及基线时高危HPV类型的DNA阳性。
我们证实了HPV - 6和HPV - 11在GW中的主要作用以及相关危险因素。包含这些HPV类型的疫苗可大幅降低HPV疾病的总体负担。
