Kin Cho Goon Peter, Scholtz Lars-Uwe, Sudhoff Holger
Department of Dermatology (P.K.C.G.) Norfolk and Norwich University Hospital Colney Lane Norwich UK.
Department of Ear, Nose and Throat Surgery (L.-U.S., H.S.) Bielefeld Germany.
Laryngoscope Investig Otolaryngol. 2017 May 28;2(4):184-186. doi: 10.1002/lio2.80. eCollection 2017 Aug.
Recurrent respiratory papillomatosis (RRP) is a rare disease, but one with severe morbidity and occasional mortality. The aetiological agent is human papillomavirus (HPV), and HPV types 6 and 11 account for over 90% of all cases. In the active phase of the disease, patients require multiple hospital admissions for surgical removal or ablation of these benign tumors, which are likely to obstruct the airways if left unchecked. Long-term sequelae include scarring of the vocal cords, change in voice timbre, or even muteness if a tracheostomy is required. The aim of this study was to determine if adjuvant vaccination with the quadrivalent HPV L1 vaccine (Gardasil™) would decrease numbers of surgical treatments post-vaccination.
A prospective pilot study following a cohort of 12 RRP patients, all of whom gave fully informed consent to participate. All patients had their papillomas typed and if they were found to have types 6 or 11, were vaccinated at the time of first surgical treatment in the hospital, according to the manufacturer's protocols. Patients were followed up closely with 3 or 6 month follow-up visits. Standard surgical treatments were given and were not affected by whether they participated in the study.
We found a >7-fold decrease in the incidence rates of papillomatosis requiring surgical intervention from the pre-vaccination period (47.44/1000 patient-months) compared to the post-vaccination period (6.71/1000 patient-months).
Surgical treatments for RRP are robust markers for papillomata which require treatment because of the dangers of obstruction of the airway. Despite the small size of this cohort (due to the rarity of this disease), the data suggests that adjuvant use of quadrivalent HPV L1 vaccine imparts significant benefit to this group of patients. A large multi-center randomized placebo controlled trial is required to definitively establish whether this hypothesis is true and can become the new standard of therapy.
3b.
复发性呼吸道乳头状瘤病（RRP）是一种罕见疾病，但发病率高，偶有致死情况。其病原体为人乳头瘤病毒（HPV），其中6型和11型HPV占所有病例的90%以上。在疾病活动期，患者需要多次住院手术切除或消融这些良性肿瘤，否则可能阻塞气道。长期后遗症包括声带瘢痕形成、音色改变，若需气管切开则甚至会导致失声。本研究的目的是确定四价HPV L1疫苗（佳达修™）辅助疫苗接种是否会减少接种疫苗后的手术治疗次数。
一项前瞻性试点研究，纳入12例RRP患者队列，所有患者均完全知情同意参与。所有患者的乳头状瘤均进行分型，若发现为6型或11型，则在医院首次手术治疗时按照制造商方案进行疫苗接种。患者每3或6个月进行密切随访。给予标准手术治疗，且不受其是否参与研究的影响。
我们发现，与接种疫苗后时期（6.71/1000患者 - 月）相比，接种疫苗前时期（47.44/1000患者 - 月）需要手术干预的乳头状瘤病发病率下降了7倍以上。
由于气道阻塞的危险，RRP的手术治疗是乳头状瘤需要治疗的有力标志。尽管该队列规模较小（由于该疾病罕见），但数据表明，四价HPV L1疫苗的辅助使用对这组患者有显著益处。需要进行一项大型多中心随机安慰剂对照试验，以明确该假设是否成立，并能否成为新的治疗标准。
3b。
