一项比较局部用硝酸锌复合溶液与冷冻疗法治疗肛门生殖器疣的多中心随机临床试验。
A Multicentre, Randomised Clinical Trial to Compare a Topical Nitrizinc Complex Solution Versus Cryotherapy for the Treatment of Anogenital Warts.
作者信息
Pontini Paolo, Mastorino Luca, Gaspari Valeria, Granger Corinne, Ramoni Stefano, Delmonte Sergio, Evangelista Valeria, Cusini Marco
机构信息
Unit of Dermatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via Pace 9, 20122, Milan, Italy.
Dermatology Clinic, Department of Medical Sciences, Azienda Ospedaliera Universitaria Città della Salute e della Scienza-University of Turin, Turin, Italy.
出版信息
Dermatol Ther (Heidelb). 2020 Oct;10(5):1063-1073. doi: 10.1007/s13555-020-00430-7. Epub 2020 Jul 30.
INTRODUCTION
Anogenital warts (AGW) are a relevant clinical issue in the field of sexually transmitted disease, and to date no treatment provides a satisfactory clearance rate. Treatment can be both medical and surgical, and be provided by a healthcare provider or by the patient. Cryotherapy (CRYO) is among the most common treatments for AGW. Nitrizinc® Complex solution (NZCS) is a solution containing organic acids, nitric acid and zinc and copper salts that is applied topically to warts, producing mummification of the damaged tissue. It is considered to be an effective and well-tolerated treatment for genital and common warts. The aim of our study was to compare NZCS to CRYO in the treatment of AGW.
METHODS
We performed a prospective, multicentre, single-blind, randomised, superiority clinical study involving 120 patients, aged 18-55 years, diagnosed with a first episode of AGW, with each patient having from three to ten AGW. The patients were treated either with NZCS or CRYO for a maximum of four treatments. Primary endpoints were: (1) comparison of the clinical efficacy of CRYO and NZCS, based on response to treatment (clearance of AGW) within four treatment sessions; and (2) tolerability, assessed via a short questionnaire at the end of each treatment session. Secondary endpoints were: (1) number of treatments needed for clearance; and (2) recurrence at 1 and 3e months after confirmed clearance. The results were analysed on an intention-to-treat basis.
RESULTS
A complete response was achieved in 89.7% of the NZCS group and in 75.4% of the CRYO group (p = 0.0443). NZCS was found to be better tolerated. There was no difference between the NZCS and CRYO treatment arms in the number of sessions needed to clear the lesions. Recurrence occurred after 1 month in 18.4% of the NZCS group and 38.1% of the CRYO group (p = 0.0356), and after 3 months in 25 and 40.6% of these groups, respectively (p = 0.1479).
CONCLUSIONS
Nitrizinc® Complex solution can be considered to be as effective as CRYO for the treatment of small (< 5 mm) external AGW, with a better tolerability profile and lower rate of recurrence.
TRIAL REGISTRATION
ISRCTN identifier, ISRCTN36102369.
引言
肛门生殖器疣（AGW）是性传播疾病领域的一个重要临床问题，迄今为止，尚无治疗方法能提供令人满意的清除率。治疗方法包括药物治疗和手术治疗，可由医疗保健提供者或患者自行进行。冷冻疗法（CRYO）是治疗AGW最常用的方法之一。Nitrizinc®复合溶液（NZCS）是一种含有有机酸、硝酸以及锌盐和铜盐的溶液，局部应用于疣体，可使受损组织形成干尸化。它被认为是治疗生殖器疣和寻常疣的一种有效且耐受性良好的方法。我们研究的目的是比较NZCS与CRYO治疗AGW的效果。
方法
我们进行了一项前瞻性、多中心、单盲、随机、优效性临床研究，纳入120例年龄在18至55岁之间、被诊断为首次发作AGW且每人有3至10个AGW的患者。患者分别接受NZCS或CRYO治疗，最多治疗4次。主要终点为：（1）基于四个治疗疗程内的治疗反应（AGW清除情况）比较CRYO和NZCS的临床疗效；（2）通过每次治疗疗程结束时的简短问卷评估耐受性。次要终点为：（1）清除所需的治疗次数；（2）确认清除后1个月和3个月时的复发情况。结果采用意向性分析。
结果
NZCS组的完全缓解率为89.7%，CRYO组为75.4%（p = 0.0443）。发现NZCS的耐受性更好。NZCS和CRYO治疗组在清除病变所需的疗程数上没有差异。NZCS组18.4%的患者在1个月后复发，CRYO组为38.1%（p = 0.0356）；在3个月后，这两组的复发率分别为25%和40.6%（p = 0.1479）。
结论
对于治疗小的（<5mm）外部AGW，Nitrizinc®复合溶液可被认为与CRYO一样有效，且耐受性更好，复发率更低。
试验注册
ISRCTN标识符，ISRCTN36102369。
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