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冷冻疗法联合小剂量口服异维A酸与单纯冷冻疗法治疗肛门生殖器疣的随机临床试验

Cryotherapy plus low-dose oral isotretinoin vs cryotherapy only for the treatment of anogenital warts: a randomized clinical trial.

作者信息

Reyna-Rodríguez Irving Llibran, Chavez-Alvarez Sonia, Garza-Rodríguez Veronica, Franco-Marquez Rodolfo, Gonzalez-Martinez Gerardo, Ocampo-Candiani Jorge, Villarreal-Martinez Alejandra

机构信息

Dermatology Department, Facultad de Medicina Y Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo León, Avenida Francisco I. Madero Y Avenida Gonzalitos S/N Colonia Mitras Centro, 64460, Monterrey, Nuevo Leon, Mexico.

Pathology Department, Facultad de Medicina Y Hospital Universitario "Dr. José Eleuterio Gonzalez", Universidad Autónoma de Nuevo León, Monterrey, Mexico.

出版信息

Arch Dermatol Res. 2021 Dec;313(10):815-827. doi: 10.1007/s00403-020-02182-y. Epub 2021 Jan 12.

DOI:10.1007/s00403-020-02182-y
PMID:33433720
Abstract

BACKGROUND

Anogenital warts are a common human papillomavirus infection. They cause emotional distress, especially when they are in the anogenital region. Cryotherapy is a first-line treatment. Previous clinical trials and case series have reported variable results with retinoids (isotretinoin) as adjuvant therapy.

OBJECTIVE

To determine the safety and efficacy of low-dose oral isotretinoin as adjuvant treatment of anogenital warts.

METHODS

Forty-six patients with anogenital warts were randomly assigned to isotretinoin + cryotherapy (n = 23) or only cryotherapy (n = 23). Patients were allocated via an interactive web-based randomization system. Evaluators were blinded to treatments. Isotretinoin 20 mg/daily + cryotherapy or cryotherapy were prescribed for 6 weeks. Patients were followed for 4 months. Genotyping of lesions was performed before treatment started. Dermatology Life Quality Index (DLQI) and Columbia-Suicide Severity Rating Scale (C-SSRS) were measured at the beginning and end of therapy. All patients completed the study.

RESULTS

Both Groups had 50% clearance at the end of treatment. Recurrence in the combined group was not significantly lower than in the cryotherapy group (P = 0.59). Improvement was observed in the DLQI of all patients in both groups (P = 0.001). No suicidal intention was detected with the C-SSRS. Two patients (one in each group) had liver function test abnormalities after treatment.

CONCLUSION

Combined therapy showed a slight not significant efficacy for anogenital warts in Hispanic patients. Low-dose isotretinoin seems to be safe even when it is used with cryotherapy on anogenital warts.

TRIAL REGISTRATION

On April 25, 2019 with registration number DE19-00004, CONBIOÉTICA-19-CEI-001-20160404. Prospectively registered.

摘要

背景

肛门生殖器疣是一种常见的人乳头瘤病毒感染。它们会引起情绪困扰,尤其是当它们出现在肛门生殖器区域时。冷冻疗法是一线治疗方法。先前的临床试验和病例系列报道了维甲酸(异维甲酸)作为辅助治疗的效果不一。

目的

确定低剂量口服异维甲酸作为肛门生殖器疣辅助治疗的安全性和有效性。

方法

46例肛门生殖器疣患者被随机分为异维甲酸+冷冻疗法组(n = 23)或仅冷冻疗法组(n = 23)。患者通过基于网络的交互式随机系统进行分配。评估人员对治疗情况不知情。给予异维甲酸20毫克/天+冷冻疗法或仅冷冻疗法,为期6周。对患者进行4个月的随访。在治疗开始前对病变进行基因分型。在治疗开始和结束时测量皮肤病生活质量指数(DLQI)和哥伦比亚自杀严重程度评定量表(C-SSRS)。所有患者均完成了研究。

结果

两组在治疗结束时清除率均为50%。联合治疗组的复发率并不显著低于冷冻疗法组(P = 0.59)。两组所有患者的DLQI均有改善(P = 0.001)。C-SSRS未检测到自杀意图。两名患者(每组各一名)治疗后出现肝功能检查异常。

结论

联合治疗对西班牙裔患者的肛门生殖器疣显示出轻微但不显著的疗效。低剂量异维甲酸即使与肛门生殖器疣的冷冻疗法联合使用似乎也是安全的。

试验注册

2019年4月25日,注册号DE19 - 00004,CONBIOÉTICA - 19 - CEI - 001 - 20160404。前瞻性注册。

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