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卡介菌多糖核酸与卡介苗治疗疣的对比、双盲、对照研究。

Bacillus Calmette-Guerin polysaccharide nucleic acid vs Bacillus Calmette-Guerin vaccine in the treatment of warts: A comparative, double-blind, controlled study.

机构信息

Faculty of Medicine, Department of Dermatology, Venereology, and Andrology, Zagazig University, Zagazig, Egypt.

出版信息

Dermatol Ther. 2021 Jan;34(1):e14549. doi: 10.1111/dth.14549. Epub 2020 Nov 27.

Abstract

Bacillus Calmette-Guerin polysaccharide nucleic acid (BCG-PSN) is a relatively new generation, bacteria lipopolysaccharide fraction extracted from BCG vaccine. It has a strong immunomodulatory effect with higher efficacy and fewer side effects. To assess the clinical efficacy and safety of BCG-PSN vs the viable BCG vaccine in treatment of multiple warts. One hundred twenty patients with warts were allocated into three groups each containing 40 patients. Each group received intralesionally 0.1 mL of BCG-PSN, BCG vaccine, saline in group A, B, and C, respectively, for a maximum of five sessions, 3 weeks apart. Complete response occurred in 77.5% of group A vs 63.8% in group B. Partial response detected in 7.9% of control group (P < .0001). The distant warts showed 72.5% complete clearance in group A compared to 58.3% in group B (P = .19). Group A showed fewer number of sessions (P = .03) and earlier response than group B (P = .0003). A significant increase in the frequency of adverse effects was found among group B than group A (P < .0001). No recurrence was seen in both groups. BCG-PSN immunotherapy has a higher therapeutic efficacy with almost no serious side effects compared to the BCG vaccine in warts therapy.

摘要

卡介菌多糖核酸(BCG-PSN)是一种相对较新的一代,从卡介苗疫苗中提取的细菌脂多糖部分。它具有很强的免疫调节作用,疗效更高,副作用更少。评估 BCG-PSN 与活卡介苗疫苗治疗多发性疣的临床疗效和安全性。将 120 例疣患者随机分为三组,每组 40 例。每组患者分别接受病灶内注射 0.1ml 的 BCG-PSN、卡介苗疫苗和生理盐水,间隔 3 周,最多 5 次。A 组完全缓解率为 77.5%,B 组为 63.8%。对照组部分缓解率为 7.9%(P<0.0001)。A 组远处疣完全清除率为 72.5%,B 组为 58.3%(P=0.19)。A 组的治疗次数(P=0.03)和反应时间(P=0.0003)均早于 B 组。B 组不良反应发生率明显高于 A 组(P<0.0001)。两组均无复发。与卡介苗疫苗相比,BCG-PSN 免疫疗法治疗疣的疗效更高,几乎没有严重的副作用。

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