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病灶内注射结核菌素纯蛋白衍生物与病灶内注射W型分枝杆菌疫苗治疗顽固性外生殖器疣的随机、单盲、对照研究。

Intralesional Purified Protein Derivative of Tuberculin Versus Intralesional Mycobacterium W Vaccine in Treatment of Recalcitrant Extragenital Warts: A Randomized, Single-Blinded, Comparative Study.

作者信息

Mohta Alpana, Jain Suresh Kumar, Mehta Rajesh Dutt, Arora Aakanksha

机构信息

Department of Dermatology, Venereology and Leprosy, Sardar Patel Medical College, Bikaner, Rajasthan, India.

Department of Dermatology, Venereology and Leprosy, Government Medical College, Kota, Rajasthan, India.

出版信息

Indian J Dermatol. 2022 Jan-Feb;67(1):26-30. doi: 10.4103/ijd.ijd_521_21.

Abstract

INTRODUCTION

Of late, immunotherapy has emerged as a promising therapeutic modality for the treatment of recalcitrant and difficult to treat warts. Purified protein derivative of tuberculin (PDD) and mycobacterium w (Mw) vaccine hold promising prospects for the treatment of verruca, especially in a country like ours where a majority of the population is already sensitized to mycobacterium tuberculosis both due to disease endemicity and Bacillus Calmette-Guérin (BCG) vaccination.

AIMS AND OBJECTIVES

We aimed at evaluating the treatment outcome of intralesional PPD tuberculin and Mw vaccine in the treatment of recalcitrant extragenital warts in immunocompetent subjects.

MATERIALS AND METHODS

The patients included immunocompetent subjects between the ages of 16 and 65 years with two or more extragenital warts. The patients were randomized into two groups, namely A (PPD Tuberculin) and B (Mw vaccine). In both groups, 0.1 mL of active intralesional immunogen was injected at the base of the largest wart. The doses were repeated at 4 weeks' intervals for a maximum of 5 injections. Additionally, the improvement in quality of life was measured using the Hindi-validated version of the Dermatology Quality of Life Index (DLQI) questionnaire.

RESULTS

Ninety-seven patients completed the study, with 46 in group A and 51 in group B. In group A, 24 (52.17%) patients had complete clearance in all warts, and in group B, 32 (62.75%) ( = 0.38). The most common adverse event in patients of group A was transient injection site erythema and swelling, whereas that in group B was mild transient fever. None of the patients showed any signs of recurrence in the ensuing follow-up period. There was a statistically significant improvement in the mean DLQI scores after treatment in both groups ( < 0.0001).

CONCLUSION

Both PPD Tuberculin and Mw vaccine are effective in the treatment of recalcitrant warts with minimal recurrence rate. The safety profile of PPD is superior to Mw vaccine. We suggest both to be used as first-line therapy in the treatment of difficult to treat warts.

摘要

引言

近年来,免疫疗法已成为治疗顽固性和难治性疣的一种有前景的治疗方式。结核菌素纯蛋白衍生物(PDD)和w型分枝杆菌(Mw)疫苗在疣的治疗方面具有广阔前景,尤其是在像我们这样的国家,由于疾病流行和卡介苗(BCG)接种,大多数人口已对结核分枝杆菌致敏。

目的

我们旨在评估病灶内注射PPD结核菌素和Mw疫苗治疗免疫功能正常受试者顽固性外生殖器疣的治疗效果。

材料与方法

患者为年龄在16至65岁之间、患有两个或更多外生殖器疣的免疫功能正常受试者。患者被随机分为两组,即A组(PPD结核菌素)和B组(Mw疫苗)。在两组中,均在最大疣体的基底部注射0.1 mL活性病灶内免疫原。每隔4周重复给药,最多注射5次。此外,使用印地语验证版的皮肤病生活质量指数(DLQI)问卷来衡量生活质量的改善情况。

结果

97名患者完成了研究,A组46名,B组51名。A组中,24名(52.17%)患者的所有疣体完全清除,B组中为32名(62.75%)(P = 0.38)。A组患者最常见的不良事件是注射部位短暂性红斑和肿胀,而B组是轻度短暂性发热。在随后的随访期内,没有患者出现任何复发迹象。两组治疗后平均DLQI评分均有统计学显著改善(P < 0.0001)。

结论

PPD结核菌素和Mw疫苗在治疗顽固性疣方面均有效,复发率极低。PPD的安全性优于Mw疫苗。我们建议将两者均用作难治性疣治疗的一线疗法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40e5/9154150/6a09a90dadc9/IJD-67-26-g001.jpg

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