中华皮肤科杂志 ›› 2025, Vol. 58 ›› Issue (5): 440-445.doi: 10.35541/cjd.20240188

• 论著 • 上一篇    下一篇

无针注射干扰素α2a治疗掌跖疣的疗效与安全性:一项前瞻性、随机、对照、开放标签试验

杜雅馨    笪美红    胡雅坤    吴雯婕    陶咪    严翘    董正邦    王飞   

  1. 东南大学附属中大医院皮肤科,南京  210009
  • 收稿日期:2024-04-10 修回日期:2024-08-14 发布日期:2025-04-30
  • 通讯作者: 王飞 E-mail:ffwangfei@163.com
  • 基金资助:
    江苏省研究生科研与实践创新计划项目(SJCX22_0069)

Efficacy and safety of needle-free injection of interferon-α2a for the treatment of palmoplantar warts: a prospective, randomized, controlled, open-label trial

Du Yaxin, Da Meihong, Hu Yakun, Wu Wenjie, Tao Mi, Yan Qiao, Dong Zhengbang, Wang Fei   

  1. Department of Dermatology, Zhongda Hospital, Southeast University, Nanjing 210009, China
  • Received:2024-04-10 Revised:2024-08-14 Published:2025-04-30
  • Contact: Wang Fei E-mail:ffwangfei@163.com
  • Supported by:
    Postgraduate Research & Practice Innovation Program of Jiangsu Province(SJCX22_0069)

摘要: 【摘要】 目的 观察无针及有针注射重组人干扰素α2a治疗掌跖疣的临床疗效及安全性。方法 前瞻性纳入2023年3 - 9月东南大学附属中大医院皮肤科6 ~ 75岁掌跖疣患者,收集患者的基线资料,按照随机数字表法分为无针注射组和有针注射组,两组均接受注射用重组人干扰素α2a局部注射治疗,无针注射组采用无针注射法注射,有针注射组采用有针注射法注射,每2 ~ 3周治疗1次,最多治疗4次。以皮肤镜下疣体大小、皮纹形态变化来评估疗效;记录疼痛程度、不良反应发生情况,治疗结束后随访6个月。采用卡方检验比较两组的治愈率、复发率以及不良反应发生率。采用 logistic回归分析来检验与掌跖疣清除相关的因素。结果 掌跖疣患者160例,每组80例。无针注射组80例中女45例(56.2%),男35例(43.8%);年龄[M(Q1,Q3)]27(23,40)岁,病程[M(Q1,Q3)]12(3,24)个月;疣位于手部12例(15.0%),足部60例(75.0%),两部位均有8例(10.0%);疣直径 ≤ 1 cm 71例(88.8%), > 1 cm 9例(11.3%)。有针注射组80例中,女37例(46.2%),男43例(53.8%);年龄28(22,39)岁,病程6(2,12)个月;疣位于手部23例(28.7%),足部55例(68.8%),两部位均有2例(2.5%);疣直径 ≤ 1 cm 67例(83.8%), > 1cm 13例(16.3%)。两组患者的性别构成、年龄、疣体直径、既往治疗、疣数量差异均无统计学意义(均P > 0.05)。无针注射组病程长于有针注射组(P = 0.041),使用干扰素剂量小于有针注射组(P < 0.001)。无针注射组治愈44例(55.0%),有针注射组治愈39例(48.8%),两组治愈率比较,差异无统计学意义(χ2 = 0.63,P = 0.429)。多发疣患者中(无针注射组42例,有针注射组38例),无针注射组治愈23例(54.8%),有针注射组治愈18例(47.4%),两组治愈率差异无统计学意义(χ2 = 1.28,P = 0.509)。最常见不良反应是发热或流感样症状(186例次),141例次自行缓解,45例次口服布洛芬后缓解;186例次中,无针注射组流感样症状发生率(57例次,21.6%)显著低于有针注射组(129例次,53.3%),χ2 = 54.63,P < 0.001。无针注射组疼痛评分为(3.65 ± 1.25)分,有针注射组为(5.16 ± 1.17)分(t = -7.90,P < 0.001)。无针注射组和有针注射组疣的病程、位置、患者的年龄和既往治疗情况均对疗效无影响(均P > 0.05)。结论 无针及有针注射干扰素治疗掌跖疣的疗效相似,但无针注射疼痛更轻,干扰素相关的不良反应发生率更低。无针注射组和有针注射组疣的病程、位置、患者年龄和既往治疗情况对疗效均无影响。

关键词: 疣, 干扰素α2, 皮肤镜检查, 无针注射, 掌跖疣

Abstract: 【Abstract】 Objective To investigate the clinical efficacy and safety of needle-free and needle-based injections of recombinant human interferon (IFN)-α2a in the treatment of palmoplantar warts. Methods Patients aged 6 to 75 years with palmoplantar warts were prospectively enrolled from the Department of Dermatology, Zhongda Hospital, Southeast University between March and September 2023, and baseline data were collected. The patients were randomly and equally divided into a needle-free injection group and a needle-based injection group by using a random number table method, and received needle-free and needle-based injections of recombinant human IFN-α2a once every 2 to 3 weeks, respectively, with a maximum of 4 treatment sessions. Efficacy was assessed based on changes in wart size and skin lines under a dermoscope. Pain degrees and adverse reactions were recorded, and patients were followed up for 6 months after the end of treatment. Chi-square test was used to compare the cure rates, recurrence rates, and incidence rates of adverse reactions between the two groups. Logistic regression analysis was employed to identify factors related to the clearance of palmoplantar warts. Results A total of 160 patients with palmoplantar warts were included, with 80 patients in each group. In the needle-free injection group, there were 45 females (56.2%) and 35 males (43.8%); their ages (M[Q1, Q3]) were 27 (23, 40) years, and the duration of disease (M[Q1, Q3]) was 12 (3, 24) months; warts were located on the hands in 12 cases (15.0%), on the feet in 60 cases (75.0%), and on both sites in 8 cases (10.0%); warts measuring ≤ 1 cm in diameter were observed in 71 cases (88.8%), and those measuring > 1 cm were observed in 9 cases (11.3%). In the needle-based injection group, there were 37 females (46.2%) and 43 males (53.8%); their ages were 28 (22, 39) years, and the duration of disease was 6 (2, 12) months; warts were located on the hands in 23 cases (28.7%), on the feet in 55 cases (68.8%), and on both sites in 2 cases (2.5%); warts measuring ≤ 1 cm in diameter were observed in 67 cases (83.8%), and those measuring > 1 cm in diameter were observed in 13 cases (16.3%). There were no significant differences in gender distribution, age, wart diameters, prior treatment status, or number of warts between the two groups (all P > 0.05). The duration of disease was longer in the needle-free injection group than in the needle-based injection group (P = 0.041), and the dose of interferon was lower in the needle-free injection group than in the needle-based injection group (P < 0.001). After treatment, 44 patients (55.0%) were cured in the needle-free injection group, and 39 (48.8%) in the needle-based injection group, with no significant difference in the cure rates between the two groups (χ2 = 0.63, P = 0.429). Among patients with multiple warts, 54.8% (23/42) were cured in the needle-free injection group, and 47.4%(18/38) in the needle-based injection group, with no significant difference in cure rates between the two groups (χ2 = 1.28, P = 0.509). The most common adverse reaction was fever or flu-like symptoms (186 instances), which resolved spontaneously in 141 instances and resolved after treatment with oral ibuprofen in 45 instances; the incidence rate of flu-like symptoms was significantly lower in the needle-free injection group (57 instances, 21.6%) than in the needle-based injection group (129 instances, 53.3%; χ2 = 54.63, P < 0.001). The pain score was significantly lower in the needle-free injection group (3.65 ± 1.25 points) than in the needle-based injection group (5.16 ± 1.17 points, t = -7.90, P < 0.001). The logistic regression analysis showed that the duration of disease, lesion sites, patient age, and previous treatment history had no impact on the efficacy in either the needle-free injection group or the needle-based injection group (all P > 0.05). Conclusions The efficacy of needle-free and needle-based injections of interferon was similar in the treatment of palmoplantar warts, whereas needle-free injections resulted in less pain and a lower incidence of interferon-related adverse reactions. None of the duration of disease, lesion sites, patient age, or prior treatment status showed significant impact on the efficacy in the two groups.

Key words: Warts, Interferon alpha-2, Dermoscopy, Needle-free injection, Palmoplantar warts

引用本文

杜雅馨 笪美红 胡雅坤 吴雯婕 陶咪 严翘 董正邦 王飞. 无针注射干扰素α2a治疗掌跖疣的疗效与安全性:一项前瞻性、随机、对照、开放标签试验[J]. 中华皮肤科杂志, 2025,58(5):440-445. doi:10.35541/cjd.20240188

Du Yaxin, Da Meihong, Hu Yakun, Wu Wenjie, Tao Mi, Yan Qiao, Dong Zhengbang, Wang Fei. Efficacy and safety of needle-free injection of interferon-α2a for the treatment of palmoplantar warts: a prospective, randomized, controlled, open-label trial[J]. Chinese Journal of Dermatology, 2025, 58(5): 440-445.doi:10.35541/cjd.20240188