组织工程表皮片移植治疗白癜风的随机对照研究

Auto-cultured tissue engineering epidermal sheets transplantation for the treatment of stable vitiligo:A randomized controlled trial

目的比较组织工程表皮片移植和负压吸疱表皮移植治疗白癜风的有效性和安全性。方法纳入2021年2月至2023年1月于华山医院皮肤科门诊招募的18~65岁稳定期白癜风患者130例,随机分配至组织工程表皮片移植组(简称组织工程组)或负压吸疱表皮移植组(简称负压吸疱组),每组各65例。术后1、3、6个月记录复色情况,记录不良反应,统计术后6个月时两组复色有效率差异。结果组织工程植组失访7例,最后纳入统计58例,其中男性32例,女性26例,平均(28.10±7.75)岁;负压吸疱组失访4例,最后纳入统计61例,其中男性27例,女性34例,平均(31.80±11.83)岁。术后6个月统计显示,组织工程组总有效率为91.37%,负压吸疱组为96.72%,差异无统计学意义(P>0.05)。组织工程组显效率(复色面积大于75%)为79.31%,痊愈率(复色面积大于95%)为58.62%;负压吸疱组显效率为93.34%,痊愈率为77.05%,高于组织工程组(P<0.05)。不同类型比较发现,非节段型白癜风组织工程组显效率84%,负压吸疱组90%,两组之间无明显统计学差异(P>0.05)。结论两种手术方法对稳定期白癜风患者均有较高的疗效;组织工程表皮片移植更适合大面积白癜风患者,复色更均匀,两种手术方式互为补充。

Objective To compare the effectiveness and safety of auto-cultured tissue engineering epidermal sheets(ATEE)transplantation and suction blister epidermal graft(SBEG)in the treatment of vitiligo.Methods A total of 130 vitiligo patients in stable stage who aged 18-65 were enrolled in the Department of Dermatology of Huashan Hospital form February 2021 to January 2023 and assigned to the ATEE group or SBEG group.The color recovery,effective rate,and adverse reactions were recorded in 1,3,and 6 months after surgery.Effective rate of color recovery was analyzed between two groups.Results There were 7 cases lost follow-up in ATEE group and a total of 58 patients were analyzed finally.There were 36 males and 29 females in the ATEE group,with an average age of(27.63±7.73)years.There were 30 males and 35 females in the SBEG group,with an average age of(32.43±13.32)years.Six months after the operation,the total effective rate of the ATEE group was 91.37%,while that of the SBEG group was 96.72%,with no significant statistical difference(P>0.05).The effective rate of ATEE group(with a color area greater than 75%)was 79.31%,and the recovery rate(with a color area greater than 95%)was 58.62%.The effective rate of the SBEG group was 93.34%,and the recovery rate was 77.05%,which was higher than that of the ATEE group(P<0.05).For different types subanalysis,it was found that the non-segmental vitiligo of ATEE group had a significant improvement rate of 84%,while the SBEG group had a 90%improvement rate without significant difference(P>0.05).Conclusions Both surgical methods have high therapeutic effects for vitiligo patients in stable stage.ATEE transplantation is more suitable for patients with large-area vitiligo,with a more uniform color reproduction,and the two surgical methods show the complement with each other.