中华皮肤科杂志 ›› 2025, Vol. 58 ›› Issue (7): 603-607.doi: 10.35541/cjd.20250032

• 论著·毛发疾病 • 上一篇    下一篇

某国产毛囊提取系统提取雄激素性秃发患者毛囊的有效性和安全性：多中心、前瞻性、随机、自身对照临床试验

杨凯1    林尽染1，2    祝飞3    冯苏云4    李政1    张悦1    胡瑞铭1    程含皛3    周圳滔3    吴亚桐4    杨顶权4    张菊芳3    吴文育1，2，5   

  1. 1复旦大学附属华山医院皮肤科  上海市皮肤病研究所，上海  200040；2上海市静安区中心医院皮肤科，上海  200040；3西湖大学医学院附属杭州市第一人民医院医学美容中心，杭州  310022；4中日友好医院皮肤科，北京  100029；5复旦大学工程与应用技术研究院，上海  200433
  • 收稿日期:2025-01-20 修回日期:2025-04-22 发布日期:2025-07-03
  • 通讯作者: 吴文育 E-mail:wenyu_wu@fudan.edu.cn
  • 基金资助:
    上海市卫生健康领军人才项目（2022LJ017）；上海申康医院发展中心项目（SHDC12025139、SHDC22022302）；静安区学科建设项目培育学科（2024PY01）；上海市重中之重研究中心建设项目（2023ZZ02018）；上海毛发医学工程技术研究中心项目（19DZ2250500）

Efficacy and safety of a domestic hair follicle extraction system in extracting hair follicles from patients with androgenetic alopecia: a multicenter, prospective, randomized, self-controlled clinical trial

Yang Kai1, Lin Jinran1,2, Zhu Fei3, Feng Suyun4, Li Zheng1, Zhang Yue1, Hu Ruiming1, Cheng Hanxiao3, Zhou Zhentao3, Wu Yatong4, Yang Dingquan4, Zhang Jufang3, Wu Wenyu1,2,5   

  1. 1Department of Dermatology, Huashan Hospital, Shanghai Institute of Dermatology, Fudan University, Shanghai 200040, China; 2Department of Dermatology, Jing′an District Central Hospital, Shanghai 200040, China; 3Department of Plastic Surgery, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou 310022, China; 4Department of Dermatology, China-Japan Friendship Hospital, Beijing 100029, China; 5Academy for Engineering and Technology, Fudan University, Shanghai 200433, China
  • Received:2025-01-20 Revised:2025-04-22 Published:2025-07-03
  • Contact: Wu Wenyu E-mail:wenyu_wu@fudan.edu.cn
  • Supported by:
    Leading Talent Project of Shanghai Health Commission （2022LJ017）; Clinical Research Plan of Shanghai Hospital Development Center Foundation （SHDC12025139, SHDC22022302）; Jing'an District Discipline Development Education Program （2024PY01）; Key Specialty Research Centre of Shanghai Health Commission （2023ZZ02018）;Shanghai Engineering Research Center of Hair Medicine （19DZ2250500）

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摘要： 【摘要】 目的 比较某国产毛囊提取系统与传统毛囊单位钻取术提取雄激素性秃发患者毛囊的有效性和安全性。方法 采用多中心、随机、自身左右侧对照研究，2023年6月至2024年9月在复旦大学附属华山医院、杭州市第一人民医院、中日友好医院招募18 ~ 59周岁的雄激素性秃发患者作为研究对象，以信封法随机将同一患者头皮左右两侧分组，分别使用毛囊提取系统（试验组）与传统毛囊单位钻取术（对照组）在后枕部优势供区范围内进行毛囊提取，并种植于同侧脱发区。以术中毛囊提取完成即刻计算的毛发横断率作为主要有效性评价指标，同时以毛囊单位丢弃率、术后14 d受区毛发密度变化值作为次要有效性评价指标，以术后14 d供区毛囊炎发生率、不良事件发生率作为安全性评价指标。术后9个月随访评估手术效果。评价指标的组间比较采用配对t检验或Wilcoxon符号秩和检验。结果 共55例雄激素性秃发患者完成毛发移植手术及术后随访，其中男性51例，女性4例，年龄（32.71 ± 5.75）岁。结果显示，试验组毛发横断率M（Q1，Q3）为6.65%（4.56%，10.16%），对照组为5.28%（3.04%，8.89%），两组间差值为1.24%（95% CI：-0.24%，2.65%）。试验组的毛囊单位丢弃率为2.00%（1.00%，3.50%），对照组为0.50%（0，2.00%），两组间差异有统计学意义（P = 0.008）。术后14 d试验组与对照组的毛发密度变化值分别为（72.20 ± 25.95）根/cm2和（76.49 ± 30.84）根/cm2（P = 0.173）。术后9个月随访，试验组与对照组受区研究者总体评分均有改善。试验组和对照组分别有7例受试者（12.72%）发生供区不良事件7例次，均为轻度毛囊炎，严重程度为轻度。结论 国产毛囊提取系统与传统毛囊单位钻取术相比，植发手术的有效性和安全性相似。

关键词: 秃发, 雄激素性秃发, 毛囊, 毛发移植, 机器人植发, 毛囊单位钻取术, 随机对照试验

Abstract: 【Abstract】 Objective To compare the efficacy and safety of a domestic hair follicle extraction system versus traditional follicular unit excision （FUE） in extracting hair follicles for the treatment of androgenetic alopecia （AGA）. Methods A multicenter, randomized, self-controlled clinical trial was conducted on AGA patients aged 18 - 59 years who were recruited from the Huashan Hospital, Fudan University, the Affiliated Hangzhou First People's Hospital, and the China-Japan Friendship Hospital between June 2023 and September 2024. Each patient′s scalp was randomly divided into two sides （experimental side vs. control side） using an envelope method. The experimental side underwent robotic hair transplantation with a domestic hair follicle extraction system, and the control side underwent traditional FUE. Hair follicles were extracted from the safe donor area in the occipital region, and implanted into the ipsilateral hair loss area. The primary outcome was the hair transection rate which was calculated immediately after follicular extraction. The secondary outcomes included the hair follicle unit loss rate and the change in hair density at the recipient site on postoperative day 14. Safety was evaluated by assessing the incidence of folliculitis at the donor site on postoperative day 14 and the overall incidence of adverse events. Surgical outcomes were evaluated at 9 months after surgery. Comparisons of evaluation indicators among groups were performed by using a paired t test or Wilcoxon signed-rank test. Results A total of 55 patients with AGA （51 males and 4 females, aged 32.71 ± 5.75 years） completed the hair follicle transplantation and postoperative follow-up. The hair transection rate （M ［Q1, Q3］） was 6.65%（4.56%，10.16%） in the experimental group and 5.28%（3.04%，8.89%） in the control group （difference = 1.24%, 95% CI：-0.24%，2.65%）. The hair follicle unit loss rate was 2.00%（1.00%，3.50%） in the experimental group and 0.50%（0，2.00%） in the control group, with a significant difference between the two groups （P =0.008）. On postoperative day 14, there was no significant difference in the hair density between the experimental group and control group （72.20 ± 25.95 per cm2 vs. 76.49 ± 30.84 per cm2, P = 0.173）. At 9-month follow-up, both groups showed improvement in the investigator's overall score in the recipient areas. Seven adverse events occurred in 7 subjects （12.72%） in each group, and all were mild folliculitis. Conclusion The domestic hair follicle extraction system demonstrated comparable efficacy and safety to the traditional FUE in hair transplantation.

Key words: Alopecia, Androgenetic alopecia, Hair follicle, Hair transplantation, Robotic hair transplantation, Follicular unit excision, Randomized controlled trial

引用本文

杨凯 林尽染, 祝飞 冯苏云 李政 张悦 胡瑞铭 程含皛 周圳滔 吴亚桐 杨顶权 张菊芳 吴文育, . 某国产毛囊提取系统提取雄激素性秃发患者毛囊的有效性和安全性：多中心、前瞻性、随机、自身对照临床试验[J]. 中华皮肤科杂志, 2025,58(7):603-607. doi:10.35541/cjd.20250032

Yang Kai, Lin Jinran, Zhu Fei, Feng Suyun, Li Zheng, Zhang Yue, Hu Ruiming, Cheng Hanxiao, Zhou Zhentao, Wu Yatong, Yang Dingquan, Zhang Jufang, Wu Wenyu, . Efficacy and safety of a domestic hair follicle extraction system in extracting hair follicles from patients with androgenetic alopecia: a multicenter, prospective, randomized, self-controlled clinical trial[J]. Chinese Journal of Dermatology, 2025, 58(7): 603-607.doi:10.35541/cjd.20250032