一项随机临床试验评估单次和多次局内胶原酶注射治疗收缩疤痕的疗效

Shuangbai Zhou , Poh-Ching Tan , Cheng-An Chiang, Yun Xie, Peiqi Zhang, Qingfeng Li, Kai Liu
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引用次数: 0

摘要

背景:创伤或烧伤引起的疤痕收缩可引起继发性身体功能障碍和毁容。许多微创疤痕收缩方法的适用性和有效性有限。本研究探讨局灶内注射胶原酶治疗瘢痕收缩的可行性及疗效。方法于2017年7月至2018年2月在上海第九人民医院招募了1年关节活动受限、肢体毁容的瘢痕患者进行单盲、随机临床试验。多次治疗组在紧缩疤痕处注射胶原酶(15 U/cm2),每隔4周注射3次,单次治疗组注射1次,对照组注射安慰剂。在4周和12周的随访中记录疤痕长度和皮肤质地。并对胶原酶治疗的安全性进行了评价。结果单次和多次胶原酶治疗后,瘢痕收缩明显延长。结果显示,与一次性治疗相比,12周时重复注射更有效,平均改善26.83(15.79%)。12周时,78.9%的多药组患者和52.9%的单药组患者在12周时获得显著改善。未观察到严重的不良事件。结论瘢痕内注射胶原酶对瘢痕收缩有明显的改善作用,为瘢痕萎缩患者提供了一种新的治疗方法。试验注册chictr, ChiCTR-IIR-16009910。2016年11月18日注册。预期注册,https://www.chictr.org.cn/showproj.html?proj=16853。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A randomized clinical trial assessing the efficacy of single and multiple intralesional collagenase injections for treating contracted scars

Background

Scar contractions caused by trauma or burns can cause secondary physical dysfunction and disfigurement. Many minimally invasive methods for scar contraction have shown limited applicability and efficacy. This study investigated the feasibility and efficacy of intralesional collagenase injections for scar contraction treatment.

Methods

Patients with contracted scars who had limited joint movement and physical disfiguration for >1 year were enrolled in this single-blind, randomized clinical trial from July 2017 to February 2018 ​at Shanghai Ninth People’s Hospital. Collagenase was injected into the firm-contracted scar (15 U/cm2) three times at 4-week intervals in the multiple treatment group and once in the single treatment group, and a placebo injection was performed in the control group. Scar length and skin texture were documented at the 4- and 12-week follow-ups. The safety of the collagenase treatment was also evaluated.

Results

The contracted scar was significantly elongated after both single and multiple collagenase treatments. The results showed that, compared to a one-time treatment, repeated injections were more effective at 12 weeks, with an average improvement of 26.83 (15.79%). At 12 weeks, 78.9% of the patients in the multiple group and 52.9% in the single group achieved significant improvement at 12 weeks. No severe adverse events were observed.

Conclusion

Intralesional collagenase injection showed promising results in improving scar contraction and provides an alternative treatment for patients.

Trial registration

ChiCTR, ChiCTR-IIR-16009910. Registered November 18, 2016. Prospective registration, https://www.chictr.org.cn/showproj.html?proj=16853.

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来源期刊
Chinese Journal of Plastic and Reconstructive Surgery
Chinese Journal of Plastic and Reconstructive Surgery Surgery, Otorhinolaryngology and Facial Plastic Surgery, Pathology and Medical Technology, Transplantation
CiteScore
0.40
自引率
0.00%
发文量
115
审稿时长
55 days
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