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自体浓缩生长因子联合米诺地尔治疗男性雄激素性脱发:一项随机对照临床试验。

Autologous Concentrated Growth Factors Combined with Topical Minoxidil for the Treatment of Male Androgenetic Alopecia: A Randomized Controlled Clinical Trial.

机构信息

Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, P.R. China.

出版信息

Facial Plast Surg Aesthet Med. 2021 Jul-Aug;23(4):255-262. doi: 10.1089/fpsam.2020.0288. Epub 2020 Aug 21.

Abstract

Minoxidil (MXD) is an U.S. Food and Drug Administration-approved drug for the topical treatment of androgenetic alopecia (AGA) with minor side effects, but its hair growth (HG) effect is unsatisfactory. A double-blinded within-subjects randomized clinical trial was conducted on 16 male AGA patients who showed limited improvement after MXD treatment. Eligible participants received three concentrated growth factor (CGF) injections on half of the scalp and the placebo on the other side at 4-week intervals, and MXD was applied twice daily on both sides throughout the follow-up period. The primary endpoint was the HG ratio at V4. The secondary endpoints included the HG ratios at V2, V3, and V5; hair density and T/V ratio at V2, V3, V4, and V5; Global Aesthetic Improvement Scale (GAIS) scores at V4 and V5; and participant satisfaction at V4. Each group included 16 subjects; each half of the scalp was randomly assigned to the MXD+CGF or MXD group. The HG ratio at V4 was higher in the MXD+CGF group than in the MXD group. The MXD+CGF group had significant improvements in hair density, HG ratio, and T/V ratio compared with the MXD group over the follow-up period. The GAIS scores and participant satisfaction were higher in the MXD+CGF group than in the MXD group. Unexpectedly, the MXD+CGF treatment hastened HG, which was sustained for 3 months after discontinuation. No severe adverse events occurred. The combined treatment of MXD and CGF is safe and more efficient for AGA patients. Combining CGF can expedite the potency of MXD and provide patients with fast and lasting HG.

摘要

米诺地尔(MXD)是一种经美国食品和药物管理局批准的用于治疗雄激素性脱发(AGA)的局部药物,副作用较小,但生发(HG)效果并不理想。我们对 16 名男性 AGA 患者进行了一项双盲、自身对照随机临床试验,这些患者在接受 MXD 治疗后改善有限。符合条件的参与者在 4 周的间隔内,一侧头皮接受三次浓缩生长因子(CGF)注射,另一侧接受安慰剂注射,在整个随访期间,两侧均每天涂抹两次 MXD。主要终点是 V4 时的 HG 比值。次要终点包括 V2、V3 和 V5 时的 HG 比值;V2、V3、V4 和 V5 时的头发密度和 T/V 比值;V4 和 V5 时的全球美学改善量表(GAIS)评分;以及 V4 时的参与者满意度。每组包括 16 名受试者;头皮的每一半随机分配到 MXD+CGF 或 MXD 组。与 MXD 组相比,MXD+CGF 组在 V4 时的 HG 比值更高。与 MXD 组相比,MXD+CGF 组在随访期间的头发密度、HG 比值和 T/V 比值均有显著改善。与 MXD 组相比,MXD+CGF 组的 GAIS 评分和参与者满意度更高。出乎意料的是,MXD+CGF 治疗加速了 HG 的发生,并且在停止治疗后持续了 3 个月。未发生严重不良事件。MXD 和 CGF 的联合治疗对 AGA 患者是安全且更有效的。联合 CGF 可以加速 MXD 的效力,并为患者提供快速持久的 HG。

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