中药生发凝胶治疗雄激素性秃发的临床研究

发布时间：2018-04-12 18:43

  本文选题：雄激素性秃发 + 中药生发凝胶　； 参考：《北京中医药大学》2017年硕士论文

【摘要】：文献综述部分:综述一总结了雄激素性秃发(Androgenetic Alopecia AGA)的病因、发病机制及毛发镜检查的研究进展,以及近些年AGA的各种治疗的进展,治疗方法及其优势与其不良反应。综述二主要对于近年来中医药治疗AGA的进展和临床应用作以总结和阐述。临床研究部分:研究目的:综合评价中药生发凝胶治疗雄激素性秃发的疗效和安全性。研究方法:采用随机单盲与自体前后对照的实验方法。将43名男性AGA患者随机分为中药生发凝胶治疗组(以下简称治疗组)和空白凝胶治疗对照组(以下简称对照组),其中治疗组29例,对照组14例,采用同期治疗研究,治疗组患者于头皮两侧额角处使用中药生发凝胶,对照组患者于头皮两侧额角处使用空白凝胶,临床观察时间为6个月。治疗期间患者每6周复诊一次,填写病例报告表(CRF表)、进行毛发镜检测及领取下一治疗周期的药物。通过患者复诊时所采集毛发镜图像进行系统分析,通过治疗前后头发直径变异率、总毛发计数、头皮炎症等指标以及CRF表中患者临床症状的改善情况判定中药生发凝胶治疗AGA的治疗效果及临床应用的安全性。研究结果:①本次研究的治疗组和对照组在一般临床资料方面均无统计学差异(P0.05),认为其相关性一致,表明两组所进行的后续临床试验的疗效判定是具有可比性的。②治疗组的患者经6个月的中药生发凝胶外用治疗后,在头发直径变异率、头皮炎症分级方面具有明显改善,具有显著统计学差异(P≤0.001),在总毛发增长率方面亦有一定程度的改善,总毛发增长率在30%～70%的患者有7例,毛发增长率30%的患者有22例,临床有效率为24.14%。且治疗组与对照组的客观疗效指标比较,差异具有显著统计学意义(P0.001)。治疗组患者的主观症状头皮油脂分泌和毛囊炎在治疗后改善,前后差异具有统计学意义(P0.05),其中头皮油脂分泌情况与对照组相比具有显著差异(P0.001)。③参加本次临床研究的43例受试者外用中药生发凝胶及空白凝胶后均无任何不良反应出现,说明中药生发凝胶的安全性是很高的。④中药生发凝胶的方药组成是以清热除湿、养血活血、补益肝肾的治疗原则创立的,在治疗中较好地起到了减轻患者头皮油脂分泌、改善头皮炎症及增加头发生长的作用。研究结论:本临床研究的中药生发凝胶具有较好的治疗男性AGA的疗效,疗效明显优于对照组。本次临床研究的患者外用中药生发凝胶治疗后无1例发生不良反应,证明中药生发凝胶治疗男性AGA的安全性具有保障。中药生发凝胶是治疗男性AGA的切实有效且安全性高的中药外用制剂。
[Abstract]:Literature review: 1. The etiology, pathogenesis and hair microscopic examination of androgen alopecia areata (Androgenetic Alopecia AGA) were summarized. The advances in various treatments, treatment methods, advantages and adverse reactions of AGA in recent years were also reviewed.The second review summarizes the progress and clinical application of traditional Chinese medicine (TCM) in the treatment of AGA in recent years.Clinical study: objective: to evaluate the efficacy and safety of germinal gel in the treatment of androgen alopecia.Methods: a randomized single blind and self-controlled experimental method was used.43 male patients with AGA were randomly divided into two groups: the traditional Chinese medicine germinal gel treatment group (hereinafter referred to as the treatment group) and the blank gel treatment group (the control group, 29 cases in the treatment group and 14 cases in the control group).The patients in the treatment group were treated with traditional Chinese medicine germinal gel at the frontal horn of both sides of the scalp, while the patients in the control group were treated with the blank gel at the bilateral frontal horn of the scalp. The clinical observation time was 6 months.During the course of treatment, the patients were reviewed every 6 weeks, the CRF form was filled in the case report form, the hair microscope was performed and the medication for the next treatment cycle was obtained.The hair mirror images collected by the patients were analyzed systematically. The hair diameter variation rate and the total hair count before and after treatment were analyzed.The indexes of scalp inflammation and the improvement of clinical symptoms of patients in CRF table were used to evaluate the efficacy and safety of traditional Chinese medicine germinal gel in the treatment of AGA.Results: 1 there was no significant difference in general clinical data between the treatment group and the control group in this study.The results showed that the curative effect of the follow-up clinical trials in the two groups was comparable. 2 patients in the treatment group were significantly improved in hair diameter variation rate and scalp inflammation grade after 6 months of external treatment with traditional Chinese medicine germinal gel.There was significant statistical difference (P 鈮，

本文编号：1740960