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中藥生發(fā)凝膠治療雄激素性禿發(fā)的臨床研究

發(fā)布時(shí)間:2018-04-12 18:43

  本文選題:雄激素性禿發(fā) + 中藥生發(fā)凝膠; 參考:《北京中醫(yī)藥大學(xué)》2017年碩士論文


【摘要】:文獻(xiàn)綜述部分:綜述一總結(jié)了雄激素性禿發(fā)(Androgenetic Alopecia AGA)的病因、發(fā)病機(jī)制及毛發(fā)鏡檢查的研究進(jìn)展,以及近些年AGA的各種治療的進(jìn)展,治療方法及其優(yōu)勢與其不良反應(yīng)。綜述二主要對于近年來中醫(yī)藥治療AGA的進(jìn)展和臨床應(yīng)用作以總結(jié)和闡述。臨床研究部分:研究目的:綜合評價(jià)中藥生發(fā)凝膠治療雄激素性禿發(fā)的療效和安全性。研究方法:采用隨機(jī)單盲與自體前后對照的實(shí)驗(yàn)方法。將43名男性AGA患者隨機(jī)分為中藥生發(fā)凝膠治療組(以下簡稱治療組)和空白凝膠治療對照組(以下簡稱對照組),其中治療組29例,對照組14例,采用同期治療研究,治療組患者于頭皮兩側(cè)額角處使用中藥生發(fā)凝膠,對照組患者于頭皮兩側(cè)額角處使用空白凝膠,臨床觀察時(shí)間為6個(gè)月。治療期間患者每6周復(fù)診一次,填寫病例報(bào)告表(CRF表)、進(jìn)行毛發(fā)鏡檢測及領(lǐng)取下一治療周期的藥物。通過患者復(fù)診時(shí)所采集毛發(fā)鏡圖像進(jìn)行系統(tǒng)分析,通過治療前后頭發(fā)直徑變異率、總毛發(fā)計(jì)數(shù)、頭皮炎癥等指標(biāo)以及CRF表中患者臨床癥狀的改善情況判定中藥生發(fā)凝膠治療AGA的治療效果及臨床應(yīng)用的安全性。研究結(jié)果:①本次研究的治療組和對照組在一般臨床資料方面均無統(tǒng)計(jì)學(xué)差異(P0.05),認(rèn)為其相關(guān)性一致,表明兩組所進(jìn)行的后續(xù)臨床試驗(yàn)的療效判定是具有可比性的。②治療組的患者經(jīng)6個(gè)月的中藥生發(fā)凝膠外用治療后,在頭發(fā)直徑變異率、頭皮炎癥分級方面具有明顯改善,具有顯著統(tǒng)計(jì)學(xué)差異(P≤0.001),在總毛發(fā)增長率方面亦有一定程度的改善,總毛發(fā)增長率在30%~70%的患者有7例,毛發(fā)增長率30%的患者有22例,臨床有效率為24.14%。且治療組與對照組的客觀療效指標(biāo)比較,差異具有顯著統(tǒng)計(jì)學(xué)意義(P0.001)。治療組患者的主觀癥狀頭皮油脂分泌和毛囊炎在治療后改善,前后差異具有統(tǒng)計(jì)學(xué)意義(P0.05),其中頭皮油脂分泌情況與對照組相比具有顯著差異(P0.001)。③參加本次臨床研究的43例受試者外用中藥生發(fā)凝膠及空白凝膠后均無任何不良反應(yīng)出現(xiàn),說明中藥生發(fā)凝膠的安全性是很高的。④中藥生發(fā)凝膠的方藥組成是以清熱除濕、養(yǎng)血活血、補(bǔ)益肝腎的治療原則創(chuàng)立的,在治療中較好地起到了減輕患者頭皮油脂分泌、改善頭皮炎癥及增加頭發(fā)生長的作用。研究結(jié)論:本臨床研究的中藥生發(fā)凝膠具有較好的治療男性AGA的療效,療效明顯優(yōu)于對照組。本次臨床研究的患者外用中藥生發(fā)凝膠治療后無1例發(fā)生不良反應(yīng),證明中藥生發(fā)凝膠治療男性AGA的安全性具有保障。中藥生發(fā)凝膠是治療男性AGA的切實(shí)有效且安全性高的中藥外用制劑。
[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,

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