【摘要】：目的特比萘芬標準持續(xù)治療方案是治療甲真菌病的經典方法,但由于其多個方面的缺陷,研究者們嘗試了多種其他治療方案。文中擬對特比萘芬標準持續(xù)治療方案對比其他方案治療甲真菌病的有效性和安全性進行系統(tǒng)評價。方法計算機檢索Pubmed、Cochrane圖書館、EMbase、CNKI、CBMdisc和萬方數據庫中關于特比萘芬治療甲真菌病的隨機對照試驗(randomized controlled trial,RCT)。由2名研究者按照計劃書進行選擇文獻、提取數據、核對,而后進行Meta分析。結果共納入20個RCT。Meta分析結果提示,標準持續(xù)治療方案在長期真菌學治愈要優(yōu)于沖擊治療方案[P=0.01,RR=0.81(0.69,0.96)]、COMBO方案[P=0.05,RR=0.68(0.46,1.01)]和間歇給藥方案[P=0.0001,RR=0.81(0.73,0.90)]。而標準持續(xù)治療方案在長期真菌學治愈方面要亞于持續(xù)治療聯合局部治療方案[P=0.005,RR=1.19(1.05,1.35)]和持續(xù)治療3月方案[P=0.02,RR=1.12(1.02,1.24)]。對中-重度甲真菌病患,持續(xù)治療聯合清創(chuàng)術方案與標準方案相比有潛在的優(yōu)勢。在安全性方面,持續(xù)聯合局部治療方案在胃腸道反應發(fā)生低于標準方案[P=0.03,RR=0.24(0.07,0.90)],間歇給藥方案在所有不良事件[P=0.03,RR=0.81(0.67,0.98)]和味覺障礙[P=0.05,RR=0.44(0.19,1.00)]發(fā)生低于標準治療方案。在評價研究質量方面,根據Cochrane圖書館推薦的"偏倚風險評估"工具評估后發(fā)現某些高度偏倚可能對結果影響較大。結論特比萘芬治療甲真菌病的最佳治療方案尚待更多高質量的RCT來證實。
[Abstract]:Objective Terbinafine standard continuous therapy is a classic treatment for onychomycosis, but due to its shortcomings in many aspects, researchers have tried a variety of other treatments. The efficacy and safety of terbinafine in the treatment of onychomycosis were systematically evaluated. Methods A computerized search was conducted for the Pubmed,Cochrane library and (randomized controlled trial,RCT, a randomized controlled trial of terbinafine for the treatment of onychomycosis. According to the plan, two researchers selected documents, extracted data, checked them, and then analyzed them by Meta. Results A total of 20 RCT.Meta analysis showed that the standard continuous therapy regimen was superior to the impact therapy regimen [P0. 01 RRN 0. 81 (0. 69 0. 96)] Combo regimen [P0. 05 RN 0. 68 (0. 46 鹵1. 01)] and intermittent administration regimen [P0. 0001 RRN 0. 81 (0. 73 ~ 0. 90)]. However, the standard continuous therapy regimen was less than that of continuous therapy combined with local treatment (P0. 005 RRN 1. 19 (1. 05 鹵1. 35) and continuous therapy regimen of 3 months [P0. 02 RRN 1. 12 (1. 02 鹵1. 24)] in the long term mycological cure. For moderate-severe onychomycosis patients, continuous therapy combined with debridement has potential advantages over standard protocols. In terms of safety, the incidence of continuous combined local therapy was lower than the standard regimen [P0. 03 RRR 0.24 (0. 07 鹵0. 90)], intermittent administration regimen was lower than the standard treatment regimen in all adverse events [P0. 03 RRR 0. 61 (0. 67 0. 98)] and taste disorder [P0. 05 RR0. 44 (0. 19 鹵1. 00)]. In terms of evaluation of research quality, according to the "bias risk assessment" tool recommended by Cochrane library, it is found that some high bias may have a great impact on the results. Conclusion Terbinafine is the best treatment for onychomycosis and needs more high quality RCT.
【作者單位】： 南京軍區(qū)南京總醫(yī)院皮膚科;
【基金】：國家自然科學基金(81071331)
【分類號】：R756.4

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