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href="/news_zh/typeid/1.html" title="新聞資訊">新聞資訊</a> ? <a href="/news_zh/typeid/2.html">行業(yè)資訊</a> ? 詳細信息 </div> <div id="qeyqmqm" class="ny_news_da"> <h1 align="center" style=" width:100%">氯法齊明治療非結核分枝桿菌?。ㄒ唬?/h1> <p style="text-align:center; color:#fb6926;width:100%">[2021-01-05]</p> <br> <div style="border-top:1px dashed #cccccc;height: 1px;overflow:hidden"></div> <br> <p>非結核分枝桿菌（non-tuberculous mycobacteria，NTM）是指除結核分枝桿菌復合群和麻風(fēng)分枝桿菌以外的其他分枝桿菌。NTM可侵犯易感者肺臟、淋巴結、骨骼、關(guān)節、皮膚和軟組織等組織器官，并可導致免疫抑制人群發(fā)生全身性播散。近年來(lái)，NTM病呈明顯增多的趨勢，并逐步成為威脅人類(lèi)健康的重要公共衛生問(wèn)題。雖然與結核分枝桿菌同為分枝桿菌屬，但NTM菌株對大多數一線(xiàn)抗結核藥品具有高度耐藥性，導致NTM病治療效果差，治療困難，相關(guān)藥物的研發(fā)十分匱乏且進(jìn)展緩慢。在臨床實(shí)踐中發(fā)現一些藥品對于NTM病具有較好的治療作用，并得到了基礎研究的印證，但沒(méi)有治療NTM的適應證，也有部分藥品通過(guò)改變劑量或改變用藥途徑取得了較好的治療療效；上述幾種情況均已超出原有藥品說(shuō)明書(shū)的用藥指征、用法、推薦用量、療程等，不僅缺乏規范用藥的依據，而且長(cháng)期以來(lái)臨床醫生用藥承擔著(zhù)較大的風(fēng)險，也給患者造成困惑。已有多個(gè)藥品被國內外指南推薦為NTM病的治療用藥，基于此，中國防癆協(xié)會(huì )非結核分枝桿菌專(zhuān)業(yè)分會(huì )、《中國防癆雜志》編輯委員會(huì )組織國內該領(lǐng)域內的專(zhuān)家進(jìn)行專(zhuān)題討論，并以國內外指南或共識推薦、循證醫學(xué)證據、重要醫學(xué)科學(xué)研究結果為基礎，對長(cháng)期臨床治療NTM病的實(shí)踐中已證實(shí)安全有效的藥品用法、用量、療程等進(jìn)行歸納總結，撰寫(xiě)了《非結核分枝桿菌病治療藥品超說(shuō)明書(shū)用法專(zhuān)家共識》（簡(jiǎn)稱(chēng)“《共識》”），以指導臨床規范用藥。<br /> 氯法齊明<br /> 氯法齊明（clofazimine， Cfz）是一種吩嗪類(lèi)化合物，抗菌作用可能通過(guò)干擾分枝桿菌的核酸代謝并與其DNA結合，抑制依賴(lài)DNA的RNA聚合酶，阻止RNA的合成，從而抑制細菌蛋白的合成，發(fā)揮其抗菌作用?？蛇M(jìn)入巨噬細胞，不僅對麻風(fēng)分枝桿菌有緩慢的殺菌作用，對潰瘍分枝桿菌等部分NTM也有效。<br /> 一、說(shuō)明書(shū)摘要<br /> 目前，我國只有氯法齊明軟膠囊口服劑型。<br /> 1.國內批準的適應證：（1）作為瘤型麻風(fēng)的選用藥，通常應與氨苯砜聯(lián)合使用。（2）與利福平或乙硫異煙胺聯(lián)合應用于耐砜類(lèi)藥品的菌株所致的感染。（3）可用于紅斑結節性麻風(fēng)反應和其他藥品引起的急性麻風(fēng)反應。（4）亦可與其他抗結核藥品聯(lián)合應用于A(yíng)IDS并發(fā)NTM病的患者。<br /> 2.用法用量：口服。（1）耐氨苯砜的各型麻風(fēng)：50～100mg/次，1次/d；與其他一種或幾種抗麻風(fēng)藥品合用。（2）伴紅斑結節麻風(fēng)反應的各型麻風(fēng)并發(fā)神經(jīng)系統損傷或皮膚潰瘍者，口服100～300mg/d，1次/d；待反應控制后，逐漸遞減至100mg/d，1次/d。（3）成人最大量不超過(guò)300mg/d；小兒劑量尚未確認。<br /> 3.不良反應：皮膚黏膜色素沉著(zhù)為其主要不良反應，大部分患者在治療結束后數月或數年逐漸消退?？墒鼓蛞?、汗液、乳汁、精液和唾液呈淡紅色，且可通過(guò)胎盤(pán)使胎兒著(zhù)色，但未有致畸報道。約70%～80%的患者皮膚有魚(yú)鱗病樣改變。個(gè)別患者可產(chǎn)生眩暈、嗜睡、肝炎、上消化道出血、皮膚瘙癢、皮膚色素減退及阿-斯綜合征（Adams-Stokes綜合征）。<br /> 二、超說(shuō)明書(shū)用藥<br /> （一）超適應證<br /> 對于膿腫分枝桿菌感染者，治療前應對氯法齊明行藥敏試驗，敏感者推薦使用。<br /> 膿腫分枝桿菌、龜分枝桿菌對氯法齊明中度敏感，故可用于治療膿腫分枝桿菌病、龜分枝桿菌病。氯法齊明在體外與阿米卡星有協(xié)同抗菌作用，可用于膿腫分枝桿菌和其他快速生長(cháng)分枝桿菌病的治療。也可作為治療MAC肺病、猿分枝桿菌肺病的可選藥品。<br /> （二）超療程及用法用量<br /> 1.用法用量：成人100～200mg，1次/d；如果需要較低劑量，可以隔日給藥，不宜將軟膠囊打開(kāi)。嬰幼兒慎用。<br /> 2.降階梯療法：成人200mg/d，連續2個(gè)月；然后100mg/d，1次/d。<br /> 3.療程：數月至1年以上，用至痰培養結果陰轉12個(gè)月以上。<br /> 需要注意的是，嚴重肝腎功能不全及嚴重胃腸道疾病者慎用。孕婦避免使用，哺乳期婦女不宜應用。氯法齊明可引起Q-Tc間期延長(cháng)，因此，與貝達喹啉、德拉馬尼、莫西沙星和克拉霉素等延長(cháng)Q-Tc間期的藥品同時(shí)使用時(shí)，應密切監測心電圖的變化。<br /> 參考文獻：《非結核分枝桿菌病治療藥品超說(shuō)明書(shū)用法專(zhuān)家共識》中國防癆雜志2020年8月第42卷第8期</p> <br> <br> <div style="border-top:1px dashed #cccccc;height: 1px;overflow:hidden"></div> <br> <br> <table width="100%" border="0" align="center" cellpadding="0" cellspacing="0"> <tr> <td 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