三氧自體血療法專家共識(shí)
《三氧自體血療法專家共識(shí)》:言明三氧和臭氧 ----------轉(zhuǎn)自 安建雄 博文標(biāo)簽:三氧自體血專家共識(shí)聲明:本共識(shí)已經(jīng)被中文核心期刊《轉(zhuǎn)化醫(yī)學(xué)雜志》接收,經(jīng)雜志社同意在此公布。三氧自體血療法專家共識(shí)中華醫(yī)學(xué)會(huì)麻醉學(xué)分會(huì)疼痛學(xué)組中國(guó)醫(yī)師協(xié)會(huì)麻醉醫(yī)師分會(huì)中國(guó)民族醫(yī)藥學(xué)會(huì)疼痛分會(huì)三氧學(xué)組三氧自體血療法(ozonated autohemotherapy,O3-AHT,又名major ozonated autohemotherapy或major autohaemotherapy)從本世紀(jì)初開(kāi)始在我國(guó)逐漸開(kāi)展,由于缺乏可借鑒的中文指南或?qū)<夜沧R(shí),不僅存在不規(guī)范臨床行為,甚至有濫用傾向。為此我國(guó)三氧醫(yī)學(xué)相關(guān)專家組織撰寫三氧自體血療法專家共識(shí)。本共識(shí)文獻(xiàn)主要來(lái)源于PUBMED數(shù)據(jù)庫(kù)及參與編寫專家的臨床實(shí)踐。三氧醫(yī)學(xué)是指利用氣態(tài)、液態(tài)或固態(tài)的醫(yī)用三氧,通過(guò)不同途徑用于人體,以達(dá)到預(yù)防和治療疾病目的應(yīng)用學(xué)科。O3-AHT是將一定濃度氧氣和三氧混合氣體與自體血等容量混勻,再回輸?shù)襟w內(nèi)的一種療法。本共識(shí)所指三氧是醫(yī)用三氧與氧氣的混合氣體.需要特別強(qiáng)調(diào),這里描述的三氧不同于所謂臭氧。臭氧是指自然生成或者人工高溫放電法處理空氣后生成的、含有對(duì)人體有害的氮氧化物的工業(yè)用三氧混合氣體,而我們討論的三氧則是指醫(yī)用三氧發(fā)生器在安全惰性環(huán)境下對(duì)醫(yī)用純氧進(jìn)行處理后得到的不含有有毒物質(zhì)的純凈三氧氣體。一、絕對(duì)禁忌證1.葡萄糖-6-磷酸脫氫酶缺乏癥(蠶豆?。?.毒性彌漫性甲狀腺腫(Graves病)3.血小板減少低于50X109/L、嚴(yán)重的凝血障礙4.嚴(yán)重的不穩(wěn)定性心血管病、急性心肌梗死5.急性酒精中毒6.大量失血、急性出血、貧血(<90g/L)7、水電解質(zhì)紊亂8.癲癇發(fā)作9.血色素沉著病、接受銅或鐵劑治療的患者10、抗凝劑(枸櫞酸鈉)過(guò)敏11、妊娠12、嚴(yán)重肝功能不全二、相對(duì)禁忌證1.女性月經(jīng)期。2.未成年人不建議做O3-AHT,建議用三氧直腸灌注替代。3.年齡上限無(wú)嚴(yán)格規(guī)定,80歲以上老年人可選用三氧直腸灌注替代。三、O3-AHT期間相關(guān)藥物影響1.治療期間不建議口服維生素或抗氧化劑,但治療前后可以服用。2.血管緊張素酶抑制劑:本療法可能增加血管緊張素酶抑制劑降壓作用而導(dǎo)致病人血壓過(guò)低。3.抗凝藥物:不推薦使用抗凝藥物期間進(jìn)行O3-AHT。四、臨床應(yīng)用建議根據(jù)循證醫(yī)學(xué)證據(jù)及專家臨床經(jīng)驗(yàn),本共識(shí)將O3-AHT治療疾病按適應(yīng)證、效果不確定疾病、正在研究療效及安全性的疾病和不建議開(kāi)展的疾病等進(jìn)行分類。根據(jù)循證醫(yī)學(xué)(EBM),參考美國(guó)預(yù)防服務(wù)工作組及牛津循證醫(yī)學(xué)中心疾病證據(jù)等級(jí)制定方法,將O3-AHT治療的疾病可以分為四類,【1、2】:A級(jí)證據(jù):有良好的科學(xué)證據(jù)證實(shí)O3-AHT的臨床益處遠(yuǎn)超過(guò)潛在的風(fēng)險(xiǎn)?;陔S機(jī)對(duì)照試驗(yàn)的系統(tǒng)回顧、同質(zhì)性隊(duì)列研究的系統(tǒng)評(píng)價(jià)或同種病例對(duì)照研究的系統(tǒng)評(píng)價(jià)。B級(jí)證據(jù):至少公平的科學(xué)證據(jù)表明O3-AHT的臨床益處大于潛在的風(fēng)險(xiǎn)?;趥€(gè)體隨機(jī)置信區(qū)間小、隊(duì)列研究或病例對(duì)照研究。PUBMED數(shù)據(jù)庫(kù)均可查到相關(guān)文獻(xiàn)。C級(jí)證據(jù):至少有公平的科學(xué)證據(jù)表明O3-AHT能夠提供的臨床益處,但利益風(fēng)險(xiǎn)不能確定。基于沒(méi)有明確的批判性評(píng)價(jià)的專家意見(jiàn)、病例報(bào)告,或基于生理學(xué)、實(shí)驗(yàn)室研究,或“基本原則”,或描述性流行病學(xué)。PUBMED數(shù)據(jù)庫(kù)均可查到相關(guān)文獻(xiàn)。D級(jí)證據(jù):主要根據(jù)O3-AHT編寫組專家臨床實(shí)踐,PUBMED數(shù)據(jù)庫(kù)暫無(wú)相關(guān)文獻(xiàn)支持。(一)適應(yīng)證A級(jí)證據(jù):無(wú)B級(jí)證據(jù):1.慢性肝炎【3-4】2.下肢動(dòng)脈缺血【5-8】3.突發(fā)性耳聾【9-10】4.年齡相關(guān)性黃斑變性(萎縮性)【11】C級(jí)證據(jù):1.哮喘【12】2.多發(fā)性硬化【13-14】3.頭痛【15】4.痛風(fēng)【16-17】5.腦梗死【18-19】6.骶髂關(guān)節(jié)炎【20】7.帶狀皰疹后神經(jīng)痛【21】8.癌癥輔助治療[22-23]D級(jí)證據(jù)1.慢性缺血性心臟病2.失眠3.類風(fēng)濕(二)效果不確定疾病1.呼吸衰竭:個(gè)案報(bào)道O3-AHT對(duì)改善呼吸衰竭癥狀有效果,需要更多臨床研究證據(jù)支持。2.腎功能衰竭:有文獻(xiàn)報(bào)道O3-AHT可以增加腎小球過(guò)濾【4】,需要更多臨床研究證據(jù)支持。3.銀屑?。号R床實(shí)踐O3-AHT對(duì)部分銀屑病有效,但也有少部分病人病情反而加重。4.高脂血癥:O3-AHT對(duì)部分高血脂病人療效顯著。(三)正在研究療效和安全性的疾病1.系統(tǒng)性紅斑狼瘡、干燥綜合征、皮肌炎、硬皮病、強(qiáng)直性脊柱炎等免疫性疾病,從機(jī)制上推斷O3-AHT有效,臨床實(shí)踐也發(fā)現(xiàn)部分病人有效,但需要更多臨床經(jīng)驗(yàn)和循證醫(yī)學(xué)證據(jù)。2.帕金森病、亨廷頓氏病、克雅氏病、小腦萎縮等神經(jīng)退行性疾?。阂炎C實(shí)O3-AHT對(duì)多發(fā)性硬化病有效,對(duì)其他神經(jīng)退行性病變的療效不明確。3.呼吸系統(tǒng)(呼吸系統(tǒng)腫瘤除外):目前僅有證據(jù)O3-AHT對(duì)哮喘有效,其他呼吸系統(tǒng)疾病的療效有待研究。4.泌尿、消化、生殖系統(tǒng)疾?。荷袩o(wú)O3-AHT對(duì)這三個(gè)系統(tǒng)常見(jiàn)病療效的證據(jù)。(四)不建議開(kāi)展疾病1.血液系統(tǒng)疾病。2.甲狀腺功能減退。3.肺栓塞。五.主要風(fēng)險(xiǎn)1、抗凝劑:抗凝劑偏少會(huì)引起血栓,而過(guò)量會(huì)導(dǎo)致凝血功能障礙。2、氣體栓塞:操作不當(dāng)可能造成氣體進(jìn)入血管,形成氣體栓塞。3、對(duì)高齡及心功能不全患者,引血或回輸過(guò)快有誘發(fā)心力衰竭的可能。六.安全性、副作用及并發(fā)癥1、O3-AHT副作用發(fā)生率0.0007%【24】。2、O3-AHT可能加重銀屑病癥狀,并出現(xiàn)皮膚水腫,甚至有報(bào)道O3-AHT導(dǎo)致銀屑病死亡1例【25】。3、三氧化自體血回輸過(guò)程出現(xiàn)低血壓、尤其口服ACEI藥物患者,低血壓發(fā)生幾率增高,此類患者實(shí)施O3-AHT時(shí)應(yīng)全程監(jiān)測(cè)血壓。4、可能誘發(fā)急性冠脈綜合征和急性心肌梗死?!?6】5、慢性腎衰合并糖尿病患者,O3-AHT可能誘發(fā)高血鉀。【27】七.操作流程1.每個(gè)療程開(kāi)始前,應(yīng)檢查血常規(guī)、凝血、生化、甲狀腺功能和傳染病。2.建議治療前1小時(shí)飲水≧300ml,利于血液稀釋和引血。3.核對(duì)病人信息,常規(guī)監(jiān)測(cè)脈搏血氧飽和度,急救設(shè)施和藥品處于備用狀態(tài)。4.病人取坐位或仰臥位,首選肘靜脈、正中靜脈和貴要靜脈等大靜脈。5 .建議按1.2mL/kg至1.3mL/kg計(jì)算采血量,為方便臨床應(yīng)用,通常采血100ml與25毫升抗凝劑混合,也即抗凝劑與血液容量按1:4比例混合。6 .推薦三氧濃度為10-40ug/ml,可以從低濃度開(kāi)始,隨治療次數(shù)增加逐漸提高;三氧混合氣體與血液容量按1:1比例混合,氣體與血液混合后,緩慢搖勻3-5分鐘,避免劇烈振蕩。7.三氧化血回輸速度為75-150滴/分鐘(5-10毫升/分鐘)。推薦將100ml三氧化血20分鐘內(nèi)輸回體內(nèi)?;剌斔俣劝聪嚷罂斓脑瓌t進(jìn)行調(diào)節(jié)。8.建議拔除套管針后按壓5分鐘以上,留觀15分鐘左右。八、治療參數(shù)及注意事項(xiàng)1.治療頻率:每天一次,或每周1-3次。2.療程:每個(gè)療程10次,每年兩個(gè)療程或更多。3.O3-AHT過(guò)程中所有接觸三氧的容器和管路均應(yīng)選用抗氧化材料或玻璃器皿。4.嚴(yán)禁將任何氣體直接注入血管。附:寫作組組長(zhǎng):安建雄(中國(guó)醫(yī)科大學(xué)航空總醫(yī)院)寫作組成員:王永(中國(guó)醫(yī)科大學(xué)航空總醫(yī)院,執(zhí)筆人)錢曉焱(中國(guó)醫(yī)科大學(xué)航空總醫(yī)院,執(zhí)筆人)李彤(甘肅省蘭州市婦幼保健院)程志祥(南京醫(yī)科大學(xué)第二附屬醫(yī)院)張小梅(昆明醫(yī)科大學(xué)附屬第一醫(yī)院)史可梅(天津醫(yī)科大學(xué)第二醫(yī)院)羅民(吉林大學(xué)中日聯(lián)誼醫(yī)院)鄢建勤(中南大學(xué)湘雅醫(yī)院)馮藝(北京大學(xué)人民醫(yī)院)王祥瑞(同濟(jì)大學(xué)附屬東方醫(yī)院)俞衛(wèi)鋒(上海交通大學(xué)仁濟(jì)醫(yī)院)安建雄(中國(guó)醫(yī)科大學(xué)航空總醫(yī)院)通訊作者:安建雄北京市北苑路3號(hào)中國(guó)醫(yī)科大學(xué)航空總醫(yī)院暨中國(guó)科學(xué)院北京轉(zhuǎn)化醫(yī)學(xué)研究院100012.E-mail: anjianxiong@yeah.net參考文獻(xiàn)1.Sherman M, Burak K, Maroun J, et al. 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