中华血液学杂志
中華血液學雜誌
중화혈액학잡지
Chinese Journal of Hematology
2013年
6期
502-506
,共5页
刘欣%黄勇%杨栋林%魏嘉璘%何祎%马巧玲%庞爱明%冯四洲%韩明哲
劉訢%黃勇%楊棟林%魏嘉璘%何祎%馬巧玲%龐愛明%馮四洲%韓明哲
류흔%황용%양동림%위가린%하의%마교령%방애명%풍사주%한명철
伊曲康唑%侵袭性真菌感染%白血病,髓样,急性%预防
伊麯康唑%侵襲性真菌感染%白血病,髓樣,急性%預防
이곡강서%침습성진균감염%백혈병,수양,급성%예방
Itraconazole%Invasive fungal infections%Leukemia,myeloid,acute%Prophylaxis
目的 研究不同方案伊曲康唑预防急性髓系白血病(AML)患者中性粒细胞缺乏(粒缺)期侵袭性真菌感染(IFI)的有效性、安全性及血药浓度与疗效的相关性.方法 2009年4月至2011年5月诊治的112例AML患者,以每例患者诱导化疗及巩固治疗中每个伊曲康唑疗程作为1个例次,共统计310例次,可供分析297例次.通过Excel软件设计随机分组表,将99例次诱导化疗和198例次巩固化疗患者分别随机分为伊曲康唑序贯治疗组(静脉制剂+口服液)和口服液组,检测给药不同时间点伊曲康唑血药浓度,观察IFI发生率和药物不良反应.结果 序贯治疗组与口服液组IFI的突破率分别为10.1％和20.9％ (P =0.010).两组分别有7例次及9例次患者因不良反应而停药,差异无统计学意义.序贯治疗组和口服液组患者稳态血药浓度分别为672(299 ～1097)和534(210～936) μg/L(P ＜0.01).预防成功患者伊曲康唑稳态血药浓度[576(274 ～ 878) μg/L]高于IFI突破患者[437(105 ～821)μg/L],差异有统计学意义(P＜0.01).结论 伊曲康唑在AML患者粒缺期预防IFI安全有效,且静脉滴注2d序贯口服的治疗方案能使患者尽早获得有效血药浓度,其预防效果明显优于单纯口服方案.
目的 研究不同方案伊麯康唑預防急性髓繫白血病(AML)患者中性粒細胞缺乏(粒缺)期侵襲性真菌感染(IFI)的有效性、安全性及血藥濃度與療效的相關性.方法 2009年4月至2011年5月診治的112例AML患者,以每例患者誘導化療及鞏固治療中每箇伊麯康唑療程作為1箇例次,共統計310例次,可供分析297例次.通過Excel軟件設計隨機分組錶,將99例次誘導化療和198例次鞏固化療患者分彆隨機分為伊麯康唑序貫治療組(靜脈製劑+口服液)和口服液組,檢測給藥不同時間點伊麯康唑血藥濃度,觀察IFI髮生率和藥物不良反應.結果 序貫治療組與口服液組IFI的突破率分彆為10.1％和20.9％ (P =0.010).兩組分彆有7例次及9例次患者因不良反應而停藥,差異無統計學意義.序貫治療組和口服液組患者穩態血藥濃度分彆為672(299 ～1097)和534(210～936) μg/L(P ＜0.01).預防成功患者伊麯康唑穩態血藥濃度[576(274 ～ 878) μg/L]高于IFI突破患者[437(105 ～821)μg/L],差異有統計學意義(P＜0.01).結論 伊麯康唑在AML患者粒缺期預防IFI安全有效,且靜脈滴註2d序貫口服的治療方案能使患者儘早穫得有效血藥濃度,其預防效果明顯優于單純口服方案.
목적 연구불동방안이곡강서예방급성수계백혈병(AML)환자중성립세포결핍(립결)기침습성진균감염(IFI)적유효성、안전성급혈약농도여료효적상관성.방법 2009년4월지2011년5월진치적112례AML환자,이매례환자유도화료급공고치료중매개이곡강서료정작위1개례차,공통계310례차,가공분석297례차.통과Excel연건설계수궤분조표,장99례차유도화료화198례차공고화료환자분별수궤분위이곡강서서관치료조(정맥제제+구복액)화구복액조,검측급약불동시간점이곡강서혈약농도,관찰IFI발생솔화약물불량반응.결과 서관치료조여구복액조IFI적돌파솔분별위10.1％화20.9％ (P =0.010).량조분별유7례차급9례차환자인불량반응이정약,차이무통계학의의.서관치료조화구복액조환자은태혈약농도분별위672(299 ～1097)화534(210～936) μg/L(P ＜0.01).예방성공환자이곡강서은태혈약농도[576(274 ～ 878) μg/L]고우IFI돌파환자[437(105 ～821)μg/L],차이유통계학의의(P＜0.01).결론 이곡강서재AML환자립결기예방IFI안전유효,차정맥적주2d서관구복적치료방안능사환자진조획득유효혈약농도,기예방효과명현우우단순구복방안.
Objective To evaluate the efficacy and safety of antifungal prophylaxis of itraconazole in patients with acute myeloid leukemia (AML) to probe the relationship of the antifungal effect and the adverse events with serum concentration.Methods From April 2009 to May 2011,a total of 310 courses from 112 patients referred to our institute were enrolled in this study; of them,297 courses were eligible for analysis.Eligible cases were randomized into oral group and injection/oral group according to different chemotherapy of induction and consolidation.Blood samples were collected at different timepoints for measurements of serum itraconazole levels.The morbidity of IFI and the adverse events were analyzed.Results The morbidities of IFI in injection/oral and oral groups were 10.1％ and 20.9％,respectively (P =0.010).7 and 9 cases in injection/oral and oral groups,respectively were withdrawn from the study because of adverse events,and the difference between these two groups was of no significance.Serum itraconazole levels of injection/oral and oral groups were 672(299-1097) μg/L and 534(210-936) μg/L,respectively (P ＜0.0l).Conclusions Antifungal prophylaxis with itraconazole in AML patients was effective and safe.Prophylactic effect with injection/oral itraconazole was superior to oral itraconazole solution; moreover,prophylactic effect of itraconazole was highly correlated with its serum level.
