CAJ | 학술논문

目的：评价卡泊芬净注射剂治疗中国成年人侵袭性念珠菌病和食管念珠菌病的疗效及安全性。方法本研究为非对照、多中心、开放性临床研究，入选对象为年龄≥18岁，确诊为侵袭性念珠菌病或食管念珠菌病需要进行抗真菌治疗的中国成人患者。采用卡泊芬净静脉给药，每日50 mg ，首日采用70 mg负荷剂量。在最后一次血液或其他正常无菌部位培养阳性后继续治疗至少14 d。食管念珠菌病患者每日50 mg ，疗程至少7 d ，症状缓解后继续治疗72 h。结果共入选63例患者，包括侵袭性念珠菌病60例，食管念珠菌病3例，其中安全性分析集（SS ）63例，全分析集（FAS ）63例，符合方案集（PPS ）50例。SS 63例患者中，14例发生19例次严重不良事件，均与研究药物无关；发生与药物有关的非严重不良事件31例73例次，其中4例同时发生临床不良事件和实验室指标异常；8例发生12例次临床不良事件，主要为皮疹等，其中91．7％（11/12）属轻、中度。27例发生实验室指标异常，主要为A L T等肝酶升高、血钾降低等。与研究药物相关的不良事件总发生率为49．2％（31/63），其中临床不良事件发生率为12．7％（8/63），实验室指标异常发生率为42．9％（27/63）。1例因不良事件终止治疗，占1．6％（1/63）。FAS和PPS中的总有效率分别为58．1％（36/62）和70．0％（35/50）。FAS中，侵袭性念珠菌病的有效率为57．6％（34/59），食管念珠菌病为2/3。PPS中，侵袭性念珠菌病的有效率为68．8％（33/48），食管念珠菌病为3/3。结论卡泊芬净治疗中国成年人侵袭性念珠菌病和食管念珠菌病临床不良反应大多为轻、中度，患者可耐受。卡泊芬净可有效治疗中国成年人侵袭性念珠菌病和食管念珠菌病。
목적：평개잡박분정주사제치료중국성년인침습성념주균병화식관념주균병적료효급안전성。방법본연구위비대조、다중심、개방성림상연구，입선대상위년령≥18세，학진위침습성념주균병혹식관념주균병수요진행항진균치료적중국성인환자。채용잡박분정정맥급약，매일50 mg ，수일채용70 mg부하제량。재최후일차혈액혹기타정상무균부위배양양성후계속치료지소14 d。식관념주균병환자매일50 mg ，료정지소7 d ，증상완해후계속치료72 h。결과공입선63례환자，포괄침습성념주균병60례，식관념주균병3례，기중안전성분석집（SS ）63례，전분석집（FAS ）63례，부합방안집（PPS ）50례。SS 63례환자중，14례발생19례차엄중불량사건，균여연구약물무관；발생여약물유관적비엄중불량사건31례73례차，기중4례동시발생림상불량사건화실험실지표이상；8례발생12례차림상불량사건，주요위피진등，기중91．7％（11/12）속경、중도。27례발생실험실지표이상，주요위A L T등간매승고、혈갑강저등。여연구약물상관적불량사건총발생솔위49．2％（31/63），기중림상불량사건발생솔위12．7％（8/63），실험실지표이상발생솔위42．9％（27/63）。1례인불량사건종지치료，점1．6％（1/63）。FAS화PPS중적총유효솔분별위58．1％（36/62）화70．0％（35/50）。FAS중，침습성념주균병적유효솔위57．6％（34/59），식관념주균병위2/3。PPS중，침습성념주균병적유효솔위68．8％（33/48），식관념주균병위3/3。결론잡박분정치료중국성년인침습성념주균병화식관념주균병림상불량반응대다위경、중도，환자가내수。잡박분정가유효치료중국성년인침습성념주균병화식관념주균병。
Objective This study was designed to evaluate the safety ,tolerability and efficacy of intravenous caspofungin for treatment of invasive candidiasis and esophageal candidiasis in Chinese adults .Methods This was a non-controlled ,multicenter ,candidiasis .All the 63 patients were included in the safety set (SS) and the full analysis set (FAS) .In the SS ,19 SAEs occurred in 14 patients .All these SAEs were unrelated to caspofungin .There were 73 caspofungin-related non-serious AEs in 31 patients (49 .2% ) .Five patients (7 .9% ) had both clinical AEs and laboratory abnormalities .Eight patients (12 .7% ) had clinical AEs (mainly rashes) ,and 27 patients (42 .9% ) had laboratory abnormalities ,mainly increases in liver enzymes alanine transaminase and aspartate transaminase and reduction in blood potassium .About 91 .7% of the clinical AEs were mild to moderate .Treatment was discontinued in 1 patient (1 .6% ,1/63) due to AEs .The overall efficacy was 58 .1% (36/62) in the FAS and 70 .0% (35/70) in the per-protocol set (PPS) .In the FAS ,the therapeutic efficacy was 57 .6% (34/59) for invasive candidiasis and 66 .7% (2/3) for esophageal candidiasis .In the PPS , the therapeutic efficacy was 68 .8% (33/48 ) for invasive candidiasis and 100% (3/3 ) for esophageal candidiasis .Conclusions The AEs of caspofungin were mostly mild to moderate in the treatment of invasive candidiasis and esophageal candidiasis in Chinese adults .Only one patient terminated therapy due to drug-related AE .Caspofungin is safe and effective for the treatment of invasive candidiasis and esophageal candidiasis in Chinese adults .