比较两性霉素B脂质体与两性霉素B用于治疗极低出生体重儿全身性念珠菌病的疗效。
A comparison of AmBisome to amphotericin B for treatment of systemic candidiasis in very low birth weight infants.
作者信息
Jeon Ga Won, Koo Soo Hyun, Lee Jang Hoon, Hwang Jong Hee, Kim Sung Shin, Lee Eun Kyung, Chang Wook, Chang Yun Sil, Park Won Soon
机构信息
Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-dong, Kangnam-gu, Seoul 135-710, Korea.
出版信息
Yonsei Med J. 2007 Aug 31;48(4):619-26. doi: 10.3349/ymj.2007.48.4.619.
PURPOSE
Amphotericin B is considered the treatment of choice for systemic candidiasis, but adverse effects may limit its use. An alternative option for the treatment of candidiasis includes lipid preparations of amphotericin B. This study investigated the safety and efficacy of AmBisome, a lipid formulation of amphotericin B containing liposomal structures, for the treatment of systemic candidiasis in very low birth weight infants (VLBWI).
MATERIALS AND METHODS
Data from 26 VLBWI treated with AmBisome in the study group (AmBisome group) from October 2003 to July 2006 were compared with data from 20 VLBWI treated with amphotericin B as a historical control (Amphotericin group). This study was a prospective, historical control, multi-center trial.
RESULTS
Candida spp. was isolated in 73% (19/26) of the cases for the AmBisome group and 90% (18/20) of the cases for the Amphotericin group. The fungal eradication rate and the time to eradication was 84% (16/19) and 9+/-8 days in the AmBisome group, and 89% (16/18) and 10+/-9 days in the Amphotericin group, respectively (p=0.680 vs p=0.712). The major adverse effects were lower in the AmBisome group (renal toxicity, 21% vs 55%, p=0.029; hepatotoxity, 25% vs 65%, p=0.014, AmBisome group vs Amphotericin group, respectively). There was no significant difference in mortality attributed to systemic candidiasis (12% in the AmBisome group, 10% in the Amphotericin group, p=0.868).
CONCLUSION
AmBisome is effective and safe for treating systemic fungal infections in VLBWI.
目的
两性霉素B被认为是系统性念珠菌病的首选治疗药物，但不良反应可能会限制其使用。治疗念珠菌病的另一种选择包括两性霉素B的脂质制剂。本研究调查了两性霉素B的脂质制剂安必素（含脂质体结构）治疗极低出生体重儿（VLBWI）系统性念珠菌病的安全性和有效性。
材料与方法
将2003年10月至2006年7月研究组中接受安必素治疗的26例极低出生体重儿（安必素组）的数据与20例接受两性霉素B治疗作为历史对照的极低出生体重儿（两性霉素组）的数据进行比较。本研究为前瞻性、历史对照、多中心试验。
结果
安必素组73%（19/26）的病例分离出念珠菌属，两性霉素组90%（18/20）的病例分离出念珠菌属。安必素组的真菌清除率和清除时间分别为84%（16/19）和9±8天，两性霉素组分别为89%（16/18）和10±9天（p=0.680对比p=0.712）。安必素组的主要不良反应较低（肾毒性，21%对比55%，p=0.029；肝毒性，25%对比65%，p=0.014，分别为安必素组对比两性霉素组）。系统性念珠菌病导致的死亡率无显著差异（安必素组为12%，两性霉素组为10%，p=0.868）。
结论
安必素治疗极低出生体重儿系统性真菌感染有效且安全。
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