Techapornroong Malee, Suankratay Chusana
Department of Medicine, Division of Infectious Diseases, Chulalongkorn University, Bangkok, Thailand.
Scand J Infect Dis. 2007;39(10):896-901. doi: 10.1080/00365540701383147.
Animal studies and case series have demonstrated the dose-dependent efficacy and long half-life of amphotericin B deoxycholate (ABd), providing the rationale for our randomized controlled study to compare once-daily (OD) (1 mg/kg) and alternate-d (AD) (2 mg/kg) administration of ABd in the treatment of cryptococcal meningitis in patients with AIDS hospitalized at King Chulalongkorn Memorial Hospital, Thailand, from 2003 to 2004. Of 28 patients, 15 and 13 received OD and AD administration, respectively. There was no significant difference between the 2 groups regarding the demography, clinical features, and laboratory data. After 2 weeks of the intensive-phase treatment, there was no significant difference in the clinical response between the OD (80%) and AD (76.9%) groups. Mycological response was observed in 33.3% and 10% of patients in the OD and AD groups, respectively (p = 0.3). There was no difference in nephrotoxicity and infusion-related events. In conclusion, this is the first randomized controlled study comparing OD and AD administration of ABd in the treatment of cryptococcal meningitis. Although our study was not sufficiently powered to draw conclusions on clinical efficacy and toxicities, the results are encouraging and should warrant further clinical trials evaluating the efficacy and adverse effects with a larger sample size.
动物研究和病例系列已证明去氧胆酸两性霉素B（ABd）具有剂量依赖性疗效和较长的半衰期，这为我们的随机对照研究提供了理论依据，该研究旨在比较2003年至2004年在泰国朱拉隆功国王纪念医院住院的艾滋病患者隐球菌性脑膜炎治疗中，每日一次（OD）（1mg/kg）和隔日一次（AD）（2mg/kg）给予ABd的疗效。28例患者中，分别有15例和13例接受OD和AD给药。两组在人口统计学、临床特征和实验室数据方面无显著差异。强化治疗2周后，OD组（80%）和AD组（76.9%）的临床反应无显著差异。OD组和AD组分别有33.3%和10%的患者出现真菌学反应（p=0.3）。肾毒性和输液相关事件无差异。总之，这是第一项比较OD和AD给予ABd治疗隐球菌性脑膜炎的随机对照研究。尽管我们的研究样本量不足以就临床疗效和毒性得出结论，但结果令人鼓舞，应该进行进一步的临床试验，以更大的样本量评估疗效和不良反应。
