Liposomal amphotericin B (AmBisome) compared with amphotericin B both followed by oral fluconazole in the treatment of AIDS-associated cryptococcal meningitis
Liposomal amphotericin B (AmBisome) compared with amphotericin B both followed by oral fluconazole in the treatment of AIDS-associated cryptococcal meningitis
复制标题
DOI：
10.1097/00002030-199712000-00010
复制
发表时间：
1997-10-01
期刊：
影响因子：
3.8
通讯作者：
deMarie, S
中科院分区：
文献类型：
--
作者：
Leenders, ACAP;Reiss, P;deMarie, S
目的：两性霉素B脱氧胆酸盐初始治疗和氟康唑维持治疗是艾滋病相关隐球菌脑膜炎的治疗选择。然而，阿替霉素B的给药与相当大的毒性有关。一个潜在的策略，减少毒性和增加的治疗指数的阿替西霉素B是使用脂质制剂的这种drug.Design和方法：HIV感染的隐球菌脑膜炎患者随机治疗与脂质体阿替西霉素B（AmBisome）4毫克/公斤，每天或标准阿替西霉素B 0.7毫克/公斤，每天3周，随后氟康唑400毫克，每天7周。在前3周，每天评估临床疗效。结果：在28例可评价的患者中，15例接受AmBisome治疗，13例接受阿替霉素B治疗。基线特征相当。两组的至临床应答时间和临床应答率相同。AmBisome治疗导致6/15例患者在7天内CSF培养转化，而1/12例接受阿替霉素B治疗的患者在7天内CSF培养转化（P= 0.09），15例AmBisome患者中有10例在14天内，而9例阿替霉素B患者中有1例在14天内15名AmBisome患者中有11名在21天内对8名阿替霉素B患者中有3名在21天内（P = 0.01）。当使用Kaplan-Meier估计值比较CSF培养转化时间时，AmBisome更有效（P< 0.05; AmBisome的中位时间为7 - 14天，而阿替西霉素B> 21天）。AmBisome是显着减少nephrotoxic.Conclusions：一个为期3周的过程中，4毫克/公斤AmBisome导致在一个显着更早的CSF培养转换比0.7毫克/公斤阿替霉素B，具有相同的临床疗效，并显着减少肾毒性时，用于治疗艾滋病相关的隐球菌性脑膜炎的原发性发作。
Objective: Amphotericin B deoxycholate initial therapy and fluconazole maintenance therapy is the treatment of choice for AIDS-associated cryptococcal meningitis. However, the administration of amphotericin B is associated with considerable toxicity. A potential strategy for reducing the toxicity and increasing the therapeutic index of amphotericin B is the use of lipid formulations of this drug.Design and methods: HIV-infected patients with cryptococcal meningitis were randomized to treatment with either liposomal amphotericin B (AmBisome) 4 mg/kg daily or standard amphotericin B 0.7 mg/kg daily for 3 weeks, each followed by fluconazole 400 mg daily for 7 weeks. During the first 3 weeks, clinical efficacy was assessed daily. Mycological response was primarily evaluated by cerebrospinal fluid (CSF) cultures at days 7, 14, 21 and 70.Results: Of the 28 evaluable patients, 15 were assigned to receive AmBisome and 13 to receive amphotericin B. Baseline characteristics were comparable. The time to and the rate of clinical response were the same in both arms. AmBisome therapy resulted in a CSF culture conversion within 7 days in six out of 15 patients versus one out of 12 amphotericin B-treated patients (P= 0.09), within 14 days in 10 out of 15 AmBisome patients versus one out of nine amphotericin B patients (P= 0.01), and within 21 days in 11 out of 15 AmBisome patients versus three out of eight amphotericin B patients (P= 0.19). When Kaplan-Meier estimates were used to compare time to CSF culture conversion, AmBisome was more effective (P< 0.05; median time between 7 and 14 days for AmBisome versus > 21 days for amphotericin B). AmBisome was significantly less nephrotoxic.Conclusions: A 3-week course of 4 mg/kg AmBisome resulted in a significantly earlier CSF culture conversion than 0.7 mg/kg amphotericin B, had equal clinical efficacy and was significantly less nephrotoxic when used for the treatment of primary episodes of AIDS-associated cryptococcal meningitis.