Chavanet P Y, Garry I, Charlier N, Caillot D, Kisterman J P, D'Athis M, Portier H
Service des Maladies Infectieuses, Hopital du Bocage, Dijon, France.
BMJ. 1992 Oct 17;305(6859):921-5. doi: 10.1136/bmj.305.6859.921.
To compare the tolerance, efficacy, and pharmacokinetics of amphotericin deoxycholate (Fungizone) prepared in a parenteral fat emulsion (Intralipid 20%) or glucose in HIV patients with candidiasis.
Non-blind randomised controlled trial.
University hospital; tertiary clinical care.
22 HIV positive patients with oral candidiasis.
Amphotericin 1 mg/kg/day given on four consecutive days as a one hour infusion dissolved in either 5% glucose (amphotericin-glucose) or parenteral fat emulsion at a final concentration of 2 g/l fat emulsion (amphotericin-fat emulsion).
Clinical tolerance (fever, chills, sweats, nausea, arterial pressure, and pulse rate); biological tolerance (serum creatinine, electrolyte, and magnesium values); clinical score of candidiasis; and serum concentrations of amphotericin.
11 patients were enrolled in each group. All the amphotericin-fat emulsion infusions were given without serious problem whereas four amphotericin-glucose infusions were stopped because of renal impairment (n = 3) or severe chills (n = 2), or both. For patients completing the amphotericin-glucose treatment creatine concentration increased by 42 mumol/l; four of seven patients had at least one creatinine value > or = 133 mumol/l versus one of 11 receiving amphotericin-fat emulsion. Magnesium concentration fell significantly with amphotericin-glucose but not with amphotericin-fat emulsion. Clinical side effects were noted in 36/38 infusions with amphotericin-glucose but 10/44 with amphotericin-fat emulsion. Oral candidiasis score was reduced similarly in both groups. Serum amphotericin concentrations were significantly lower and the volume of distribution of the drug higher after infusion of amphotericin-fat emulsion than after amphotericin-glucose.
Clinical and renal toxicity of amphotericin are reduced when the drug is prepared in fat emulsion. Preparation is simple and cost effective. Its efficacy is similar to that of conventional amphotericin.
比较在接受肠外脂肪乳剂（英脱利匹特20%）或葡萄糖中制备的去氧胆酸盐两性霉素（两性霉素B）对念珠菌病HIV患者的耐受性、疗效和药代动力学。
非盲随机对照试验。
大学医院；三级临床护理。
22例患有口腔念珠菌病的HIV阳性患者。
两性霉素1mg/kg/天，连续四天给药，以一小时输注的方式溶解于5%葡萄糖（两性霉素 - 葡萄糖组）或最终浓度为2g/l脂肪乳剂的肠外脂肪乳剂中（两性霉素 - 脂肪乳剂组）。
临床耐受性（发热、寒战、出汗、恶心、动脉压和脉搏率）；生物学耐受性（血清肌酐、电解质和镁值）；念珠菌病临床评分；以及两性霉素血清浓度。
每组纳入11例患者。所有两性霉素 - 脂肪乳剂输注均无严重问题，而4次两性霉素 - 葡萄糖输注因肾功能损害（n = 3）或严重寒战（n = 2）或两者而停止。对于完成两性霉素 - 葡萄糖治疗的患者，肌酐浓度升高42μmol/l；7例患者中有4例至少有一次肌酐值≥133μmol/l，而接受两性霉素 - 脂肪乳剂的11例患者中有1例。两性霉素 - 葡萄糖组镁浓度显著下降，而两性霉素 - 脂肪乳剂组未下降。两性霉素 - 葡萄糖组38次输注中有36次出现临床副作用，而两性霉素 - 脂肪乳剂组44次输注中有10次。两组口腔念珠菌病评分均有类似降低。两性霉素 - 脂肪乳剂输注后血清两性霉素浓度显著低于两性霉素 - 葡萄糖输注后，且药物分布容积更高。
当两性霉素在脂肪乳剂中制备时，其临床和肾毒性降低。制备简单且具有成本效益。其疗效与传统两性霉素相似。
