ITRACONAZOLE COMPARED WITH AMPHOTERICIN-B PLUS FLUCYTOSINE IN AIDS PATIENTS WITH CRYPTOCOCCAL MENINGITIS
ITRACONAZOLE COMPARED WITH AMPHOTERICIN-B PLUS FLUCYTOSINE IN AIDS PATIENTS WITH CRYPTOCOCCAL MENINGITIS
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DOI：
10.1097/00002030-199202000-00007
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发表时间：
1992-02-01
期刊：
影响因子：
3.8
通讯作者：
STAM, J
中科院分区：
文献类型：
--
作者：
DEGANS, J;PORTEGIES, P;STAM, J
目的：我们进行了伊曲康唑与阿替霉素B加氟胞嘧啶在艾滋病隐球菌脑膜炎患者的初始治疗中的比较，并确定了伊曲康唑作为维持治疗的疗效。设计：该试验是一项前瞻性随机非盲研究。设置：该研究在荷兰阿姆斯特丹的一个艾滋病学术中心进行。患者，参与者：28例HIV-1血清阳性男性隐球菌脑膜炎的推定诊断，随机1987年2月5日和1990年1月1日之间，纳入分析。干预措施：口服伊曲康唑（200 mg，每日两次），与阿替霉素B相比（每日0.3 mg/kg）静脉给药+口服氟胞嘧啶（150 mg/kg/d）给药6周，随后口服伊曲康唑维持治疗（200 mg/d）。主要结果指标：结果指标为完全或部分缓解、复发和复发。在完成伊曲康唑初始治疗6周的12名患者中，有5名患者观察到完全缓解，而在完成阿替霉素B+氟胞嘧啶治疗的所有10名患者中观察到完全缓解（P = 0.009）。 在分配至伊曲康唑组的14例患者中，7例观察到部分缓解。 在维持治疗期间，12名最初接受伊曲康唑治疗的患者中有7名出现复发（n = 6）或复发（n = 1），而9名最初接受阿替霉素B联合氟胞嘧啶治疗的患者中有2名出现复发（P = 0.22）;临床症状复发与6周时脑脊液培养阳性显著相关结论：伊曲康唑对AIDS合并隐球菌脑膜炎患者的初治完全缓解率低于阿替霉素B联合氟胞嘧啶。
Objective: We conducted a comparison of itraconazole versus amphotericin B plus flucytosine in the initial treatment of cryptococcal meningitis is patients with AIDS and established the efficacy of itraconazole as maintenance treatment.Design: The trial was a prospective randomized, and non-blinded study.Setting: The study was performed at an academic centre for AIDS, Amsterdam, The Netherlands.Patients, participants: Twenty-eight HIV-1-seropositive men with a presumptive diagnosis of cryptococcal meningitis, randomized between 5 February 1987 and 1 January 1990, were included for analysis. Interventions: Oral itraconazole (200 mg twice daily), versus amphotericin B (0.3 mg/kg daily) intravenously plus oral flucytosine (150 mg/kg daily) was administered for 6 weeks followed by maintenance therapy with oral itraconazole (200 mg daily) to all patients.Main outcome measures: Outcome measures were a complete or partial response recrudescence and relapse.Results: A complete response was observed in five out of the 12 patients who completed 6 weeks of initial treatment with itraconazole versus all 10 patients who completed treatment with amphotericin B plus flucytosine (P = 0.009). A partial response was observed in seven out of the 14 patients assigned to itraconazole. During maintenance therapy, recrudescence (n = 6) or relapse (n = 1) occurred in seven out of the 12 patients initially assigned to itraconazole, whereas two relapses occurred among nine patients initially treated with amphotericin B plus flucytosine (P = 0.22); recurrence of clinical symptoms was significantly related to a positive cerebrospinal fluid culture at 6 weeks (P = 0.003).Conclusion: Itraconazole is less effective compared with amphotericin B plus flucytosine in achieving a complete response in initial therapy in AIDS patients with cryptococcal meningitis.