A multicentre, randomized, double-blind, placebo-controlled trial of primary cryptococcal meningitis prophylaxis in HIV-infected patients with severe immune deficiency
A multicentre, randomized, double-blind, placebo-controlled trial of primary cryptococcal meningitis prophylaxis in HIV-infected patients with severe immune deficiency
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DOI：
10.1111/j.1468-1293.2004.00201.x
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发表时间：
2004-05-01
期刊：
影响因子：
3
通讯作者：
Boonyaprawit, P
中科院分区：
文献类型：
--
作者：
Chetchotisakd, P;Sungkanuparph, S;Boonyaprawit, P
目的评价小剂量氟康唑（400 mg/周）对HIV感染者隐球菌脑膜炎（CNM）一级预防的疗效和生存益处。方法采用前瞻性、多中心、随机、双盲、安慰剂对照研究方法，对CD 4 <100个/pL的HIV感染者进行研究。两组的基线特征相似。在帐篷到治疗的基础上，10例隐球菌脑膜炎，氟康唑组3例（6.8%），安慰剂组7例（15.2%）。安慰剂组患者比氟康唑组患者更容易发生隐球菌性脑膜炎[风险比2.23; 95%置信区间（Cl）：0.58-8.63; P 0.245]。氟康唑的生存获益大于安慰剂。氟康唑组每10000人-天的死亡人数为2.7（2/7342），安慰剂组为11.7（9/7713）（率差9; 95% CI：0.4-17.5; P = 0.046）。根据生存分析，安慰剂组患者的死亡率是氟康唑组的4.3倍（95%CI：0.9-19.8; P = 0.065）。结论氟康唑400 mg，每周一次，作为泰国隐球菌脑膜炎的一级预防，应考虑在HIV感染患者中，我们的研究表明，生存的好处。然而，需要进行更大规模的研究来证实我们的发现。
Objectives To assess the efficacy and survival benefit of low-dose fluconazole (400 mg weekly) for primary prophylaxis for cryptococcal meningitis in patients with advanced HIV infection.Methods A prospective multicentre, randomized, double-blind, placebo-controlled study was carried out in HIV-infected patients with CD4 counts < 100cells/pL.Results Of 90 patients enrolled, 44 received fluconazole and 46 received placebo. The baseline characteristics were similar in the two groups. On an in tent-to-treat basis, 10 cases of cryptococcal meningitis developed, three (6.8%) in the fluconazole group and seven (15.2%) in the placebo group. Patients in the placebo group were more likely to develop cryptococcal meningitis than those in the fluconazole group [hazard ratio 2.23; 95% confidence interval (Cl): 0.58-8.63; P 0.245]. The survival benefit of fluconazole was greater than that of the placebo. The number of deaths per 10 000 person-days was 2.7 for the fluconazole group (2/7342) and 11.7 for the placebo group (9/7713) (rate difference 9; 95% Cl: 0.4-17.5; P = 0.046). Based on survival analysis, patients in the placebo group were 4.3 times more likely to die than those in the fluconazole group (95% CI: 0.9-19.8; P = 0.065).Conclusion Fluconazole 400 mg once weekly for primary prophylaxis for cryptococcal meningitis in Thailand should be considered in HIV-infected patients, as our study suggested a survival benefit. However, a larger study should be conducted to confirm our findings.