Recombinant interferon-γ1b as adjunctive therapy for AIDS-related acute cryptococcal meningitis
Recombinant interferon-γ1b as adjunctive therapy for AIDS-related acute cryptococcal meningitis
复制标题
DOI：
10.1086/420829
复制
发表时间：
2004-06-15
影响因子：
6.4
通讯作者：
Hsu, HH
中科院分区：
文献类型：
--
作者：
Pappas, PG;Bustamante, B;Hsu, HH
我们进行了一项2期、双盲、安慰剂对照研究，以评估佐剂重组干扰素(rIFN)-gamma1b在获得性免疫缺陷综合征和急性隐球菌性脑膜炎患者中的安全性和抗真菌活性。患者接受100或200杯rIFN-gamma1b或安慰剂治疗，每周3次，持续10周，加上静脉注射两性霉素B（含或不含氟胞嘧啶）的标准治疗，随后接受氟康唑治疗。终点包括2周脑脊液真菌培养从阳性到阴性的转化，症状的缓解和生存。在75名患者中，13%的安慰剂受体、36%的rIFN-gamma1b（100马克杯）受体和32%的rIFN-gamma1b（200马克杯）受体发生了2周的培养转化。rIFN-gamma1b受体的真菌学和临床成功率有提高的趋势（26%对8%；P = 0.078）。使用rIFN-gamma1b治疗耐受性良好，对CD4细胞计数和人类免疫缺陷病毒载量测量没有明显影响。用rIFN-gamma1b辅助治疗急性隐球菌脑膜炎患者有希望，值得进一步研究。
We conducted a phase 2, double-blind, placebo-controlled study to evaluate the safety and antifungal activity of adjuvant recombinant interferon (rIFN)-gamma1b in patients with acquired immunodeficiency syndrome and acute cryptococcal meningitis. Patients received 100 or 200 mug of rIFN-gamma1b or placebo, thrice weekly for 10 weeks, plus standard therapy with intravenous amphotericin B, with or without flucytosine, followed by therapy with fluconazole. End points included conversion of cerebrospinal fluid fungal cultures from positive to negative at 2 weeks, resolution of symptoms, and survival. Among 75 patients, 2-week culture conversion occurred in 13% of placebo recipients, 36% of rIFN-gamma1b (100 mug) recipients, and 32% of rIFN-gamma1b (200 mug) recipients. There was a trend toward improved combined mycologic and clinical success in rIFN-gamma1b recipients (26% vs. 8%; P = .078). Therapy with rIFN-gamma1b was well tolerated, and there was no apparent influence on serial CD4 cell counts and human immunodeficiency virus load measurements. Adjunctive therapy with rIFN-gamma1b holds promise for patients with acute cryptococcal meningitis and warrants further study.