在初治慢性丙型肝炎患者中，干扰素、利巴韦林与金刚烷胺联用对比干扰素、利巴韦林与安慰剂联用的随机、双盲、安慰剂对照试验。
Randomised, double blind, placebo controlled trial of interferon, ribavirin, and amantadine versus interferon, ribavirin, and placebo in treatment naïve patients with chronic hepatitis C.
作者信息
Thuluvath P J, Maheshwari A, Mehdi J, Fairbanks K D, Wu L L-W, Gelrud L G, Ryan M J, Anania F A, Lobis I F, Black M
机构信息
Division of Gastroenterology and Hepatology, the Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA.
出版信息
Gut. 2004 Jan;53(1):130-5. doi: 10.1136/gut.53.1.130.
BACKGROUND AND AIM
In this study, we compared the efficacy of triple therapy (interferon alfa, ribavirin, and amantadine) with standard therapy (interferon alfa and ribavirin) in treatment naïve patients with chronic hepatitis C virus (HCV).
METHODS
In this prospective, randomised, double blind, placebo controlled, multicentre study, 85 patients (amantadine group) received a three drug regimen of interferon alfa-2b 3 million units three times per week, ribavirin 1000-1200 mg daily in divided doses, and amantadine 100 mg twice daily, and 86 patients (placebo group) received interferon alfa-2b, ribavirin, and identical placebo. Treatment was discontinued at 24 weeks if patients had detectable HCV RNA by polymerase chain reaction (PCR). All patients were followed for 24 weeks after completion of treatment. The primary end point was undetectable HCV-RNA by PCR at 24 weeks (sustained viral clearance) after completion of treatment.
RESULTS
At the end of treatment, HCV RNA clearance was seen in 32.9% of the amantadine group and 38.4% of the placebo group (p=0.3). Sustained virological response was seen in 24.7% of the amantadine group and in 27.9% of the placebo group by intention to treat analysis; response rate was 30.4% and 34.8%, respectively, in those who completed 24 weeks of treatment. Poor response was seen in both groups among cirrhotics, African-Americans, genotype 1, and those with a higher viral load. By multivariate analysis, genotype 1, high viral load, and low serum albumin were the only predictors of poor response. Addition of amantadine to the standard regimen did not result in any unexpected side effects.
CONCLUSION
Response to triple therapy of interferon alfa, ribavirin, and amantadine was similar to standard therapy of interferon alfa and ribavirin. Our results suggest that amantadine has no role in the management of HCV.
背景与目的
在本研究中，我们比较了三联疗法（干扰素α、利巴韦林和金刚烷胺）与标准疗法（干扰素α和利巴韦林）对初治慢性丙型肝炎病毒（HCV）患者的疗效。
方法
在这项前瞻性、随机、双盲、安慰剂对照、多中心研究中，85例患者（金刚烷胺组）接受了一种三联药物方案，即干扰素α-2b 300万单位，每周3次，利巴韦林1000 - 1200mg，每日分剂量服用，金刚烷胺100mg，每日2次；86例患者（安慰剂组）接受干扰素α-2b、利巴韦林和相同的安慰剂。如果患者在24周时通过聚合酶链反应（PCR）检测到HCV RNA，则停止治疗。所有患者在完成治疗后随访24周。主要终点是治疗完成后24周时通过PCR检测不到HCV - RNA（持续病毒清除）。
结果
治疗结束时，金刚烷胺组32.9%的患者出现HCV RNA清除，安慰剂组为38.4%（p = 0.3）。在意向性分析中，金刚烷胺组24.7%的患者出现持续病毒学应答，安慰剂组为27.9%；在完成24周治疗的患者中，应答率分别为30.4%和34.8%。在肝硬化患者、非裔美国人、基因1型患者以及病毒载量较高的患者中，两组的应答均较差。通过多变量分析，基因1型、高病毒载量和低血清白蛋白是应答较差的唯一预测因素。在标准方案中添加金刚烷胺未导致任何意外的副作用。
结论
干扰素α、利巴韦林和金刚烷胺的三联疗法的应答与干扰素α和利巴韦林的标准疗法相似。我们的结果表明金刚烷胺在HCV的治疗中没有作用。
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