Amantadine therapy for chronic hepatitis C.
Amantadine therapy for chronic hepatitis C.
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金刚烷胺治疗慢性丙型肝炎。
DOI：
10.1111/j.1525-1497.2004.30057.x
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发表时间：
2004
影响因子：
5.7
通讯作者：
Kunselman,Allen
中科院分区：
文献类型：
--
作者：
Smith,JillP;Riley3rd,ThomasR;Devenyi,Attila;Bingaman,SandraI;Kunselman,Allen
目的：尽管丙型肝炎的治疗已经有所改善，但高达50%的丙型肝炎患者对干扰素标准治疗方案没有反应，或者由于副作用而不能耐受治疗。本研究的目的是评估抗病毒药物金刚烷胺治疗丙型肝炎的安全性和有效性，这些丙型肝炎患者以前干扰素治疗失败或不适合干扰素治疗。设计：前瞻性双盲随机安慰剂对照试验。单位：教学医院门诊部研究部。患者/参与者：152例确诊的丙型肝炎患者，肝酶异常，血液中检测到丙型肝炎RNA，肝组织活检异常，随机分为治疗组和安慰剂组。测量和主要结果：患者接受金刚烷胺100 mg，每日2次口服或安慰剂治疗，疗程6个月。6个月后，安慰剂组的患者被交叉使用金刚烷胺治疗6个月，金刚烷胺治疗的患者接受6个月的额外治疗。与安慰剂相比，金刚烷胺治疗导致血清丙氨酸转氨酶显著下降（P=.03）。9%的人在治疗结束时清除了病毒，6.8%的人在停用金刚烷胺6个月后有持续的病毒学反应，但这没有统计学意义。使用金刚烷胺12个月后，副作用最小，社会生活质量调查有所改善（P= 0.02）。结论：口服金刚烷胺可能为干扰素不耐受或无反应的患者提供一种安全的替代治疗。
OBJECTIVE:Although treatment of hepatitis C has improved, up to 50% do not respond to standard therapy with interferon regimes or cannot tolerate the treatment due to side effects. The purpose of the present investigation was to evaluate the safety and effectiveness of the antiviral drug amantadine for the treatment of hepatitis C in those who had either previously failed interferon therapy or were not candidates for interferon.DESIGN:A prospective double-blind randomized placebocontrolled trial.SETTING:Outpatient research clinic of a teaching hospital.PATIENTS/PARTICIPANTS:One hundred fifty-two patients with confirmed hepatitis C with abnormal liver enzymes, detectable hepatitis C RNA in the blood, and abnormal liver histology by biopsy were randomized to receive treatment or placebo.MEASUREMENTS AND MAIN RESULTS:Patients received either amantadine 100 mg twice daily by mouth or placebo for 6 months. After 6 months, placebo-treated patients were crossed over and treated with amantadine for 6 months and amantadine-treated subjects received 6 additional months of therapy. Amantadine therapy resulted in a significant decline in serum alanine aminotransferase compared to placebo (P=.03). Nine percent cleared the virus at the end of therapy and 6.8% had a sustained virologic response 6 months after discontinuation of amantadine, but this was not statistically significant. Side effects were minimal, and the social quality of life survey improved with 12 months of amantadine (P=.02).CONCLUSIONS:Oral amantadine may provide a safe alternative treatment for those patients who are intolerant or unresponsive to interferon.