Di Bisceglie A M, Conjeevaram H S, Fried M W, Sallie R, Park Y, Yurdaydin C, Swain M, Kleiner D E, Mahaney K, Hoofnagle J H
Liver Diseases Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Ann Intern Med. 1995 Dec 15;123(12):897-903. doi: 10.7326/0003-4819-123-12-199512150-00001.
To evaluate ribavirin, an oral antiviral agent, as therapy for chronic hepatitis C.
Randomized, double-blind, placebo-controlled study.
Clinical Center of the National Institutes of Health, a tertiary referral research hospital.
29 patients with chronic hepatitis C who received oral ribavirin (600 mg twice daily) for 12 months and 29 controls with chronic hepatitis C who received placebo for 12 months.
Effects of therapy were evaluated by measuring serum aminotransferase and hepatitis C virus (HCV) RNA levels before, during, and for 6 months after therapy and by histologic examination of liver specimens before and at the end of treatment.
Patients treated with ribavirin had a prompt decrease in serum aminotransferase levels (54% overall) compared with levels before treatment and levels in controls (5% decrease). Serum aminotransferase levels became normal or nearly normal in 10 patients treated with ribavirin (35% [95% CI, 18% to 54%]) but in no controls (0% [CI, 0% to 12%]). Aminotransferase levels remained normal in only 2 patients after ribavirin therapy was discontinued (7% [CI, 1% to 23%]). Serum HCV RNA levels did not change during or after therapy. Liver biopsy specimens showed a decrease in hepatic inflammation and necrosis among ribavirin-treated patients whose aminotransferase levels became normal.
Ribavirin has beneficial effects on serum aminotransferase levels and histologic findings in the liver in patients with chronic hepatitis C, but these effects are not accompanied by changes in HCV RNA levels and are not sustained when ribavirin therapy is discontinued. Thus, ribavirin alone for periods as long as 12 months is unlikely to be of value as therapy for chronic hepatitis C.
评估口服抗病毒药物利巴韦林对慢性丙型肝炎的治疗效果。
随机、双盲、安慰剂对照研究。
国立卫生研究院临床中心，一家三级转诊研究医院。
29例慢性丙型肝炎患者接受口服利巴韦林（每日两次，每次600毫克）治疗12个月，29例慢性丙型肝炎对照患者接受安慰剂治疗12个月。
通过在治疗前、治疗期间以及治疗后6个月测量血清转氨酶和丙型肝炎病毒（HCV）RNA水平，并在治疗前和治疗结束时对肝脏标本进行组织学检查，来评估治疗效果。
与治疗前水平及对照组水平（下降5%）相比，接受利巴韦林治疗的患者血清转氨酶水平迅速下降（总体下降54%）。10例接受利巴韦林治疗的患者血清转氨酶水平恢复正常或接近正常（35% [95%可信区间，18%至54%]），而对照组无一例（0% [可信区间，0%至12%]）。停用利巴韦林治疗后，只有2例患者转氨酶水平仍保持正常（7% [可信区间，1%至23%]）。治疗期间及治疗后血清HCV RNA水平未发生变化。肝活检标本显示，转氨酶水平恢复正常的利巴韦林治疗患者肝脏炎症和坏死有所减轻。
利巴韦林对慢性丙型肝炎患者的血清转氨酶水平和肝脏组织学表现有有益影响，但这些影响并未伴随HCV RNA水平的变化，且在停用利巴韦林治疗后效果不能持续。因此，单独使用利巴韦林长达12个月作为慢性丙型肝炎的治疗方法可能没有价值。
