Interferon and ursodeoxycholic acid combined therapy in the treatmet of chronic viral C hepatitis: Results from a controlled randomized trial in 80 patients
Interferon and ursodeoxycholic acid combined therapy in the treatmet of chronic viral C hepatitis: Results from a controlled randomized trial in 80 patients
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干扰素和熊去氧胆酸联合治疗慢性病毒性丙型肝炎：80 例患者随机对照试验的结果
作者：
E. Boucher;H. Jouanolle;P. André;A. Ruffault;D. Guyader;R. Moirand;B. Turlin;C. Jacquelinet;P. Brissot;Y. Deugnier
由于70%-75%的慢性丙型肝炎患者在干扰素（IFN）治疗后无应答或复发，并且熊去氧胆酸（UDCA）已被证明可降低慢性肝炎患者的转氨酶水平，我们在80例慢性丙型肝炎患者中进行了一项IFN（I组）与IFN + UDCA（II组）的前瞻性对照随机试验。两组均给予IFN 6个月（300 - 500万单位[MU]，每周3次），第II组给予UDCA（10 mg/kg/d）和IFN，然后单独给药3个月。对治疗的反应被定义为丙氨酸转氨酶（ALT）水平的正常化。结果表明，6个月后停止干扰素，59%的反应者复发，在第一组，但只有27%复发，在第二组（P = 0.03）。两组间对IFN的初始（6个月）和晚期（15个月和18个月）应答率无差异。在IFN治疗中加入UDCA没有引起病毒学效应或显著的组织学改善。总之，本研究的结果表明，在IFN治疗基础上加用UDCA可显著延长停用IFN后血清ALT保持在正常范围内的时间。需要进一步研究以确定UDCA是否具有长期改善丙型肝炎病毒（HCV）感染引起的肝脏疾病组织学严重程度的潜力，因此，是否可以提倡将其作为抗病毒治疗的辅助治疗。（《肝脏学》1995年;21：322-327）
Because 70% to 75% of patients with chronic hepatitis C either do not respond to or relapse after interferon (IFN) therapy, and because ursodeoxycholic acid (UDCA) has been shown to reduce aminotransferase levels in patients with chronic hepatitis, we undertook a prospective controlled randomized trial of IFN (group I) versus IFN plus UDCA (group II) in 80 patients with chronic hepatitis C. IFN was administered in both groups for 6 months (3 to 5 million units [MU] three times a week), and in group II UDCA (10 mg/kg/d) was administered with IFN and then alone for 3 additional months. Response to therapy was defined as the normalization of alanine transaminase (ALT) levels. The results showed that 6 months after cessation of IFN, 59% of responders had relapsed in group I but only 27% had relapsed in group II (P = .03). There was no difference between the two groups for the initial (month 6) and the late (months 15 and 18) response rates to IFN. There was no virological effect or significant histological improvement attributable to the addition of UDCA to IFN treatment. In conclusion, the results of this study show that the addition of UDCA to IFN therapy significantly prolongs the period for which serum ALT remain, within the normal range after discontinuation of IFN. Further studies would be required to determine whether UDCA has any potential for long‐term amelioration of the histological severity of liver disease caused by hepatitis C virus (HCV) infection, and therefore, whether it could be advocated as an adjunct to antiviral therapy. (HEPATOLOGY 1995;21:322–327.)