Kiso S, Kawata S, Tamura S, Imai Y, Inui Y, Nagase T, Maeda Y, Yamasaki E, Tsushima H, Igura T, Himeno S, Seki K, Matsuzawa Y
Second Department of Internal Medicine, Osaka University Medical School, Japan.
J Gastroenterol. 1997 Feb;32(1):56-62. doi: 10.1007/BF01213297.
The efficacy of interferon-alpha therapy in the treatment of chronic hepatitis C is still limited. A combination therapy of interferon-alpha with ursodeoxycholic acid (UDCA) was tested for its efficacy in the treatment of chronic hepatitis C by a randomized controlled study. Eighty consecutive Japanese patients with chronic hepatitis C were randomly divided into two groups: one group was treated with interferon-alpha (group A, n = 40) and the other with a combination of interferon-alpha and UDCA (group B, n = 40). In both groups, human interferon-alpha (6 million units per day) was intramuscularly injected daily for 2 weeks and then three times a week for 22 weeks: this 24-week period was followed by 24 weeks of observation. In group B, UDCA was also administered, daily at a dose of 600 mg orally, from the beginning of the interferon therapy and administration was continued for 48 weeks. The rates for ALT normalization and clearance of hepatitis C virus (HCV) viremia at the end of the 24-week interferon therapy were similar for groups A and B (58% vs 60% and 55% vs 48%, respectively). At the end of the 24-week follow-up, the sustained normalization rates for ALT levels for the two groups were not different (35% vs 43%), while the rate of clearance was higher in group B (40%) than in group A (23%), but the difference was not significant (P = 0.14). The sustained complete response, i.e., HCV RNA negativity at the end of the follow-up, as well as the maintenance of ALT normalization during the follow-up period, was more frequent in group B (38%) than in group A (18%) although the difference was not significant (P = 0.08). The rate of HCV reactivation after interferon was discontinued was significantly lower in group B (16%) than in group A (59%) (P < 0.01). Although this combination therapy did not lead to a sufficiently sustained complete response, it could serve as adjuvant antiviral therapy when a suitable dosage and administration period are determined.
α-干扰素疗法在慢性丙型肝炎治疗中的疗效仍然有限。通过一项随机对照研究，对α-干扰素与熊去氧胆酸（UDCA）联合疗法治疗慢性丙型肝炎的疗效进行了测试。80例连续的日本慢性丙型肝炎患者被随机分为两组：一组接受α-干扰素治疗（A组，n = 40），另一组接受α-干扰素与UDCA联合治疗（B组，n = 40）。两组均每日肌肉注射人α-干扰素（每日600万单位），持续2周，然后每周3次，持续22周：这24周疗程之后是24周的观察期。在B组中，从干扰素治疗开始就同时口服UDCA，每日剂量为600 mg，并持续给药48周。在24周干扰素治疗结束时，A组和B组的谷丙转氨酶（ALT）正常化率和丙型肝炎病毒（HCV）血症清除率相似（分别为58%对60%和55%对48%）。在24周随访结束时，两组ALT水平的持续正常化率没有差异（35%对43%），而B组的清除率（40%）高于A组（23%），但差异不显著（P = 0.14）。持续完全缓解，即在随访结束时HCV RNA阴性，以及在随访期间维持ALT正常化，在B组（38%）比A组（18%）更常见，尽管差异不显著（P = 0.08）。停用干扰素后HCV再激活率在B组（16%）显著低于A组（59%）（P < 0.01）。虽然这种联合疗法没有导致足够的持续完全缓解，但当确定合适的剂量和给药期时，它可以作为辅助抗病毒疗法。
