Clerici C, Distrutti E, Gentili G, Solinas A, Miglietti M, Balò S, Giansanti M, Rusticali A G, Morselli-Labate A M, Morelli A
Clinica di Gastroenterologia ed Endoscopia Digestiva, Università degli Studi, Perugia.
Minerva Med. 1997 May;88(5):219-25.
The aim of as study was to ascertain whether the association of interferon alpha-2a and ursodeoxycholic acid (IFN+UDCA) was more efficacious in ameliorating liver parameters than interferon (IFN) alone in patients with chronic hepatitis C.
Forty-one chronic hepatitis C patients, who had at least twice the normal value of one transaminase, were randomly assigned to treatment with IFN + UDCA (n = 21) or IFN alone (n = 20). IFN was administered subcutaneously at a dose of 3 MU thrice weekly, UDCA orally at 10 mg/kg bw/day. IFN therapy was terminated 6 months later and the responders (normalized transaminases) of both groups were treated with UDCA alone for a further 12 months.
In the IFN + UDCA group there were 2 drop-outs from therapy and 11 responders, while in the IFN group they were, respectively, 3 and 10. Transaminases normalized after the first month of treatment in 7/11 responders with IFN + UDCA compared with 3/10 in the IFN responders group. The trend to normalization was more rapid with IFN + UDCA than with IFN alone (chi 2t = 3.95; p < 0.05). Disease relapse (defined as at least one transaminase > x 1.5 the normal value) was 3/11 in the IFN + UDCA group and 4/10 in the IFN group. 2/11 responders in the IFN + UDCA and 1/10 in the IFN group were HCV RNA negative by PCR. The total Knodell histological score decreased more in the IFN+UDCA than in the IFN group (-2.67 +/- 3.44. vs -1.67 +/- 2.16, mean +/- SD).
The administration of UDCA determine an earlier normalization-time of transaminases in the patients responders to IFN therapy and could be useful to reduce the relapse into disease after the IFN therapy.
本研究的目的是确定在慢性丙型肝炎患者中，干扰素α-2a与熊去氧胆酸联合使用（IFN+UDCA）在改善肝脏参数方面是否比单独使用干扰素（IFN）更有效。
41例慢性丙型肝炎患者，其转氨酶至少为正常值的两倍，被随机分配接受IFN+UDCA治疗（n = 21）或单独接受IFN治疗（n = 20）。IFN皮下注射，剂量为3 MU，每周三次，UDCA口服，剂量为10 mg/kg体重/天。6个月后终止IFN治疗，两组的应答者（转氨酶正常化）再单独接受UDCA治疗12个月。
IFN+UDCA组有2例退出治疗，11例应答者，而IFN组分别为3例和10例应答者。IFN+UDCA组7/11的应答者在治疗第一个月后转氨酶正常化，而IFN应答者组为3/10。与单独使用IFN相比，IFN+UDCA使转氨酶正常化的趋势更快（卡方检验t = 3.95；p < 0.05）。疾病复发（定义为至少一种转氨酶>正常值的1.5倍）在IFN+UDCA组为3/11，在IFN组为4/10。IFN+UDCA组2/11的应答者和IFN组1/10的应答者经PCR检测HCV RNA为阴性。IFN+UDCA组的总Knodell组织学评分比IFN组下降更多（-2.67±3.44对-1.67±2.16，均值±标准差）。
在对IFN治疗有应答的患者中，使用UDCA可使转氨酶更早正常化，并且可能有助于减少IFN治疗后疾病的复发。
