Ellis M E, Alfurayh O, Halim M A, Sieck J O, Ali M A, Bernvil S S, Ali H, Barri Y, Ayub A, al-Fadda M
Department of Medicine, King Faisal Specialist Hospital and Research Centre, Riyadh, Kingdom of Saudi Arabia.
J Hepatol. 1993 Jun;18(2):210-6. doi: 10.1016/s0168-8278(05)80248-x.
Chronic non-A, non-B hepatitis occurs in 50% of Saudi patients with end-stage renal failure and requires long-term hemodialysis since it is a contraindication to renal transplantation. Thirteen patients with biochemical and histological documented chronic non-A, non-B hepatitis (11 with HCV antibodies) entered a double-blind placebo controlled cross-over study, in which Roferon A 3 MU or placebo were administered subcutaneously 3 times weekly after hemodialysis for 6 months. The mean ALT fell significantly from pretreatment levels of 74.7 (95% confidence interval (CI) 54.7, 92.5) (13 patients in the 6-month run-in period) and 66.8 (CI 47.7, 85.8) (7 patients in the run-in period + 6 patients in the placebo period) (difference NS) to 37.6 (CI 21.0, 54.2) during interferon treatment (P < 0.005). In 10/13 patients (77%) ALT levels became normal. In the 6-month follow-up period immediately after therapy, the mean ALT was 45.2 (CI 28.0, 62.0). Although this change was not significant (P = 0.49), only 7 of these 10 patients sustained biochemical remission in the 6-month follow-up period. The corresponding total Histological Activity Index improved from 8.9 (CI 7.5, 10.3), 8.9 (CI 7.2, 10.7) (difference NS) to 6.2 (CI 3.9, 8.5) (P < 0.05; P = 0.052, respectively). Intralobular inflammation and periportal inflammation showed the most significant changes. Five of 13 (39%) and 2/13 patients (15%) had complete resolution of piecemeal necrosis and intralobular inflammation, respectively. Toxic effects of interferon were mild, early and self-limiting.(ABSTRACT TRUNCATED AT 250 WORDS)
在沙特终末期肾衰竭患者中,50%会发生慢性非甲非乙型肝炎,由于其是肾移植的禁忌证,所以需要长期进行血液透析。13例有生化和组织学证据支持的慢性非甲非乙型肝炎患者(11例有丙肝抗体)进入了一项双盲安慰剂对照交叉研究,研究中在血液透析后每周皮下注射3次罗扰素A 3 MU或安慰剂,持续6个月。平均丙氨酸转氨酶(ALT)从治疗前水平显著下降,在6个月导入期的13例患者中为74.7(95%置信区间(CI)54.7, 92.5),在导入期的7例患者加安慰剂期的6例患者中为66.8(CI 47.7, 85.8)(差异无统计学意义),在干扰素治疗期间降至37.6(CI 21.0, 54.2)(P < 0.005)。13例患者中有10例(77%)ALT水平恢复正常。在治疗后的6个月随访期,平均ALT为45.2(CI 28.0, 62.0)。虽然这一变化无统计学意义(P = 0.49),但这10例患者中只有7例在6个月随访期维持生化缓解。相应的总组织学活动指数从8.9(CI 7.5, 10.3)、8.9(CI 7.2, 10.7)(差异无统计学意义)改善至6.2(CI 3.9, 8.5)(分别为P < 0.05;P = 0.052)。小叶内炎症和汇管区炎症变化最为显著。13例患者中有5例(39%)和2例(15%)的桥接坏死和小叶内炎症分别完全消退。干扰素的毒性作用轻微、出现早且为自限性。(摘要截短于250词)