Shindo M, Di Bisceglie A M, Cheung L, Shih J W, Cristiano K, Feinstone S M, Hoofnagle J H
National Institutes of Health, Bethesda, Maryland.
Ann Intern Med. 1991 Nov 1;115(9):700-4. doi: 10.7326/0003-4819-115-9-700.
To assess the effect of alpha-interferon therapy on hepatitis C viral RNA in serum of patients with chronic hepatitis C.
Retrospective testing for hepatitis C viral (HCV) RNA and antibody to the hepatitis C virus (anti-HCV) of stored serum samples from a randomized, double-blind, placebo-controlled trial of alpha-interferon therapy.
Warren Grant Magnuson Clinical Center of the National Institutes of Health, a tertiary referral center.
Forty-one patients with chronic non-A, non-B hepatitis were entered in this trial.
Twenty-one patients were treated with alpha-interferon, and 20 patients were treated with placebo for 6 months. Seventeen placebo recipients were then treated with alpha-interferon for up to 1 year.
Samples were tested for anti-HCV by enzyme-linked immunosorbent assay. Hepatitis C viral RNA was detected in serum using the polymerase chain reaction. Titers of both antibody and RNA were determined by serial end-point dilution.
At entry into the trial, 37 (90%) of 41 patients had anti-HCV and 39 (95%) had HCV RNA in serum. Anti-HCV titers decreased slightly with treatment. Serum levels of HCV RNA decreased in all patients who responded to alpha-interferon therapy with improvements in serum aminotransferases; in 17 of 21 responders (81%; 95% Cl, 58% to 95%) HCV RNA became undetectable. In contrast, in only 2 of 16 (12%; Cl, 2% to 38%) patients who did not respond to treatment did HCV RNA become undetectable. In 19 patients treated during the preliminary 6-month period with placebo, HCV RNA remained detectable. Finally, in the 11 patients who relapsed when treatment was stopped, HCV RNA reappeared in the serum, but in 4 of 7 patients with a sustained improvement in serum aminotransferases, HCV RNA remained undetectable.
These results indicate that the clinical and serum biochemical response to alpha-interferon in chronic hepatitis C is associated with a loss of detectable HCV genome from serum.
评估α-干扰素治疗对慢性丙型肝炎患者血清中丙型肝炎病毒RNA的影响。
对一项α-干扰素治疗的随机、双盲、安慰剂对照试验中储存的血清样本进行丙型肝炎病毒（HCV）RNA和丙型肝炎病毒抗体（抗-HCV）的回顾性检测。
国立卫生研究院沃伦·格兰特·马格努森临床中心，一家三级转诊中心。
41例慢性非甲非乙型肝炎患者进入该试验。
21例患者接受α-干扰素治疗，20例患者接受安慰剂治疗6个月。然后，17名接受安慰剂治疗的患者接受α-干扰素治疗长达1年。
采用酶联免疫吸附试验检测样本中的抗-HCV。使用聚合酶链反应检测血清中的丙型肝炎病毒RNA。通过系列终点稀释法测定抗体和RNA的滴度。
在试验开始时，41例患者中有37例（90%）抗-HCV阳性，39例（95%）血清中HCV RNA阳性。抗-HCV滴度随治疗略有下降。所有对α-干扰素治疗有反应且血清转氨酶改善的患者血清中HCV RNA水平均下降；21例有反应的患者中有17例（81%；95%可信区间，58%至95%）HCV RNA检测不到。相比之下，16例无反应患者中只有2例（12%；可信区间，2%至38%）HCV RNA检测不到。在初步6个月期间接受安慰剂治疗的19例患者中，HCV RNA仍可检测到。最后，在治疗停止后复发的11例患者中，血清中HCV RNA再次出现，但7例血清转氨酶持续改善的患者中有4例HCV RNA检测不到。
这些结果表明，慢性丙型肝炎患者对α-干扰素的临床和血清生化反应与血清中可检测到的HCV基因组缺失有关。
