Sangiovanni A, Morales R, Spinzi G, Rumi M, Casiraghi A, Ceriani R, Colombo E, Fossati M, Prada A, Tavani E, Minoli G
Division of Medicine, Valduce Hospital, Como, Italy.
Hepatology. 1998 Mar;27(3):853-6. doi: 10.1002/hep.510270330.
Most patients with serum hepatitis C virus (HCV) RNA and persistently normal alanine transaminase (ALT) levels show histological features of mild to moderately active chronic hepatitis. Some cirrhosis has also been reported. To assess whether interferon (IFN) treatment led to long-term HCV suppression in these patients, 31 previously untreated patients (15 men, 16 women; mean age, 44 years) with serum HCV RNA, persistently normal ALT levels on at least four consecutive occasions 2 months apart, and histological features of chronic hepatitis (21 mild activity, 10 moderate activity) were randomized to receive 1FN-alpha-2a, 3 MU three times a week for 6 months (n = 16), or no treatment (n = 15). All patients were followed up for at least 6 months after treatment ended. HCV RNA was tested by nested reverse-transcription polymerase chain reaction (RT-PCR) using 5'-untranslated region complementary primers, quantified by branched-DNA assay, and typed by nested RT-PCR testing for the HCV core region. Treated and untreated patients had similar epidemiological, virological, and histological characteristics. At the end of treatment, serum HCV RNA was still detected in 15 patients (94%) and 14 controls (93%). ALT levels flared up in 10 patients receiving IFN (62%) and in 1 control (62% vs. 7%; P < .005, chi2 test). In conclusion, 6 months' treatment with IFN-alpha-2a did not eradicate HCV RNA from serum in carriers with persistently normal ALT levels but caused ALT flare-ups in two thirds of them. Until more is known about the natural history of HCV RNA carriers with normal ALT levels, these patients should not be treated with IFN.
大多数血清丙型肝炎病毒（HCV）RNA阳性且丙氨酸转氨酶（ALT）水平持续正常的患者表现出轻度至中度活动性慢性肝炎的组织学特征。也有一些肝硬化的报道。为了评估干扰素（IFN）治疗是否能使这些患者长期抑制HCV，31例既往未接受治疗的患者（15例男性，16例女性；平均年龄44岁），血清HCV RNA阳性，至少连续4次（间隔2个月）ALT水平持续正常，且具有慢性肝炎的组织学特征（21例轻度活动，10例中度活动），被随机分为接受IFN-α-2a治疗组（3MU，每周3次，共6个月，n = 16）或未治疗组（n = 15）。所有患者在治疗结束后至少随访6个月。采用5'-非翻译区互补引物通过巢式逆转录聚合酶链反应（RT-PCR）检测HCV RNA，通过分支DNA分析进行定量，并通过巢式RT-PCR检测HCV核心区进行分型。治疗组和未治疗组患者在流行病学、病毒学和组织学特征方面相似。治疗结束时，15例患者（94%）和14例对照组患者（93%）血清中仍可检测到HCV RNA。接受IFN治疗的10例患者（62%）和1例对照组患者（62%对7%；P <.005，卡方检验）ALT水平出现波动。总之，对于ALT水平持续正常的携带者，6个月的IFN-α-2a治疗未能从血清中清除HCV RNA，但三分之二的患者出现了ALT波动。在对ALT水平正常的HCV RNA携带者的自然史有更多了解之前，这些患者不应接受IFN治疗。
