Hegarty J E, Nouri Aria K T, Eddleston A L, Williams R
Gut. 1984 Mar;25(3):279-83. doi: 10.1136/gut.25.3.279.
A randomised controlled trial of thymic hormone extracts (Thymostimulin) (1 mg/kg/day for seven days; 1 mg/kg/weekly thereafter) was undertaken in 30 patients (21 women, nine men) with treated, apparently inactive 'autoimmune' chronic active hepatitis during withdrawal of maintenance corticosteroid and azathioprine therapy. Reactivation of disease occurred in 26 patients (86%) during or after treatment withdrawal and was as frequent in the Thymostimulin treated (11 of 13; 84%) and untreated (15 of 17; 88%; p greater than 0.05) groups. Reactivation of disease was accompanied by a severe defect in concanavalin A induced suppressor cell activity, the magnitude of which was similar in the Thymostimulin treated and untreated groups (mean % suppression = 16.4 and 3.2 respectively; p greater than 0.05 vs 84.4 in control subjects). Further studies assessing the optimal dose, duration of treatment, and mode of administration are required to establish a therapeutic role for thymic hormone extracts in 'autoimmune' chronic active hepatitis.
对30例（21例女性，9例男性）接受过治疗、表面静止的“自身免疫性”慢性活动性肝炎患者进行了一项胸腺激素提取物（胸腺刺激素）的随机对照试验（1mg/kg/天，共7天；此后每周1mg/kg），试验期间停用维持性皮质类固醇和硫唑嘌呤治疗。26例患者（86%）在治疗期间或停药后疾病复发，胸腺刺激素治疗组（13例中的11例；84%）和未治疗组（17例中的15例；88%）复发频率相似（p>0.05）。疾病复发伴随着刀豆球蛋白A诱导的抑制细胞活性严重缺陷，胸腺刺激素治疗组和未治疗组缺陷程度相似（平均抑制率分别为16.4%和3.2%；与对照组的84.4%相比，p>0.05）。需要进一步研究以评估最佳剂量、治疗持续时间和给药方式，从而确立胸腺激素提取物在“自身免疫性”慢性活动性肝炎中的治疗作用。
