Drosos A A, van Vliet-Dascalopoulou E, Andonopoulos A P, Galanopoulou V, Skopouli F N, Moutsopoulos H M
University of Ioannina, School of Medicine, Department of Medicine, Greece.
Clin Exp Rheumatol. 1988 Jan-Mar;6(1):53-7.
The efficacy and side-effects of Deca-Durabolin (DD) were tested, in a double blind fashion, in twenty female primary Sjögren's syndrome (1 degree SS) patients. Ten randomly assigned patients received DD (100 mg IM bi-weekly) for six months, and ten others placebo, for the same period. Analysis of the results revealed that the DD-treated patients showed a moderate improvement of subjective xerostomia, a significant decrease of the erythrocyte sedimentation rate (ESR), and an overall improvement of their feeling of well-being, -judged by themselves and the investigator subjectively-, when compared with the placebo group. All the sicca objective parameters (results of Schirmer's I test, slit lamp eye examination after rose bengal staining, stimulated parotid flow rate measurements and labial minor salivary gland histopathology) were not significantly altered in either group. The clinical side-effects were the expected ones, i.e. hirsutism, hoarseness and an increase in libido, more pronounced in the DD-treated group. At the end of the study, one DD-treated patient, developed a diffuse well-differentiated B-lymphocytic lymphoma, which regressed spontaneously three months later.
以双盲方式对20例女性原发性干燥综合征（I度SS）患者进行了癸酸诺龙（DD）疗效和副作用的测试。10例随机分组患者接受DD（每两周100mg肌肉注射）治疗6个月，另外10例接受安慰剂治疗相同时间。结果分析显示，与安慰剂组相比，接受DD治疗的患者主观口干有中度改善，红细胞沉降率（ESR）显著降低，自我和研究者主观判断其整体幸福感有所改善。两组的所有干燥客观参数（Schirmer I试验结果、孟加拉玫瑰红染色后裂隙灯眼部检查、刺激腮腺流速测量和唇小唾液腺组织病理学）均无显著改变。临床副作用为预期出现的，即多毛症、声音嘶哑和性欲增强，在接受DD治疗的组中更为明显。研究结束时，1例接受DD治疗的患者发生弥漫性高分化B淋巴细胞淋巴瘤，3个月后自行消退。
