Drosos A A, Skopouli F N, Costopoulos J S, Papadimitriou C S, Moutsopoulos H M
Ann Rheum Dis. 1986 Sep;45(9):732-5. doi: 10.1136/ard.45.9.732.
The efficacy and toxicity of cyclosporin A (CyA) were studied in a blind fashion in 20 patients with primary Sjögren's syndrome (pSS). The dose of CyA or placebo was 5 mg/kg of body weight daily. Among the 20 patients, 10 received CyA and 10 placebo. The two groups were matched for age, sex, and disease duration. Patients treated with CyA improved in subjective xerostomia in comparison with patients treated with placebo. Subjective xerophthalmia and recurrent parotid gland enlargement did not differ in the two groups. No change in Schirmer's test and stimulated parotid flow rate was observed in either group. In contrast, the histopathological lesion of patients treated with CyA remained unchanged in most of the patients, while in the placebo treated group the lesion deteriorated. Laboratory parameters did not change before or after treatment in either group. The only clinical side effect observed in the CyA treated group was hypertrichosis.
以盲法研究了环孢素A(CyA)对20例原发性干燥综合征(pSS)患者的疗效和毒性。CyA或安慰剂的剂量为每日5mg/kg体重。20例患者中,10例接受CyA治疗,10例接受安慰剂治疗。两组在年龄、性别和病程方面相匹配。与接受安慰剂治疗的患者相比,接受CyA治疗的患者主观口干症状有所改善。两组患者的主观眼干和腮腺反复肿大情况无差异。两组患者的泪液分泌试验和刺激后的腮腺流速均未观察到变化。相比之下,接受CyA治疗的患者中大多数患者的组织病理学病变保持不变,而接受安慰剂治疗的组病变恶化。两组治疗前后实验室参数均未改变。CyA治疗组观察到的唯一临床副作用是多毛症。