[Effectiveness and safety of using cyclosporin A in the treatment of primary Sjögren's syndrome].

We used oral cyclosporine-A (CyA) (5 mg/kg/day) initially in a double blind study for 6 mos. 10 patients received CyA and 10 placebo. At the end of this study it was observed that CyA improved subjective xerostomia, while subjective xerophthalmia, parotid gland enlargement, Schirmer-I-test and parotid flow rate did not show any significant differences in the two study groups. 9 of 10 patients who had received CyA for 6 mos and 9 of 10 in the placebo group continued in an open trial (CyA at the same dose) for an additional 6 mos. At the end of the study the only efficacy of CyA observed was improvement of subjective xerostomia. The side-effects observed were hypertrichosis (14 persons), mild hypertension (4), infections (5) and 3 dropped out because of nausea, tremor, paresthesias and infections. In conclusion, small doses of CyA for 12 mos are rather ineffective for Sjogren's syndrome.