Evaluation Of The Efficacy And Safety Of Topical 0.05% Cyclosporine Eye Drops(Ⅱ) In The Treatment Of Dry Eye Associated With Primary Sj(?)gren’s Syndrome

Background: Dry eye disease is one of the most common complications of primary Sjogren’s syndrome.The clinical manifestations of the dry eye associated with primary Sjogren’s syndrome(PSSDE)include dry eyes,foreign body sensation,less tears and other symptoms due to the decreased function of lacrimal gland,reduced mucin secretion,and other abnormalities involving the neural pathway.Some patients have repeated suppurative infection,conjunctivitis,keratitis and so on.PSSDE is usually moderate to severe,and severe ocular symptoms often affect patients’ quality of life.The patient’s physical and mental health are all affected.Its treatment has also become a major problem in the fields of ophthalmology and rheumatology.Imbalance of immune homeostasis and inflammation are the basis of all autoimmune diseases.0.05% cyclosporine has antiinflammatory effects as an immunosuppressive drug.So,it is suitable for the treatment of immune-related dry eye in primary Sjogren’s syndrome patients.Objective: We conducted this research to evaluate the efficacy and safety of 0.05%cyclosporine eye drops(Ⅱ)for the treatment of PSSDE.Methods: 60 patients with primary Sj(?)gren’s syndrome-associated dry eye were randomly divided into three groups,received treatment with unit dose vials of unpreserved cyclosporine 0.05% at one drop twice daily(C group),preservative-free hyaluronic acid sodium artificial tears at one drop 4 times per day(S group),or their combination(SC group)for 3 months.C group was given 0.05% cyclosporine eye drops(II)(manufacturer: Sinqi Pharmmaceutical,Shenyang,China;drug lot number:H20203239;specification: 0.4 ml: 0.2 m;drug concentration: 0.05%)twice daily,one drop each time,12 hours apart.S group was given hyaluronic acid sodium eye drops(manufacturer: URSA PHARM Arzneimittel Gmb H,Germany;drug lot number: 297927;specification: 10 ml/pcs;drug concentration: 0.1%)four times a day,one drop each time.CS group was given 0.05% cyclosporine eye drops(II)combined with hyaluronic acid sodium eye drops,and the usage and dosage of each drug were same as the first two groups.Hyaluronic acid sodium eye drop was given first,followed by 0.05% cyclosporine eye drops(II),with an interval of 15 minutes.The changes in symptoms [ocular dryness,foreign body sensation,burning,photophobia and ocular surface disease index score(OSDI)] and signs [schirmer I test(SⅠt),corneal fluorescent staining combined with conjunctival lissamine green staining score(OSS),tear break-up time(BUT)and tear meniscus height(TMH)] were evaluated from baseline at weeks 2,4,and 12.The safety profile was evaluated by examining adverse events,changes in visual acuity and intraocular pressure.Results: Ocular symptoms were significantly reduced in C and CS groups.OSDI scores at week 4(F = 5.234,P = 0.008)in 2 groups were significantly lower than it in S group.BUT(F= 9.283,P < 0.001)was significantly different between S and C groups as well as S and CS groups at week 2.SⅠt(F = 4.838,P = 0.011),OSS(F = 7.961,P = 0.001)and conjunctival congestion score(F = 21.67,P <0.001)were significantly different between S and C groups as well as S and CS groups at week 4,but no significant differences were observed between C and CS groups.After 12 weeks of treatment(F =3.197,P = 0.048),there was a significant difference in TMH between S and CS groups,but not between C and S groups as well as C and CS groups.During treatment,no patients in the three groups had visual decline and intraocular pressure was within normal range.No serious adverse events occurred.Conclusion: 0.05% cyclosporine is an effective and safe treatment for patients with PSSDE.