A Comparative Study On The Efficacy And Safety Of Tacrolimus And Cyclosporine In The Treatment Of Non-infectious Uveitis

ObjectiveTo compare the clinical efficacy and safety of tacrolimus and cyclosporine in the treatment of non-infectious uveitis.MethodNon-infectious uveitis patients were selected from January 2017 to January 2018.There were 60 patients(104 eyes)who met the criteria.They were divided into two groups by randomized controlled trial design:treatment group(30 cases)and control group(30 cases).The treatment group was given oral tacrolimus capsule,the clinical initial dose was 1 mg/d,and then increased by 1 mg/d per week to maintain a steady state for 1 week when the expected maintenance dose was increased to 3 mg/d.The control group was given oral cyclosporine capsule,the initial dose was 100 mg/d,and the drug dosage was adjusted according to the clinical reaction and blood drug concentration.Both groups were treated with prednisone acetate tablets at the initial dosage of 0.5 mg/kg/d.They were taken at once every morning.Both groups were given tobramycin and dexamethasone eye drops,propofol eye drops and compound topicamide eye drops at the early stage of treatment.The best corrected visual acuity(BCVA),mean arterial pressure(MAP),serum total cholesterol,serum creatinine,blood sugar and other adverse reactions were compared between the two groups before and after treatment.The results were statistically analyzed to compare the efficacy and safety of the two groups.ResultThe visual acuity of tacrolimus group and cyclosporine group was observed and compared before and after treatment.BCVA in tacrolimus group was(0.64±0.36)log MAR before treatment and(0.37±0.32)log MAR after treatment.The visual acuity of tacrolimus group was significantly improved(t=5.397,P<0.001).BCVA in cyclosporine group was(0.68±0.23)log MAR before treatment and(0.40±0.31)log MAR after treatment.The visual acuity was significantly improved(t=5.268,P<0.001).There was no significant difference in BCVA between the two groups after treatment(P>0.05).The total effective rate of tacrolimus was 73.3%,and the total effective rate of cyclosporine group was 70.0%.The comparison of the efficacy of the two groups of drugs was performed using non-parametric tests of ordered multi-class data.The results showed no significant difference(Z=-1.753,P=0.08).The mean arterial pressure(MAP)of the two groups before treatment was the same.In the first month after treatment,there was no significant difference in the mean arterial pressure(MAP)between the two groups(P=0.17);in the third month after treatment,there was significant difference in the mean arterial pressure(MAP)between the two groups(P=0.03);compared with the mean arterial pressure(MAP)before treatment,the first and third months after treatment.The mean arterial pressure(MAP)in tacrolimus group did not increase significantly in the last month(P=0.06;P=0.08).The mean arterial pressure(MAP)in cyclosporine group increased significantly(P=0.02;P=0.03).The serum total cholesterol of the two groups was similar before treatment,and there was no significant difference between the two groups in the first and third months after treatment(P=0.03;P=0.04).Compared with the serum total cholesterol before treatment,there was no significant increase in the serum total cholesterol of the tacrolimus group in the first and third months after treatment(P=0.1;P=0.12).The serum total cholesterol in cyclosporine group increased significantly(P=0.03;P=0.04).The serum creatinine of the two groups was similar before treatment.There was no significant difference in serum creatinine between the two groups in the first month and the third month after treatment(P=0.56;P=0.61).Twelve patients(40%)in tacrolimus group had no adverse reactions,while only two patients(6.7%)in cyclosporine group had no adverse reactions.There was significant difference in the incidence of adverse reactions between the two groups by x~2 test(x~2=0.415,P<0.05).Among the other systemic adverse reactions observed during the treatment period,9 patients(30%)in the cyclosporine group had gingival hyperplasia,while 7 patients(23.3%)in the cyclosporine group had hypertension,while 2 patients(6.7%)in the other group had hypertension.The incidence of fatigue(60%)and headache(40%)in the cyclosporine group was higher than that in the tacrolimus group.In tacrolimus group,10 patients(33%)had distal hand tremor and 8 patients(27%)in cyclosporine group had distal hand tremor.ConclusionTacrolimus is similar to cyclosporine in the treatment of non-infectious uveitis,but the incidence of adverse reactions in the group of tacrolimus is lower,especially in terms of mean arterial pressure and serum cholesterol level.Therefore,tacrolimus can be used for long-term treatment of non-infectious uveitis to stabilize or improve visual function.