TY - JOUR
T1 - Clinical efficacy of cyclosporin A Neoral in the treatment of paediatric lupus nephritis with heavy proteinuria
AU - Fu, L. W.
AU - Yang, L. Y.
AU - Chen, W. P.
AU - Lin, C. Y.
PY - 1998
Y1 - 1998
N2 - Cyclosporin A (CsA) was introduced in recent years for the treatment of lupus nephritis in patients with steroid resistance or in those with severe corticosteroid toxicity. Our previous study on paediatric patients showed that Neoral (a new microemulsion formulation) had better bioavailability than CsA capsules. To evaluate the clinical efficacy of Neoral in children with lupus nephritis compared with conventional therapy, we performed an open randomized study on 40 children, ranging from 9 to 14 yr old, with class III-V lupus nephritis and heavy proteinuria. They were randomly assigned to either Neoral (5 mg/kg/day), administered q.12.h, or prednisolone (2 mg/kg/day) plus cyclophosphamide (2 mg/kg/day) for 1 yr. Both groups showed a significant decrease in proteinuria (Neoral: 4.62 ± 1.93 to 0.35 ± 0.29 g/day, P < 0.05; prednisolone plus cyclophosphamide: 4.52 ± 1.86 to 0.62 ± 0.21 g/day, P < 0.01). The CH50 haemolytic assay titre decreased after 1 yr of Neoral treatment (26.5 ± 0.9 to 21.4 ± 2.2 U/ml, P < 0.05). Serum C3 and anti-double-stranded (ds) DNA antibody levels also fell with Neoral (C3: 86.2 ± 6.8 to 76.3 ± 4.5 mg/dl; anti-ds DNA antibodies: 14.1 ± 3.2 to 8.2 ± 1.4 IU/ml, P < 0.05). The Neoral group had a significant increase in growth rate over the prednisolone plus cyclophosphamide group (8.2 ± 1.1 cm/yr vs 2.7 ± 0.6 cm/yr, P < 0.01) with improvement of growth status. During the study period, patients tolerated Neoral well with no significant changes in renal function, liver function or lipid profile. Our study implies that Neoral appears to be effective in suppressing proteinuria. Neoral should be regarded as being adjunctive therapy, perhaps with a steroid-sparing effect, in paediatric lupus nephritis. However, its long-term use awaits further studies.
AB - Cyclosporin A (CsA) was introduced in recent years for the treatment of lupus nephritis in patients with steroid resistance or in those with severe corticosteroid toxicity. Our previous study on paediatric patients showed that Neoral (a new microemulsion formulation) had better bioavailability than CsA capsules. To evaluate the clinical efficacy of Neoral in children with lupus nephritis compared with conventional therapy, we performed an open randomized study on 40 children, ranging from 9 to 14 yr old, with class III-V lupus nephritis and heavy proteinuria. They were randomly assigned to either Neoral (5 mg/kg/day), administered q.12.h, or prednisolone (2 mg/kg/day) plus cyclophosphamide (2 mg/kg/day) for 1 yr. Both groups showed a significant decrease in proteinuria (Neoral: 4.62 ± 1.93 to 0.35 ± 0.29 g/day, P < 0.05; prednisolone plus cyclophosphamide: 4.52 ± 1.86 to 0.62 ± 0.21 g/day, P < 0.01). The CH50 haemolytic assay titre decreased after 1 yr of Neoral treatment (26.5 ± 0.9 to 21.4 ± 2.2 U/ml, P < 0.05). Serum C3 and anti-double-stranded (ds) DNA antibody levels also fell with Neoral (C3: 86.2 ± 6.8 to 76.3 ± 4.5 mg/dl; anti-ds DNA antibodies: 14.1 ± 3.2 to 8.2 ± 1.4 IU/ml, P < 0.05). The Neoral group had a significant increase in growth rate over the prednisolone plus cyclophosphamide group (8.2 ± 1.1 cm/yr vs 2.7 ± 0.6 cm/yr, P < 0.01) with improvement of growth status. During the study period, patients tolerated Neoral well with no significant changes in renal function, liver function or lipid profile. Our study implies that Neoral appears to be effective in suppressing proteinuria. Neoral should be regarded as being adjunctive therapy, perhaps with a steroid-sparing effect, in paediatric lupus nephritis. However, its long-term use awaits further studies.
KW - Cyclosporin A
KW - Heavy proteinuria
KW - Lupus nephritis
KW - Neoral
UR - http://www.scopus.com/inward/record.url?scp=0031926311&partnerID=8YFLogxK
U2 - 10.1093/rheumatology/37.2.217
DO - 10.1093/rheumatology/37.2.217
M3 - Article
C2 - 9569080
AN - SCOPUS:0031926311
SN - 0263-7103
VL - 37
SP - 217
EP - 221
JO - British Journal of Rheumatology
JF - British Journal of Rheumatology
IS - 2
ER -