3.Pharmacokinetics of enteric-coated mycophenolate sodium in Chinese renal transplantation recipients.
Kui QIU ; Hui TIAN ; Wei WANG ; Xiao-Peng HU ; Xiao-Bei LI ; Li-Li GONG ; Wei LUO ; Li-Hong LIU ; Xiao-Dong ZHANG ; Hang YIN
Chinese Medical Journal 2012;125(23):4226-4232
BACKGROUNDMycophenolic acid (MPA) as an anti-proliferative immune-suppressive agent is used in the majority of immunosuppressive regimens in solid organ transplantation. This study aimed to investigate the pharmacokinetic (PK) characteristics of enteric-coated mycophenolate sodium (EC-MPS) and area under the curve (AUC) from 0 to 12 hours with limited sampling strategies (LSSs) in Chinese renal transplant recipients.
METHODSThis study was conducted in 10 Chinese renal transplant patients receiving living donor and treated with EC-MPS, cyclosporine, and corticosteroids. MPA concentrations were measured by enzyme multiplied immunoassay technique (EMIT). Whole 12-hour PK profiles were obtained on Day 4 after operation. LSSs with jackknife technique, multiple stepwise regression analysis, and Bland-Altman analysis were developed to estimate MPA AUC.
RESULTSThe mean maximum plasma concentration, the mean time for it to reach peak (T(max)), and the mean MPA AUC were (11.38 ± 2.49) mg/L, (4.85 ± 3.32) hours, and (63.19 ± 13.54) mg×h×L(-1), respectively. Among the 10 profiles, MPA AUC of four patients was significantly higher than that of the other six patients, and the corresponding T(max) was significantly longer than that of the other six patients. No patient exhibited a second peak caused by enterohepatic recirculation. The best models were as follows: 27.46 + 0.94C(3) + 3.24C(8) + 2.81C(10) (r(2) = 0.972), which was used to predict AUC of fast metabolizer with a mean prediction error (MPE) of -0.21% and a mean absolute prediction error (MAE) of 2.59%; 36.65 + 3.08C(8) + 5.30C(10) - 4.04C(12) (r(2) = 0.992), which was used to predict AUC of slow metabolizer with a MPE of 0.58% and a MAE of 1.95%.
CONCLUSIONSThe PKs of EC-MPS had a high variability among Chinese renal transplant recipients. The preliminary PK data indicated the existence of slow and fast metabolizer. These findings may be associated with the enterohepatic recirculation.
Adrenal Cortex Hormones ; therapeutic use ; Adult ; Aged ; Cyclosporine ; therapeutic use ; Female ; Humans ; Kidney Transplantation ; methods ; Male ; Middle Aged ; Mycophenolic Acid ; analogs & derivatives ; pharmacokinetics ; therapeutic use ; Young Adult
4.Clinical efficacy of mycophenolate mofetil in the treatment of systemic-onset juvenile idiopathic arthritis.
Tong-Xin HAN ; Cai-Feng LI ; Jiang WANG ; Wei-Ying KUANG ; Yi-Fang ZHOU ; Jiang-Hong DENG
Chinese Journal of Contemporary Pediatrics 2013;15(8):666-670
OBJECTIVETo evaluate the clinical efficacy of mycophenolate mofetil (MMF) in the treatment of systemic-onset juvenile idiopathic arthritis (SoJIA).
METHODSThirty-five patients with a confirmed diagnosis of SoJIA who had received initial treatment were randomly divided into control (n=15), MMF1 (n=7) and MMF2 groups (n=13). The control group received conventional treatment, the MMF1 group received MMF after 2 weeks of conventional treatment that had not led to remission, and the MMF2 group received combination therapy with non-steroidal anti-inflammatory drugs, prednisone and MMF. Symptoms, signs, laboratory indices, and adverse events were observed after 2, 4, and 12 weeks of treatment, and follow-up was performed for 3-6 months.
RESULTSBefore treatment, the MMF2 group had a significantly longer disease course than the control group (P<0.05). After 2 weeks of treatment, the MMF1 and MMF2 groups had a significantly lower prednisone dose and erythrocyte sedimentation rate (ESR) than the control group (P<0.05). The MMF1 group had significantly higher body temperature than the other two groups (P<0.05). After 4 weeks of treatment, the MMF1 group had a significantly lower prednisone dose and ESR than the control group (P<0.05). The MMF2 group had a significantly lower prednisone dose, body temperature (recovery to normal), white blood cell count, ESR and serum ferritin concentration than the control group (P<0.05). Body temperature was significantly lower in the MMF2 group than in the MMF1 group (P<0.05). No adverse events were observed in either the MMF1 or MMF2 groups during treatment.
CONCLUSIONSCombination therapy with MMF can lead to better control of the patient's condition, more rapid relief of clinical symptoms and reduced glucocorticoid dose. The therapy with MMF is safe in children.
Arthritis, Juvenile ; blood ; drug therapy ; Blood Sedimentation ; Child, Preschool ; Female ; Humans ; Immunosuppressive Agents ; therapeutic use ; Male ; Mycophenolic Acid ; analogs & derivatives ; therapeutic use ; Prednisone ; therapeutic use
6.Clinical evidence of therapy of IgA nephropathy.
Wei-Hua GAN ; Ai-Qing ZHANG ; Gui-Xia DING ; Jing GONG
Chinese Journal of Contemporary Pediatrics 2007;9(2):101-103
Angiotensin-Converting Enzyme Inhibitors
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therapeutic use
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Anticoagulants
;
therapeutic use
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Cyclophosphamide
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therapeutic use
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Cyclosporine
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therapeutic use
;
Fish Oils
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therapeutic use
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Glomerulonephritis, IGA
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therapy
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Glucocorticoids
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therapeutic use
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Humans
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Mycophenolic Acid
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analogs & derivatives
;
therapeutic use
8.Retrospective study of mycophenolate mofetil treatment in IgA nephropathy with proliferative pathological phenotype.
Yan LIANG ; Junjun ZHANG ; Dongwei LIU ; Songxia QUAN ; Guolan XING ; Zhangsuo LIU
Chinese Medical Journal 2014;127(1):102-108
BACKGROUNDMycophenolate mofetil (MMF) and cyclophosphamide (CTX) are widely used in treating various kidney diseases. However, whether they are effective and which one is better for treating IgA nephropathy patients with proliferative pathological phenotype in renal diseases, such as endocapillary proliferation, cellular crescents, and/or capillary loops fibrinoid necrosis is still unknown. We, therefore, initiated a study to compare the effects of MMF and CTX in treating IgA nephropathy with the above pathological lesions.
METHODSOne hundred and nineteen patients with IgA nephropathy who had at least one of the three aforementioned lesions were enrolled. All patients were treated with prednisone; 48 patients received prednisone only (Pred group), 40 received MMF and prednisone (MMF + Pred group), and 31 were treated with CTX and prednisone (CTX + Pred group). The median time of follow-up was 30 months (maximum: 96 months). The primary endpoint was defined as renal survival. The incidence of remission of proteinuria was the secondary endpoint.
RESULTSSerum creatinine in all groups declined significantly at different follow-up times (P = 0.002), and the differences among the three groups were significant (P < 0.001). At 24 months of follow-up, the decline rates were 12.35%, 32.95%, and 24.14% in the Pred, MMF + Pred, and CTX + Pred groups respectively. For urine protein excretion, the decline rates were 49.12% (Pred), 73.67% (MMF + Pred), and 63.53% (CTX + Pred) respectively at 24 months of follow-up. The differences among the three groups were not significant (P = 0.714). Renal survival (the primary endpoint) was significantly different (P = 0.027); however, the sencondary endpoint was similar for all the three groups (P = 0.100).
CONCLUSIONSFor IgA nephropathy patients with endocapillary proliferation, cellular crescents, and/or fibrinoid necrosis of capillary loops, prednisone combined with MMF was more effective in lowering the serum creatinine than with CTX. Combined MMF and prednisone treatment led to a better renal survival compared to that of prednisone with CTX.
Adult ; Female ; Glomerulonephritis, IGA ; drug therapy ; pathology ; Humans ; Immunosuppressive Agents ; therapeutic use ; Male ; Mycophenolic Acid ; analogs & derivatives ; therapeutic use ; Retrospective Studies ; Young Adult
10.Assessment of mycophenolate mofetil for treatment of frequently relapsing nephrotic syndrome in children.
Zhu-wen YI ; Xi-qiang DANG ; Qing-nan HE ; Xiao-chuan WU ; Yan CAO ; Dan-lin HUANG ; Xiao-jie HE ; Shuang-hong MO
Journal of Central South University(Medical Sciences) 2007;32(6):938-940
OBJECTIVE:
To investigate the efficacy and adverse effect of mycophenolate mofetil (MMF) in the treatment of frequently relapsing nephrotic syndrome in children.
METHODS:
The study population consisted of 37 children (24 simple nephrotic syndrome and 13 nephritis-type syndrome) suffering from frequently relapsing nephrotic syndrome. Patients received 20-30 mg/(kg d) of MMF in conjunction with 1 mg/(kg d) prednisone for 3-6 months.
RESULTS:
Out of 24 patients suffered from simple nephrotic syndrome, 17 patients (70.8%) with complete relief, 4 patients (16.7%) with partial relief and 3 patients (12.5%) with non-relief, whereas out of 13 patients suffered from nephritis-type syndrome 6 patients (46.2%) with complete relief, 3 patients (23.1%) with partial relief and 4 patients (30.7%) with non-relief. Eight patients with Minimal Change Disease (MCD) achieved complete relief. Of 23 patients with Mesangial Proliferative Glomerulonephritis (MsPGN) or Membranoproliferative Glomerulonephritis (MPGN), complete relief was observed in 17 patients (73.9%), partial relief in 4 patients (17.4%) and non-relief in 2 patients.
CONCLUSION
These Results suggest that MMF has better efficacy against simple renal disease than against nephritis-type syndrome, and MMF may be more suitable for the treatment of frequently relapsing nephrotic syndrome characterized by proliferative lesions.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Immunosuppressive Agents
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adverse effects
;
therapeutic use
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Male
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Mycophenolic Acid
;
adverse effects
;
analogs & derivatives
;
therapeutic use
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Nephrotic Syndrome
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drug therapy
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Recurrence
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Treatment Outcome