| Reference | [1]. Zhonghua Er Ke Za Zhi. 2018 Sep 2;56(9):651-656. doi: 10.3760/cma.j.issn.0578-1310.2018.09.004.<br />
[Mycophenolate mofetil versus cyclosporine A in children with primary refractory nephrotic syndrome].<br />
[Article in Chinese; Abstract available in Chinese from the publisher]<br />
Geng HY(1), Ji LN, Chen CY(2), Tu J, Li HR, Bao R, Lin Y.<br />
Author information: (1)Department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics, Beijing100020, China. (2)Department of Pediatrics, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing102218, China Geng Haiyun and Ji Lina contributed equally to this article. Objective: To compare the efficacy and safety of mycophenolate mofetil versus cyclosporine A in treating children with primary refractory nephrotic syndrome. Methods: Conducted a prospective randomized controlled clinical trial in 62 pediatric patients (including 44 boys and 18 girls), age ranged from 2.1 to 17.0 years; 32 cases presented with frequently relapsing nephrotic syndrome (FRNS) and 30 cases presented with steroid-resistant nephrotic syndrome (SRNS), who were admitted to department of Nephrology, Children's Hospital Affiliated to Capital Institute of Pediatrics from October 2013 to October 2015. The patients received either mycophenolate mofetil (20-30)mg/(kg·d) or cyclosporine A (3-5)mg/(kg·d) randomly, on the basis of prednisone treatment. Follow-up interview was conducted regularly for at least one year. Efficacy rate, relapse rate, time required for induction of remission, relapse-free period and prednisone dosage were compared between the two groups. Results: (1) Renal histologic examination, which was available for 17 patients, revealed minimal change disease in 8 patients, mesangial proliferative glomerulonephritis (MsPGN) in five, membranous nephropathy in two, and focal segmental glomerulosclerosis (FSGS) in two. (2) Comparison of mycophenolate mofetil versus cyclosporine A in children with FRNS: There were 14 patients with FRNS in mycophenolate mofetil group and 18 patients with FRNS in cyclosporine A group respectively. The relapse rate (episodes/year) in cyclosporine A group was lower than that of mycophenolate mofetil group (1.0 (0.0, 1.0) vs. 1.0 (1.0, 3.0), Z=-2.405, P=0.016). The relapse-free period (months) in cyclosporine A group was longer than that of mycophenolate mofetil group (10.0 (5.7, 12.1) vs. 5.0 (1.0, 11.0), Z=-1.984, P=0.047). No significant difference in dosage of prednisone was found between cyclosporine A and mycophenolate mofetil groups when followed up for 1 year. (3) Comparison of mycophenolate mofetil versus cyclosporine A in children with SRNS: The efficacy rate was 6/14 in mycophenolate mofetil group and 13/16 in cyclosporine A group. The complete remission rate was 4/14 in mycophenolate mofetil group and 12/16 in cyclosporine A group (P<0.05). The time (months) required for induction of remission in cyclosporine A group was significantly shorter than that of mycophenolate mofetil group (1.0 (1.0, 2.0) vs. 3.0 (2.5, 4.0), Z=-2.529, P=0.011). No significant differences were found between the two groups with respect to relapse-free period and relapse rate. (4) Except that one patient developed hypertensive encephalopathy in cyclosporine A group, no other serious adverse events were recorded. There were no significant differences between two groups with respect to adverse events. Conclusion: Our results indicated that both mycophenolate mofetil and cyclosporine A were effective in the treatment of children with refractory nephrotic syndrome. Cyclosporine A was superior to mycophenolate mofetil in preventing relapses in patients with FRNS and inducing complete remission in patients with SRNS. Although most patients were able to tolerate mycophenolate mofetil and cyclosporine A, but the toxicity and safety of cyclosporine A should be monitored closely.<br />
DOI: 10.3760/cma.j.issn.0578-1310.2018.09.004 PMID: 30180402 [Indexed for MEDLINE]<br />
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[2]. Eur J Gastroenterol Hepatol. 2019 Jul;31(7):873-877. doi: 10.1097/MEG.0000000000001367.<br />
Comparison of mycophenolate mofetil with standard treatment for autoimmune hepatitis: a meta-analysis.<br />
Yu ZJ(1)(2), Zhang LL(1), Huang TT(2), Zhu JS(1)(2), He ZB(1)(2).<br />
Author information: (1)Department of Infectious Diseases, Taizhou Enze Medical Center (Group) Enze Hospital, Taizhou. (2)Department of Infectious Diseases, Affiliated Taizhou Hospital of Wenzhou Medical University, Taizhou, China.<br />
OBJECTIVE: To systematically evaluate the efficacy of mycophenolate mofetil (MMF) compared with the standard treatment for autoimmune hepatitis. METHODS: Medline (PubMed), Embase, and Cochrane Library databases were searched between 1966 and June 2018 for studies on prednisone and/or azathioprine/mycophenolate mofetil in autoimmune hepatitis. The keywords and descriptor terms used were 'hepatitis', 'autoimmunity', 'prednisone', 'prednisolone', 'azathioprine', and 'mycophenolate mofetil'. The Z test and Cochrane Q test were used in the statistical analysis. RESULTS: Seven hundred and eighty-eight related articles were found; 779 studies were excluded after further review. Ultimately, seven studies (583 participants) were included. The remission rate of aminotransferase and immunoglobulin (Ig)-G levels with standard treatment was 33.33-86.67%, and the nonresponse rate was 15.15-66.67%. Although the remission rate of the aminotransferase level with prednisone and MMF was 55.17-88.89% and that of the IgG level was 61.16-88.89%, the nonresponse rate was 6.42-33.33%. Remission rates of the aminotransferase level (P<0.05, I=49%) and IgG level (P<0.01, I=0) with MMF were superior to those of standard treatment, and the nonresponse rate was lower (P<0.01, I=0). For those with no response to the standard treatment who were switched to MMF, the remission rates were 0, 13.33, 22.22, 25, and 34.04%. Sequential treatment with MMF was effective (P<0.01, I=90%). CONCLUSION: Compared with the standard treatment, the combination of prednisone and MMF as a first-line treatment enables patients with autoimmune hepatitis to obtain higher remission rates of aminotransferase and IgG levels and a lower nonresponse rate. The validity and safety of long-term MMF use needs investigated further.<br />
DOI: 10.1097/MEG.0000000000001367 PMID: 31150366 [Indexed for MEDLINE]<br />
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[3]. Neurol Neuroimmunol Neuroinflamm. 2020 Mar 13;7(3):e705. doi: 10.1212/NXI.0000000000000705. Print 2020 May.<br />
Long-term efficacy of mycophenolate mofetil in myelin oligodendrocyte glycoprotein antibody-associated disorders: A prospective study.<br />
Li S(1), Ren H(1), Xu Y(2), Xu T(2), Zhang Y(1), Yin H(1), Zhang W(1), Li J(1), Ren X(1), Fang F(1), Li W(1), Zhu Y(1), Peng B(1), Wang J(1), Zhong Y(1), Cui L(1).<br />
Author information: (1)From the Department of Neurology (S.L., H.R., Y.X., Y. Zhang, H.Y., Y. Zhu, B.P., L.C.), Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences; Department of Epidemiology and Biostatistics Institute of Basic Medical Sciences (T.X.), Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College; Department of Neurology (W.Z., J.L., X.R., F.F.), Beijing Children's Hospital, Capital Medical University, National Center for Children's Health; Oumeng V Medical Laboratory (W.L.), Hangzhou; CAS Key Laboratory of Mental Health (J.W.), Institute of Psychology, Beijing, China Department of Psychology, University of Chinese Academy of Sciences; Department of Ophthalmology (Y. Zhong), Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences; and Neurosciences Center (L.C.), Chinese Academy of Medical Sciences, Beijing, China. (2)From the Department of Neurology (S.L., H.R., Y.X., Y. Zhang, H.Y., Y. Zhu, B.P., L.C.), Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences; Department of Epidemiology and Biostatistics Institute of Basic Medical Sciences (T.X.), Chinese Academy of Medical Sciences & School of Basic Medicine, Peking Union Medical College; Department of Neurology (W.Z., J.L., X.R., F.F.), Beijing Children's Hospital, Capital Medical University, National Center for Children's Health; Oumeng V Medical Laboratory (W.L.), Hangzhou; CAS Key Laboratory of Mental Health (J.W.), Institute of Psychology, Beijing, China Department of Psychology, University of Chinese Academy of Sciences; Department of Ophthalmology (Y. Zhong), Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences; and Neurosciences Center (L.C.), Chinese Academy of Medical Sciences, Beijing, China. [email protected].<br />
OBJECTIVE: To investigate whether the use of mycophenolate mofetil (MMF) could reduce the relapse risk in patients with myelin oligodendrocyte glycoprotein (MOG)-immunoglobulin G (IgG)-associated disorders (MOGADs). METHODS: This prospective observational cohort study included patients with MOGAD at Peking Union Medical College Hospital between January 1, 2017, and April 30, 2019. The patients were divided into 2 groups: those with (MMF+) or without (MMF-) MMF therapy. The primary outcome was relapse at follow-up. We used Cox proportional hazards models to calculate hazard ratios (HRs) for relapse. RESULTS: Seventy-nine patients were included in our MOG cohort. Fifty (63.3%) were adults at index date, and 47 (59.5%) were women. Fifty-four (68.4%) were in the MMF+ group, and 25 (31.6%) were in the MMF- group. Clinical and demographic factors, MOG-IgG titer, and follow-up time (median, 472.5 days for MMF+, 261.0 days for MMF-) were comparable between the groups. Relapse rates were 7.4% (4/54) in the MMF+ group and 44.0% (11/25) in the MMF- group. Of all potential confounders, only the use of MMF was associated with reduced risk of relapse. The HR for relapse among patients in the MMF+ group was 0.14 (95% CI, 0.05-0.45) and was 0.08 (95% CI, 0.02-0.28) in a model adjusted for age, sex, disease course, and MOG-IgG titer. MMF therapy also remained associated with a reduced relapse risk in sensitivity analyses. Only one patient (1.9%) discontinued MMF therapy because of adverse effect. CONCLUSIONS: These findings provide a clinical evidence that MMF immunosuppression therapy may prevent relapse in patients with MOGAD. CLASSIFICATION OF EVIDENCE: This study provides class IV evidence that for patients with MOGAD, MMF reduces relapse risk.<br />
DOI: 10.1212/NXI.0000000000000705 PMCID: PMC7136046 PMID: 32170045 [Indexed for MEDLINE]<br />
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[4]. Z Rheumatol. 2012 Nov;71(9):813-5. doi: 10.1007/s00393-012-1022-8.<br />
[Mycophenolate mofetil seems to be superior to azothioprine in maintenance therapy of lupus nephritis].<br />
[Article in German]<br />
Schmalzing M(1), Kötter I.<br />
Author information: (1)Abteilung Innere Medizin II (Hämatologie, Onkologie, Immunologie, Rheumatologie, Pulmologie), Medizinische Universitätsklinik, Otfried-Müller-Str. 10, 72076, Tübingen, Deutschland. [email protected]<br />
DOI: 10.1007/s00393-012-1022-8 PMID: 22926540 [Indexed for MEDLINE]<br />
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[5]. J Sep Sci. 2015 Oct;38(20):3533-44. doi: 10.1002/jssc.201500779. Epub 2015 Sep 18.<br />
Liquid chromatography tandem mass spectrometry method for the quantitation of mycophenolate mofetil in human plasma: Application to a bioequivalence study and metabolite identification.<br />
Partani P(1), Verma SM(2), Monif T(1).<br />
Author information: (1)Department of Clinical Pharmacology and Pharmacokinetics, Sun Pharmaceutical Industries Ltd, HSIIDC, Gurgaon, Haryana, India. (2)Department of Pharmaceutical Sciences and Technology, Birla Institute of Technology, Mesra, Ranchi, Jharkhand, India.<br />
We established a sensitive, selective, and rapid analytical method for the quantitation and pharmacokinetic investigation of mycophenolate mofetil in human plasma. To our knowledge, this is the first method that characterizes presence of mycophenolate mofetil glucuronide in clinical samples through tandem mass spectrometry detection and resolves mycophenolate mofetil from its glucuronide metabolite. Liquid chromatography coupled to tandem mass spectrometry detection in positive ion mode was selected to provide optimal selectivity and sensitivity. Due to the ionizable characteristics of the mycophenolate mofetil, a mixed-mode cation-exchange disposable extraction cartridge was prudently chosen. The chromatographic separation was achieved on Luna(®) C18(2) (100×4.60 mm) column using mobile phase consisting of a mixture of 1±0.05 mM ammonium formate in water, titrated to pH 3.1±0.1 with formic acid, and methanol (20:80, v/v), at a flow rate of 0.7 mL/min. The detection was led at m/z ratios of 434.4→ 114.2 and 438.4→ 118.3, for mycophenolate mofetil and mycophenolate mofetil-D4, respectively. The developed method was linear between 40.2-4986.0 pg/mL. All validation parameters were within the defined limits. The validated method was then successfully applied for the evaluation of bioequivalence parameters of mycophenolate mofetil after an oral administration of 500 mg mycophenolate mofetil tablet to healthy male Indian volunteers.<br />
DOI: 10.1002/jssc.201500779 PMID: 26383052 [Indexed for MEDLINE]
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