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ข้อมูลการเผยแพร่ผลงาน
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ชื่อบทความ |
A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience |
วัน/เดือน/ปี ที่ได้ตอบรับ |
13 ธันวาคม 2558 |
วารสาร |
ชื่อวารสาร |
Lupus Science & Medicine |
มาตรฐานของวารสาร |
SCOPUS |
หน่วยงานเจ้าของวารสาร |
British Medical Journal |
ISBN/ISSN |
doi:10.1136/lupus-2015- 000120 |
ปีที่ |
1 |
ฉบับที่ |
3 |
เดือน |
1 |
ปี พ.ศ. ที่พิมพ์ |
2559 |
หน้า |
e000120 |
บทคัดย่อ |
Objective: The optimal treatment of relapse or resistant lupus nephritis (LN) is still unclear. Mycophenolate might be an alternative therapy to avoid toxicities of cyclophosphamide (CYC). This study was aimed to compare enteric-coated mycophenolate sodium (ECMPS) versus intravenous CYC as an induction therapy.
Methods: The study was a 12-month period of
multicentre, open-labelled randomised controlled trial. Fifty-nine patients who had relapsed (36%) or who were resistant to previous CYC treatment (64%) and all who were biopsy-proven class III/IV, were randomised into CYC (n=32) and EC-MPS groups (n=27). The CYC group received intravenous CYC 0.5–1 g/m2 monthly and the
EC-MPS group was treated with EC-MPS 1440 mg/day for first 6 months. After induction therapy, both groups received EC-MPS 720 mg/day until the end of study at 12 months.
Results: The study was prematurely terminated due to high rate of serious adverse events in CYC arm. Death and serious infections were observed more in the CYC group (15.6% in CYC and 3.5% in EC-MPS; p=0.04). The early discontinuation rates, mainly from serious infections, were significantly higher in CYC group (percentage differences of 16.9; 95% CI 1.3 to 32.4). At the 12th month, both arms were comparable in terms of
complete and partial remission rates (68% CYC and 71% EC-MPS) and times to remission (96 days CYC and 97 days EC-MPS). Composites of unfavourable outcomes (death, doubling of serum creatinine, non-remission and intolerance to treatment) were 46.9% and 37% in CYC
and EC-MPS (risk difference=9.84; p=0.44).
Conclusions: EC-MPS may have comparable efficacy, but was better tolerated than CYC. EC-MPS should be an alternative choice of treatment for difficult-to-treat LN, particularly in CYC-experienced LN patients. Due to an early termination of the study, further clinical
implementation could be cautiously used. |
คำสำคัญ |
relapse lupus nephritis, resistant lupus nephritis, mycophenolate, cyclophosphamide |
ผู้เขียน |
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การประเมินบทความ |
มีผู้ประเมินอิสระ |
สถานภาพการเผยแพร่ |
ตีพิมพ์แล้ว |
วารสารมีการเผยแพร่ในระดับ |
นานาชาติ |
citation |
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Citation |
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