지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 저널정보
- 대한외과학회 Annals of Surgical Treatment and Research Annals of Surgical Treatment and Research Vol.86 No.4
- 발행연도
- 2014.4
- 수록면
- 192 - 198 (7page)
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초록· 키워드
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Purpose: Generic substitution of brand-name medications can lead to significant cost savings and is an accepted medical practice. This study evaluated clinical and safety outcomes among liver transplant recipients whose mycophenolate mofetil (MMF) was converted from the brand-name formulation (Cellcept) to a generic formulation (My-rept).
Methods: Clinical data from multiple centers were prospectively collected for determination of complications, safety, and quality of life after in 154 clinically stable, adult liver transplant recipients whose MMF was converted to a generic formulation between April 2010 and September 2012. This protocol was approved by Institutional Review Boards of all involved sites.
Results: In eight patients (5.19%), nine instances of drug-related complications occurred after medication conversion. Half of these complications were gastrointestinal disorders (n = 4), and most (7 of 9) were mild. No significant differences were noted in mean pre- and postconversion gastrointestinal symptoms via a rating system (8.9 vs. 10.4) or gastrointestinal quality-of-life index scores (125.6 vs. 123.1). More than 90% of patients reported a status of “about the same” when questioned about the brand-name and generic formulation using the Patient Overall Treatment Effect and Investigator Overall Treatment Effect measures. The incidence of serious adverse events was 5.8%. Acute rejection occurred in two patients, with no graft loss or death.
Conclusion: Clinical experience as well as research data showed that generic MMF was comparable in efficacy to the brand-name drug. Given the lack of adverse events and the safety findings, conversion from brand-name MMF to generic MMF should be encouraged.
Methods: Clinical data from multiple centers were prospectively collected for determination of complications, safety, and quality of life after in 154 clinically stable, adult liver transplant recipients whose MMF was converted to a generic formulation between April 2010 and September 2012. This protocol was approved by Institutional Review Boards of all involved sites.
Results: In eight patients (5.19%), nine instances of drug-related complications occurred after medication conversion. Half of these complications were gastrointestinal disorders (n = 4), and most (7 of 9) were mild. No significant differences were noted in mean pre- and postconversion gastrointestinal symptoms via a rating system (8.9 vs. 10.4) or gastrointestinal quality-of-life index scores (125.6 vs. 123.1). More than 90% of patients reported a status of “about the same” when questioned about the brand-name and generic formulation using the Patient Overall Treatment Effect and Investigator Overall Treatment Effect measures. The incidence of serious adverse events was 5.8%. Acute rejection occurred in two patients, with no graft loss or death.
Conclusion: Clinical experience as well as research data showed that generic MMF was comparable in efficacy to the brand-name drug. Given the lack of adverse events and the safety findings, conversion from brand-name MMF to generic MMF should be encouraged.
목차
INTRODUCTION
METHODS
RESULTS
DISCUSSION
REFERENCES
참고문헌 (15)
참고문헌 신청
1. [학술지(정기간행물)] - Sollinger HW. / 1995 / Mycophenolate mofetil for the prevention of acute rejection in primary cadaveric renal allograft recipients. U. S. Renal Transplant Mycophenolate Mofetil Study Group / Transplantation 60 : 225 ~ 232
2. [학술지(정기간행물)] - The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. / 1996 / A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation / Transplantation 61 : 1029 ~ 1037
3. [학술지(정기간행물)] - Ekberg H. / 2007 / Increased prevalence of gastrointestinal symptoms associated with impaired quality of life in renal transplant recipients / Transplantation 83 : 282 ~ 289
4. [학술지(정기간행물)] - Knoll GA. / 2003 / Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation / J Am Soc Nephrol 14 : 2381 ~ 2386
5. [학술지(정기간행물)] - Pelletier RP. / 2003 / The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation / Clin Transplant 17 : 200 ~ 205
2. [학술지(정기간행물)] - The Tricontinental Mycophenolate Mofetil Renal Transplantation Study Group. / 1996 / A blinded, randomized clinical trial of mycophenolate mofetil for the prevention of acute rejection in cadaveric renal transplantation / Transplantation 61 : 1029 ~ 1037
3. [학술지(정기간행물)] - Ekberg H. / 2007 / Increased prevalence of gastrointestinal symptoms associated with impaired quality of life in renal transplant recipients / Transplantation 83 : 282 ~ 289
4. [학술지(정기간행물)] - Knoll GA. / 2003 / Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation / J Am Soc Nephrol 14 : 2381 ~ 2386
5. [학술지(정기간행물)] - Pelletier RP. / 2003 / The impact of mycophenolate mofetil dosing patterns on clinical outcome after renal transplantation / Clin Transplant 17 : 200 ~ 205
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UCI(KEPA) : I410-ECN-0101-2015-510-001432260