CAJ | 학술논문

目的探讨口服吗替麦考酚酯(MMF)和麦考酚钠肠溶片(EC-MPS)在肾移植患者体内药代动力学情况并探讨其有效性和安全性.方法应用前瞻性研究,入组102例肾移植受者,随机数字表法分为两组,分别口服MMF和EC-MPS.用10点有限样本法测定移植后7和30 d两组患者0～12 h麦考酚酸曲线下面积(MPA-AUC0-12h).应用胃肠道症状评定量表(GSRS)评估受者用药后不良反应症状,分值越高症状越明显,并对比两组的排斥反应发生率.结果两组患者在年龄、性别、体质量、冷热缺血时间、供受者间HLA配型、群体反应抗体以及病毒感染等方面的差异均无统计学意义.术后7d时MMF组血药浓度达峰时间(Tmax)为(1.18±0.97)h,小于EC-MPS组的(2.76±1.35)h(P=0.00);而两组MPA-AUC0-12h分别为(48.48±7.65)mg·h·L-1和(52.39±5.93) mg·h·L-1,差异无统计学意义(P=0.062);7 d内两组排斥反应发生率分别为2.00％和1.96％,差异无统计学意义(P=0.978).术后30d,MMF组的Lmax为(1.09±0.91)h,小于EC-MPS组的(3.11±1.43)h,差异有统计学意义(P=0.00);MMF组的MPA-AUC-12h为于(41.96±6.39)mg·h· L-1,低于EC-MPS组的(50.66±4.21)mg·h·L-1,差异有统计学意义(P=0.00);MMF组的GSRS评分为42.74±7.34,高于EC-MPS组的21.04±7.83,差异有统计学意义(P=0.00);术后30 d内MMF组总的排斥反应发生率为16.0％,EC-MPS组为7.7％,差异无统计学意义(P=0.193).结论与MMF相比较,EC-MPS的达峰时间延长,总体MPA-AUC0-12h大于MMF,药物胃肠道不良反应较轻.
목적 탐토구복마체맥고분지(MMF)화맥고분납장용편(EC-MPS)재신이식환자체내약대동역학정황병탐토기유효성화안전성.방법 응용전첨성연구,입조102례신이식수자,수궤수자표법분위량조,분별구복MMF화EC-MPS.용10점유한양본법측정이식후7화30 d량조환자0～12 h맥고분산곡선하면적(MPA-AUC0-12h).응용위장도증상평정량표(GSRS)평고수자용약후불량반응증상,분치월고증상월명현,병대비량조적배척반응발생솔.결과 량조환자재년령、성별、체질량、랭열결혈시간、공수자간HLA배형、군체반응항체이급병독감염등방면적차이균무통계학의의.술후7d시MMF조혈약농도체봉시간(Tmax)위(1.18±0.97)h,소우EC-MPS조적(2.76±1.35)h(P=0.00);이량조MPA-AUC0-12h분별위(48.48±7.65)mg·h·L-1화(52.39±5.93) mg·h·L-1,차이무통계학의의(P=0.062);7 d내량조배척반응발생솔분별위2.00％화1.96％,차이무통계학의의(P=0.978).술후30d,MMF조적Lmax위(1.09±0.91)h,소우EC-MPS조적(3.11±1.43)h,차이유통계학의의(P=0.00);MMF조적MPA-AUC-12h위우(41.96±6.39)mg·h· L-1,저우EC-MPS조적(50.66±4.21)mg·h·L-1,차이유통계학의의(P=0.00);MMF조적GSRS평분위42.74±7.34,고우EC-MPS조적21.04±7.83,차이유통계학의의(P=0.00);술후30 d내MMF조총적배척반응발생솔위16.0％,EC-MPS조위7.7％,차이무통계학의의(P=0.193).결론 여MMF상비교,EC-MPS적체봉시간연장,총체MPA-AUC0-12h대우MMF,약물위장도불량반응교경.
Objective To evaluate the efficacy and safety of the enteric-coated mycophenolate sodium (EC-MPS) and mycophenolate mofetil (MMF) by pharmacokinetic characteristics after taking the drug.Method 102 renal transplantation recipients were divided into EC-MPS group and MMF group with random number table.Ten limited sampling strategies were used to determine area under the curve (AUC) 0-12 h of mycophenolic acid (MPA) 7 and 30 days after transplantation.Gastrointestinal Symptom Rating Scale (GSRS) was used to assess symptoms of adverse reactions in patients after treatment,and the higher the score,the more obvious symptoms.Simultaneously,rejection rate in both groups was compared.Result There was no significant difference between the two groups in age,sex,weight,cold ischemia time,HLA matching between donor and recipient type,panel reactive antibody (PRA) and viral infections.Seven days after transplantation,the mean time to reach peak (Tmax) in MMF group was significantly shorter than EC-MPS group (1.18 ± 0.97 h vs.2.76 ± 1.35 h,P =0.00).MPA-AUC0-12h of two groups was similar (48.48 ± 7.65 vs.52.39 ± 5.93 mg· h · L-1,P =0.062) ; during 7 days the rejection rate showed no significant difference between two groups (2.00％ vs.1.96％,P =0.978).Thirty days after transplantation,the Tmax of MMF group was still shorter than that of EC-MPS group (1.09 ± 0.91 h vs.3.11 ± 1.43 h,P =0.00).MPA-AUC0-12hof MMF group was lower than EC-MPS group (41.96 ± 6.39 vs.50.66 ± 4.21 mg·h· L-1,P =0.00).Although there was no significant difference between two groups in rejection rate,the rejection rate in MMF group was slightly higher than in EC-MPS group (16.0％ vs.7.7％,P =0.193) during the 30 days after renal transplantation.Conclusion Tmax was significantly shorter,and MPA-AUC0-12h higher in MMF group than in EC-MPS group.EC-MPS drugs reduced gastrointestinal adverse reactions of MPA.