中华器官移植杂志
中華器官移植雜誌
중화기관이식잡지
CHINESE JOURNAL OF ORGAN TRANSPLANTATION
2011年
4期
217-220
,共4页
栗光明%郑树森%刘永锋%朱志军%夏强%周俭%傅志仁%黄磊%朱继业%冷希圣
慄光明%鄭樹森%劉永鋒%硃誌軍%夏彊%週儉%傅誌仁%黃磊%硃繼業%冷希聖
률광명%정수삼%류영봉%주지군%하강%주검%부지인%황뢰%주계업%랭희골
肝移植%他克莫司%迟效制剂%治疗效果%安全性
肝移植%他剋莫司%遲效製劑%治療效果%安全性
간이식%타극막사%지효제제%치료효과%안전성
Liver transplantation%Tacrolimus%Delayed-action preparations%Treatment outcome%Security
目的 研究稳定期的肝移植受者分别服用他克莫司缓释胶囊和他克莫司胶囊在预防急性排斥反应的效果和安全性方面的差异.方法 采用多中心、随机、开放、对照的研究方法.试验组和对照组入组的稳定期肝移植受者各86例.试验组受试者的年龄为(46±10)岁;对照组受试者的年龄为(49±9)岁.试验组口服他克莫司缓释胶囊,每天1次,根据血药浓度谷值调整药量,维持血药浓度谷值为2～10 μg/L;对照组口服他克莫司胶囊,每天2次,维持血药浓度谷值为2～10 μg/L.结果 试验组和对照组分别有1.20%和1.18%的受试者发生急性排斥反应,两组的95%可信区间分别为-3.25%～3.31%和-3.26%～3.34%,可信区间上限均低于10%的非劣效标准.试验组和对照组急性排斥反应的发生率分别为1.20%和1.18%,两组患者发生急性排斥反应的次数均为1次,患者及移植物的存活率均为100%,以上指标两组间的差异均无统计学意义(P＞0.05).试验组有15例(占17.65%)共发生16次与试验药物相关的不良反应,对照组有10例(11.63%)共发生10次与试验药物相关的不良反应;试验药物有关严重不良反应中,试验组有4例(占4.71%)共发生4次,对照组有2例(占2.33%)共发生2次.两组不良反应发生率的差异均无统计学意义.结论 稳定期肝移植受者服用他克莫司缓释胶囊和他克莫司胶囊在预防急性排斥反应的疗效和安全性方面无明显差异.
目的 研究穩定期的肝移植受者分彆服用他剋莫司緩釋膠囊和他剋莫司膠囊在預防急性排斥反應的效果和安全性方麵的差異.方法 採用多中心、隨機、開放、對照的研究方法.試驗組和對照組入組的穩定期肝移植受者各86例.試驗組受試者的年齡為(46±10)歲;對照組受試者的年齡為(49±9)歲.試驗組口服他剋莫司緩釋膠囊,每天1次,根據血藥濃度穀值調整藥量,維持血藥濃度穀值為2～10 μg/L;對照組口服他剋莫司膠囊,每天2次,維持血藥濃度穀值為2～10 μg/L.結果 試驗組和對照組分彆有1.20%和1.18%的受試者髮生急性排斥反應,兩組的95%可信區間分彆為-3.25%～3.31%和-3.26%～3.34%,可信區間上限均低于10%的非劣效標準.試驗組和對照組急性排斥反應的髮生率分彆為1.20%和1.18%,兩組患者髮生急性排斥反應的次數均為1次,患者及移植物的存活率均為100%,以上指標兩組間的差異均無統計學意義(P＞0.05).試驗組有15例(佔17.65%)共髮生16次與試驗藥物相關的不良反應,對照組有10例(11.63%)共髮生10次與試驗藥物相關的不良反應;試驗藥物有關嚴重不良反應中,試驗組有4例(佔4.71%)共髮生4次,對照組有2例(佔2.33%)共髮生2次.兩組不良反應髮生率的差異均無統計學意義.結論 穩定期肝移植受者服用他剋莫司緩釋膠囊和他剋莫司膠囊在預防急性排斥反應的療效和安全性方麵無明顯差異.
목적 연구은정기적간이식수자분별복용타극막사완석효낭화타극막사효낭재예방급성배척반응적효과화안전성방면적차이.방법 채용다중심、수궤、개방、대조적연구방법.시험조화대조조입조적은정기간이식수자각86례.시험조수시자적년령위(46±10)세;대조조수시자적년령위(49±9)세.시험조구복타극막사완석효낭,매천1차,근거혈약농도곡치조정약량,유지혈약농도곡치위2～10 μg/L;대조조구복타극막사효낭,매천2차,유지혈약농도곡치위2～10 μg/L.결과 시험조화대조조분별유1.20%화1.18%적수시자발생급성배척반응,량조적95%가신구간분별위-3.25%～3.31%화-3.26%～3.34%,가신구간상한균저우10%적비렬효표준.시험조화대조조급성배척반응적발생솔분별위1.20%화1.18%,량조환자발생급성배척반응적차수균위1차,환자급이식물적존활솔균위100%,이상지표량조간적차이균무통계학의의(P＞0.05).시험조유15례(점17.65%)공발생16차여시험약물상관적불량반응,대조조유10례(11.63%)공발생10차여시험약물상관적불량반응;시험약물유관엄중불량반응중,시험조유4례(점4.71%)공발생4차,대조조유2례(점2.33%)공발생2차.량조불량반응발생솔적차이균무통계학의의.결론 은정기간이식수자복용타극막사완석효낭화타극막사효낭재예방급성배척반응적료효화안전성방면무명현차이.
Objective To evaluate the efficacy and safety of tacrolimus exposure in stable liver transplant recipients converted from FK506 twice a day to Advagraf (tacrolimus extended-release capsules) once daily. Methods This was an open-label, random, control and multi-center study.Eligible patients were 19 to 70 years of age, 6 months post-transplant with stable renal and hepatic function and receiving stable doses of tacrolimus twice a day for 2 weeks prior to enrollment. There were 86 patients in the experimental group and the control group, separately. The average age of experimental group and control group was 46 ± 10 and 49 ± 9, respectively. Patients in experimental group received Advagraf, once daily, and the dose was adjusted according to the drug concentration,and the drug concentration was between 2 to 10 μg/L. The control group given tacrolimus, twice daily, and the drug concentration was between 2 to 10 μg/L. Results The incidence of acute rejection reaction was 1.20 % and 1.18 % respectively in experimental group and control group, and the 95 %confidence interval was -3.25% ～3.31 % and -3.26% ～ 3.34 %, individually. There was 1 case of acute rejection reaction in experimental group and control group, respectively. The patient and organ survival rate was 100%. Sixteen adverse events occurred in 15 patients (17.65 %) of the experimental group, and 10 adverse events occurred in 10 patients (11.63 %) of control group. Severe adverse events relating to the test drug in experimental group occurred in 4 patients (4. 71 %). and 2 patients (2. 33) in control group.Conclision Clinical trials indicated that Advagraf has efficacy and safety profiles similar to those of tacrolimus. The drug is safe and may improve patient compliance.
