中华器官移植杂志
中華器官移植雜誌
중화기관이식잡지
CHINESE JOURNAL OF ORGAN TRANSPLANTATION
2012年
5期
280-282
,共3页
张珉%朱志军%彭志海%董家鸿%傅志仁%樊嘉%何晓顺%夏强%刘振文%霍枫%彭承宏%郑树森
張珉%硃誌軍%彭誌海%董傢鴻%傅誌仁%樊嘉%何曉順%夏彊%劉振文%霍楓%彭承宏%鄭樹森
장민%주지군%팽지해%동가홍%부지인%번가%하효순%하강%류진문%곽풍%팽승굉%정수삼
肝移植%他克莫司%可重复性,结果
肝移植%他剋莫司%可重複性,結果
간이식%타극막사%가중복성,결과
Liver transplantation%Tacrolimus%Reproducibility of results
目的 评估杭州中美华东制药有限公司生产的他克莫司(Tac)胶囊(赛氏Tac胶囊)用于肝移植受者的临床疗效及安全性.方法 11家肝移植中心共入选了83例符合入组标准的肝移植受者,术后采用Tac+吗替麦考酚酯+糖皮质激素预防排斥反应.Tac于移植后48 h内应用,起始剂量为0.10～0.15 mg·kg-1·d-1,每12 h给药1次.术后60 d内目标血药浓度谷值维持在8～12 μg/L,之后维持在5～10μg/L,直至观察终点(术后12周).随访期间,观察急性排斥反应的发生率,受者和移植物的存活率,记录药物剂量及治疗窗浓度的量效关系.主要有效性终点为发生经病理证实的急性排斥反应,次要有效性终点为移植肝或受者的存活情况.安全性评价指标为研究期间药物不良反应的发生情况.结果 术后第1、2、4、8和12周,Tac的使用剂量分别为(4.1±1.9)、(4.5±2.1)、(4.5±2.1)、(4.4±1.8)和(4.1±2.1) mg/d,相对应的血药浓度谷值分别为(8.1±4.5)、(8.9±4.5)、(8.8±4.3)、(8.8±4.1)和(8.0±2.8) μg/L.随访期内经病理证实的急性排斥反应发生率为4.8％(4/83),治疗后排斥反应均得到逆转,观察期结束时移植肝存活率为100％.随访期内受者肺部感染发生率为6.02％,糖尿病发生率为6.02％,肾功能未发现明显异常.结论 赛氏Tac胶囊应用于肝移植受者是安全、有效的.
目的 評估杭州中美華東製藥有限公司生產的他剋莫司(Tac)膠囊(賽氏Tac膠囊)用于肝移植受者的臨床療效及安全性.方法 11傢肝移植中心共入選瞭83例符閤入組標準的肝移植受者,術後採用Tac+嗎替麥攷酚酯+糖皮質激素預防排斥反應.Tac于移植後48 h內應用,起始劑量為0.10～0.15 mg·kg-1·d-1,每12 h給藥1次.術後60 d內目標血藥濃度穀值維持在8～12 μg/L,之後維持在5～10μg/L,直至觀察終點(術後12週).隨訪期間,觀察急性排斥反應的髮生率,受者和移植物的存活率,記錄藥物劑量及治療窗濃度的量效關繫.主要有效性終點為髮生經病理證實的急性排斥反應,次要有效性終點為移植肝或受者的存活情況.安全性評價指標為研究期間藥物不良反應的髮生情況.結果 術後第1、2、4、8和12週,Tac的使用劑量分彆為(4.1±1.9)、(4.5±2.1)、(4.5±2.1)、(4.4±1.8)和(4.1±2.1) mg/d,相對應的血藥濃度穀值分彆為(8.1±4.5)、(8.9±4.5)、(8.8±4.3)、(8.8±4.1)和(8.0±2.8) μg/L.隨訪期內經病理證實的急性排斥反應髮生率為4.8％(4/83),治療後排斥反應均得到逆轉,觀察期結束時移植肝存活率為100％.隨訪期內受者肺部感染髮生率為6.02％,糖尿病髮生率為6.02％,腎功能未髮現明顯異常.結論 賽氏Tac膠囊應用于肝移植受者是安全、有效的.
목적 평고항주중미화동제약유한공사생산적타극막사(Tac)효낭(새씨Tac효낭)용우간이식수자적림상료효급안전성.방법 11가간이식중심공입선료83례부합입조표준적간이식수자,술후채용Tac+마체맥고분지+당피질격소예방배척반응.Tac우이식후48 h내응용,기시제량위0.10～0.15 mg·kg-1·d-1,매12 h급약1차.술후60 d내목표혈약농도곡치유지재8～12 μg/L,지후유지재5～10μg/L,직지관찰종점(술후12주).수방기간,관찰급성배척반응적발생솔,수자화이식물적존활솔,기록약물제량급치료창농도적량효관계.주요유효성종점위발생경병리증실적급성배척반응,차요유효성종점위이식간혹수자적존활정황.안전성평개지표위연구기간약물불량반응적발생정황.결과 술후제1、2、4、8화12주,Tac적사용제량분별위(4.1±1.9)、(4.5±2.1)、(4.5±2.1)、(4.4±1.8)화(4.1±2.1) mg/d,상대응적혈약농도곡치분별위(8.1±4.5)、(8.9±4.5)、(8.8±4.3)、(8.8±4.1)화(8.0±2.8) μg/L.수방기내경병리증실적급성배척반응발생솔위4.8％(4/83),치료후배척반응균득도역전,관찰기결속시이식간존활솔위100％.수방기내수자폐부감염발생솔위6.02％,당뇨병발생솔위6.02％,신공능미발현명현이상.결론 새씨Tac효낭응용우간이식수자시안전、유효적.
Objective To demonstrate the efficacy and safety of Hangzhou tacrolimus capsule (Saishi Tac capsule,Hangzhou Zbongmei Huadong Pharmaceutical Co.Ltd,China) in Chinese liver transplant recipients.Methods Multicenter,randomized open-labeled,prospective controlled clinical trial was performed in de novo Chinese liver transplant recipients.According to inclusive and exclusive criterion,83 liver recipients from 11transplant centers were enrolled.The recipients accepted Saishi Tac capsule,mycopheolate and steroid 48 h post-operation.The initial dose of Tac was 0.1-0.15 mg kg-1day-1and C0 was 8-12 ng/ml in the first 60 days,followed by 5-10 ng/ml until the terminal observation time poiut (12 weeks after transplantation).The efficacy and safety were estimated during the period.The primary efficacy endpoint of the study was the incidence of biopsy-confirmed acute rejection.Graft survival was the secondary endpoint.Safety was assessed by monitoring laboratory parameters and adverse events reported over the course of the study,such as infection,renal damage,hypertension,hyperlipema and diabetes mellitus and other adverse affairs.Results The dose of Tac at 1st,2nd,4th and 8th week post-operation was (4.1±1.9),(4.5±2.1),(4.5±2.1),(4.4±1.8) and (4.1±2.1) mg,and correspondjng values to the C0 were (8.1±4.5),(8.9±4.5),(8.8±4.3),(8.8±4.1) and (8.0±2.8) ng/ml.During 12 weeks of follow-up,the incidence of biopsy-confirmed acute rejection was 4.8％ (4/83),and all of cases were reversed by implosive therapy.The survival rate of graft hver was 100％.The incidence of lung infection and diabetes mellitus was both 6.02％.Conclusion Saishi Tac capsule was safe and effective to Chinese liver transplant recipients.
