中华内科杂志
中華內科雜誌
중화내과잡지
CHINESE JOURNAL OF INTERNAL MEDICINE
2012年
7期
502-507
,共6页
陈楠%钱家麒%梅长林%张爱华%邢昌赢%王莉%刘文虎%王梅%陈江华%刘必成%侯凡凡%陈香美%左力%史伟%于凌博%张怡
陳楠%錢傢麒%梅長林%張愛華%邢昌贏%王莉%劉文虎%王梅%陳江華%劉必成%侯凡凡%陳香美%左力%史偉%于凌博%張怡
진남%전가기%매장림%장애화%형창영%왕리%류문호%왕매%진강화%류필성%후범범%진향미%좌력%사위%우릉박%장이
肾功能不全,慢性%贫血%透析%持续性促红细胞生成素受体激活剂
腎功能不全,慢性%貧血%透析%持續性促紅細胞生成素受體激活劑
신공능불전,만성%빈혈%투석%지속성촉홍세포생성소수체격활제
Renal insufficiency,chronic%Anemia%Dialysis%Continuous erythropoietin receptor activator
目的 观察每4周1次皮下注射持续性促红细胞生成素受体激活剂(C.E.R.A.)维持慢性肾脏病(CKD)透析贫血患者Hb水平的疗效和安全性.方法 采用开放、随机、对照、多中心临床试验方法.选择血液透析或腹膜透析且已接受促红细胞生成素(EPO)治疗的CKD贫血成年患者,在6周的预治疗期接受EPO-β3每周1～3次皮下注射,维持Hb于100～120 g/L.其后符合入选标准的患者以2∶1比例随机接受C.E.R.A.每4周1次皮下注射(C.E.R.A.组,187例)或EPO-β每周1～3次皮下注射(EPO组,94例)持续治疗28周(包括20周剂量滴定期和8周疗效评估期).C.E.R.A.的起始剂量根据首次给药前1周内使用的EPO-β剂量换算而定.主要研究终点为疗效评估期Hb值相对基线水平的变化.结果 共253例患者完成了28周的治疗.C.E.R.A.组在疗效评估期Hb值相对基线的变化为+2.57 g/L,EPO组为+1.23 g/L,两组差异为1.34 g/L(95％CI-1.11 ～3.78 g/L),其95％ CI的下限大于预设的非劣效性界值-7.5 g/L(P＜0.0001),故认为C.E.R.A.每4周1次皮下注射对CKD透析贫血患者维持Hb水平的疗效非劣于EPO-β.C.E.R.A.组和EPO组平均Hb值维持于目标值的患者比例相当(69.0％比68.9％).C.E.R A.组和EPO组不良事件的总发生率相似(41.7％比46.2％),安全性结果与研究人群的基础疾病有关.结论 在已接受EPO治疗的CKD透析贫血患者中,换用C.E.R.A.每4周1次皮下注射可有效维持Hb水平,且非劣效于EPO-β治疗.CKD透析贫血患者对于皮下注射C.E.R.A.总体上耐受良好.
目的 觀察每4週1次皮下註射持續性促紅細胞生成素受體激活劑(C.E.R.A.)維持慢性腎髒病(CKD)透析貧血患者Hb水平的療效和安全性.方法 採用開放、隨機、對照、多中心臨床試驗方法.選擇血液透析或腹膜透析且已接受促紅細胞生成素(EPO)治療的CKD貧血成年患者,在6週的預治療期接受EPO-β3每週1～3次皮下註射,維持Hb于100～120 g/L.其後符閤入選標準的患者以2∶1比例隨機接受C.E.R.A.每4週1次皮下註射(C.E.R.A.組,187例)或EPO-β每週1～3次皮下註射(EPO組,94例)持續治療28週(包括20週劑量滴定期和8週療效評估期).C.E.R.A.的起始劑量根據首次給藥前1週內使用的EPO-β劑量換算而定.主要研究終點為療效評估期Hb值相對基線水平的變化.結果 共253例患者完成瞭28週的治療.C.E.R.A.組在療效評估期Hb值相對基線的變化為+2.57 g/L,EPO組為+1.23 g/L,兩組差異為1.34 g/L(95％CI-1.11 ～3.78 g/L),其95％ CI的下限大于預設的非劣效性界值-7.5 g/L(P＜0.0001),故認為C.E.R.A.每4週1次皮下註射對CKD透析貧血患者維持Hb水平的療效非劣于EPO-β.C.E.R.A.組和EPO組平均Hb值維持于目標值的患者比例相噹(69.0％比68.9％).C.E.R A.組和EPO組不良事件的總髮生率相似(41.7％比46.2％),安全性結果與研究人群的基礎疾病有關.結論 在已接受EPO治療的CKD透析貧血患者中,換用C.E.R.A.每4週1次皮下註射可有效維持Hb水平,且非劣效于EPO-β治療.CKD透析貧血患者對于皮下註射C.E.R.A.總體上耐受良好.
목적 관찰매4주1차피하주사지속성촉홍세포생성소수체격활제(C.E.R.A.)유지만성신장병(CKD)투석빈혈환자Hb수평적료효화안전성.방법 채용개방、수궤、대조、다중심림상시험방법.선택혈액투석혹복막투석차이접수촉홍세포생성소(EPO)치료적CKD빈혈성년환자,재6주적예치료기접수EPO-β3매주1～3차피하주사,유지Hb우100～120 g/L.기후부합입선표준적환자이2∶1비례수궤접수C.E.R.A.매4주1차피하주사(C.E.R.A.조,187례)혹EPO-β매주1～3차피하주사(EPO조,94례)지속치료28주(포괄20주제량적정기화8주료효평고기).C.E.R.A.적기시제량근거수차급약전1주내사용적EPO-β제량환산이정.주요연구종점위료효평고기Hb치상대기선수평적변화.결과 공253례환자완성료28주적치료.C.E.R.A.조재료효평고기Hb치상대기선적변화위+2.57 g/L,EPO조위+1.23 g/L,량조차이위1.34 g/L(95％CI-1.11 ～3.78 g/L),기95％ CI적하한대우예설적비렬효성계치-7.5 g/L(P＜0.0001),고인위C.E.R.A.매4주1차피하주사대CKD투석빈혈환자유지Hb수평적료효비렬우EPO-β.C.E.R.A.조화EPO조평균Hb치유지우목표치적환자비례상당(69.0％비68.9％).C.E.R A.조화EPO조불량사건적총발생솔상사(41.7％비46.2％),안전성결과여연구인군적기출질병유관.결론 재이접수EPO치료적CKD투석빈혈환자중,환용C.E.R.A.매4주1차피하주사가유효유지Hb수평,차비렬효우EPO-β치료.CKD투석빈혈환자대우피하주사C.E.R.A.총체상내수량호.
Objective To evaluate the efficacy and safety of continuous erythropoietin receptor activator (C.E.R.A.) once every 4 weeks by subcutaneous administration on hemoglobin (Hb)maintenance in dialytic patients with chronic renal anemia who had been treated with stable dose of erythropoietin (EPO).Methods This was an open,randomized,controlled,multi-center trial.All the hemodialysis or peritoneal dialytic patients in EPO maintenance treatment received subcutaneous EPO-β during the 6-week pre-treatment period to maintain Hb level between 100 g/L and 120 g/L.Eligible patients were randomized (2∶1 ) to accept either C.E.R.A.once every 4 weeks by subcutaneous administration ( C.E.R.A.group,n =187 ) or subcutaneous EPO-β 1-3 times weekly ( EPO group,n =94) for 28 weeks (including 20-week dose titration period and 8-week efficacy evaluation period ). The starting dose of C.E.R.A.was converted according to the dose of EPO-β administered in the week preceding the first study drug administration.The primary outcome was the change of Hb level between the baseline and that in the efficacy evaluation period.Results Totally 253 patients completed the whole 28-week treatment.The change of baseline-adjusted mean Hb was +2.57 g/L for C.E.R.A.group and + 1.23 g/L for EPO group,resulting in a treatment difference of 1.34 g/L (95％ CI - 1.11-3.78 g/L).Since the lower limit of 95％ CI was greater than the pre-defined non-inferiority margin -7.5 g/L( P ＜ 0.0001 ),C.E.R.A.once every 4 weeks by subcutaneous administration was clinically non-inferior to EPO regarding the maintenance of stable Hb level.The proportion of patients maintaining Hb level within the range of 100-120 g/L through efficacy evaluation period was similar between the two groups ( 69.0％ for C.E.R.A.group vs 68.9％ for EPO group,P ＞0.05 ).The overall incidence of adverse events was similar between the C.E.R.A.(41.7％)and EPO (46.2％ ) groups ( P ＞ 0.05 ).The safety findings were in accordance with the patients' primary diseases rather than the administration.Conclusions Conversion from EPO to C.E.R.A.once every 4 weeks by subcutaneous injection could maintain the Hb in target level in dialytic patients with renal anemia,and it was non-inferior to EPO.In general,subcutaneous administration of C.E.R.A.is well tolerated in dialytic patients with chronic renal anemia.
