中华临床感染病杂志
中華臨床感染病雜誌
중화림상감염병잡지
CHINESE JOURNAL OF CLINICAL INFECTIOUS DISEASES
2014年
2期
121-124
,共4页
肝炎,乙型,慢性%阿德福韦酯%血肌酐%血磷
肝炎,乙型,慢性%阿德福韋酯%血肌酐%血燐
간염,을형,만성%아덕복위지%혈기항%혈린
Chronic hepatitis B%Adefovir dipivoxil%Serum creatinine%Serum phosphorus
目的 回顾性分析阿德福韦酯(ADV)治疗中国慢性乙型肝炎(CHB)患者2年的肾脏安全性.方法 本研究1 013例CHB患者均为中国ADV四期多中心临床研究(ADF30001和ADF106632)入选者.所有患者均口服ADV(10 mg/d)治疗,分析治疗104周内不同时间点的血磷和血肌酐变化.肾功能损害定义为连续2次检测血肌酐比基线升高≥44.2 μmol/L或血磷水平下降至＜0.4845 mmol/L.采用配对t检验对不同时间点的血磷、血肌酐与基线水平进行比较.结果 治疗28,52,80和104周时,患者血肌酐的中位值分别为74.963,76.996,76.820和77.969 μmol/L,与基线比较差异无统计学意义(t=0.91,0.23,0.59和0.97,P＞0.05).无一例患者血肌酐升高≥44.2 μmol/L.治疗28,80和104周时,患者血磷的中位值分别为1.098,1.088和1.048 mmol/L,与基线比较差异具有统计学意义(t=2.34,3.06和4.94,P＜0.05或＜0.01).至治疗104周累计血磷异常下降发生率为0.8％ (8/104).无一例患者发生血磷下降至＜0.4845 mmol/L.结论 ADV治疗2年未见明显的肾功能损害,中国CHB患者对ADV治疗的耐受性良好.
目的 迴顧性分析阿德福韋酯(ADV)治療中國慢性乙型肝炎(CHB)患者2年的腎髒安全性.方法 本研究1 013例CHB患者均為中國ADV四期多中心臨床研究(ADF30001和ADF106632)入選者.所有患者均口服ADV(10 mg/d)治療,分析治療104週內不同時間點的血燐和血肌酐變化.腎功能損害定義為連續2次檢測血肌酐比基線升高≥44.2 μmol/L或血燐水平下降至＜0.4845 mmol/L.採用配對t檢驗對不同時間點的血燐、血肌酐與基線水平進行比較.結果 治療28,52,80和104週時,患者血肌酐的中位值分彆為74.963,76.996,76.820和77.969 μmol/L,與基線比較差異無統計學意義(t=0.91,0.23,0.59和0.97,P＞0.05).無一例患者血肌酐升高≥44.2 μmol/L.治療28,80和104週時,患者血燐的中位值分彆為1.098,1.088和1.048 mmol/L,與基線比較差異具有統計學意義(t=2.34,3.06和4.94,P＜0.05或＜0.01).至治療104週纍計血燐異常下降髮生率為0.8％ (8/104).無一例患者髮生血燐下降至＜0.4845 mmol/L.結論 ADV治療2年未見明顯的腎功能損害,中國CHB患者對ADV治療的耐受性良好.
목적 회고성분석아덕복위지(ADV)치료중국만성을형간염(CHB)환자2년적신장안전성.방법 본연구1 013례CHB환자균위중국ADV사기다중심림상연구(ADF30001화ADF106632)입선자.소유환자균구복ADV(10 mg/d)치료,분석치료104주내불동시간점적혈린화혈기항변화.신공능손해정의위련속2차검측혈기항비기선승고≥44.2 μmol/L혹혈린수평하강지＜0.4845 mmol/L.채용배대t검험대불동시간점적혈린、혈기항여기선수평진행비교.결과 치료28,52,80화104주시,환자혈기항적중위치분별위74.963,76.996,76.820화77.969 μmol/L,여기선비교차이무통계학의의(t=0.91,0.23,0.59화0.97,P＞0.05).무일례환자혈기항승고≥44.2 μmol/L.치료28,80화104주시,환자혈린적중위치분별위1.098,1.088화1.048 mmol/L,여기선비교차이구유통계학의의(t=2.34,3.06화4.94,P＜0.05혹＜0.01).지치료104주루계혈린이상하강발생솔위0.8％ (8/104).무일례환자발생혈린하강지＜0.4845 mmol/L.결론 ADV치료2년미견명현적신공능손해,중국CHB환자대ADV치료적내수성량호.
Objective To assess the renal safety of adefovir dipivoxil (ADV) in Chinese patients with chronic hepatitis B (CHB).Methods A retrospective study was performed on 1 013 CHB patients from Chinese ADV multicenter clinical trials (ADF30001 and ADF106632).All patients were administrated with ADV 10 mg daily.The serum creatinine and phosphorus levels were measured in different time pointsduring 104-week treatment.Nephrotoxicity was defined as an increase ≥44.2 μ mol/L from baseline in serum creatinine or a serum phosphorus value of ＜ 0.4845 mmol/L on two consecutive occasions.Paired t test was used to analyze serum creatinine and phosphorous data before treatment and at different time points during treatment.Results At week 28,week 52,week 80 and week 104,the median levels of serum creatinine were 74.963,76.996,76.820 and 77.969 μmol/L,respectively,and there were no significant differences from baseline (t =0.91,0.23,0.59 and 0.97,P ＞ 0.05).No patient experienced a ≥ 44.2 μmol/L increase from baseline.For serum phosphorus,the median levels at week 28,week 80 and week 104 were 1.098,1.088 and 1.048 mmol/L,and there were significant decreases from baseline (t =2.34,3.06 and 4.94,P ＜0.05 or ＜ 0.01).The cumulative incidence of serum phosphorus abnormality was 0.8％ (8/104).There were no confirmed serum phosphorous decreases to ＜ 0.4845 mmol/L.Conclusion Two years treatment with ADV (10 mg/d) does not result in marked nephrotoxicity,indicating that ADV 10 mg daily is well tolerated by Chinese patients.
