依达拉奉注射液肾脏安全性的回顾性研究

Retrospective analysis of kidney＇s safety of edaravone injection

目的评价依达拉奉注射液的肾脏安全性。方法收集2014年1至6月因脑血管疾病在首都医科大学附属北京友谊医院神经内科住院并使用过依达拉奉注射液、年龄≥45岁并有完整病历记录患者的临床资料进行回顾性分析。记录患者一般资料、合并疾病、使用依达拉奉注射液（30mg、2次／d静脉滴注）的时间、合并用药情况和肾功能检测结果。肾损伤诊断标准为用药后血清肌酐（Ser）升高≥26.4umol／L或增加至基线值1．5倍以上。结果纳入分析的患者共237例，男性163例，女性74例；年龄50～86岁，平均（65±9）岁。应用依达拉奉时间为2～26d，平均11d。237例患者中出现肾损伤者11例，发生率为4．6％。男、女性患者‘肾损伤发生率差异无统计学意义[4．9％（8／163）比4．1％（3／74），P〉0．05]。年龄≥75岁患者肾损伤发生率高于45～59者和60～74岁者[11．4％（4／35）比3．8％（3／80）、3．3％（4／122），均P〈0．05]。合并慢性肾功能不全或肾囊肿患者。肾损伤发生率明显高于无慢性。肾功能不全或肾囊肿的患者[9．1％（2／22）比4．2％（9／215），7．7％（2／26）比4．3％（9／211），均P〈0．05]。11例出现肾损伤者用药前Ser为26～113μmol／L，平均（68±24）μmoL／L，应用依达拉奉9～13d（平均11d）后升至52～187μmol/L，平均（101±36）μmol／L；停用依达拉奉后Scr均恢复至用药前水平。11例肾损伤患者均联合使用了≥3种药物。结论年龄〈75岁且无慢性肾功能不全或肾囊肿的患者应用依达拉奉较安全；≥75岁、合并慢性肾功能不全或肾囊肿者应用依达拉奉时应监测肾功能。

Objective To evaluate the kidney＇s safety of edaravone injection. Methods The clinical data of patients who were hospitalized in Neurology Department of Beijing Friendship Hospital, Capital Medical University from January 2014 to June 2014 and had complete medical records, aged ≥45 years and received edaravone injection for cerebrovaseular disease were collected and analyzed retrospectively. The patients＇ information, complications, time of application of edaravone injection （30 mg, twice daily, IV infusion） , drug combination and the levels of serum ereatinine were recorded. The serum creatinine elevated to 〉~ 26.4 p, mol/L, or increased 1.5 times of baseline were the diagnostic criteria of kidney injury after receiving edaravone injection. Results A total of 237 patients＇ medical records comprised 163 male and 74 female, with average age of （65 -± 9 ） years （50 to 86 years ） were collected. The average time of edaravone injection administration was 11 days （2 to 26 days） for all patients. Eleven patients （4.6%） developed kidney injury. There was no statistical significance in the incidence of kidney injury between male and female patients[4.9% （8/163） vs. 4.1% （3/74） ,P 〉0.05 for all comparisons]. The incidence of kidney injury in patients who were 75 years or older was higher than those in the patients who aged between 45 to 59 years and 60 to 74 years [ 11.4% （4/35） vs. 3.8% （3/80）, 3.3% （4/122）, P 〈 0.05 for all comparisons 1. The incidence of kidney injury in patients with chronic renal insufficiency or renal cyst was higher than that in patients without chronic renal insufficiency or renal cyst [ 9.1% （2/22） vs. 4.2 % （9/215 ） ,7.7 % （ 2/26 ） vs. 4.3 % （9/211 ）, P 〈 0.05 ]. The average level of serum ereatinine in the 11 patients before treatment was （68 ±24） μ mol/L （26 to 113 μmol/L） and increased to （101 ± 36） μ mol/L （52 to 187μmol/L） after receiving edaravone injection for 9 to 13 days （average days of 11 ）. The serum creatinine levels of the 11 patients returned to the levels before administration after edaravone withdrawal. The 11 patients with kidney injury were all co-treated with three or more kinds of drugs.Conclusions The kidney＇s safety of edaravone injection is higher in patients who were under 75 years, without chronic renal insufficiency and renal cyst. Dynamic monitoring of kidney function should be given in patients who are 75 years or older, with chronic renal insufficiency or renal cyst when receiving edaravone injection.