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目的初步评价马来酸桂哌齐特注射液的肾脏安全性。方法收集2011年8月至2012年7月在北京友谊医院医疗保健中心住院、因心脑血管疾病使用过马来酸桂哌齐特注射液、年龄≥60岁并有完整病历记录患者的临床资料进行回顾性分析。肾损伤诊断标准为使用马来酸桂哌齐特后血清肌酐升高≥26.4μmol/L或增加至基线值1.5倍以上,或尿量<0.5 ml/(kg·h)。结果共收集到489例患者,男性377例,年龄60~106岁,平均(83±7)岁;女性112例,年龄63~100岁,平均(81±8)岁。60~80岁者160例(32.7%),>80岁者329例(67.3%)。合并感染者265例(54.2%)、慢性肾功能不全者223例(45.6%)、糖尿病者125例(25.6%)、恶性肿瘤者32例(6.5%)、危重症者24例(4.9%)。联合应用血管紧张素转换酶抑制剂/血管紧张素Ⅱ受体阻断剂(ACEI/ARB)类药物者150例。马来酸桂哌齐特用法均为320 mg,1次/d静脉滴注;用药时间为2~68 d,平均12 d。有14例患者出现肾损伤(2.9%),男性12例(3.2%),女性2例(1.8%),60~80岁者1例(0.6%),>80岁者13例(4.0%)。用药前血清肌酐54~217μmol/L,平均(105±48)μmol/L;静脉滴注马来酸桂哌齐特2~15 d(平均6 d)后,血清肌酐为86~276μmol/L,平均(142±57)μmol/L。>80岁者。肾损伤发生率高于60~80岁者(P=0.043)。合并慢性肾功能不全者肾损伤发生率高于无慢性肾功能不全者(P=0.002)。14例患者均未出现少尿或无尿症状。9例患者(64.3%)有动态肾功能监测记录,其中6例出现肾损伤后停用马来酸桂哌齐特,3例继续用药至疗程结束,结果示血清肌酐于停药后3~12 d内(平均6 d)恢复至基础水平。5例患者(35.7%)无肾功能动态监测记录,其中1例停药,4例未停药。所有出现肾损伤的患者均未给予药物治疗,均未发生不可逆肾损伤并未对原发疾病产生影响。结论马来酸桂哌齐特注射液可导致老年患者肾损伤。高龄且合并慢性肾功能不全的患者应用马来酸桂哌齐特注射液时应实施肾功能动态监测。
Objective To evaluate the renal safety of cinepazide maleate injection. Methods The clinical data of patients who were hospitalized at the Beijing Friendship Hospital Medical Center from August 2011 to July 2012 and who were given cinepazide maleate for cardiovascular and cerebrovascular diseases and whose age was over 60 years old were collected. Retrospective analysis. The diagnostic criteria for renal impairment were serum creatinine ≥26.4 μmol / L or increased to 1.5 times more than baseline or urine output <0.5 ml / (kg · h) after administration of cinepazide maleate. Results A total of 489 patients were collected, including 377 males and 60 to 106 years old (83 ± 7) years old; 112 females, aged 63-100 years (mean, 81 ± 8 years). 160 (32.7%) were 60-80 years old and 329 (67.3%) were> 80 years old. There were 265 cases (54.2%) with infection, 223 cases (45.6%) with chronic renal insufficiency, 125 cases (25.6%) with diabetes mellitus, 32 cases (6.5%) with malignant tumors and 24 cases (4.9% . 150 cases of angiotensin-converting enzyme inhibitor / angiotensin Ⅱ receptor blocker (ACEI / ARB) drugs. Cinepazide maleate usage are 320 mg, 1 / d intravenous infusion; medication for 2 ~ 68 d, an average of 12 d. There were 14 patients with renal injury (2.9%), 12 males (3.2%), 2 females (1.8%), 60-80 years old in 1 case (0.6%) and> 80 years old in 13 cases (4.0% . Serum creatinine was 54 ~ 217μmol / L before treatment, with an average of (105 ± 48) μmol / L. Serum creatinine was 86 ~ 276μmol / L after intravenous instillation of cinepazide maleate for 2 ~ 15 days Average (142 ± 57) μmol / L. > 80 years old. The incidence of renal injury was higher than 60 to 80 years old (P = 0.043). The incidence of renal injury in patients with chronic renal failure was higher than that in patients without chronic renal failure (P = 0.002). None of the 14 patients experienced oliguria or anuria. Nine patients (64.3%) had dynamic renal monitoring records. Among them, 6 cases were given cinepazide maleate after renal injury, and 3 cases continued treatment till the end of treatment. The results showed that serum creatinine was stopped after 3 to 12 d (average 6 d) returned to the baseline level. Five patients (35.7%) had no dynamic monitoring of renal function, of which 1 was discontinued and 4 were not discontinued. None of the patients with kidney damage had any drug treatment, and no irreversible kidney injury had occurred without affecting the primary disease. Conclusion Cinepazide maleate injection can cause renal damage in elderly patients. In elderly patients with chronic renal insufficiency, dynamic monitoring of renal function should be performed when using cinepazide maleate injection.