曲美他嗪对休克患者肾功能影响的临床研究

Effect of trimetazidine on renal function in patients with shock

目的 探讨曲美他嗪对休克患者肾功能的影响.方法 采用前瞻性随机对照双盲研究方法,收集2011年4月到2013年4月入住广州市红十字会医院重症监护病房（ICU）的各种原因休克患者共128例,按照随机数字表法分为对照组和曲美他嗪治疗组,每组64例.两组患者均接受常规抗休克治疗方案,治疗组加用曲美他嗪20 mg口服,每日3次;对照组加用灭菌注射用水10 mL作为安慰剂,每日3次;两组均治疗7d.于治疗前、治疗后48 h、治疗后1周测定每小时尿量、血肌酐（SCr）、血尿素氮（BUN）、胱抑素C,计算肌酐清除率（CCr）,同时监测患者动态平均动脉压（MAP）,并记录48 h和1周病死率.结果 两组患者治疗前肾功能指标差异均无统计学意义.治疗后患者SCr、BUN、胱抑素C逐渐下降,CCr、MAP逐渐升高.与对照组比较,治疗组治疗后48 h胱抑素C下降、CCr升高差异即有统计学意义[胱抑素C（mg/L）：0.85±0.81比1.01±0.91,t=2.562,P＝0.017;CCr（mL/s）：0.93±0.64比0.69±0.40,t=2.155,P=0.033];治疗后1周SCr、BUN下降差异有统计学意义[SCr（μmol/L）：94.23±88.31比104.99±98.37,t=2.921,P=0.003; BUN（mmol/L）：9.46±8.24比11.87±8.65,t=2.611,P=0.010].两组治疗后每小时尿量、MAP均所改善,但治疗组与对照组比较差异均无统计学意义[每小时尿量（mL）：治疗后48 h 55.67±31.43比45.34±11.79,t=0.934,P=0.323;治疗后1周71.67±37.23比75.35±22.88,t=1.280,P=0.210;MAP （mmHg,1 mmHg=0.133 kPa）：治疗后48 h 72.13±33.24比69.28±39.98,t=1.408,P=0.179;治疗后1周71.44±21.98比72.32±31.11,t=1.184,P=0.252].治疗组病死率较对照组有所降低,但差异无统计学意义[治疗后48 h：31.2％（20/64）比32.8％（21/64）,x2=0.084,P=0.785;治疗后1周：32.8％（21/64）％比35.9％（23/64）,x2=2.084,P=0.173].结论 曲美他嗪可以改善休克患者的肾功能.

Objective To investigate the effects of trimetazidine on renal function in patients with shock.Methods A prospective randomized controlled double-blind study was conducted.128 patients with shock admitted to intensive care unit （ICU） of Guangzhou Red Cross Hospital from April 2011 to April 2013 were enrolled and randomly divided into control group and trimetazidine treatment group,each n＝64.All patients received anti-shock treatment,while the patients in trimetazidine group received trimetazidine treatment （20 mg orally,tid） for 7 days,and patients in control group received placebo （10 mL of sterile water for injection,tid） for 7 days.The urinary output,serum creatinine （SCr）,blood urea nitrogen （BUN）,cystatin C,and creatinine clearance （CCr） reflecting renal function were recorded in both groups,and the values were compared before treatment,48 hours after treatment,and 1 week after the treatment.At the same time,dynamic mean arterial pressure （MAP） was monitored,and 48-hour and 1-week mortality rates were recorded.Results There was no significant difference in results in all the renal function parameters before the treatment between two groups.The levels of SCr,BUN,cystatin C were gradually decreased after treatment in both groups,but CCr and MAP were gradually increased.Compared with the control group,cystatin C at 48 hours after treatment was significantly decreased,while CCr was significantly increased in treatment group [cystatin C （mg/L）：0.85 ± 0.81 vs.1.01 ± 0.91,t=2.562,P=0.017; CCr （mL/s）：0.93 ± 0.64 vs.0.69 ± 0.40,t=2.155,P=0.033].SCr and BUN at 1 week after treatment were significantly decreased in treatment group [SCr （lμmol/L）：94.23 ± 88.31 vs.104.99 ± 98.37,t=2.921,P=0.003 ; BUN （mmol/L）：9.46 ± 8.24 vs.11.87 ± 8.65,t=2.611,P=0.010].Urine output per hour and MAP was improved after treatment in both groups,and no significant difference was found between treatment group and control group [urine output （mL）：48 hours after treatment 55.67 ± 31.43 vs.45.34 ± 11.79,t =0.934,P=0.323 ; 1 week after treatment 71.67 ± 37.23 vs.75.35 ± 22.88,t=1.280,P=0.210; MAP （mmHg,1 mmHg=0.133 kPa）：48 hours after treatment 72.13 ± 33.24 vs.69.28 ± 39.98,t=1.408,P=0.179; 1 week after treatment 71.44 ± 21.98 vs.72.32 ± 31.11,t =1.184,P =0.252].Mortality rate in treatment group was lowered compared with control group,however no statistical significance was found [48 hours after treatment：31.2％ （20/64） vs.32.8％ （21/64）,x2=0.084,P=0.785; 1 week after treatment：32.8％ （21/64） vs.35.9％ （23/64）,x2=2.084,P=0.173].Conclusions Trimetazidine can improve renal function in patients with shock.