坦索罗辛胶囊联合益气活血方治疗经皮肾镜超声弹道碎石术后肾损伤的临床研究

Clinical trial of tamsulosin capsules combined with Yiqihuoxue in the treatment of kidney injury after percutaneous nephrolithotripsy

目的观察坦索罗辛胶囊联合益气活血方治疗经皮肾镜超声弹道碎石术后肾损伤的临床疗效及安全性。方法将52例经皮肾镜超声弹道碎石术后肾损伤患者随机分为对照组26例与试验组26例。对照组予以口服盐酸坦索罗辛缓释胶囊每次0.4 mg,qd;试验组在对照组治疗的基础上,予以口服益气活血方每次100 m L,早晚各一次。2组患者均治疗28 d。比较2组患者的临床疗效、血清胱抑素C(Cys-C)、肾损伤分子1(Kim^(^(-1)))、24 h尿蛋白定量(24 h Up)、血尿酸(UA)、血清肌酸酐(SCr)、尿素氮(BUN)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为84.62%(22/26例)和57.69%(15/26例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的Cys-C分别为(1.65±0.27),(2.01±0.29)mg·L^(^(-1));Kim^(^(-1))分别为(31.38±3.76),(39.02±4.88)pg·m L^(^(-1));24 h Up分别为(0.52±0.07),(0.81±0.10)g·d^(^(-1));UA分别为(428.07±50.39),(468.93±52.26)μmol·L^(^(-1));SCr分别为(329.02±40.11),(398.02±45.44)μmol·L^(^(-1));BUN分别为(14.09±1.78),(18.00±2.44)mmol·L^(^(-1)),差异均有统计学意义(均P<0.05)。试验组的药物不良反应主要有头痛、腹泻和手足皮肤反应,对照组的药物不良反应主要有头痛、高血压和腹泻。试验组和对照组的药物不良反应发生率分别为11.54%和15.38%,差异无统计学意义(P>0.05)。结论坦索罗辛胶囊联合益气活血方治疗经皮肾镜超声弹道碎石术后肾损伤的临床疗效显著,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of tamsulosin capsules combined with Yiqihuoxue in the treatment of kidney injury after percutaneous nephrolithotripsy.Methods A total of 52 patients with kidney injury after percutaneous nephrolithotripsy were randomly divided into control group and treatment group with 26 cases per group.Control group was treated with tamsulosin hydrochloride sustained release capsules 0.4 mg qd oral.Treatment group was given Yiqihuoxue100 m L per time,oral,twice a day,morning and night,on the basis of the control group.Two groups were treated for 28 d.The clinical efficacy,levels of serum cystatin C（Cys-C）,kidney injury molecule 1（Kim-1）,24 h urine protein（24 h Up）,uric acid（UA）,serum creatinine（SCr）,urea nitrogen（BUN） and adverse drug reactions werecompared between the two groups.Results After treatment,the total effective rates in treatment and control groups were 84.62%（22/26 cases） and 57.69%（15/26 cases）,with significant differences（P 〈 0.05）.After treatment,the main indexes in treatment and control groups were compared： Cys-C were（1.65 ± 0.27）,（2.01 ± 0.29）mg·L-1; Kim-1 were（31.38 ± 3.76）,（39.02 ± 4.88） pg·m L-1; 24 h Up were（0.52 ± 0.07）,（0.81 ± 0.10）g· d-1; UA were（428.07 ± 50.39）,（468.93 ± 52.26） μmol · L-1; SCr were（329.02 ± 40.11）,（398.02 ± 45.44） μmol·L-1; BUN were（14.09 ± 1.78）,（18.00 ± 2.44） mmol·L-1,with significant differences（P 〈 0.05）.The adverse drug reactions in treatment group were based on headache,diarrhea and hand foot skin reaction,which in control group were headache,hypertension and diarrhea.The incidence of treatment and control groups were 11.54% and 15.38% without significant difference（P 〉 0.05）.Conclusion Tamsulosin capsules combined with Yiqihuoxue has a definitive clinical efficacy in the treatment of kidney injury after percutaneous nephrolithotripsy,without increasing the incidence of adverse drug reactions.