索利那新治疗小儿尿道下裂术后膀胱痉挛的疗效分析

Efficacy of solifenacin in the treatment of bladder spasm after surgical operation of chlidren hypospadias

目的 评价索利那新治疗小儿尿道下裂术后膀胱痉挛的有效性及安全性.方法 2014年1月至2015年5月采用随机对照试验,60例50个月以上小儿尿道下裂手术当天出现膀胱痉挛症状者纳入本研究.患儿均为男性,年龄50 ～ 84个月,平均（61.14＆#177;8.25）个月.随机分为试验组（30例）和对照组（30例）,观察并记录首日膀胱痉挛次数、膀胱痉挛持续时间及尿外渗次数作为人组当天膀胱痉挛情况,试验组于出现膀胱痉挛次日起即术后第1天口服索利那新5 mg,每日1次,共9d;对照组,实施空白对照.比较两组患儿术后第3天和第9天的膀胱痉挛次数、膀胱痉挛持续时间及尿外渗次数,观察两组患儿口干、便秘等不良反应及用药后试验组患儿肝肾功能指标的异常变化.结果 试验组术后第3、9天的24 h膀胱痉挛次数、膀胱痉挛持续时间及尿外渗次数,显著低于该组首日和对照组第3、9天的对应指标,差异均有统计学意义（P＜0.01）,对照组首日及术后第3、9天的对应指标差异无统计学意义（P＞0.05）.试验中两组不良反应发生率差异无统计学意义（JD＞0.05）,试验组用药第9天复查肝肾功能与术前相比无明显变化（P＞0.05）.结论 索利那新治疗小儿尿道下裂术后膀胱痉挛有效、安全.

Objective To evaluate the efficacy and safety of solifenacin in the treatment of bladder spasm after surgical operation of chlidren hypospadias.Methods From January 2014 to May 2015,60 cases of children more than 4 years old after surgical operation of hypospadias who had symptom of bladder spasm on the day of surgery were assigned into the study group （n =30） and control group （n =30）,based on simple randomization.On the first day,the frequency of spasm,the duration of spasm and the incidence of urine extravasation were recorded regarded as the first day condition of bladder spasm.Patients in the study group were treated with solifenacin （5 mg once daily） for a nine days period from l th day postoperation.Patients in the control group were not treated with solifenacin.The frequency of spasm,the duration of spasm and the incidence of urine extravasation of the two groups were recorded and compared on the 3th and 9th day.Adverse events with solifenacin of two groups were recorded.The function of liver and kidney in the study group were recorded and compared.Results There were statistically significant differences（P 〈0.01） in favor of the study group over the control group in the aspect of the frequency of spasm,the duration of spasm and the incidence of urine extravasation on the 3th and 9th day.In the study group,the data compared among l th,3th and 9th was statistically significantly different,opposite to the control group.There was no statistically significant difference between the liver and kidney function of preoperation and the 9th day in the study group.The frequency of adverse events between two groups had no statistically significant difference.Conclusions Solifenacin is effective and safe in the treatment of bladder spasm after surgical operation of chlidren hypospadias