琥珀酸索利那新治疗小儿尿道下裂术后膀胱痉挛有效性及安全性研究

On Effectiveness and Safety of Solifenacin Succinate on Bladder Spasm after Surgery of Hypospadias in Children

目的观察琥珀酸索利那新用于小儿尿道下裂术后膀胱痉挛的临床疗效及其安全性评价.方法将入选的60例小儿尿道下裂患者根据个体病情选择适当的尿道成形术,术后将患者随机分为两组.实验组(30例)患儿于手术当日起口服琥珀酸索利那新,3 mg/次,1次/d,服用7 d;对照组(30例)患儿在出现膀胱痉挛疼痛时予以吲哚美辛直肠栓剂25 mg作镇痛处理.记录术后7 d患儿膀胱痉挛每日发作次数、膀胱痉挛平均持续时间;记录患儿术后3 d内每日排尿次数、单次排尿量和急迫性尿失禁次数;观察患儿术后并发症尿道瘘和尿道狭窄、不良反应的发生情况.结果实验组术后每日膀胱痉挛次数、膀胱痉挛持续时间、术后3 d内平均排尿次数和急迫性尿失禁次数均显著低于对照组(P<0.05),而单次排尿量明显高于对照组(P<0.05).比较两组患者术后尿道瘘和尿道狭窄发生率,差异均无统计学意义(P>0.05).实验组患者服用琥珀酸索利那新后未出现严重不良反应.结论琥珀酸索利那新能够有效预防和治疗小儿尿道下裂术后膀胱痉挛,术后并发症、不良反应发生率低,符合临床应用的有效性和安全性.

Objective To observe and evaluate the clinical efficacy and safety of Solifenacin Succinate in treating bladder spasm after the surgery of hypospadias.Method 60 Cases of children with hypospadias were treated with appropriate urethroplasty according to their individual conditions,and then were randomly divided into two groups after the surgery.The patients in the experimental group（30 cases） were administrated with Solifenacin Succinate（orally,3 mg/time daily,successively for 7 days from the first day after the surgery）.The patients in the control group（30 cases） were treated with Indomethacin（in anus,25 mg） when they underwent pain induced by bladder spasm.Within 7 days after surgery,the daily episodes and average duration of bladder spasm were recorded.The average daily numbers of urination,the amount of single urine output and the number of urge incontinence were also recorded during 3 days after the surgery.The incidences of postoperative complications,such as urethral fistula,urethral stricture and adverse reactions,were also observed and recorded.Results The daily episodes and average duration of bladder spasm,the average daily urination number,and the incidence of urge incontinence during 3 days post-operation in the experimental group were significantly lower than those in the control group（P〈0.05）,while the amount of single urine output was significantly more than that in the control group（P〈0.05）.There was no significant difference in the postoperative complications,such as urethral fistula and urethral stricture（P〈0.05）.No adverse reaction was found in the patients who administered with Solifenacin Succinate in the experimental group.Conclusion Solifenacin Succinate can prevent and treat bladder spasm after surgery of hypospadias in children,the incidence of postoperative complications,and not cause serious adverse reactions,which conformed to the efficacy and safety of clinical application.