罗西维林片联合缩泉胶囊治疗膀胱过度活动症的临床观察

摘要

目的 探讨罗西维林片联合缩泉胶囊治疗膀胱过度活动症(OAB)的临床疗效及安全性.方法 收集2011年10月至2013年10月期间OAB患者126例,采用完全随机方法将患者分为4组:A组(34例,缩泉胶囊1.8g,3次/d+罗西维林片10 mg,3次/d),B组(32例,罗西维林片10 mg,3次/d),C组(32例,缩泉胶囊1.8g,3次/d),D组(28例,仅给予膀胱训练指导),疗程均为4周.所有患者都给予膀胱训练指导.观察各组治疗前后的主观指标膀胱过度活动症症状评分(OABSS)及客观指标24 h排尿次数、尿急次数、尿失禁次数、夜尿次数、每次排尿量的变化,评估治疗后患者OAB症状的改善情况及安全性.结果 治疗前后OABSS评分、24 h排尿次数、尿急次数、夜尿次数、尿失禁次数、平均每次排尿量A组分别为(9.5±2.1)和(2.4±1.0)分,(13.6±3.8)和(7.2±1.3)次,(7.7±2.7)和(2.4±1.2)次,(4.1±2.1)和(1.0±0.3)次,(3.5±1.4)和(0.8±0.3)次,(124±28)和(280±36) ml;B组分别为(9.7±1.8)和(5.4±1.9)分,(13.9±3.6)和(8.8±1.4)次,(7.6±2.5)和(4.4±1.4)次,(4.2±1.8)和(1.8±0.4)次,(3.6±1.3)和(1.6±0.4)次,(122±29)和(210±38) ml;C组分别为(9.6±2.0)和(5.3±1.8)分,(13.8±3.7)和(8.7±1.2)次,(7.7±2.4)和(4.3±1.3)次,(4.3±2.1)和(1.7±0.5)次,(3.6±1.5)和(2.0±0.2)次,(124±27)和(212±36) ml;D组分别为(9.2±1.9)和(8.4±1.8)分,(13.5±3.4)和(11.2±2.2)分,(7.6±2.6)和(6.4±2.1)分,(4.3±2.0)和(3.3±0.4)分,(3.5±1.3)和(2.8±0.3)次,(125 ±28)和(161±38) ml;4组治疗前后组内对比,主观指标及客观指标差异均有统计学意义(均P＜0.05).A组、B组、C组治疗后各项指标与D组比较,差异均有统计学意义(均P＜0.05).A组与B组、C组之间比较,差异均有统计学意义(P＜0.05).总的不良反应发生率A组为8.8％ (3/34),B组为21.8％(7/32),C组为9.3％ (3/32),A组与B组之间差异有统计学意义(P＜0.05),A组与C组之间比较,差异无统计学意义(P＞0.05).4组患者均无严重不良事件发生.结论 罗西维林片联合缩泉胶囊治疗膀胱过度活动症疗效较好,安全可靠.%Objective To assess the efficacy and safety of combining Rociverine Tablets with Suoquan capsule in treatment of patients with overactive bladder(OAB).Methods Totally 126 cases of overactive bladder were collected to research and were randomly divided into four groups.Patients in A group were administrated with Rociverine Tablets at 10mg and Suoquan capsule at 1.8g three times a day for 4 weeks.Patients in B group were administrated only with Rociverine Tablets for 4 weeks.Patients in C group were administrated only with Suoquan capsule for 4 weeks.All patients had the bladder training.The efficacy and safety of treatment were assessed before and after treatment in the subjective outcome measure of OABSS and the objective outcome measures including daily frequency of micturition,urgency,urgency incontinence,nocturia and avoiding volumes.Results The subjective outcome measure and objective outcome measures in the A group before-and after-treatment:(9.5 ± 2.1)and (2.4 ± 1.0) for OABSS,(13.6 ± 3.8) and (7.2 ± 1.3) for frequency of micturition,(7.7 ± 2.7) and (2.4 ± 1.2) for frequency of urgency,(3.5 ± 1.4) and (0.8 ± 0.3) for frequency of nocturia,(4.1 ± 2.1) and (1.0 ± 0.3)for frequency of urgency incontinence,(124 ± 28) and (280 ± 36) ml for voiding volumes.These data in the B group were(9.7 ± 1.8)and(5.4± 1.9),(13.9 ±3.6)and(8.8 ± 1.4),(7.6±2.5)and(4.4 ± 1.4),(4.2 ± 1.8)and (1.8 ±0.4),(3.6± 1.3)and(1.6 ±0.4),(122 ±29)and(210 ±38).These in the C group were (9.6 ±2.0) and (5.3 ±1.8),(13.8 ±3.7) and (8.7±1.2),(7.7±2.4) and (4.3±1.3),(4.3±2.1) and (1.7 ± 0.5),(3.6±1.5)and(2.0±0.2),(124±27)and(212±36).These in the D group were (9.2±1.9) and (8.4 ±1.8),(13.5 ±3.4) and (11.2 ±2.2),(7.6 ±2.6) and (6.4±2.1),(4.3 ±2.0) and (3.3 ±0.4),(3.5 ± 1.3) and (2.8 ± 0.3),(125 ± 28) and(161 ± 38).There wre significant differences in subjective and objective outcome measures of patients in each group before and after treatment (P ＜ 0.05).Moreover,compared with D groups,A,B and C groups all had significant differences in subjective and Objective outcome measures of patients at the end of treatments(P ＜ 0.05).There were significant differences in subjective and Objective outcome measures of patients between A and B groups.The incidences of adverse events of A,B and C groups were 8.8％ (3/34),21.8％ (7/32) and 9.3％ (3/32) respectively.There were significant differences in the incidences of adverse events between A group and B group (P ＜ 0.05).There were no significant differences in the incidences of adverse events between A group and C group (P ＞ 0.05).No severe adverse events happened in four groups.Conclusion Combining Rociverine Tablets with Suoquan capsule in treatment of patients with overactive bladder can significantly improve the clinical efficiency.