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目的探讨索利那新联合贇式盆底优化训练疗法治疗女性重度膀胱过度活动症(OAB)的疗效及安全性。方法女性重度OAB患者318例,随机分为对照组(162例)和试验组(156例)。对照组口服索利那新10 mg·d~(-1),12周后联合贇式盆底优化训练疗法0.5 h·d~(-1),治疗时间共24周。试验组口服索利那新10 mg·d~(-1)联合贇式盆底优化训练疗法0.5 h·d~(-1),12周后单用贇式盆底优化训练疗法,治疗时间共24周。评估临床疗效及患者感知膀胱症状量表(PPBC)评分、膀胱过度活动症状评分(OABSS,包括白天排尿次数、夜尿次数、尿急次数、急迫性尿失禁次数)总分,泌尿生殖道疾病相关问卷(UDI-6)评分和尿失禁影响程度相关问卷(IIQ-7)评分,检测血清C反应蛋白和最大尿流率(Q_(max))、平均尿流率(Q_(ave))、尿量(VV)、残余尿量水平,记录不良事件发生情况。结果共314例患者完成研究,其中对照组158例,试验组156例,两组间基线资料比较无显著差异(P>0.05)。试验组总有效率为98.1%(153/156),高于对照组[74.6%(118/158),P<0.01]。与治疗前比较,治疗12周末两组PPBC评分、OABSS总分、UDI-6评分和IIQ-7评分均降低(P<0.01),Q_(ave)、Q_(max)和VV均升高(P<0.05或P<0.01),试验组改善程度优于对照组(P<0.01)。与治疗12周末比较,治疗24周末两组PPBC评分、OABSS总分、UDI-6评分和IIQ-7评分均进一步降低(P<0.05或P<0.01),Q_(ave)、Q_(max)和VV均进一步升高(P<0.05或P<0.01),组间比较无显著差异(P>0.05)。两组残余尿量及血清CRP水平在治疗各阶段无显著差异(P>0.05)。治疗过程中,两组均无严重不良反应及急性尿潴留发生。结论索利那新联合贇式盆底优化训练疗法能改善女性重度OAB症状,疗效优于索利那新单用,并可缩短用药时间且安全。
Objective To investigate the efficacy and safety of solifenacin in combination with Yun-style pelvic floor optimal training for the treatment of female severe overactive bladder (OAB). Methods A total of 318 female patients with severe OAB were randomly divided into control group (162 cases) and experimental group (156 cases). The control group was given solifenacin 10 mg · d ~ (-1) for 12 weeks and then combined with Yun-style pelvic floor training for 0.5 h · d ~ (-1) for 24 weeks. The experimental group was given solifenacin 10 mg · d -1 combined with pelvic floor optimization training for 0.5 h · d -1. After 12 weeks, 24 weeks. Assess the clinical efficacy and PPBC score, OABSS (OABSS, including the number of urination during the day, nocturnal urination, urinary urgency, the number of urge incontinence), genitourinary tract related Serum C-reactive protein and maximal urinary flow rate (Q max), mean urinary flow rate (Q ave) and urinary incontinence were measured by questionnaire (UDI-6) Volume (VV), residual urine volume level, record the occurrence of adverse events. Results A total of 314 patients completed the study, of which 158 were in the control group and 156 in the experimental group. There was no significant difference in baseline data between the two groups (P> 0.05). The total effective rate in the experimental group was 98.1% (153/156), higher than that in the control group [74.6% (118/158), P <0.01]. Compared with those before treatment, PPBC score, OABSS score, UDI-6 score and IIQ-7 score of the two groups were all decreased at 12 weeks of treatment (P <0.01), Qve, Qmax and VV were increased <0.05 or P <0.01), and the improvement in the experimental group was better than that in the control group (P <0.01). Compared with the 12-week treatment, the PPBC score, OABSS score, UDI-6 score and IIQ-7 score of the two groups at the end of the 24th week of treatment were further decreased (P <0.05 or P <0.01) VV were further increased (P <0.05 or P <0.01), no significant difference between the two groups (P> 0.05). Residual urine volume and serum CRP levels in the two groups had no significant difference (P> 0.05). During the treatment, no serious adverse reactions and acute urinary retention occurred in both groups. Conclusion Solifenac combined with Yun-type pelvic floor optimization training can improve women with severe OAB symptoms, the effect is superior to solifenac alone and can shorten the medication time and safety.