研究目的 本研究欲了解Solifenacin與其他抗膽鹼藥物治療膀胱過動症病人的療效比較,同時彙整過去這些藥物治療膀胱過動症病人的成本效益,進行統合分析(Meta-Analysis)。經由分析比較,統整出最佳的藥物使用方式,能夠有效達到醫療品質的提升。 研究方法 本研究為回溯性研究,採用目前各個實證醫學資料庫搜尋到膀胱過動症患者接受抗膽鹼藥物治療成本效益的所有文獻。根據國際尿失禁學會於2002年針對膀胱過動症的定義及診斷標準當作病人收錄標準(Inclusion Criteria),並以抗膽鹼藥物治療,追蹤時間點有三個時間點,分別為接受治療前、接受治療後12周與52周。以系統性回顧的方式,將Solifenacin與其他抗膽鹼藥物來做比較,進行統合性的分析。比較Solifenacin與其他抗膽鹼藥物的療效Efficacy (急迫性尿失禁、夜尿次數、頻尿次數、尿急感、解尿量)以及副作用。比較成本花費,品質調整存活年(QALYs),成本效果比(ICER),以及何種藥物較具成本效益。 研究結果 經過統合分析比較,在藥物療效方面,Solifenacin 5 mg 及Solifenacin 10 m都比安慰劑組表現較佳;Solifenacin 5 mg 及Solifenacin 10 mg二組比較則是差異性不大;Solifenacin 5 mg與Tolterodine比較在減少急迫性尿失禁次數上差異性不大,其他方面都是較為傾向Solifenacin 5 mg;Solifenacin 10 mg與Tolterodine比較則是較為傾向Solifenacin 10 mg;Solifenacin 5 mg與Propiverine 20mg比較在減少急迫性尿失禁次數上較為傾向Solifenacin 5 mg,其他方面差異性不大;Solifenacin 10 mg與Propiverine 20mg比較在減少夜尿次數上差異性不大,其他方面均較為傾向Solifenacin 10 mg。抗膽鹼藥物副作用方面主要還是Dry Mouth、Constipation、Vision Blurred,而Solifenacin並不會比其他抗膽鹼藥物產生較多的藥物副作用(Dry Mouth: Solifenacin 10.9%~35%,Others 18.6%~83%)。成本效益方面,11篇文獻中有2篇認為以Fesoterodine治療膀胱過動症較為Cost-effectiveness,而這二篇都是西班牙的研究報告。其他9篇不同國家的研究文獻認為以Solifenacin 療膀胱過動症較為 Cost-effectiveness。
Purpose To understand the efficacy of solifenacin compared with other antimuscarinics to treat idiopathic overactive bladder patients. Via the systematic reviews and meta-analysis of the literatures for the cost-effectiveness of antimuscarinics in managing idiopathic overactive bladder patients, the results can provide the physician the best chose to treat idiopathic overactive bladder patients. Method Two Urologists searched the evidence-based databases ( retrospective study), to find the cost-effectiveness study of antimuscarinics in managing idiopathic overactive bladder patients. The definition of idiopathic overactive bladder and the inclusion criteria were based on the ICS( international continence society ) 2002 definition. There were three end-points ( pre-treatment、post-treatment weeks 12、post-treatment weeks 52). Compared solifenacin with other antimuscarinics for the efficacy (the mean number of urge incontinence, nocturia, urinary frequency, urgency, micturition urine amount and side effect ) and then proceed the meta-analysis. The cost-effectiveness were composed of cost, QALYs,ICER and ICER/QALY gains。 Result Solifenacin 5 mg is better than tolterodine in the mean number of nocturia, urinary frequency, urgency and micturition urine amount. Solifenacin 10 mg is better than tolterodine in all outcomes. Solifenacin 5 mg is better than propiverine 20mg in decreasing the mean number of urge incontinence. Solifenacin 10 mgis bette than propiverine 20mg in all outcoms except nocturi. The side effect rate of solifenacin compared with other antimuscarincs is not inferior ( Dry Mouth: Solifenacin 10.9%~35%,Others 18.6%~83%)。 There are two cost-effective studys of Spain concluded fesoterodine is the most cost-effectiveness and nine cost-effective studys from different nations concluded that solifenacin is the most cost-effectiveness medication in managing idiopathic overactive bladder patients。 Conclusion Solifenacin is the most cost-effective medication to treat idiopathic overactive bladder patients. But the literaturs included were nation-based study, there were so many bias between different nations such as medical environment, medical cost, economic level…. The results of this study can provide the physician another issue to care the idiopathic overactive bladder patients. In fact, there were few head-to-head comparison studys focusing the efficacy and cost-effectiveness of antimuscarinics. So, solifenacin is saft, efficient, and cost-effective , compared with other antimuscarics in managing idiopathic overactive bladder patients..