- 學位論文
對於攝護腺肥大造成的下泌尿道症狀，比較合併使用甲型阻斷劑及第五型磷酸二酯酵素抑制劑以及單一使用甲型阻斷劑：系統性回顧及統合分析研究
Combination of alpha blocker and phosphodiesterase 5 inhibitors versus alpha blocker monotherapy for lower urinary tract symptoms associated with benign prostate hyperplasia: a systematic review and meta-analysis
摘要
研究背景與目的： 甲型阻斷劑是傳統治療攝護腺肥大引起的下泌尿道症狀的第一線藥物，然而有些病人在接受甲型阻斷劑之後症狀仍然沒有辦法達到理想的改善；攝護腺肥大的病人常常伴隨有勃起功能障礙的問題，第五型磷酸二酯酵素抑制劑可以同時治療攝護腺肥大以及勃起功能障礙。 本研究希望可以探討在攝護腺肥大引起的下泌尿道症狀病人，同時使用甲型阻斷劑及第五型磷酸二酯酵素抑制劑的效果是否優於單一使用甲型阻斷劑，如此一來在甲型阻斷劑無效的病人，便可以考慮加上第五型磷酸二酯酵素抑制劑，尤其是在那些伴隨有勃起功能障礙的病人。 研究方法： 本研究採用系統性回顧及統合分析，在Pubmed、Embase及Cochrane library等資料庫搜尋比較合併治療與單一使用甲型阻斷劑的隨機分派研究。目標族群為攝護腺肥大造成下泌尿道症狀的病人，實驗組為合併使用使用甲型阻斷劑及第五型磷酸二酯酵素抑制劑，而對照組為單一使用甲型阻斷劑，臨床結果為國際攝護腺症狀評分，最大尿流速，殘尿，國際勃起功能指標量表的分數。 統合分析採用隨機效應模型，而我們也進行了統合回歸來分析什麼樣的影響因子決定病人接受合併治療能夠得到最大的好處。 研究結果： 本研究收錄了13個隨機分派研究共1173位病人，相較於單一使用甲型阻斷劑，合併甲型阻斷劑及第五型磷酸二酯酵素抑制劑顯著可以改善國際攝護腺症狀評分的分數，平均可以多改善1.73分(95%CI: 1.1-2.35)，國際攝護腺症狀評分的排尿分數及儲尿分數也有顯著改善，平均可以多改善0.99分(95%CI: 0.54-1.44)及0.57分(95% CI: 0.03-1.1)；最大尿流速方面，合併治療組可以顯著多增加0.69cc/s (95%CI: 0.27 to 1.1)；此外，勃起功能問卷的分數在合併治療組亦顯著優於單一使用甲型阻斷劑。 在統合回歸分析方面，治療前的國際攝護腺症狀評分、最大尿流速、攝護腺體積、年齡、勃起功能問卷評分及第五型磷酸二酯酵素抑制劑的劑量都和國際攝護腺症狀評分的改善程度無關，本研究未發現顯著影響國際攝護腺症狀評分改善程度的因子。 結論： 合併甲型阻斷劑及第五型磷酸二酯酵素抑制劑在攝護腺肥大引起的下泌尿道症狀病人，相較單一使用甲型阻斷劑有更好的療效。
並列摘要
Purpose: Alpha blockers are effective drugs for lower urinary tract symptoms (LUTS) caused by benign prostate hyperplasia (BPH). However, urinary symptoms may remain unresolved in some patients after taking alpha blockers. The prevalence of erectile dysfunction is higher in patients with lower urinary tract symptoms. Phosphodiesterase 5 inhibitors can improve both erectile dysfunction and lower urinary tract symptoms and therefore is useful for these patients. Our aim of this study is to evaluate whether combination therapy of alpha blockers and phosphodiesterase 5 inhibitor (PDE5i) is more effective than alpha blockers monotherapy for the treatment of LUTS in men. Material and methods: A systematic review and meta-analysis were undertaken to assess the difference between the combination therapy and alpha blockers monotherapy by searching published randomized controlled trials from electronic databases PubMed, Embase, and the Cochrane Library up to April, 2018. The PICO statement of our study searching is (1) Population: patients with LUTS/BPH; (2) Intervention: LUTS/BPH patients who received combination therapy of alpha blocker and PDE5i; (3) Comparison: LUTS/BPH patients who received alpha blocker therapy only; and (4) Outcome: International Prostate Symptom Score (IPSS), Qmax (peak uroflow rate), PVR (post voiding residual urine), and international index of erectile function score (IIEF) of these patients. Random effect meta-analysis was undertaken to calculate the pooled effect size, and meta-regression was performed to identify potential factors associated with the difference in the treatment effects between the two therapeutic regimens. Results： A total of 13 randomized controlled studies with 1173 patients were included in our meta-analysis. Compared with alpha blocker monotherapy, the combination therapy obtained a significantly better improvement in IPSS (1.73, 95%CI: 1.1 to 2.35), IPSS voiding subscore (0.99, 95% CI: 0.54-1.44, IPSS storage subscore (0.57, 95% CI: 0.03-1.1), peak flow rate (0.69 cc/s, 95%CI: 0.27 to 1.1) and erectile function (IIEF5 3.84, 95%CI 1.55-6.12 and IIEF-EF 3.87 95%CI 2.27-5.46). Meta-regression showed that baseline IPSS, baseline peak flow rate, baseline prostate volume, age, baseline IIEF-EF score, baseline IIEF5 score and PDE5i dosage were not associated with the difference in IPSS improvement. Conclusion: Combination of alpha blockers and PDE5i has better therapeutic effects than alpha blocker monotherapy on lower urinary tract symptoms related to benign prostate hyperplasia.