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題 名 | 威爾森氏症常見藥物療法有效性及安全性之文獻回顧分析=A Systematic Review of Studies on Effectiveness and Safety of Commonly Used Medications for Treating Wilson's Disease |
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作 者 | 陳瑞奇; 莊政宏; 謝盛元; 王經篤; | 書刊名 | 醫療資訊雜誌 |
卷 期 | 24:1 2015.03[民104.03] |
頁 次 | 頁11-22 |
分類號 | 415.596 |
關鍵詞 | 威爾森氏症; 有效性; 安全性; 系統性回顧; Wilson's disease; Effectiveness; Safety; Systematic review; |
語 文 | 中文(Chinese) |
中文摘要 | 目前就我們所知,國際間在威爾森氏症治療藥物的使用上未有明確最佳化的共識,本文以系統性回顧進行常見藥物療效與安全性之調查分析,過濾生醫文獻索引摘要資料庫PubMed最近25年間相關文獻,納入分析共計50篇3,231位患者(平均年齡約20歲,男略多於女)。整合分析結果為,常見青黴胺(D-penicillamine)、三乙烯四胺(Trientine)、與鋅鹽(Zinc)這三種單一藥物療效之間並無統計上的顯著差異,聯合平均療效約77%,但鋅鹽與螯合劑合併療法最不利於肝臟表現型患者(療效約47%)。而前述三種單一藥物療法若只對肝臟型患者的進行平均療效調查還可高達88.3%(95% CI 85.6%-91.0%),比合併療法顯著有效(RR=1.87 [95% CI1.55-2.27], p < 0.001),可使絕對風險下降41.2%(95% CI 33.4%-48.9%)。至於對神經型患者而言,四種藥物療法之療效則無統計上的差別(p=0.735)。另外就不同藥物療法所導致的副作用來說,青黴胺單一療法與合併療法之間的平均副作用比例没有顯著差異(p=0.839),兩者聯合平均副作用比例為35.3%(95% CI 32.4%-38.1%);三乙烯四胺與鋅鹽單一療法之間的平均副作用也無顯著差別(p=0.661),兩者聯合平均副作用比例為19.5%(95% CI 16.8%-22.1%);前兩者與後兩者分析比較則有顯著性差異(RR=1.81 [95% CI 1.55-2.13], p < 0.001),青黴胺單一療法與合併療法將使副作用絕對風險提高15.8%(95% CI 11.8%-19.9%)。就致命率(將死亡與肝臟移植人數併入計算)而言,螯合劑單一療法的平均致命率非常接近(6.9% vs. 6.7%;p=0.468),以鋅鹽單一療法的表現最好(3.4%, 95% CI 2.1%-4.7%),鋅鹽常用於維持時期(Maintenance)或無症狀時的治療,患者本身的預後狀況就比較好,很有可能是致命率最低的主因。合併療法顯然不佳(12.7%, 95%CI 9.5%-15.9%),致命風險最高。縱觀上述,雖然仍有待未來更進一步嚴謹的研究驗證,但保守建議在整體療效與安全性考量下,應該提醒盛行此種合併療法的臨床醫療專業人員,能夠密切觀察、謹慎照顧患者(尤其是肝臟型),並給予更密集、多樣的生化檢驗與病程變化上的關注。 |
英文摘要 | To our knowledge there is no clear international consensus on optimal medication therapy for treating Wilson's disease (WD). This study systematically reviewed the effectiveness and safety of different medications now in common use. We performed a systematic search of the PubMed database for original WD treatment studies published in the past 25 years. A total of 50 included studies involving 3,231 patients (Mean age at diagnosis was around 20 years.) were reviewed. Results from a pooled analysis indicate no statistically significant differences were found for overall effectiveness rates between D-penicillamine (DPA), Trientine (TETA), and Zinc (Zn) monotherapies. Their pooled effectiveness rate was around 77%. A combination therapy using a chelating agent and zinc for hepatic patients had the lowest effectiveness rate of 47%. Nevertheless, an overall effectiveness rate of 88.3% (95% confidence interval [CI] 85.6%-91.0%) was found when the hepatic patients were treated with one of the above three monotherapies (vs. the combination therapy; relative risk ratio [RR]=1.87 [95% CI 1.55-2.27], p < 0.001; absolute risk reduction [ARR]=41.2% [95% CI 33.4%-48.9%]). No significant differences were found for overall effectiveness rates between the four commonly used medications for neurological manifestations (p=0.735). No significant differences were found for overall adverse effects between the DPA monotherapy and combination therapy (p=0.839). Their pooled adverse effect rate was 35.3% (95% CI 32.4%-38.1%). Further, no significant differences were found for overall adverse effects between the TETA and Zn monotherapies (p=0.661). Their pooled adverse effect rate was 19.5% (95% CI 16.8%-22.1%). The first two therapies resulted in a significantly higher adverse effect rate compared to the latter two therapies (RR=1.81 [95% CI 1.55-2.13], p < 0.001; absolute risk increase [ARI]=15.8% [95% CI 11.8%-19.9%]). The overall mortality (counting who died and received liver transplants) rates of the DPA and TETA monotherapies were close (6.9% vs. 6.7%; p=0.468). Zinc had the lowest mortality rate (3.4%, 95% CI 2.1%-4.7%). In contrast, the mortality rate for all patients receiving some form of combination therapy was 12.7% (95% CI 9.5%-15.9%). Combination therapy patients clearly suffered from a much higher mortality rate compared to those receiving the other frequently used medications. The use of combination therapies involving a chelating agent and zinc should be carefully monitored with close clinical observations and frequent biochemical tests, especially for WD patients with hepatic manifestations. |
本系統中英文摘要資訊取自各篇刊載內容。