【骨鬆Q&A 003】 骨質疏鬆症藥物治療期間需要監測骨質密度嗎?

根據葡萄牙風濕病學會(the Portuguese Society of Rheumatology,SPR)在2018年的建議。(Rodrigues AM 2018 )

 

 

建議8A

應每年重新評估臨床風險因素,骨折發生率,身高以及生活方式改變和藥物治療順從性(adherence)。

必要時可以進行椎體成像(Vertebral imaging)。

 

建議8B

DXA評估不應在2年內重複進行,除非臨床風險因素發生顯著變化。

生化指標(Biochemical markers)在評估個體患者的治療反應/順從性方面幾乎沒有作用。

 

 

順從性差是臨床最重要的治療問題之一。研究表明,只有40%的骨質疏鬆症患者接受治療超過一年。而在兩年內,只剩20%的患者仍在服藥。

 

骨質疏鬆症患者對於骨質疏鬆藥物的低/中度順從性,會導致預防骨折的效力喪失 (Kothawala P 2007, Imaz I 2010)。

 

定期隨訪(Periodic follow-up)對確保治療、生活型態、監測不良事件和評估治療反應非常重要 (Briot K 2012, Maraka S 2015)。定期的臨床評估已證明可以增加治療順從性 (McCloskey EV 2007)。

 

在門診時,還應該詢問患者有關新的臨床危險因素,新發生的繼發性骨質疏鬆症和骨質疏鬆症藥物相關的不良事件,如果發生這些事件,可能需要調整治療計劃 (Cosman F 2014)。

 

為了評估療效,應詢問受試者有關新發脆性骨折的發生。如果懷疑有新的椎骨骨折,應進行椎體成像 (Cosman F 2014, Maraka S 2015)。

 

提倡DXA測試可以監測骨質疏鬆症治療效果?

 

骨質密度(BMD)

 

事實上,使用抗骨質疏鬆藥物的試驗研究顯示,在不同試驗中BMD增加骨折風險降低之間存在小到中等的關係。

 

然而,一些研究表明,即使BMD沒有增加,用雙磷酸鹽,Raloxifen和Teriparatide治療的女性也可以從骨折率降低中獲益 (Cummings SR 2002, Sarkar S 2002, Chapurlat RD 2005, Watts NB 2005, Chen P 2006, Miller PD 2010, Austin M 2012)。

 

因此,許多專家認為即便藥物預期效率高,臨床醫生在這方面最重要的任務是保證堅持循證治療

 

美國醫師協會(ACP最近的建議明確建議在女性藥物治療期間,禁止對骨密度進行監測 (Qaseem A 2017)。

 

RCT沒有證據顯示在骨質疏鬆症治療期間監測BMD的頻率

 

中等質量的證據表明大多數婦女不需要定期監測 (Cummings SR 2002, Sarkar S 2002, Watts NB 2004, Chapurlat RD 2005, Watts NB 2005, Chen P 2006, Bell KJ 2009, Watts NB 2009, Miller PD 2010, Rabenda V 2011, Gourlay ML 2012, Berry SD 2013)。

 

來自1項研究 (Bell KJ 2009)的數據顯示,只有

 

  1. 10%的DXA正常或輕度骨質減少的女性(T評分> -1.49)
    在15年內發生骨質疏鬆症;
  2. 10%中度骨量減少患者(T評分,-1.50至-1.99)
    在5年內出現骨質疏鬆症;
  3. 10%的嚴重骨量減少女性(T評分,-2.0至-2.49)
    在1年內發生骨質疏鬆症。

 

另一項研究顯示,在基線後4年測量BMD的女性中,對於髖關節或主要骨折的預測沒有改善 (Berry SD 2013)。

 

無論如何,重複DXA的時間間隔必須足夠長,以允許可檢測到的變化,這意味著DXA評估不應在不到2年的時間內重複進行 (Briot K 2012, Kanis JA 2013, Cosman F 2014)。

 

骨轉換標誌物(BTM)

 

骨轉換標誌物(BTM),即前膠原I N-末端延伸肽(P1NP)和C-端肽斷裂(CTX)的血清水平通常在3-6個月的抑骨吸收治療後降低,並且在1-3個月促骨合成療法後增加 (Briot K 2012, Diez-Perez A 2012, Kanis JA 2013, Lewiecki EM 2013, Cosman F 2014, Maraka S 2015)。

 

研究表明,骨轉換標誌物的短期下降BMD增加脆性骨折率降低有關 (Ravn P 1999, Eastell R 2003, Bauer DC 2004, Eastell R 2006, Eastell R 2011, Vasikaran S 2011)。

 

國際骨質疏鬆症基金會(International Osteoporosis Foundation)和歐洲鈣化組織學會(European Calcified Tissue Society) (Diez-Perez A 2017)建議,根據Trio研究結果,BTM應該被用作檢測雙磷酸鹽的順從性篩檢策略 (Naylor KE 2016)。

 

然而,這些標誌物的血清水平是非常可變的,取決於幾個與骨代謝無關的因素,例如飲食,一天中的時間和一年的時間,伴隨的藥物等等。儘管對群體水平的變化敏感,但這大大降低了個體患者的價值。

 

總之,我們認為它們在臨床實踐中的使用幾乎沒有合理的意見,最近的意大利準則明確指出 (Rossini M 2016),

 

“目前骨骼標誌物不能用於常規臨床評估”
“bone markers cannot be used for routine clinical evaluations at present”。

 

小魏醫師提醒,目前的證據並不支持頻繁監測骨質疏鬆症患者骨密度正常的婦女,因為數據顯示,大多數DXA評分正常的女性在15年內並不會發展為骨質疏鬆症。在服用藥物治療骨質疏鬆症的患者最初5年的治療期間,數據也不支持監測BMD。重複DXA的時間間隔必須足夠長,以允許可檢測到的變化。如有可能,臨床醫師應選擇原廠藥治療骨質疏鬆症患者。

 

 

 

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