1. 全民健康保險藥物給付項目及支付標準共同擬訂會議特材部份第 16 次(104 年 9 月)會議紀錄之附錄. 衛生福利部中央健康保險署.
http://www.nhi.gov.tw/Resource/webdata/29472_2_10409%e5%85%b1%e6%93%
ac%e6%9c%83%e8%ad%b0%e8%b3%87%e6%96%99_%e9%99%84%e9%8c%8 4.pdf. Published 104 年 9 月. Accessed October 28, 2016.
2. TA279 Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for treating osteoporotic vertebral compression fractures. National Institute for Health and Care Excellence. https://www.nice.org.uk/guidance/ta279. Published 24 April 2013. Accessed October 28, 2016.
3. Issues in Emerging Health Technologies: Percutaneous vertebroplasty: A bone cement procedure for spinal pain relief. Canadian Agency for Drugs and Technologies in Health.
https://www.cadth.ca/percutaneous-vertebroplasty-bone-cement-procedure-spinal-p ain-relief-0. Published June 7, 2002. Accessed October 28, 2016.
4. Mehbod A, Aunoble S, Le Huec JC. Vertebroplasty for osteoporotic spine fracture:
prevention and treatment. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society 2003; 12 Suppl 2: S155-162.
5. IPG179 Percutaneous cementoplasty for palliative treatment of bony malignancies.
National Institute for Health and Care Excellence.
https://www.nice.org.uk/guidance/ipg179. Published June 2006. Accessed October 28, 2016.
6. Buchbinder R, Golmohammadi K, Johnston RV, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. The Cochrane database of
systematic reviews 2015; (4): Cd006349.
7. Murphy KJ, Deramond H. Percutaneous vertebroplasty in benign and malignant disease. Neuroimaging clinics of North America 2000; 10(3): 535-545.
8. 郭俊麟, 吳佳駿, 楊榮森. 經皮穿刺椎體成形術治療疼痛性骨質疏鬆之脊椎壓 迫性骨折. 台灣老年醫學暨老年學雜誌 2009; 4(4): 214-221.
9. Provenzano MJ, Murphy KP, Riley LH, 3rd. Bone cements: review of their physiochemical and biochemical properties in percutaneous vertebroplasty. AJNR American journal of neuroradiology 2004; 25(7): 1286-1290.
10. Balloon Kyphoplasty for the Treatment of Vertebral Compression Fractures: A Review of the Guidelines and Clinical and Cost-Effectiveness. Canadian Agency for Drugs and Technologies in Health.
https://www.cadth.ca/media/pdf/htis/Balloon%20Kyphoplasty%20for%20the%20T reatment%20of%20Vertebral%20Compression%20Fractures%20in%20Adults%20
醫療科技評估報告補充資料
Clinical%20and%20Cos.pdf. Published 30 July 2008. Accessed October 28, 2016.
11. Heini PF, Berlemann U. Bone substitutes in vertebroplasty. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society 2001; 10 Suppl 2: S205-213.
12. Lieberman IH, Togawa D, Kayanja MM. Vertebroplasty and kyphoplasty: filler materials. The spine journal : official journal of the North American Spine Society 2005; 5(6 Suppl): 305s-316s.
13. Lewis G. Injectable bone cements for use in vertebroplasty and kyphoplasty:
state-of-the-art review. Journal of biomedical materials research Part B, Applied biomaterials 2006; 76(2): 456-468.
14. PMMA 骨水泥臨床前測試基準 Guidance for Pre-clinical Testing of
Polymethylmethacrylate (PMMA) Bone Cement. 衛生福利部食品藥物管理署.
http://www.fda.gov.tw/tc/includes/GetFile.ashx?mID=46&id=1450&chk=6bddb10 4-ef5f-4450-ba1d-8c709348739a. Accessed November 1, 2016.
15. Nieuwenhuijse MJ, Muijs SP, van Erkel AR, Dijkstra SP. A clinical comparative study on low versus medium viscosity polymethylmetacrylate bone cement in percutaneous vertebroplasty: viscosity associated with cement leakage. Spine 2010;
35(20): E1037-1044.
16. Pitton MB, Herber S, Koch U, Oberholzer K, Drees P, Duber C. CT-guided vertebroplasty: analysis of technical results, extraosseous cement leakages, and complications in 500 procedures. European radiology 2008; 18(11): 2568-2578.
17. Middleton ET, Rajaraman CJ, O'Brien DP, Doherty SM, Taylor AD. The safety and efficacy of vertebroplasty using Cortoss cement in a newly established
vertebroplasty service. British journal of neurosurgery 2008; 22(2): 252-256.
18. Bae H, Shen M, Maurer P, et al. Clinical experience using Cortoss for treating vertebral compression fractures with vertebroplasty and kyphoplasty: twenty four-month follow-up. Spine 2010; 35(20): E1030-1036.
19. 林忠男, 吳玉娟, 王乃弘. 骨泥灌漿脊椎整型術手術品質及病患安全指標之建 構. 光田醫學雜誌 2006; 1(2): 75-84.
20. Boyd D, Towler MR, Wren A, Clarkin OM. Comparison of an experimental bone cement with surgical Simplex P, Spineplex and Cortoss. Journal of materials science Materials in medicine 2008; 19(4): 1745-1752.
21. Lewis G. Effect of loading rate on the apparent fracture toughness of acrylic bone cement. Bio-medical materials and engineering 2002; 12(2): 149-155.
22. Medicare - Australian Government Department of Human Services.
Commonwealth of Australia.
https://www.humanservices.gov.au/customer/dhs/medicare. Accessed October 9, 2016.
醫療科技評估報告補充資料
23. Prostheses List. Commonwealth of Australia.
http://www.health.gov.au/internet/main/publishing.nsf/Content/prostheses-list-pdf.
htm. Accessed October 28, 2016.
24. Luo J, Skrzypiec DM, Pollintine P, Adams MA, Annesley-Williams DJ, Dolan P.
Mechanical efficacy of vertebroplasty: influence of cement type, BMD, fracture severity, and disc degeneration. Bone 2007; 40(4): 1110-1119.
25. Gilula L, Persenaire M. Subsequent fractures post-vertebral augmentation: analysis of a prospective randomized trial in osteoporotic vertebral compression fractures.
AJNR American journal of neuroradiology 2013; 34(1): 221-227.
26. Syed MI, Shaikh A. Does age of fracture affect the outcome of vertebroplasty?
Results from data from a prospective multicenter FDA IDE study. Journal of vascular and interventional radiology : JVIR 2012; 23(11): 1416-1422.
27. Bae H, Hatten HP, Jr., Linovitz R, et al. A prospective randomized FDA-IDE trial comparing Cortoss with PMMA for vertebroplasty: a comparative effectiveness research study with 24-month follow-up. Spine 2012; 37(7): 544-550.
28. Voormolen MH, Mali WP, Lohle PN, et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR American journal of neuroradiology 2007; 28(3): 555-560.
29. Bridgens J, Davies S, Tilley L, Norman P, Stockley I. Orthopaedic bone cement: do we know what we are using? The Journal of bone and joint surgery British volume 2008; 90(5): 643-647.
30. K043593 SPINE-FIX BIOMIMETIC BONE CEMENT. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/cdrh_docs/pdf4/K043593.pdf.
Published March 17, 2006. Accessed November 9, 2016.
31. K080108 CORTOSS BONE AUGMENTATION MATERIAL. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080108.pdf.
Published June 5, 2009. Accessed November 9, 2016.
32. K050085 OSTEOPAL V. U.S. Food and Drug Administration.
http://www.accessdata.fda.gov/cdrh_docs/pdf5/K050085.pdf. Published September 14, 2005. Accessed November 9, 2016.
33. K103433 F20. U.S. Food and Drug Administration.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K103433.
Published January 3, 2011. Accessed November 9, 2016.
34. Irani FG, Morales JP, Sabharwal T, Dourado R, Gangi A, Adam A. Successful treatment of a chronic post-traumatic 5-year-old osteoporotic vertebral compression fracture by percutaneous vertebroplasty. The British journal of radiology 2005; 78(927): 261-364.
35. MBS Online. Commonwealth of Australia.
醫療科技評估報告補充資料
http://www.mbsonline.gov.au/internet/mbsonline/publishing.nsf/Content/Home.
Accessed October 28, 2016.
36. 西藥、醫療器材、化粧品許可證查詢. 衛生福利部食品藥物管理署.
http://www.fda.gov.tw/MLMS/H0001.aspx. Accessed October 28, 2016.
37. “賀利氏”歐斯特保脊椎專用骨水泥 “Heraeus” Osteopal V Bone Cement 仿單.
衛生福利部食品藥物管理署.
http://www.fda.gov.tw/MLMS/H0001D.aspx?Type=Lic&LicId=06020591.
Accessed October 28, 2016.
38. F20 Polymethylmethacrylate Bone Cement. Teknimed S.A..S.
http://www.teknimed.com/products-portfolio/products/spine/vertebroplasty-kyphop lasty-cements-resines/f20/. Accessed October 28, 2016.
39. SpineFix Vertebroplasty Bone Cement. Teknimed S.A..S.
http://www.teknimed.com/products-portfolio/products/spine/vertebroplasty-kyphop lasty-cements-resines/spinefix/. Accessed October 28, 2016.
40. Stryker Cortoss® Bone Augmentation Material. Stryker.
http://www.stryker.com/en-us/products/Spine/InterventionalSpine/VertebralAugme ntation/CortossBoneAugmentationMaterial/index.htm. Accessed October 28, 2016.
41. 特材收錄品項表. 衛生福利部中央健康保險署.
http://www.nhi.gov.tw/webdata/webdata.aspx?menu=21&menu_id=713&WD_ID=
850&webdata_id=4745. Accessed October 28, 2016.
醫療科技評估報告補充資料
“Heraeus” Osteopal V Bone Cement
“特科渼”椎體成形術骨水泥
“Teknimed” F20
Polymethylmethacrylate Bone Cement
“泰克美”脊固骨水泥
“Teknimed” Spine-Fix
Vertebroplasty Bone Cement
“歐托維塔”寇托斯骨填充複合材料
“Orthovita” Cortoss Bone Augmentation Material
粉末 26 gm
聚甲基丙烯酸甲酯 methyl polymethacrylase 14.2 gm
過氧化苯甲醯 benzoyl peroxide 0.1 gm
二氧化鋯 zirconium dioxide 11.7 gm
粉末 25.8 gm
聚甲基丙烯酸甲酯 poly methyl methacrylate 19.2%
苯乙烯共聚物 methyl
methacrylate/styrene copolymer 35.3%
過氧化苯甲醯 benzoyl peroxide 0.5%
二氧化鋯 zirconium dioxide 45%
粉末 21 gm
聚甲基丙烯酸甲酯 methyl polymethacrylase 64.4%
過氧化苯甲醯 benzoyl peroxide 0.6%
硫酸鋇 barium sulfate 25%
氫氧基磷灰石 hydroxyapatite 10%
樹脂成分
雙酚 A 甘油酯二甲基丙烯酸
bisphenol-a-glycidal dimethacrylate 雙酚 a 乙氧基二甲基丙烯酸
bisphenol-a-ethoxy dimethacrylate 二甲基丙烯酸三甘醇酯 triethylene glycol
dimethacrylate 二羥乙基對甲苯胺
dihydroxyethyl-p-toluidine 過氧化苯
benzoyl peroxide 98%
2-羥-4-甲氧苯甲醯苯
2-hydroxy-4-methoxy-benzophenone 2,6-二第三丁基對甲酚 butyl hydroxyl
toluine
醫療科技評估報告補充資料
項次 A 項次 B 項次 C 項次 D
“賀利氏”歐斯特保脊椎專用骨 水泥
“Heraeus” Osteopal V Bone Cement
“特科渼”椎體成形術骨水泥
“Teknimed” F20
Polymethylmethacrylate Bone Cement
“泰克美”脊固骨水泥
“Teknimed” Spine-Fix
Vertebroplasty Bone Cement
“歐托維塔”寇托斯骨填充複合材料
“Orthovita” Cortoss Bone Augmentation Material
液體 10 mL
甲基丙烯酸甲酯 methyl methacrylase 9.2 gm
雙氮偶甲基對位甲苯胺 N-N dimethyl-p-toluidine 0.2 gm
液體 9.2 gm
甲基丙烯酸甲酯 methyl methacrylase 99.3%
雙氮偶甲基對位甲苯胺 N-N dimethyl-p-toluidine 0.7%
對苯二酚 hydroquinone 20 ppm
液體 9.2 gm
甲基丙烯酸甲酯 methyl methacrylase 97.6%
雙氮偶甲基對位甲苯胺 N-N dimethyl-p-toluidine 2.4%
對苯二酚 hydroquinone 20 ppm
固化成分
矽烷處理矽鈣鈉石玻璃陶瓷 silane treated combeite glass-ceramic 矽烷處理鋇硼鋁矽酸鹽玻璃 silane
treated baria-boroalumino-silicate glass 矽烷處理非晶形之二氧化矽 silane
treated amorphous silica 黏結促進劑
methacryloxypropyltrimethoxysilane 低黏性 low viscosity[37]
According to ISO 5833 standard, the temperature can be as high as 95 °C[37].
中黏性 medium viscosity[38] 低黏性 low viscosity[39]
低放熱性 low exothermicity[39]
minimal exothermal, and monomer release[40]
醫療科技評估報告補充資料
“Heraeus” Osteopal V Bone Cement
本產品適用於椎體的填充
“Teknimed” F20 Polymethylmethacrylate Bone Cement
本產品可透過椎體成形術或椎體後凸成形術來達到椎體病理
“Teknimed” Spine-Fix Vertebroplasty Bone Cement
本產品係病人脊柱因發生病變性骨折而須進行椎體成形術 (Vertebroplasty) 或椎體矯正術（Kyphoplasty） 時，用於充填 入脊柱而產生固定作用。椎體會因骨質疏鬆症、良性腫瘤（如 血管瘤 hemangiom） 或惡性腫瘤（如轉移性癌症 metastatic cancers 或骨髓瘤 myeloma） 而造成疼痛的椎骨擠壓性骨折。
“Orthovita” Cortoss Bone Augmentation Material
此產品被用於治療脊椎體的壓縮性骨折和整形外科手術中固
醫療科技評估報告補充資料
附錄三、全民健康保險已收載給付的骨水泥基本資料和支付點數[41]
項
次 特材代碼 中英文品名 產品
型號/規格 單位 支付 點數
申請者
簡稱 許可證字號
1 FBA0110001H1 "好美得卡" 辛普勒Ｐ骨水泥
SURGICAL SIMPLEX P "HOWMEDICA" 6191 BOX 839 史賽克 衛署醫器輸字第 009225 號 2 FBA011101NZ1
"西美"異量分子聚合式骨水泥
"ZIMMER" OSTEOBOND COPOLYMER BONE CEMENT 40G/20ML
1101-02 EA 839 捷邁 衛署醫器輸字第 008328 號
3 FBA011102NZ1
"西美"異量分子聚合式骨水泥
"ZIMMER" OSTEOBOND COPOLYMER BONE CEMENT 40GM
1102-12 EA 839 捷邁 衛署醫器輸字第 008328 號
4 FBA011103N6A
"捷邁"高抗力骨水泥(HFBC)
"AAP BIOMATERIALS" HI-FATIGUE BONE CEMENT(HFBC)-20G
00112012001 盒 420 台灣捷邁 衛部醫器輸字第 027626 號
5 FBA011104N6A
"捷邁"高抗力骨水泥(HFBC)
"AAP BIOMATERIALS" HI-FATIGUE BONE CEMENT(HFBC)-40G
00112022001;
00112014001 盒 839 台灣捷邁 衛部醫器輸字第 027626 號
6 FBA011105N6A
"捷邁"高抗力骨水泥(HFBC)
"AAP BIOMATERIALS" HI-FATIGUE BONE CEMENT(HFBC)-80G
00112024001 盒 1678 台灣捷邁 衛部醫器輸字第 027626 號
7 FBA011112NZ1 "西美"骨用水泥
"ZIMMER" BONE CEMENT 1102-13 盒 0 台灣捷邁 衛署醫器輸字第 006713 號 8 FBA011200A2Z "泰瑞斯"低黏性骨水泥
CEMEX RX 40GM 1200/A 盒 839 禾利行 衛署醫器輸字第 025025 號
醫療科技評估報告補充資料
項
次 特材代碼 中英文品名 產品
型號/規格 單位 支付 點數
申請者
簡稱 許可證字號
9 FBA011200S2Z "泰瑞斯"低黏性骨水泥
"TECRES"CEMEX XL 1200S 盒 839 禾利行 衛部醫器輸字第 025475 號 10 FBA0131050CM 頭顱整形泥
CRANIOPLASTIC "DEPUY" (2PKG/BOX) 431050 PKG 3622 壯生 衛署醫器輸字第 007944 號 11 FBA0131280DP
頭顱整形泥
CRANIOPLASTIC "DEPUY" (POWDER 30G+LIQUID 16.17G/20 分鐘)
43-1280 SET 7181 壯生 衛署醫器輸字第 007944 號
12 FBA01312204T "泰瑞斯"蒙締客顱骨用成形骨泥
"TECRES" MENDEC CRANIO 1220/D 組 7181 福大 衛部醫器輸字第 025972 號 13 FBA0133CMWDP "帝富"骨水泥
"DEPUY"CMW BONE CEMENT(粉末+液體)
3312040;
3322040;
3332040
EA 839 壯生 衛署醫器輸字第 014466 號
14 FBA01ER307DP
"帝富" 安杜侖斯骨水泥
ENDURANCE BONE CEMENT "DEPUY"
40GM WITH 18.88 LIQUID
3070-040 BOX 0 壯生和壯
生 衛署醫器輸字第 009552 號 15 FBA01HV040DP "帝富" 適髓骨水泥
"DEPUY" SMARTSET HV BONE CEMENT 3092040 盒 839 壯生 衛署醫器輸字第 010927 號
醫療科技評估報告補充資料
附錄四、全民健康保險已收載骨水泥的成分說明
項次 特材代碼 中英文品名 粉末（仿單內容）[36] 液體（仿單內容）[36]
1 FBA0110001 H1
"好美得卡" 辛普勒 P 骨水 泥
SURGICAL SIMPLEX P
"HOWMEDICA"
聚甲基丙烯酸甲酯 polymethyl methaccrylate 15%
苯乙烯共聚物 methyl methacrylate/styrene copolymer 75%
硫酸鋇 barium sulphate 10%
甲基丙烯酸甲酯 methylmethacrylate 97.4%
雙氮偶甲基對位甲苯胺
N-N-dimethyl-para-toluidine 2.6%
對苯二酚 hydroquinone 60-90 ppm 2 FBA011101N
Z1
"西美"異量分子聚合式骨 水泥
"ZIMMER" OSTEOBOND COPOLYMER BONE CEMENT 40G/20ML
多種[甲基丙烯酸甲酯-苯乙烯]聚合物 poly[(methyl methacrylate)-Co-styrene]
copolymer 87.5%
過氧化苯甲醯 benzoyl peroxide 1.2%-2.5%
硫酸鋇 barium sulphate 10%
甲基丙烯酸甲酯單體 methylmethacrylate monomer 99.25%
雙氮偶甲基對位甲苯胺 N-N-dimethyl-p-toluidine 0.75%
對苯二酚 hydroquinone 75±10 ppm 3 FBA011102N
Z1
"西美"異量分子聚合式骨 水泥
"ZIMMER" OSTEOBOND COPOLYMER BONE CEMENT 40GM 4 FBA011103N
6A
"捷邁"高抗力骨水泥 (HFBC)
"AAP BIOMATERIALS"
HI-FATIGUE BONE CEMENT(HFBC)-20G
[甲基丙烯酸甲酯-苯乙烯]聚合物 poly[methyl methacrylate/styrene] 58.75%
聚甲基丙烯酸-甲基丙烯酸甲酯 poly[methyl acrylate/methyl methacrylase] 28.15%
二氧化鋯 zirconium dioxide 12.24%
過氧化苯甲醯 benzoyl peroxide 0.86%
甲基丙烯酸甲酯 methylmethacrylate 99.35%
雙氮偶甲基對位甲苯胺
N-N-dimethyl-para-toluidine 0.65%
對苯二酚 hydroquinone 60 ppm 5 FBA011104N
6A
"捷邁"高抗力骨水泥 (HFBC)
"AAP BIOMATERIALS"
醫療科技評估報告補充資料
項次 特材代碼 中英文品名 粉末（仿單內容）[36] 液體（仿單內容）[36]
HI-FATIGUE BONE CEMENT(HFBC)-40G 6 FBA011105N
6A
"捷邁"高抗力骨水泥 (HFBC)
"AAP BIOMATERIALS"
HI-FATIGUE BONE CEMENT(HFBC)-80G 7 FBA011112N
Z1
"西美"骨用水泥
"ZIMMER" BONE CEMENT
不透射線性聚合物 radiopaque polymer powder 單體液體 monomer liquid
8 FBA011200A 2Z 9 FBA011200S
2Z
"泰瑞斯"低黏性骨水泥
"TECRES"CEMEX XL
聚甲基丙烯酸甲酯 85.00% 10 FBA0131050
CM
頭顱整形泥
CRANIOPLASTIC
"DEPUY" (2PKG/BOX)
聚甲基丙烯酸甲酯 methyl methaccrylate polymer 79.6%
苯乙烯共聚物 methyl methacrylate/styrene
甲基丙烯酸甲酯單體 methyl methaccrylate monomer 95.05%
乙烯二甲基丙烯酸酯單體 ethlene dimethaccrylate
醫療科技評估報告補充資料
項次 特材代碼 中英文品名 粉末（仿單內容）[36] 液體（仿單內容）[36]
11 FBA0131280 DP
頭顱整形泥
CRANIOPLASTIC
"DEPUY" (POWDER 30G+LIQUID 16.17G/20 分鐘)
copolymer 19.9%
過氧化苯甲醯 benzoyl peroxide 0.5%
monomer 4.28%
甲基對位甲苯胺 dimethyl p-toluidine 0.67%
對苯二酚 hydroquinone 20±5 ppm 四甲氧基苯酚 4-methoxyphenol 12 ppm 12 FBA0131220
4T
"泰瑞斯"蒙締客顱骨用成 形骨泥
"TECRES" MENDEC CRANIO
聚甲基丙烯酸甲酯 polymethylmethaccrylate 84.30%
硫酸鋇 barium sulphate 13.00%
過氧化苯甲醯 benzoyl peroxide 2.70%
甲基丙烯酸甲酯 methylmethacrylate 99.10%
雙氮偶甲基對位甲苯胺 N-N-dimethyl-p-toluidine 0.9%
對苯二酚 hydroquinone 75 ppm 13 FBA0133CM
WDP
"帝富"骨水泥
"DEPUY"CMW BONE CEMENT(粉末+液體) 14 FBA01ER307
DP
"帝富" 安杜侖斯骨水泥 ENDURANCE BONE
CEMENT "DEPUY"
40GM WITH 18.88 LIQUID
聚甲基丙烯酸甲酯 polymethyl methaccrylate 67.05%
苯乙烯共聚物 methyl methacrylate/styrene copolymer 21.10%
硫酸鋇 barium sulphate 10.00%
過氧化苯甲醯 benzoyl peroxide 1.85%
甲基丙烯酸甲酯 methylmethacrylate 98.00%
雙氮偶甲基對位甲苯胺 N-N-dimethyl-p-toluidine 2.00%
對苯二酚 hydroquinone 75 ppm
15 FBA01HV04 0DP
"帝富" 適髓骨水泥
"DEPUY" SMARTSET HV BONE CEMENT
甲基丙烯酸甲酯和甲基丙烯酯共聚合物 methyl
甲基丙烯酸甲酯和甲基丙烯酯共聚合物 methyl