長期以來，將可吸收骨植入物的吸收速率調整適當一直是一個巨大的挑戰。本研究第一部分探討本團隊及喜樂醫療器材合作開發的新型鈣/磷/硫基骨取代物(Ezechbone®Granule CBS-400)的一系列物理、化學性質、體內吸收性、引導新骨形成的能力以及植入缺損骨骼後骨骼機械性能的恢復狀況。CBS-400主要由羥基磷灰石和硫酸鈣組成，有高孔隙度的結構特性，且通過一系列生物相容性檢測，包含細胞毒性、皮內刺激性、皮膚敏感性、細菌內毒素、亞慢性毒性和基因毒性。本研究結果顯示CBS-400在Hanks’ solution中浸泡7天後，CBS-400顆粒的形態和完整性與未浸泡的樣品相似，沒有出現明顯的塌陷或崩解。CBS-400的顆粒大小約在400到1200 μm，並具有100到200 μm的孔洞和75%以上的孔隙度。CBS-400浸泡Hanks’ solution 1天後，溶液的酸鹼值約為5.3，呈弱酸性，隨著浸泡的時間增加而逐漸回到中性，在7天後酸鹼值提高到6.55，在14天後繼續提高到7.08。溶解度測試顯示浸泡TRIS-HCl緩衝溶液5天後，釋放的鈣、磷及硫元素分別為8.3、0.29及13.4 mg。CBS-400植入紐西蘭白兔股骨髁後的組織學觀察顯示植入的顆粒始終與周圍的新骨緊密結合。CBS-400不僅是可降解的骨取代物，並且新骨的形成和植入材料的吸收以匹配的速率同時進行。植入12週後約85%的植入物已被吸收，新形成的海綿骨比例在第4週快速增加到大於40%。隨後逐漸被重塑回到正常海綿骨的面積，新生海綿骨的比例在植入12週後下降到約30%。人工製造圓柱形骨缺損在SD大鼠股骨幹後，植入CBS-400，經8週及12週的修復，在植入位置的幾何性質上包含短軸外徑、短軸內徑、長軸外徑、長軸內徑、皮質骨面積、轉動慣量和骨骼體積皆與對照組無顯著差異。機械性質上包含降伏強度、極限彎曲強度、剛性、彈性吸收能量、吸收能量、最大彈性應力、最大應力、單位體積彈性吸收能量、彈性模數皆與對照組無顯著差異。單位體積吸收能量在植入8週時比對照組無顯著差異，僅在12週後比對照組有顯著降低約30%。
本研究第二部分的主要目的是探討無添加生物製劑且全天然合成的新型鈣/磷/硫基骨取代物CBS-400植入到經卵巢切除(OVX)誘導骨質疏鬆的山羊椎骨缺損中，新生成的骨小樑結構是否仍呈現疏鬆狀態，或是能成長為健康的骨骼結構。結果顯示在實驗的母山羊中透過OVX、低鈣飲食和避光飼養可以成功地誘導骨質疏鬆。組織學檢查發現植入CBS-400的山羊(OVX_IP組)，在手術製造的臨界骨缺損內形成了新生的骨小樑網絡，且OVX_IP組的新生骨小樑網絡緻密程度比骨質疏鬆組(OVX組)的骨小樑網絡更高，同時與健康正常的對照組山羊相當。組織型態計量學顯示在所有實驗山羊中，OVX_IP組的骨小樑厚度最高，而骨小樑袋的密度最低，OVX_IP組和對照組山羊的骨小樑距離、骨小樑數量、骨小樑面積比和骨小樑構型因素無顯著差異，指出OVX_IP組的骨小樑結構在植入後約6個月內已基本恢復到正常水平。同時偏光顯微鏡下沒有觀察到骨質疏鬆導致骨骼成熟延遲的跡象，在OVX_IP組中觀察到骨小樑結構快速且良好地恢復，表明CBS-400具有治療骨鬆性骨折的高度潛力。

Properly regulating the resorption rate of a resorbable bone implant has long been a great challenge. This study investigates a series of physical/chemical properties, and the behavior of implant resorption and bone formation of a newly-developed Ca/P/S-based bone substitute (Ezechbone® Granule CBS-400). Results show that the integrity of CBS-400 remains without disintegration after immersion in Hanks’ solution for 7 days. With immersion time, the pH value continues to increase to 7.08 after 14 days. Rabbit condyle implantation study indicate that CBS-400 are intimately bonded to the new bone. At 12 weeks post-operation 85% of the implant has been resorbed. The newly-formed bone ratio increases to >40% at 4 weeks and tapers down to normal level (30%) after 12 weeks. Bending results of the CBS-400-implanted rat femur shaft show that after 8 weeks, the geometric and mechanical properties of the femur had been restored to normal level. Other purpose of the present study is to clarify whether CBS-400 would induce healthy bone when implanted into the osteoporotic vertebral defects of ovariectomized (OVX) goats. The results show that osteoporosis was successfully induced in the female goats. The histological examination reveals a newly-formed trabecular structure within the surgically-created defect of the CBS-400-implanted (OVX_IP) goat. Histomorphometry show that the trabecular bone architecture of the OVX_IP goat has substantially recovered to the normal level in 24 weeks after implantation without osteoporosis-related delay in the bone maturing process. The nicely recovered trabeculae observed indicate that CBS-400 has a high potential to treat osteoporotic fractures.

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