中国医师杂志
中國醫師雜誌
중국의사잡지
JOURNAL OF CHINESE PHYSICIAN
2014年
8期
1039-1043
,共5页
咪唑类/治疗应用%膦酸类/治疗应用%骨质疏松/外科学%腰椎%骨折固定术,内%脊柱融合术%随机对照试验
咪唑類/治療應用%膦痠類/治療應用%骨質疏鬆/外科學%腰椎%骨摺固定術,內%脊柱融閤術%隨機對照試驗
미서류/치료응용%련산류/치료응용%골질소송/외과학%요추%골절고정술,내%척주융합술%수궤대조시험
Imidazoles/therapeutic use%Phosphonic acids/therapeutic use%Osteoporosis/surgery%Lumbar vertebrae%Fracture fixation,internal%Spinal fusion%Randomized controlled trial
目的 评估新型二膦酸盐制剂唑来膦酸(密固达)对骨质疏松症患者腰椎内固定融合术后骨融合的影响.方法 采用前瞻性随机对照双盲研究方法,按随机数字表法将79例需要行退行性腰椎滑脱症(单节段)手术治疗的骨质疏松症患者分为观察组(术后第3天给予5 mg唑来膦酸静脉滴注)和对照组(术后第3天均给予等量生理盐水).所有患者均接受后路滑脱复位、全椎板切除减压、椎间植骨融合内固定术及每日常规1 000mg钙剂和800 IU活性维生素D3的治疗.术后第3、6、9及12个月,通过摄取X线腰椎正侧位及过伸过屈位并CT腰椎扫描,评价屈伸过程中的旋转活动度、植骨融合情况(分为3个等级)和内固定是否松动断裂.在术前和术后第3、6及12个月行股骨颈双能X线扫描,测定骨密度.在术前及术后第10天、3、6、9及12个月检测患者的骨转换指标水平(Ⅰ型胶原羧基末端肽和Ⅰ型胶原氨基端前肽).运用Oswestry功能障碍指数(Oswestry disability index,ODI)在术前及术后第3、6、9及12个月评估临床疗效.结果 69例患者最终完成本研究并纳入统计分析.术后第3、6及9个月时,观察组A级和B级植骨愈合显著多于对照组,差异均有统计学意义(P＜0.05).术后第12个月,两组的植骨融合情况及坚固融合率比较差异无统计学意义(P＞0.05).观察组无一例临近椎体压缩性骨折发生,对照组6例(16.7％)临近椎体压缩性骨折发生,差异有统计学意义(P＜0.05).观察组Ⅰ型胶原羧基末端肽和Ⅰ型胶原氨基端前肽水平显著下降(P＜0.01),股骨颈骨密度得到改善而对照组变化不明显.对照组ODI评分仅在术后第3个月内迅速下降,在3个月之后达到平台期,下降不明显;观察组ODI评分直至术后第12个月仍在降低.结论 骨质疏松症患者在接受腰椎内固定融合术后应积极使用唑来膦酸(密固达)治疗骨质疏松症,既能改善股骨颈骨密度,又增加了植骨融合的速度,防止了椎体压缩性骨折,其效果好.
目的 評估新型二膦痠鹽製劑唑來膦痠(密固達)對骨質疏鬆癥患者腰椎內固定融閤術後骨融閤的影響.方法 採用前瞻性隨機對照雙盲研究方法,按隨機數字錶法將79例需要行退行性腰椎滑脫癥(單節段)手術治療的骨質疏鬆癥患者分為觀察組(術後第3天給予5 mg唑來膦痠靜脈滴註)和對照組(術後第3天均給予等量生理鹽水).所有患者均接受後路滑脫複位、全椎闆切除減壓、椎間植骨融閤內固定術及每日常規1 000mg鈣劑和800 IU活性維生素D3的治療.術後第3、6、9及12箇月,通過攝取X線腰椎正側位及過伸過屈位併CT腰椎掃描,評價屈伸過程中的鏇轉活動度、植骨融閤情況(分為3箇等級)和內固定是否鬆動斷裂.在術前和術後第3、6及12箇月行股骨頸雙能X線掃描,測定骨密度.在術前及術後第10天、3、6、9及12箇月檢測患者的骨轉換指標水平(Ⅰ型膠原羧基末耑肽和Ⅰ型膠原氨基耑前肽).運用Oswestry功能障礙指數(Oswestry disability index,ODI)在術前及術後第3、6、9及12箇月評估臨床療效.結果 69例患者最終完成本研究併納入統計分析.術後第3、6及9箇月時,觀察組A級和B級植骨愈閤顯著多于對照組,差異均有統計學意義(P＜0.05).術後第12箇月,兩組的植骨融閤情況及堅固融閤率比較差異無統計學意義(P＞0.05).觀察組無一例臨近椎體壓縮性骨摺髮生,對照組6例(16.7％)臨近椎體壓縮性骨摺髮生,差異有統計學意義(P＜0.05).觀察組Ⅰ型膠原羧基末耑肽和Ⅰ型膠原氨基耑前肽水平顯著下降(P＜0.01),股骨頸骨密度得到改善而對照組變化不明顯.對照組ODI評分僅在術後第3箇月內迅速下降,在3箇月之後達到平檯期,下降不明顯;觀察組ODI評分直至術後第12箇月仍在降低.結論 骨質疏鬆癥患者在接受腰椎內固定融閤術後應積極使用唑來膦痠(密固達)治療骨質疏鬆癥,既能改善股骨頸骨密度,又增加瞭植骨融閤的速度,防止瞭椎體壓縮性骨摺,其效果好.
목적 평고신형이련산염제제서래련산(밀고체)대골질소송증환자요추내고정융합술후골융합적영향.방법 채용전첨성수궤대조쌍맹연구방법,안수궤수자표법장79례수요행퇴행성요추활탈증(단절단)수술치료적골질소송증환자분위관찰조(술후제3천급여5 mg서래련산정맥적주)화대조조(술후제3천균급여등량생리염수).소유환자균접수후로활탈복위、전추판절제감압、추간식골융합내고정술급매일상규1 000mg개제화800 IU활성유생소D3적치료.술후제3、6、9급12개월,통과섭취X선요추정측위급과신과굴위병CT요추소묘,평개굴신과정중적선전활동도、식골융합정황(분위3개등급)화내고정시부송동단렬.재술전화술후제3、6급12개월행고골경쌍능X선소묘,측정골밀도.재술전급술후제10천、3、6、9급12개월검측환자적골전환지표수평(Ⅰ형효원최기말단태화Ⅰ형효원안기단전태).운용Oswestry공능장애지수(Oswestry disability index,ODI)재술전급술후제3、6、9급12개월평고림상료효.결과 69례환자최종완성본연구병납입통계분석.술후제3、6급9개월시,관찰조A급화B급식골유합현저다우대조조,차이균유통계학의의(P＜0.05).술후제12개월,량조적식골융합정황급견고융합솔비교차이무통계학의의(P＞0.05).관찰조무일례림근추체압축성골절발생,대조조6례(16.7％)림근추체압축성골절발생,차이유통계학의의(P＜0.05).관찰조Ⅰ형효원최기말단태화Ⅰ형효원안기단전태수평현저하강(P＜0.01),고골경골밀도득도개선이대조조변화불명현.대조조ODI평분부재술후제3개월내신속하강,재3개월지후체도평태기,하강불명현;관찰조ODI평분직지술후제12개월잉재강저.결론 골질소송증환자재접수요추내고정융합술후응적겁사용서래련산(밀고체)치료골질소송증,기능개선고골경골밀도,우증가료식골융합적속도,방지료추체압축성골절,기효과호.
Objective To investigate the effect of bisphosphonate medication (zoledronic acid,aclasta) on spinal fusion for osteoporotic patients through radiographic,clinical,and biological assessments.Methods A total of 79 patients with osteoporosis who were candidates for single-level posterior lumbar interbody fusion was randomly assigned to the experimental group (zoledronic acid injection,5mg,on the third day after surgery) or the control group (the same amount of saline injection,on the third day after surgery).Functional radiography and CT scans were used to evaluate fusion status.Bridging bone formation was graded into 3 categories:Grade A (bridging bone through bilateral vertebral),Grade B (bridging bone through a unilateral vertebral),or Grade C (incomplete bony bridging).The incidence of vertebral compression fractures occurring after surgery was assessed by means of MR imaging.A solid fusion was defined as less than 5° of angular motion in flexion-extension radiographs and the presence of Grade A or B bridging bone.Bone metabolic markers (β-C-terminal telopeptide of type Ⅰ collagen,β-CTX; and N-terminal propeptide of type Ⅰ collagen,PINP) were measured to investigate the biological effects of zoledronic acid on spinal fusion.Bone mineral density of femoral neck was measured by the dual X-ray absorptiometry.Clinical outcome was evaluated by means of the Oswestry Disability Index (ODI).Results Grade A or B bridging bone was more frequently observed in the experimental group at 3,6,and 9 months postoperatively (all P ＜ 0.05,respectively,Mann-Whitney U-test).At 12-months postoperative follow-up,bridging bone and solid fusion were not significantly different.No vertebral fractures were observed in the experimental group,whereas 6 patients in the control group showed vertebral compression fractures(P ＜ 0.05,Mann-Whitney U-test).Biochemical analysis of bone turnover demonstrated that zoledronic acid inhibited bone resorption from the early phase of the fusion process and also suppressed bone formation.Poor clinical results in the control group were demonstrated by ODI.Conclusions Osteoporosis patients undergoing spinal fusion who take bisphosphonates throughout the postoperative period was recommended.
