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[1]張旭橋,王曉暉,黃光明,等.生骨膠囊在經(jīng)皮椎體強化術治療老年骨質(zhì)疏松性胸腰椎骨折中的應用研究[J].中醫(yī)正骨,2016,28(11):21-25.
　ZHANG Xuqiao,WANG Xiaohui,HUANG Guangming,et al.Application of Shenggu Jiaonang(生骨膠囊)to the treatment of osteoporotic thoracolumbar vertebral fractures in the aged who received percutaneous vertebral augmentation[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(11):21-25.
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生骨膠囊在經(jīng)皮椎體強化術治療老年骨質(zhì)疏松性胸腰椎骨折 中的應用研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第28卷
期數(shù):
2016年11期
頁碼:
21-25
欄目:
臨床研究
出版日期:
2016-11-20

文章信息/Info

Title:
Application of Shenggu Jiaonang(生骨膠囊)to the treatment of osteoporotic thoracolumbar vertebral fractures in the aged who received percutaneous vertebral augmentation
作者:
張旭橋; 王曉暉; 黃光明; 黃超文; 湯智; 徐洪祠; 李超
湖南省湘潭市中醫(yī)醫(yī)院,湖南 湘潭 411100
Author(s):
ZHANG Xuqiao; WANG Xiaohui; HUANG Guangming; HUANG Chaowen; TANG Zhi; XU Hongci; LI Chao
Xiangtan Hospital of Traditional Chinese Medicine,Xiangtan 411100,Hunan,China
關鍵詞:
脊柱骨折;  骨質(zhì)疏松性骨折;  生骨膠囊;  椎體成形術;  椎體后凸成形術;  臨床試驗
Keywords:
spinal fractures;  osteoporotic fractures;  Shenggu Jiaonang;  vertebroplasty;  kyphoplasty;  clinical trial
摘要:
目的:觀察在常規(guī)經(jīng)皮椎體強化術的基礎上應用生骨膠囊治療老年骨質(zhì)疏松性胸腰椎骨折的臨床療效和安全性。方法:將符合要求的90例老年骨質(zhì)疏松性胸腰椎骨折患者隨機分為生骨膠囊組、阿法骨化醇組及椎體強化組,每組30例。3組患者均采用椎體強化術治療,并于術后24 h開始口服阿侖膦酸鈉片,每天10 mg,連服8周。在此基礎上,生骨膠囊組自手術當天開始口服生骨膠囊,每次5粒,每天3次,連續(xù)服用8周; 阿法骨化醇組自手術當天開始口服阿法骨化醇膠丸,每次1粒,每天1次,連續(xù)服用8周。治療期間定期檢查血、尿、大便常規(guī)及肝腎功能、血清鈣磷濃度、心電圖,并觀察并發(fā)癥發(fā)生情況。采用視覺模擬評分量表(visual analogue scale,VAS)評定患者的疼痛程度,定期拍攝胸腰椎正側(cè)位X線片觀察骨折椎體壓縮程度,采用超聲波骨密度檢測儀測定患者的跟骨骨密度,并采用自擬的療效標準評定綜合療效。結(jié)果:所有患者均按要求完成了8周的治療,至術后6個月時生骨膠囊組和椎體強化組各有7例失訪,阿法骨化醇組有8例失訪。3組患者均未發(fā)生腰肌血腫、神經(jīng)根損傷、感染等并發(fā)癥,至術后8周時阿法骨化醇組5例出現(xiàn)高血鈣。術前及術后1 d 時3組患者的疼痛VAS評分比較,組間差異均無統(tǒng)計學意義(F=0.364,P=0.696; F=0.256,P=0.768)。術后8周、6個月時3組患者的疼痛VAS評分比較,組間差異均有統(tǒng)計學意義(χ2=39.741,P=0.000; χ2=55.852,P=0.000); 進一步兩兩比較,術后8周、6個月時生骨膠囊組和阿法骨化醇組的VAS評分比較,差異均無統(tǒng)計學意義(χ2=335.000,P=0.091; χ2=200.000,P=0.080); 生骨膠囊組和阿法骨化醇組的VAS評分均低于椎體強化組(χ2=59.000,P=0.000,χ2=79.000,P=0.000; χ2=20.000,P=0.000,χ2=30.000,P=0.000)。術后1 d、8周、6個月時3組患者的椎體壓縮程度比較,組間差異均無統(tǒng)計學意義(χ2=0.228,P=0.892; χ2=0.007,P=0.996; χ2=2.695,P=0.260)。術后8周、6個月時3組患者的跟骨骨密度比較,組間差異均無統(tǒng)計學意義(χ2=2.618,P=0.270; χ2=3.317,P=0.190)。術后8周、6個月時生骨膠囊組、阿法骨化醇組的綜合療效均優(yōu)于椎體強化組,生骨膠囊組的綜合療效均優(yōu)于阿法骨化醇組(R^-生骨膠囊組=39.78,R^-阿法骨化醇組=41.07,R^-椎體強化組=55.65,χ2=9.328,P=0.009; R^-生骨膠囊組=27.46,R^-阿法骨化醇組=30.69,R^-椎體強化組=45.20,χ2=13.309,P=0.001)。結(jié)論:對老年骨質(zhì)疏松性胸腰椎骨折,在常規(guī)經(jīng)皮椎體強化術治療的基礎上應用生骨膠囊可進一步提高臨床綜合療效,效果優(yōu)于聯(lián)合應用阿法骨化醇,而且具有較高的安全性。
Abstract:
Objective:To observe the clinical curative effect and safety of combination of oral application of Shenggu Jiaonang(SGJN,生骨膠囊)with conventional percutaneous vertebral augmentation for the treatment of osteoporotic thoracolumbar vertebral fractures in the aged.Methods:Ninety aged patients with osteoporotic thoracolumbar vertebral fractures were enrolled in the study and randomly divided into SGJN group,alfacalcidol group and vertebral augmentation group,30 cases in each group.All of the patients were treated with percutaneous vertebroplasty or percutaneous kyphoplasty,and were treated with oral application of alendronate sodium tablets since the 24th hour after the begining of the surgery,10 mg a day for 8 consecutive weeks.Meanwhile,the patients in SGJN group were treated with oral application of SGJN since the day of surgery,5 pills at a time,3 times a day for 8 consecutive weeks.The patients in alfacalcidol group were treated with oral application of alfacalcidol soft capsules since the day of surgery,1 pill at a time,once a day for 8 consecutive weeks.The blood RT,urine RT,stool RT,function of liver and kidney,serum contents of calcium and phosphorus and electrocardiogram were periodically examined during the treatment,meanwhile,the complications were observed.The pain degrees were evaluated by using visual analogue scale(VAS).The anteroposterior and lateral X-ray films of thoracolumbar spine were periodically scanned for assessing the degree of fractured vertebral bodies compression.The calcaneal bone mineral density(BMD)were measured by using ultrasonography machines.The general therapeutic effect were also evaluated by using self-made therapeutic effect standard.Results:All patients completed 8 weeks of treatment as required.Seven patients in SGJN group,7 patients in vertebral augmentation group and 8 patients in alfacalcidol group lost to follo-up by the 6th month after the surgery.No complications such as psoas hematoma,nerve root injury and infection were found in the 3 groups,while hypercalcemia(5 cases)were found in alfacalcidol group by the 8th week after the surgery.There was no statistical difference in pain VAS scores between the 3 groups before surgery and at 1 day after the surgery(F=0.364,P=0.696; F=0.256,P=0.768).There was statistical difference in pain VAS scores between the 3 groups at 8 weeks and 6 months after the surgery(χ2=39.741,P=0.000; χ2=55.852,P=0.000).Further pairwise comparison showed that there was no statistical difference in VAS scores between SGJN group and alfacalcidol group at 8 weeks and 6 months after the surgery(χ2=335.000,P=0.091; χ2=200.000,P=0.080),and.the VAS scores were lower in SGJN group and alfacalcidol group compared to vertebral augmentation group(χ2=59.000,P=0.000,χ2=79.000,P=0.000; χ2=20.000,P=0.000,χ2=30.000,P=0.000).There was no statistical difference in the degree of fractured vertebral bodies compression between the 3 groups at 1 day,8 weeks and 6 months after the surgery(χ2=0.228,P=0.892; χ2=0.007,P=0.996; χ2=2.695,P=0.260).There was no statistical difference in the calcaneal BMD between the 3 groups at 8 weeks and 6 months after the surgery(χ2=2.618,P=0.270; χ2=3.317,P=0.190).SGJN group and alfacalcidol group surpassed vertebral augmentation group and SGJN group surpassed alfacalcidol group in the general therapeutic effect at 8 weeks and 6 months after the surgery(R^-SGJN group=39.78,R^-alfacalcidol group=41.07,R^-vertebral augmentation group=55.65,χ2=9.328.P=0.009; R^-SGJN group=27.46,R^-alfacalcidol group=30.69,R^-vertebral augmentation group=45.20,χ2=13.309,P=0.001).Conclusion:Oral application of SGJN can improve general therapeutic effect of conventional percutaneous vertebral augmentation with high safety in treatment of osteoporotic thoracolumbar vertebral fractures in the aged,and the therapeutic effect of percutaneous vertebral augmentation in combination with SGJN is better than in combination with alfacalcidol.

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備注/Memo

備注/Memo:
基金項目:2014年度湖南省中醫(yī)藥科研計劃項目(2014126)
通訊作者:張旭橋 E-mail:[email protected]
更新日期/Last Update: 2016-11-30