生骨胶囊在经皮椎体强化术治疗老年骨质疏松性胸腰椎骨折中的应用研究

Application of Shenggu Jiaonang(生骨胶囊) to the treatment of osteoporotic thoracolumbar vertebral fractures in the aged who received percutaneous vertebral augmentation

目的：观察在常规经皮椎体强化术的基础上应用生骨胶囊治疗老年骨质疏松性胸腰椎骨折的临床疗效和安全性。方法：将符合要求的90例老年骨质疏松性胸腰椎骨折患者随机分为生骨胶囊组、阿法骨化醇组及椎体强化组，每组30例。3组患者均采用椎体强化术治疗，并于术后24 h 开始口服阿仑膦酸钠片，每天10 mg，连服8周。在此基础上，生骨胶囊组自手术当天开始口服生骨胶囊，每次5粒，每天3次，连续服用8周；阿法骨化醇组自手术当天开始口服阿法骨化醇胶丸，每次1粒，每天1次，连续服用8周。治疗期间定期检查血、尿、大便常规及肝肾功能、血清钙磷浓度、心电图，并观察并发症发生情况。采用视觉模拟评分量表（visual analogue scale，VAS）评定患者的疼痛程度，定期拍摄胸腰椎正侧位 X 线片观察骨折椎体压缩程度，采用超声波骨密度检测仪测定患者的跟骨骨密度，并采用自拟的疗效标准评定综合疗效。结果：所有患者均按要求完成了8周的治疗，至术后6个月时生骨胶囊组和椎体强化组各有7例失访，阿法骨化醇组有8例失访。3组患者均未发生腰肌血肿、神经根损伤、感染等并发症，至术后8周时阿法骨化醇组5例出现高血钙。术前及术后1 d 时3组患者的疼痛 VAS 评分比较，组间差异均无统计学意义（F ＝0．364，P ＝0．696；F ＝0．256，P ＝0．768）。术后8周、6个月时3组患者的疼痛 VAS 评分比较，组间差异均有统计学意义（χ2＝39．741，P ＝0．000；χ2＝55．852，P ＝0．000）；进一步两两比较，术后8周、6个月时生骨胶囊组和阿法骨化醇组的 VAS 评分比较，差异均无统计学意义（χ2＝335．000，P ＝0．091；χ2＝200．000，P ＝0．080）；生骨胶囊组和阿法骨化醇组的 VAS 评分均低于椎体强化组（χ2＝59．000，P ＝0．000，χ2＝79．000，P ＝0．000；χ2＝20．000，P ＝0．000，χ2＝30．000，P ＝0．000）。术后1 d、8周、6个月时3组患者的椎体压缩程度比较，组间差异均无统计学意义（χ2＝0．228，P ＝0．892；χ2＝0．007，P ＝0．996；χ2＝2．695，P ＝0．260）。术后8周、6个月时3组患者的跟骨骨密度比较，组间差异均无统计学意义（χ2＝2．618，P ＝0．270；χ2＝3．317，P ＝0．190）。术后8周、6个月时生骨胶囊组、阿法骨化醇组的综合疗效均优于椎体强化组，生骨胶囊组的综合疗效均优于阿法骨化醇组（R生骨胶囊组＝39．78，R阿法骨化醇组＝41．07，R椎体强化组＝55．65，χ2＝9．328，P ＝0．009；R生骨胶囊组＝27．46，R阿法骨化醇组＝30．69，R椎体强化组＝45．20，χ2＝13．309，P ＝0．001）。结论：对老年骨质疏松性胸腰椎骨折，在常规经皮椎体强化术治疗的基础上应用生骨胶囊可进一步提高临床综合疗效，效果优于联合应用阿法骨化醇，而且具有较高的安全性。

Objective：To observe the clinical curative effect and safety of combination of oral application of Shenggu Jiaonang（SGJN,生骨胶囊）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 percutane-ous vertebroplasty or percutaneous kyphoplasty,and were treated with oral application of alendronate sodium tablets since the 24th hour after the begining of the surgery,1 0 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 be-tween 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 =2.61 8,P =0.270;χ2 =3.31 7,P =0.1 90）.SGJN group and alfacalcidol group surpassed vertebral augmentation group and SGJN group sur-passed alfacalcidol group in the general therapeutic effect at 8 weeks and 6 months after the surgery（RSGJN group =39.78,Ralfacalcidol group =41 .07,Rvertebral augmentation group =55.65,χ2 =9.328.P =0.009;RSGJN group =27.46,Ralfacalcidol group =30.69,Rvertebral augmentation group =45.20,χ2 =1 3.309,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 percuta-neous vertebral augmentation in combination with SGJN is better than in combination with alfacalcidol.