聚氨基酸/纳米羟基磷灰石/硫酸钙椎间融合器在腰椎融合术中的初步应用

PRELIMINARY EFFECTIVENESS OF POLYAMINOACID/NANOHYDROXYAPATITE/CALCIUM SULFATE CAGE IN LUMBAR FUSION SURGERY

目的探讨聚氨基酸/纳米羟基磷灰石/硫酸钙(polyaminoacid/nano-hydroxyapatite/calcium sulfate,PAA/HA/CS)椎间融合器(简称PHC Cage)用于腰椎融合术的早期临床疗效。方法 2014年3月-9月选择30例行单节段腰椎融合术患者纳入研究,随机分为试验组(20例)及对照组(10例),试验组于术中植入PHC Cage,对照组植入聚醚醚酮(polyetheretherketone,PEEK)Cage。两组患者均主要表现为腰腿痛、下肢放射疼痛或麻木。术前均行腰椎正侧位X线片、CT三维重建检查。两组患者性别、年龄、病变类型、手术节段、病程及术前融合节段椎间隙高度、融合节段前凸曲度、Oswestry功能障碍指数(ODI)等一般资料比较,差异均无统计学意义(P>0.05),具有可比性。观察两组患者术后1周及3、6、12个月融合节段椎间隙高度、前凸曲度及术后3、6、12个月的ODI,依据Brantigan植骨融合分级标准评价植骨融合情况。结果两组患者手术时间、术中出血量及自体血回输量比较,差异均无统计学意义(P>0.05)。术后两组患者切口均Ⅰ期愈合。两组患者均获随访,随访时间12个月。两组患者术后各时间点融合节段椎间隙高度、融合节段前凸曲度及ODI均较术前显著改善(P<0.05);术后除3个月ODI与6、12个月比较差异有统计学意义(P<0.05)外,其余各指标术后各时间点间比较差异均无统计学意义(P>0.05);术后各时间点两组间各指标比较,差异均无统计学意义(P>0.05)。末次随访时,依据Brantigan植骨融合分级标准,试验组E级5例、D级13例、C级2例;对照组E级4例、D级5例、C级1例;两组植骨融合率均为90%。结论 PHC Cage可有效恢复、维持融合节段椎间隙高度及腰椎稳定性,与PEEK Cage类似,用于腰椎融合术可获得满意的早期临床疗效。

Objective To discuss the early effectiveness of polyaminoacid/nano-hydroxyapatite/calcium sulfate（PAA/HA/CS） Cage（PHC Cage） in lumbar fusion surgery. Methods Thirty cases undergoing lumbar fusion of single segment between March and September 2014 were enrolled in this study. The patients were randomly divided into the trial group（n=20） and the control group（n=10）. The PHC Cage was implanted in the trial group, while the polyetheretherketone（PEEK） Cage was implanted in the control group. The patients of 2 groups mainly presented lumbocrural pain and lower limb radiation pain or numbness. There was no significant difference in gender, age, type, affected segment, disease duration, preoperative intervertebral height, the lordosis angle of fusion segments, and the Oswestry Disability Index（ODI） between 2 groups（P〉0.05）. Lateral lumbar X-ray films and three dimensional CT were taken preoperatively and at 1 week and 3, 6, and 12 months postoperatively. The intervertebral height and the lordosis angle of fusion segments at 1 week and 3, 6, and 12 months after operation and ODI at 3, 6, and 12 months after operation were measured; and the bone graft fusion rate was evaluated according to Brantigan criteria. Results There was no significant difference in operation time, intraoperative blood loss, and the amount of autologous blood transfusion between 2 groups（P〉0.05）. Healing by first intention was obtained in 30 cases. All patients were followed up 12 months. The intervertebral height of fusion segments, the lordosis angle of fusion segments, and ODI at each time point after operation were significantly improved when compared with preoperative ones（P〈0.05）. The ODI showed significant difference between 3 months and 6, 12 months（P〈0.05）, but there was no significant difference between the other time points after operation（P〉0.05）. There was no significant difference in the intervertebral height and the lordosis angle of fusion segments between groups at different time points（P〉0.05）. There was no significant difference in the above indexes between the trial group and the control group at each time point（P〉0.05）. At last follow-up, 5 cases were rated as Brantigan grade E, 13 cases as grade D, and 2 cases as grade C in the trial group; 4 cases were rated grade E, 5 cases as grade D, and 1 case as grade C in the control group. The bone fusion rate was 90% in 2 groups. Conclusion The PHC Cage can effectively restore and maintain the disc height of fusion segment, normal sequence and biomechanical stability of the lumbar spine. The PHC Cage is similar to the PEEK Cage and has good clinical outcome in short-term follow-up.