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目的 评估光电导航下个体化单侧穿刺椎体后凸成形术(percutaneous kyphoplasty,PKP)治疗胸腰椎骨质疏松性椎体压缩骨折(osteoporosis vertebral compression fracture,OVCF)的安全性.方法 2015年6月-2017年1月,采用随机对照研究方法,对收治的85例OVCF患者分别采用光电导航引导下个体化单侧穿刺方法(观察组43例)或常规C臂X线机透视下单侧穿刺方法(对照组42例)行PKP治疗.两组患者性别、年龄、病程、累及节段、骨折AO分型、骨密度等级及术前疼痛视觉模拟评分(VAS)等一般资料比较差异无统计学意义(p＞0.05).术后CT横断面图像上观察并计算穿刺路径与设计路径的吻合率、椎弓根内壁突破率、骨水泥渗漏率和骨水泥中心分布率;记录两组患者术中X线暴露次数、穿刺次数、手术时间、术前和术后2d VAS评分及术后血管、神经损伤等相关并发症发生情况.结果 观察组术中X线暴露次数及穿刺次数明显少于对照组(P＜0.05),但两组手术时间比较差异无统计学意义(t=0.440,P=0.661).术后2d两组VAS评分均较术前显著改善(p＜0.05);但术后2d两组间比较差异无统计学意义(t=0.406,P=0.685).两组患者均获随访,随访时间6～18个月,平均10个月.两组均无血管、神经损伤等相关并发症发生.术后48 h观察组椎弓根内壁突破率、骨水泥渗漏率、穿刺路径吻合率和骨水泥中心分布率分别为2.33％ (1/43)、2.33％(1/43)、86.05％(37/43)、88.37％(38/43),与对照组[分别为19.05％ (8/42)、21.43％ (9/42)、45.24％ (19/42)、50.00％ (21/42)]比较差异均有统计学意义(P＜0.05).结论 术中光电导航下个体化单侧穿刺PKP能提高靶点穿刺成功率,有效减少椎弓根内壁穿破,能够获得更好的骨水泥分布,具有更高的安全性.“,”Objective To evaluate the safety of photoelectric guided navigation unilateral puncture of the percutaneous kyphoplasty (PKP) in the treatment of thoracolumbar osteoporotic vertebral compression fracture (OVCF).Methods A randomized controlled clinical research was performed between June 2015 and January 2017.Eighty-five cases of OVCF were treated with photoelectric guided navigation unilateral puncture of the PKP (trial group,43 cases) or C arm fluoroscopy unilateral puncture of the PKP (control group,42 cases) respectively.There was no significant difference in gender,age,disease duration,segmental fracture,AO classification,bone mineral density,and preoperative visual analogue scale (VAS) score between 2 groups (P＞0.05).The concordance rate of puncture path and design path,the incidence of pedicle wall breaking,the incidence of bone cement leakage,and the rate of bone cement distribution center were observed and calculated on postoperative CT images;the intraoperative X-ray exposure frequency,frequency of puncture,operation time,VAS scores before operation and at 2 days after operation,and postoperative blood vessel or nerve injury were recorded and compared.Results The intraoperative X-ray exposure frequency and puncture frequency in trial group were significantly less than those in control group (P＜0.05),but there was no significant difference in operation time between 2 groups (t=0.440,P=0.661).The VAS scores of 2 groups at 2 days after operation were significantly improved when compared with preoperative ones (P＜0.05),but there was no significant difference in VAS score at 2 days after operation between 2 groups (t=0.406,P=0.685).All the patients were followed up 6-18 months (mean,10 months).No blood vessel or nerve injury occurred in 2 groups.The incidence of pedicle wall breaking,the incidence of bone cement leakage,the concordance rate of puncture path and design path,and the rate of bone cement distribution center in trial group were 2.33％ (1/43),2.33％ (1/43),86.05％ (37/43),and 88.37％ (38/43) respectively,all showing significant differences when compared with those of control group [19.05％ (8/42),21.43％ (9/42),45.24％ (19/42),and 50.00％ (21/42) respectively] (P＜0.05).Conclusion Intraoperative photoelectric guided navigation unilateral puncture of the PKP can improve the success rate of target puncture and reduce the incidence of pedicle wall breaking effectively,and achieve better bone cement distribution and better security.