Objective: To compare the effectiveness of calcium phosphate cement (CPC) loaded with recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with CPC loaded with antibiotic versus CPC loaded with antibiotic alone in one stage for chronic osteomyelitis with bone defect.
Methods: A single-blind prospective randomized controlled clinical trial was conducted. Between April 2018 and April 2019, 80 patients of chronic osteomyelitis with bone defect in accordance with the random number table were randomly divided into two groups, 40 in the trial group (CPC loaded with rhBMP-2 combined with CPC loaded with antibiotic) and 40 in the control group (CPC loaded with antibiotic). There was no significant difference in gender, age, disease duration, lesion, and preoperative white blood cells (WBC) count, platelet count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) between the two groups ( P>0.05). All patients were implanted the corresponding CPC and external fixator after lesion clearance in the two groups. The postoperative WBC count, platelet count, ESR, CRP, hospital stay, cure rate of osteomyelitis, repaired bone defect volume, the time of external fixator removal, and the time of full weight-bearing of the affected limb were compared between the two groups.
Results: All patients were followed up 12-24 months, with an average of 18.4 months. There was no significant difference in WBC count, platelet count, ESR, and CRP between the two groups at 4 weeks after operation ( P>0.05). There were significant differences in WBC count, platelet count, and CRP in the two groups between 1 week before operation and 4 weeks after operation ( P<0.05). And the ESR showed no significant difference between pre- and post-operation in the two groups ( P>0.05). In the trial group, the anaphylactic exudate occurred in 1 patient with tibial osteomyelitis and the incision healed after oral administration of loratadine. The incisions of other patients healed by first intention in the two groups. One case of distal tibial osteomyelitis recurred in each group, and 1 case of humeral osteomyelitis recurred in the control group. The cure rates of osteomyelitis were 97.5% (39/40) in the trial group and 95% (38/40) in the control group, showing no significant difference between the two groups ( χ 2 =0.000, P=1.000). There was no significant difference in the repaired bone defect volume and hospital stay between the two groups ( P>0.05). X-ray film and CT showed that the bone defects were repaired in the two groups. The time of external fixator removal and the time of full weight-bearing of the affected limb were significantly shorter in the trial group than in the control group ( P<0.05).
Conclusion: Application of CPC loaded with rhBMP-2 and antibiotic in one stage is effective for the chronic osteomyelitis with bone defect, which can accelerate the bone regeneration in situ to repair bone defect, reduce the trauma, shorten the course of treatment, and obtain good function of the affected limb.
目的: 通过与单纯载抗生素磷酸钙人工骨（calcium phosphate cement，CPC）比较，探讨载重组人 BMP-2（recombinant human BMP-2，rhBMP-2）CPC 联合载抗生素 CPC 一期治疗慢性骨髓炎伴骨缺损的疗效。.
方法: 采用单盲、前瞻性临床随机对照试验，以 2018 年 4 月—2019 年 4 月收治且符合选择标准的 80 例慢性骨髓炎伴骨缺损患者为研究对象，按随机数字表法分为试验组（采用载 rhBMP-2 CPC 联合载抗生素 CPC）与对照组（采用载抗生素 CPC），每组 40 例。两组患者性别、年龄、病程、病变部位以及术前白细胞计数、血小板计数、红细胞沉降率及 C 反应蛋白等一般资料比较，差异均无统计学意义（ P>0.05），具有可比性。术中病灶清除后，两组植入对应 CPC 修复骨缺损并外固定。比较两组术后白细胞计数、血小板计数、红细胞沉降率、C 反应蛋白，患者住院时间、取出外固定架时间、患肢完全负重时间，以及骨髓炎治愈率、修复骨容积。.
结果: 两组患者均获随访，随访时间 12～24 个月，平均 18.4 个月。两组术后 4 周白细胞计数、血小板计数、红细胞沉降率及 C 反应蛋白比较，差异均无统计学意义（ P>0.05）；两组组内术前 1 周与术后 4 周白细胞计数、血小板计数及 C 反应蛋白比较，差异均有统计学意义（ P<0.05）；红细胞沉降率比较差异无统计学意义（ P>0.05）。试验组 1 例胫骨骨髓炎切口出现无菌性渗液，经口服氯雷他定后愈合；两组其余患者切口均Ⅰ期愈合。两组各 1 例胫骨远端骨髓炎复发，对照组 1 例肱骨骨髓炎复发；试验组骨髓炎治愈率为 97.5%（39/40）、对照组为 95%（38/40），差异无统计学意义（ χ 2 =0.000， P=1.000）。两组修复骨容积及住院时间比较，差异无统计学意义（ P>0.05）；X 线片及 CT 复查示两组患者骨缺损均修复。试验组拆除外固定架时间及患肢完全负重时间均较对照组明显缩短（ P<0.05）。.
结论: 载 rhBMP-2 CPC 联合载抗生素 CPC 一期治疗慢性骨髓炎伴骨缺损有效，能加速诱导骨原位再生修复骨缺损，减少创伤，缩短疗程，恢复良好患肢功能。.
Keywords: Chronic osteomyelitis; antibiotic; bone defect; calcium phosphate cement; recombinant human bone morphogenetic protein 2; repair.