Objective: To analyze the effectiveness of percutaneous injection of autologous concentrated bone marrow aspirate (cBMA) combined with platelet-rich plasma (PRP) in the treatment of delayed fracture healing.
Methods: A prospective, randomized, controlled, single-blind case study was conducted. Between March 2016 and July 2018, 66 patients who met the inclusion and exclusion criteria for delayed fracture healing but had solid internal fixation of the fracture end were randomly divided into control group (31 cases, treated with percutaneous autogenous bone marrow blood injection) and study group (35 cases, treated with percutaneous autogenous cBMA+PRP injection). General data such as gender, age, body mass index, site of delayed fracture healing, length of bone defect at fracture end, and preoperative radiographic union score for tibia (RUST) showed no significant difference between the two groups ( P>0.05). Before injection, Kirschner wire was used in both groups to stimulate the fracture end and cause minor injury. The fracture healing time, treatment cost, and adverse reactions were recorded and compared between the two groups. Visual analogue scale (VAS) score was used to evaluate pain improvement. The tibial RUST score was extended to the tubular bone healing evaluation.
Results: No infection of bone marrow puncture needle eyes occurred in both groups. In the control group, local swelling was obvious in 5 cases and pain was aggravated at 1 day after operation in 11 cases. In the study group, postoperative swelling and pain were not obvious, but 2 cases presented local swelling and pain. All of them relieved after symptomatic treatment. Patients in both groups were followed up, the follow-up time of the control group was 16-36 months (mean, 21.8 months), and the study group lasted 14-33 months (mean, 23.2 months). The amount of bone marrow blood was significantly lower in the study group than in the control group ( t=4.610, P=0.000). The degree of postoperative pain in the study group was less than that in the control group, and the treatment cost was higher than that in the control group. But the differences between the two groups in VAS score at 1 day after operation and treatment cost were not significant ( P>0.05). Fracture healing was achieved in 19 cases (61.3%) in the control group and 30 cases (85.7%) in the study group. The difference in fracture healing rate between the two groups was significant ( χ 2=5.128, P=0.024). Fracture healing time and RUST score at last follow-up were significantly better in the study group than in the control group ( P<0.05). At last follow-up, RUST scores in both groups were significantly improved when compared with those before operation ( P<0.05).
Conclusion: Autogenous cBMA combined with PRP percutaneous injection can provide high concentration of BMSCs and growth factors, and can improve the fracture healing rate and shorten the fracture healing time better than autogenous bone marrow blood injection.
目的: 分析骨髓浓集液（concentrated bone marrow aspirate，cBMA）联合富血小板血浆（platelet-rich plasma，PRP）经皮注射治疗骨折延迟愈合的临床疗效。.
方法: 采取前瞻性随机对照单盲病例研究方法，选择 2016 年 3 月—2018 年 7 月符合选择标准的 66 例骨折延迟愈合但骨折端内固定牢靠患者，随机分为对照组（31 例，采用经皮自体骨髓血注射治疗）和研究组（35 例，采用经皮自体 cBMA+PRP 注射治疗）。两组患者性别、年龄、体质量指数、骨折延迟愈合部位、骨折端骨缺损长度、术前胫骨骨折影像学愈合评分系统（RUST）评分等一般资料比较，差异均无统计学意义（ P>0.05），具有可比性。两组注射前均采用克氏针经皮对骨折端进行刺激，造成微损伤。记录并比较两组患者骨折愈合时间、治疗费用及不良反应，采用疼痛视觉模拟评分（VAS）评价患者疼痛改善情况；并将胫骨 RUST 评分扩展到管状骨愈合评价。.
结果: 两组骨髓穿刺针眼均无感染发生。对照组 5 例术后局部肿胀明显，11 例术后 1 d 疼痛加重；研究组术后肿胀及疼痛不明显，但有 2 例出现局部红肿疼痛；均经对症处理后缓解。术后两组患者均获随访，随访时间对照组 16～36 个月，平均 21.8 个月；研究组 14～33 个月，平均 23.2 个月。研究组骨髓血抽取量显著少于对照组（ t=4.610， P=0.000）；研究组术后疼痛程度较对照组轻，治疗费用较对照组高，但差异均无统计学意义（ P>0.05）。对照组 19 例（61.3%）、研究组 30 例（85.7%）获得骨折愈合，两组骨折愈合率比较差异有统计学意义（ χ 2=5.128， P=0.024）。研究组骨折愈合时间和末次随访时 RUST 评分均显著优于对照组（ P<0.05）；两组末次随访时 RUST 评分均较术前显著改善（ P<0.05）。.
结论: 自体 cBMA 联合 PRP 经皮注射可以提供高浓度的 BMSCs 和生长因子，相对于自体骨髓血注射更能提高骨折愈合率和缩短骨折愈合时间。.
Keywords: Delayed fracture healing; concentrated bone marrow aspirate; minimally invasive therapy; platelet-rich plasma.