补肾活血方治疗胫骨下段骨折术后不愈合临床观察

Effect of Bushen Huoxue Formula on Postoperative Disunion of Distal Tibial Fracture

目的:探讨补肾活血方对胫骨下段骨折术后骨折不愈合患者的临床疗效。方法:选取92例胫骨下段骨折术后骨折不愈合患者,利用随机数字表法将其分成观察组和对照组各46例。两组均行髓内钉固定治疗,对照组术后采取常规处理及功能锻炼,观察组在对照组基础上于术后第2天开始联合补肾活血方内服治疗,连续治疗3个月后观察两组临床疗效。比较两组骨折愈合情况及治疗前后Lysholm膝关节评分系统(LKSS)、美国特种外科医院(HSS)膝关节评分系统量表评分,白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α)、C反应蛋白(CRP)水平,碱性磷酸酶(ALP)、骨钙素(BGP)、抗酒石酸酸性磷酸酶(TRACP)骨代谢标志物水平变化,并统计两组术后并发症和药物不良反应发生情况。结果:观察组总有效率为97.83%,与对照组82.61%比较,差异具有统计学意义(P<0.05)。观察组术后3个月时骨痂评分显著高于对照组同期,而骨折愈合时间显著短于对照组,差异具有统计学意义(P<0.05)。两组术后3个月时LKSS、HSS评分均较术前有显著上升,差异具有统计学意义(P<0.05),观察组上升高于对照组(P<0.05)。两组术后3个月时血清IL-6、TNF-α、CRP浓度均较术前有显著降低(P<0.05),而观察组下降更显著,与对照组比较,差异具有统计学意义(P<0.05)。两组术后3个月时血清ALP、BGP含量均较术前有显著升高,血清TRACP浓度则均显著减低,差异具有统计学意义(P<0.05);且治疗后,观察组骨代谢各项参数(ALP、BGP、TRACP)血清水平的改善较对照组同期均更佳,差异具有统计学意义(P<0.05)。两组均未见与手术相关的严重术后并发症,仅观察组出现1例与药物相关的轻度恶心。结论:补肾活血方能有效提高胫骨下段骨折术后骨折不愈合的临床疗效,有助于加快患者骨折愈合,其作用机制可能与该中药方剂显著下调血清中相关炎症因子表达水平、正性调控机体骨代谢有关。

Objective:To investigate the clinical efficacy of Bushen Huoxue Formula(补肾活血方)on postoperative nonunion of distal of tibia fracture.Methods:Ninety two patients with postoperative nonunion of distal of tibia fracture were randomly divided into observation group and control group using simple random number table method,46 cases in each group.Both groups were treated with intramedullary nail fixation.The control group was treated with routine treatment and functional exercise after surgery,and the observation group was treated with the combination of Bushen Huoxue Formula on the basis of the control group on the 2nd day after surgery.The clinical efficacy of the two groups was observed after 3 months of treatment.Before and after the treatment fracture healing and related scale scores such as Lysholm knee scoring system(LKSS)score and American hospital for special surgery(HSS)knee scoring system score,levels of interleukin(IL)-6,tumor necrosis factor(TNF)-α),C-reactive protein(CRP),changes of bone metabolic markers such as alkaline phosphatase(ALP),osteocalcin(BGP),tartrate resistant acid phosphatase(TRACP),and the postoperative complications and drug adverse reactions occurrence in both groups were compared.Results:The total effective rate of the observation group was 97.83%,which was significantly higher than 82.61%of the control group(P<0.05).Three months after surgery,the callus score in the observation group was significantly higher than that in the control group,and the fracture healing time in the observation was significantly shorter than that in the control group(P<0.05).Three months after surgery,the scores of LKSS and HSS in both groups were significantly higher than those before surgery,but in the observation group the scores were significantly higher(P<0.05).Serum levels of IL-6,TNF-α,and CRP in the two groups 3 months after surgery were significantly lower than those before surgery,while the levels in the observation group were significantly lower(P<0.05).Serum ALP and BGP levels in both groups were significantly increased 3 months after surgery compared with those before surgery(P<0.05),and serum TRACP levels were significantly decreased in both groups(P<0.05).After the treatment,the serum levels of bone metabolism parameters(ALP,BGP,TRACP)in the observation group were more significantly improved than those in the control group(P<0.05).No serious postoperative complications were found in the two groups,and only in 1 patient from the observation group drug-related mild nausea was found.Conclusions:Bushen Huoxue Formula can effectively improve the clinical efficacy of postoperative nonunion of distal tibial fracture and accelerate the fracture healing of patients.The mechanism may be related to the significant down-regulation of the expression levels of relevant inflammatory factors in serum and the positive regulation of bone metabolism of the body by this traditional Chinese medicine formula.