补肾活血汤加减配合LCP治疗四肢长骨骨干骨折不愈合的临床观察

目的:探讨补肾活血汤加减配合自体骨植骨术联合加压锁定钢板内固定(LCP)治疗四肢长骨骨干骨折不愈合的临床疗效及对微循环、成骨分化因子和骨代谢指标的影响作用。方法:按随机数字表法将70例患者随机分为对照组和观察组各35例。两组患者均采用LCP治疗。对照组口服跌打生骨颗粒,10 g/次,1次/d;观察组口服补肾活血汤,1剂/d。疗程均为治疗3个月并随访3个月。每周进行疼痛、压痛、纵向叩击痛、肿胀等症状、体征检查,比较主要症状、体征消失时间;每月进行1次X射线检查,检查骨痂形成及骨折线情况,记录骨折愈合时间;进行治疗前后Fugl-Meyer(FMA)评分;检测治疗前后纤维蛋白原(FIB),全血黏度(BV)(高切、低切)、血浆黏度(PV),血小板聚集率(PAR),D-二聚体(D-D),骨形成蛋白-2(BMP-2),BMP-7,胰岛素样生长因子-1(IGF-1),血管内皮细胞生长因子(VEGF),转化生长因子-β1(TGF-β1),骨钙素(BGP),骨保护素(OPG),血清Ⅰ型原胶原氨基端前肽(PINP),I型胶原交联C末端肽(S-CTX)和血清抗酒石酸酸性磷酸酶(TRACP)水平;进行安全性评价。结果:观察组疼痛、压痛、纵向叩击痛、肿胀消失时间和骨折愈合时间均短于对照组(P<0.01);治疗后3个月、随访3个月观察组骨痂评分和FMA评分(上肢、下肢)均高于同期对照组(P<0.01);观察组D-D,FIB,PAR,BV(高切、低切),PV水平均低于对照组(P<0.01);观察组BMP-2,BMP-7,IGF-1,VEGF和TGF-β1水平均高于对照组(P<0.01);观察组BGP,OPG,PINP水平均高于对照组(P<0.01),S-CTX和TRACP水平均低于对照组(P<0.01);观察组骨折愈合疗效优于对照组(Z=1.977,P<0.05);观察组肢体功能恢复情况优于对照组(Z=1.970,P<0.05)。未发现服用补肾活血汤后有不良反应。结论:在自体骨植骨联合LCP的基础上,内服补肾活血汤加减用于四肢长骨骨干骨折不愈合患者,可促进骨折愈合,缩短了病程,促进了肢体功能恢复,有着较好的临床疗效,并能改善微循环、促进成骨分化因子的表达、调节骨代谢,起到促进骨折愈合的作用,临床使用安全。

Clinical Efficacy of Modified Bushen Huoxuetang Combined with LCP in Treatment of Nonunion of Limb Long Bone Shaft Fracture

Objective:To discuss the clinical efficacy of modified Bushen Huoxuetang combined with autologous bone grafting and locking compression plate(LCP)in treating nonunion of long bone fractures,and the effect on microcirculation,osteogenic differentiation factor and bone metabolism index. Method:A total of70 patients were randomly divided into control group and observation group by random number table,with 35 cases in each group. Patients in both groups received LCP. Patients in control group got Dieda Shenggu granule,10 g/time, 1 time/day. Patients in observation group got Bushen Huoxuetang, 1 dose/day. The course of treatment lasted for 3 months,and 3-month follow-up data were recorded. On a weekly basis,the main symptoms,such as pain,tenderness,longitudinal percussion pain and swelling were checked,and the time of disappearing of main symptoms and signs were compared. On a weekly basis, a X-ray examination was performed for callus formation and fracture line,and the fracture healing time was recorded. Before and after treatment,Fugl-Meyer(FMA)was scored,and levels of fibrinogen(FIB),whole blood viscosity(BV)(high shear, low shear), plasma viscosity(PV), platelet aggregation rate(PAR), D-Dimer(D-D), bone morphogenetic protein-2(BMP-2),BMP-7,insulin-like growth factor-1(IGF-1),vascular endothelial growth factor(VEGF),transforming growth factor-β1(TGF-β1),osteocalcin(BGP),osteoprotegerin(OPG),procollagen type Ⅰ N-terminal propeptideserum amino pro peptide(PINP),serum type 1 collagen cross-linked C-terminal peptide(S-CTX)and serum tartrate resistant acid phosphatase(TRACP)of type I procollagen were detected,and the safety was evaluated. Result: Disappearance time of symptoms and signs and fracture healing time in observation group were all lower than those in control group(P<0.01). At the third month after treatment,and during the three-month follow-up,scores of callus and FMA(upper and lower limbs) in observation group were all higher than those in control group(P<0.01). Levels of D-D,FIB,PAR,BV and PV(high-cut and low-cut),BMP-2,BMP-7,IGF-1,VEGF,TGF-β1,S-CTX and TRACP were all lower than those in control group(P<0.01),whereas levels of BGP,OPG and PINP were higher than those in control group(P<0.01). The curative effect of fracture healing was better than that of control group(Z=1.977,P<0.05).And the limb function recovery was superior to that in control group(Z=1.970,P<0.05). Conclusion:Based on autogenous bone and LCP,modified Bushen Huoxuetang can promote the fracture healing,shorten the course of disease, and promote the recovery of limb function, with a good clinical efficacy. It can improve microcirculation,promote the expression of osteogenic differentiation factor,regulate bone metabolism,and play a role in promoting fracture healing,with a safety in clinical use.