骨宝口服液联合唑来膦酸治疗骨质疏松性股骨粗隆间骨折PFNA术后临床研究

Clinical Study on the Combination of Gubao Oral Liquid andZoledronic Acid in the Treatment of OsteoporosisIntertrochanteric Fracture of Femur after PFNA Surgery

目的 观察骨宝口服液联合唑来膦酸治疗骨质疏松性股骨粗隆间骨折PFNA术后的疗效。方法 78例骨质疏松性股骨粗隆间骨折患者,随机分为治疗组和对照组。两组患者均进行骨折闭合复位股骨近端防旋髓内钉(PFNA)内固定术治疗。对照组给予注射唑来膦酸和维D钙咀嚼片口服,治疗组在其基础上给予骨宝口服液。比较两组患者治疗前后的腰椎及健侧股骨近端骨密度,采用视觉模拟量表(Visual analogue scale, VAS)对腰部及患髋疼痛情况进行评价。检测并比较治疗前后两组患者血清中骨碱性磷酸酶(Bone alkaline phosphatase, BALP)、1型原胶原N-端前肽(type 1 procollagen N-terminal peptide, P1NP)、1型胶原交联C-末端肽β-骨胶原交联(beta crosslaps, β-CTX)、抗酒石酸酸性磷酸酶5b(Tartrate resistant acid phosphatase, TRACP-5b)。比较两组患者脆性骨折发生率及患髋Harris功能评分。结果 70例患者获随访,随访时间7~10个月。术后6个月,两组患者腰椎和健侧股骨颈骨密度均较前增加,且治疗组高于对照组;患者治疗后1个月及6个月腰部及患髋疼痛VAS评分,治疗组低于对照组;患者治疗后3个月,血清BALP、P1NP水平升高,治疗组明显高于对照组(P<0.05),而TRACP-5b、β-CTX水平下降,治疗组明显低于对照组(P<0.05)。治疗组脆性骨折发生率显著低于对照组,且患髋Harris功能评分显著优于对照组,差异均有统计学意义。结论 对于骨质疏松性股骨粗隆间骨折患者,术后应用骨宝口服液联合唑来膦酸,能明显缓解疼痛、增加骨密度、改善骨质疏松症状,并且能够恢复髋关节功能、调节骨转换标志物水平和降低脆性骨折的发生率,疗效显著。

Objective To observe the efficacy of Gubao oral liquid combined with zoledronic acid in the treatment of osteoporotic femoral intertrochanteric fractures after PFNA surgery.Methods 78 patients with osteoporotic intertrochanteric fractures of the femur were randomly divided into a treatment group and a control group.Both groups of patients underwent closed reduction of fractures and proximal femoral anti rotation intramedullary nail(PFNA)internal fixation.The control group was given oral injections of zoledronic acid and vitamin D calcium chewable tablets,while the treatment group was given Gubao oral solution on top of them.Compare the bone mineral density of the lumbar spine and proximal femur of the healthy side before and after treatment between two groups of patients,and evaluate the pain status of the lumbar and affected hip using the Visual Analog Scale(VAS).Detect and compare the serum levels of Bone alkaline phosphatase(BALP),type 1 procollagen N-terminal peptide(P1NP),and type 1 collagen cross-linked C-terminal peptide(β-CTX),Tartrate resistant acid phosphatase 5b(TRACP-5b)in two groups of patients before and after treatment.Compare the incidence of brittle fractures and Harris functional score of the affected hip between two groups of patients.Results The results showed that 70 patients were followed up for 7-10 months.Six months after surgery,the bone density of the lumbar spine and healthy femoral neck in both groups of patients increased compared to before,and the treatment group was higher than the control group;After 1 month and 6 months of treatment,the VAS scores of lower back and hip pain in the treatment group were lower than those in the control group;After 3 months of treatment,the levels of serum BALP and P1NP in the treatment group increased significantly compared to the control group(P<0.05),while TRACP-5b,β-CTX level decreased significantly in the treatment group compared to the control group(P<0.05).The incidence of brittle fractures in the treatment group was significantly lower than that in the control group,and the Harris functional score of the affected hip was significantly better than that in the control group,with statistically significant differences.Conclusion For patients with osteoporotic intertrochanteric fractures of the femur,postoperative use of Gubao oral solution combined with zoledronic acid can significantly alleviate pain,increase bone density,improve osteoporosis symptoms,and restore hip joint function,regulate bone turnover biomarker levels,and reduce the incidence of brittle fractures.The therapeutic effect is significant.