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鲍雷;余加生;张斌;王磊;李中连;孙玉明.益气温阳活血方联合微创手术治疗严重骨质疏松性股骨粗隆间骨折随机对照研究[J].中国中西医结合杂志,2023,43(12):1420-1426
益气温阳活血方联合微创手术治疗严重骨质疏松性股骨粗隆间骨折随机对照研究
Clinical Effect of Yiqi Wenyang Huoxue Decoction Combined with Minimally Invasive Procedure in the Treatment of Severe Osteoporotic Intertrochanteric Fracture of Femur:A Randomized Controlled Trial
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DOI:10.7661/j.cjim.20231011.311
中文关键词:  益气温阳活血方  微创手术  骨水泥  骨质疏松  股骨粗隆间骨折  中西医结合  随机对照试验
英文关键词:Yiqi Wenyang Huoxue Decoction  minimally invasive surgery  bone cement  osteoporosis  intertrochanteric fracture of femur  integrative medicine  randomized controlled trial
基金项目:江苏省老年健康科研课题面上课题(No.LKM2022090)
作者单位
鲍雷;余加生;张斌;王磊;李中连;孙玉明 1.南京中医药大学沭阳附属医院骨伤科(江苏 223600),2.南京中医药大学附属江苏省中医院骨伤科(南京 210029) 
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中文摘要:
      目的 观察益气温阳活血方联合微创手术治疗肾虚血瘀型严重骨质疏松性股骨粗隆间骨折的疗效及其对骨代谢标志物的影响。方法 筛选115例股骨粗隆间骨折患者,将纳入的84例患者随机分为研究组和对照组,每组各42例。对照组行骨水泥强化型股骨近端防旋髓内钉(PFNA)内固定,研究组在对照组的基础上联合益气温阳活血方内服。治疗3个月,随访6个月。比较两组的手术指标、临床疗效及治疗前后骨密度(BMD)、骨代谢标志物[骨钙素(OC)、总Ⅰ型前胶原氨基端前肽(tPINP)及Ⅰ型胶原羧基端β降解产物(β-CTX)]变化。结果 两组手术时间、术中出血量及尖顶距比较,差异无统计学意义(P>0.05)。与对照组比较,治疗后研究组患肢完全负重时间及骨折愈合时间缩短(P<0.05)。治疗后3、6个月,研究组髋关节功能Harris评分均优于对照组(P<0.05)。两组治疗前BMD、OC、tPINP及β-CTX比较,差异无统计学意义(P>0.05)。与本组治疗前比较,治疗后3、6个月,两组BMD值、OC、tPINP水平升高,β-CTX水平降低(P<0.05),且研究组BMD值、OC、tPINP水平在两时间点均高于对照组,β-CTX水平低于对照组(P<0.05)。结论 益气温阳活血方联合微创手术治疗严重骨质疏松性股骨粗隆间骨折,可缩短骨折愈合时间,促进术后髋关节功能恢复,改善BMD,提升血清OC、tPINP水平,降低β-CTX水平。
英文摘要:
      Objective To observe the clinical efficacy of Yiqi Wenyang Huoxue Decoction combined with minimally invasive surgery in the treatment of Shen deficiency blood stasis type intertrochanteric femur fracture in the elderly patients with severe osteoporosis and its influence on bone metabolism markers. Methods A total of 115 patients with intertrochanteric femur fracture were recruited. Eighty-four patients were included and randomly assigned to the study group and the control group,with 42 patients in each group. The control group was treated with proximal femoral nail antirotation(PFNA) internal fixation with bone cement,while the study group was treated with PFNA internal fixation with bone cement and Yiqi Wenyang Huoxue Decoction. Surgical indicators,clinical efficacy,bone mineral density(BMD),and bone metabolism markers[bone mineral density(BMD),osteocalcin(OC),total typeⅠprocollagen amino-terminal peptide(tPINP),and typeⅠcollagen carboxy-terminal peptide(β-CTX)] before and after treatment between two groups were compared accordingly. Results There were no significant differences in surgical time,intraoperative bleeding volume,and tip-apex distance between two groups(P>0.05). Compared with the control group,after treatment the time of complete weight-bearing and fracture healing in study group were shorter(P<0.05). After 3 and 6 months of treatment,the Harris score of hip function in study group was higher than that in control group(P<0.05). No statistical differences in BMD, OC, tPINP and β-CTX between two groups before treatment were observed(P>0.05). Compared with before treatment,BMD value,OC,tPINP level increased,β-CTX level decreased at 3 and 6 months after treatment in two groups(P<0.05),BMD value,OC,tPINP level in the study group were higher than those in the control group,and β-CTX level was lower than that in the control group at both time points(P<0.05). Conclusions Yiqi Wenyang Huoxue Decoction combined with minimally invasive surgery can achieve better hip function with shorter fracture healing time and higher BMD lever. Higher expression of OC and tPIN,and lower expression of β-CTX could be its underlying mechanism.
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