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益肾活血方联合股骨近端防旋髓内钉治疗骨质疏松性股骨转子间骨折的疗效和安全性 被引量:15

Therapeutic Effect and Safety of Yishen Huoxue Formula Combined with Proximal Femoral Nail Antirotation in the Treatment of Osteoporotic Intertrochanteric Fracture
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摘要 【目的】观察益肾活血方联合股骨近端防旋髓内钉(PFNA)治疗骨质疏松性股骨转子间骨折的疗效和安全性。【方法】将105例绝经后骨质疏松性股骨转子间骨折患者随机分为中药组53例和常规组52例。2组患者均行PFNA内固定手术治疗,术后均给予镇痛、抗生素预防感染和低分子肝素钠预防静脉血栓等常规治疗。在此基础上,常规组术后给予口服骨化三醇软胶囊和钙尔奇D治疗,中药组术后在常规组治疗的基础上给予口服益肾活血方治疗,疗程为3个月,并接受1年以上的随访。比较2组患者的骨折愈合时间、住院时间、负重时间、末次随访Harris评分和术后并发症情况,观察2组患者术前和术后健侧股骨颈骨密度值、骨代谢指标和炎症指标的变化情况。【结果】(1)研究过程中,中药组和常规组各有3例患者失访,最终99例患者(包括中药组50例和常规组49例)完成随访,平均随访时间为(2.21±0.53)年。(2)中药组的平均住院时间和骨折愈合时间均较常规组明显缩短(P<0.01);而2组患者的负重时间和末次随访Harris评分比较,差异均无统计学意义(P>0.05)。(3)术后3个月,2组患者的骨密度值均较术前升高(P<0.05),且中药组对骨密度值的升高作用明显优于常规组(P<0.01)。(4)术后3个月,2组患者血清全甲状旁腺激素(iPTH)、羧基末端肽(s CTx)水平均较术前明显降低(P<0.05),血清总Ⅰ型胶原蛋白氨基末端延伸肽(tP1NP)、碱性磷酸酶(ALP)水平均较术前明显升高(P<0.05),且中药组对血清iPTH、sCTx水平的降低作用和对血清tP1NP、ALP水平的升高作用均明显优于常规组(P<0.05或P<0.01)。(5)术后1周,2组患者血清白细胞介素6(IL-6)和肿瘤坏死因子α(TNF-α)水平均较术前明显升高(P<0.05);术后1个月,2组患者血清IL-6和TNF-α水平均较术后1周明显下降(P<0.05);组间比较,中药组在术后1周和术后1个月的血清IL-6和TNF-α水平均明显低于常规组(P<0.01)。(6)中药组患者术后并发症发生率为4.00%(2/50),明显低于常规组的18.36%(9/49),差异有统计学意义(P<0.05)。【结论】益肾活血方能明显缩短骨质疏松性股骨转子间骨折PFNA术后患者的住院时间,促进骨折愈合,降低术后炎症水平以及术后并发症发生风险。 Objective To observe the clinical efficacy and safety of Yisheng Huoxue Formula combined with proximal femoral nail antirotation(PFNA)in the treatment of osteoporotic intertrochanteric fracture.Methods A total of 105 patients with postmenopausal osteoporotic intertrochanteric fracture were randomly divided into Chinese medicine group(53 cases)and conventional group(52 cases).Patients in both groups received PFNA internal fixation surgery,and postoperative conventional treatment of analgesia,infection prevention with antibiotics,and prevention of venous thrombosis with low molecular weight heparin sodium were given.And additionally,the conventional group was treated with oral administration of Calcitriol Capsules and Caltrate after surgery,while the Chinese medicine group was treated with oral administration of Yishen Huoxue Formula after surgery on the basis of treatment for the control group.The course of treatment lasted for 3 months and the patients were followed up for more than one year.The fracture healing time,hospitalization time,weight-bearing time,Harris scores at last follow-up and incidence of the postoperative complications of two groups were compared.Meanwhile,the changes of neck bone mineral density,bone metabolism indexes and inflammatory indexes of uninjured side of the femur were observed before and after surgery in the two groups.Results(1)During the trial,both of Chinese medicine group and the conventional group had 3 patients lost to follow-up,and a total of 99 patients(including 50 cases in the Chinese medicine group and 49 cases in the conventional group)were successfully followed up,with an average follow-up time of(2.21±0.53)years.(2)The average hospitalization time and fracture healing time in Chinese medicine group were significantly shortened compared with those in the conventional group(P<0.01).But no statistically significant differences were shown in the weight-bearing time and Harris scores at the last follow-up between the two groups(P>0.05).(3)Three months after surgery,BMD in both groups was increased compared with that before surgery(P<0.05),and the increase of BMD in the Chinese medicine group was significantly superior to that in the conventional group(P<0.01).(4)Three months after surgery,the levels of intact parathyroid hormone(iPTH)and serum carboxy-terminal peptide(sCTx)in the two groups were significantly decreased compared with those before surgery(P<0.05),and the serum total procollagen typeⅠN-peptide(tP1 NP)and alkaline phosphatase(ALP)were significantly increased compared with those before surgery(P<0.05).The effect on decreasing serum iPTH and sCTx levels and the effece on increasing serum tP1 NP and ALP levels of Chinese medicine group were significantly superior to those of conventional group(P<0.05 or P<0.01).(5)One week after surgery,the levels of serum interleukin 6(IL-6)and tumor necrosis factorα(TNF-α)in the two groups were significantly increased compared with those before surgery(P<0.05).One month after surgery,the levels of serum IL-6 and TNF-αin the two groups were significantly decreased compared with those one week after surgery(P<0.05).The intergroup comparison showed that Chinese medicine group had the lower levels of IL-6 and TNF-αthan the conventional group one week and one month after surgery(P<0.01).(6)The incidence of postoperative complications in the Chinese medicine group was 4.00%(2/50),which was significantly lower than that in the conventional group[18.36%(9/49)],and the difference was statistically significant(P<0.05).Conclusion Yishen Huoxue Formula can significantly shorten the hospitalization time of patients with osteoporotic intertrochanteric fracture after PFNA,promote fracture healing,and reduce the postoperative inflammation levels and the incidence of postoperative complications.
作者 尹啸飞 周正新 韩朝永 YIN Xiao-Fei;ZHOU Zheng-Xin;HAN Chao-Yong(Dept.of Orthopedics and Traumatology,Nanjing Pukou District Hospital of Traditional Chinese Medicine,Nanjing 211899 Jiangsu,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230009 Anhui,China)
出处 《广州中医药大学学报》 CAS 2022年第3期533-539,共7页 Journal of Guangzhou University of Traditional Chinese Medicine
基金 国家自然科学基金面上项目(编号:81373664) 安徽省自然科学基金项目(编号:2008085MH281)。
关键词 益肾活血方 股骨近端防旋髓内钉(PFNA) 骨质疏松症 股骨转子间骨折 骨密度 骨折愈合 炎症水平 术后并发症 Yishen Huoxue Formula proximal femoral nail antirotation(PFNA) osteoporosis intertrochanteric fracture bone mineral density(BMD) fracture healing inflammatory level postoperative complications
作者简介 尹啸飞(1991-),男,硕士,主治医师,E-mail:Hanchaoyang189@163.com;通讯作者:韩朝永,男,主任医师,E-mail:hanchaoyong189@163.com。
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