乳香散治疗绝经后骨质疏松性骨折临床研究
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R687.3

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湖州市科学技术局基金资助项目(2022GYB37)


Clinical Study on Ruxiang San for Postmenopausal Osteoporosis Fracture
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    摘要:

    目的:观察乳香散对绝经后骨质疏松性骨折(PMOPF) 的疗效及其作用机制。方法:选取118 例 PMOPF 患者,按随机数字表法分为对照组与研究组各59 例。2 组均行内固定手术治疗,对照组予以常规药物 治疗,研究组在对照组基础上加用乳香散内服。比较2 组不良反应发生率、随访期间再骨折发生率,比较2 组 治疗前后疼痛视觉模拟评分法(VAS) 评分、骨代谢指标[骨保护素(OPG)、骨钙素(BGP)、骨碱性磷酸 酶(BALP)、Ⅰ型前胶原氨基端肽(PⅠNP)、骨形态发生蛋白(BMP-2)、Ⅰ型胶原羧基端交联肽(CTX-Ⅰ) 和抗酒石酸酸性磷酸酶(TRACP)]、骨密度(BMD) 的变化。结果:研究组住院时间、首次负重时间、骨折 愈合时间均短于对照组,首次负重时间、骨折愈合时间与对照组比较,差异有统计学意义(P<0.05)。治疗 7 d、治疗1 个月、治疗3 个月,2 组VAS 评分均较治疗前下降(P<0.05),研究组各时间段VAS 评分均低于 对照组(P<0.05)。治疗3 个月后,2 组OPG、BGP、BALP、PⅠNP、BMP-2 骨代谢指标值均较治疗前上 升(P<0.05),CTX-Ⅰ、TRACP 指标值均较治疗前下降(P<0.05);研究组OPG、BGP、BALP、PⅠNP、 BMP-2 指标值均高于对照组(P<0.05),CTX-Ⅰ、TRACP 指标值均低于对照组(P<0.05)。治疗后3个月, 2 组L1~4、全髋、股骨颈BMD 指标值均较治疗前上升(P<0.05),研究组上述3 项BMD 指标值均大于对照 组(P<0.05)。用药期间,2 组均未出现肝肾功能损伤及心电图异常,2 组不良反应发生率比较,差异无统计 学意义(P>0.05)。随访期间,研究组再骨折发生率1.72%,对照组再骨折发生率7.27%,差异无统计学意 义(P>0.05)。结论:乳香散治疗PMOPF 能缓解患者疼痛程度,促进骨折愈合,提升骨密度,调节骨代谢。

    Abstract:

    Abstract: Objective: To observe the curative effect and effect mechanism of Ruxiang San for postmenopausal osteoporosis fracture (PMOPF). Methods: A total of 118 PMOPF patients were selected and divided into the control group and the study group according to the random number table method,with 59 patients in each group. Both groups underwent internal fixation surgery; the control group received routine drug treatment, and the study group received oral administration of Ruxiang San based on the treatment of the control group. The incidence of adverse reactions and the incidence of recurrent fractures during the follow-up period were compared between the two groups. The changes in Visual Analogue Scale (VAS) scores of pain, bone metabolism indexes [osteoprotegerin (OPG), bone Gla protein (BGP), bone alkaline phosphatase (BALP),procollagen type Ⅰ N-propeptide (PⅠNP),bone morphogenetic protein-2 (BMP-2),carboxyterminal cross-linked telopeptides of type I collagen (CTX-I),and tartrate-resistant acid phosphatase (TRACP)] and bone mineral density (BMD) were compared in the two groups before and after treatment. Results: The hospitalization time, first weight-bearing time, and fracture healing time in the study group were shorter than those in the control group,the difference being significant (P<0.05). After 7 days, 1 month and 3 months of treatment, the VAS scores in the two groups were decreased when compared with those before treatment (P<0.05),and the VAS scores in the study group were lower than those in the control group (P<0.05). After 3 months of treatment,the values of bone metabolism indexes including OPG,BGP,BALP,PⅠNP and BMP-2 in the two groups were increased when compared with those before treatment (P<0.05), and the CTX - Ⅰ and TRACP values were decreased when compared with those before treatment (P<0.05); the values of OPG, BGP, BALP, P ⅠNP, and BMP-2 in the study group were higher than those in the control group (P<0.05),and the values of CTX -Ⅰ and TRACP were lower than those in the control group (P<0.05). After 3 months of treatment,the BMD index values of L1~4, total hip, and femoral neck in the two groups were increased when compared with those before treatment (P<0.05),and the above three BMD values in the study group were all higher than those in the control group (P<0.05). During the medication period,neither group experienced liver and kidney function damage or abnormal electrocardiogram,and there was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). During the follow-up period, the incidence of recurrent fractures was 1.72% in the study group, and was 7.27% in the control group, there being no significant difference (P>0.05). Conclusion: The treatment of Ruxiang San for PMOPF can alleviate pain, promote fracture healing,increase bone mineral density,and regulate bone metabolism.

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邬博来,王小军,马智敏,吴乐彬,卢梓皓.乳香散治疗绝经后骨质疏松性骨折临床研究[J].新中医,2024,56(1):7-12

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  • 在线发布日期: 2024-01-16
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