自拟益肾健脾化瘀方治疗绝经后脾肾阳虚型骨质疏松症的临床研究
Clinical Curative Effects Analysis of Self-made Yishen Jianpi Huayu Formula in the Treatment of Syndrome of Spleen and Kidney Yang Deficiency of Postmenopausal Osteoporosis
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摘要: 目的 探讨自拟益肾健脾化瘀方治疗绝经后脾肾阳虚型骨质疏松症的临床疗效。方法 选取2016年1月-2017年1月我院收治的120例绝经后骨质疏松症患者,将其按照随机数字法随机分为观察组和对照组,每组60例,2组均给予碳酸钙D3片,在此基础上,对照组给予仙灵骨葆胶囊,观察组给予自拟益肾健脾化瘀方剂,2组均治疗3月。结果 治疗后2组腰背疼痛、腰膝酸软、夜尿增加、畏寒肢冷、神疲倦怠及总评分均显著下降(P<0.01),但观察组下降更为明显(P<0.01);治疗后观察组总有效率为93.33%,显著高于对照组(80.00%,P<0.01);2组腰椎L2~L4、股骨颈、股骨大转子、Ward's三角骨密度均较治疗前显著增加(P<0.01),但观察组增加更为明显(P<0.01);2组骨特异性碱性磷酸酶(B-ALP)、抗酒石酸酸性磷酸酶(TRACP)均较治疗前显著下降(P<0.01),观察组下降更为明显(P<0.01);2组雌二醇(E2)、胰岛素生长因子(IGF-1)均较治疗前显著上升(P<0.01),观察组上升更为明显(P<0.01);2组患者不良反应发生率比较差异无统计学意义(P>0.05)。结论 采用自拟益肾健脾化瘀方可以显著改善绝经后脾肾阳虚型骨质疏松症的临床症状,同时可改善患者骨代谢和骨密度,其作用机制可能与提高雌激素和IGF-1水平有关。Abstract: OBJECTIVE To study the Clinical curative effect of self-made Yishen Jianpi Huayu Formula in the treatment of syndrome of spleen and kidney yang deficiency of postmenopausal osteoporosis. METHODS From January 2016 to January 2017, 120 postmenopausal osteoporosis patients included in our hospital were selected and randomly divided into the observation group and the control group by random number, 60 cases in each group. Both groups were given calcium carbonate D3 tablets. On the basis of this, the control group was given xianlinggubao capsules, and the observation group was given self-made Yishen Jianpi Huayu Formula. Both groups were treated for three months. RESULTS After treatment, the total clinical symptoms cores of lumbar and back pain, soreness and weakness of waist and knees, increasing of night urine, aversion to cold and cold limbs and lassitude in both groups were decreased significantly(P<0.01), but the observation group decreased more significantly (P<0.01). After treatment, the total effective rate in the observation group was 93.33%, which was significantly higher than that in the control group (80.00%, P<0.01). The bone mineral density of lumbar spine, L2~L4, femoral neck, greater trochanter of femur and Ward's pyramidal bone were significantly increased compared with pretreatment (P<0.01), but the observation group increased more significantly (P<0.01). Bone specific alkaline phosphatase (B-ALP) and tartrate resistant acid phosphatase(TRACP) in both group were decreased significantly (P<0.01) compared with pretreatment, but the observation group decreased more significantly (P<0.01). Estradiol (E2), insulin growth factor (IGF-1) in both group were increased significantly compared with pretreatment (P<0.01), and the observation group increased more significantly (P<0.01). The adverse events occurrence rates in both groups had no significant difference (P>0.05). CONCLUSION Self-made Yishen Jianpi Huayu formula can significantly improve the clinical symptoms of postmenopausal osteoporosis, and improve patients' bone metabolism and bone mineral density at the same time. Its action mechanism may be associated with increased estrogen and IGF-1 levels.
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