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[摘要]
目的 探讨金天格胶囊联合阿法骨化醇软胶囊治疗绝经后骨质疏松症的临床疗效。方法 选取2016年6月-2018年6月延安大学附属医院收治的124例绝经后骨质疏松症患者为研究对象,运用简单随机数字表法将这124例患者随机分为治疗组和对照组,每组各62例。对照组口服阿法骨化醇软胶囊,2粒/次,1次/d。治疗组在对照组基础上口服金天格胶囊,3粒/次,3次/d。两组均连续治疗6个月。观察两组的临床疗效,比较两组的症状积分、骨密度(BMD)值、骨转换标志物和炎症因子。结果 治疗后,对照组和治疗组的总有效率分别为79.0%、91.9%,两组比较差异有统计学意义(P<0.05)。治疗后,两组腰膝酸软、下肢痿弱、腰背疼痛、步履艰难、下肢疼痛积分均显著降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组症状积分明显低于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组大转子、股骨颈、Ward三角区、腰椎L1~4的BMD值均显著升高,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组大转子、股骨颈、Ward三角区、腰椎L1~4的BMD值均明显高于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组骨特异性碱性磷酸酶(BALP)、Ⅰ型原胶原N-端前肽(PⅠNP)、抗酒石酸酸性磷酸酶(TRACP)-5b、Ⅰ型胶原C-末端肽交联(CTX)水平均显著降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组BALP、PⅠNP、TRACP-5b、CTX、肿瘤坏死因子(TNF)-α、白细胞介素(IL)-17水平明显低于对照组,两组比较差异有统计学意义(P<0.05)。结论 金天格胶囊联合阿法骨化醇软胶囊治疗绝经后骨质疏松症具有较好的临床疗效,可减轻患者骨质疏松的相关症状,提高骨骼质量,减少血中炎症因子水平,具有一定的临床推广应用价值。
[Key word]
[Abstract]
Objective To explore the clinical efficacy of Jintiange Capsules combined with Alfacalcidol Soft Capsules in treatment of postmenopausal osteoporosis. Methods Patients (124 cases) with postmenopausal osteoporosis in the Affiliated Hospital of Yan'an University from June 2016 to June 2018 were randomly divided into control and treatment groups, and each group had 62 cases. Patients in the control group were po administered with Alfacalcidol Soft Capsules, 2 grains/time, once daily. Patients in the treatment group were po administered with Jintiange Capsules on the basis of the control group, 3 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacies were evaluated, and symptom scores, BMD, bone turnover markers and inflammatory factors in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 79.0% and 91.9%, respectively, and there was difference between two groups (P<0.05). After treatment, the BMD of greater trochanter, femoral neck, Ward triangle, and lumbar L1-4 in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). And the BMD indexes in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of BALP, PⅠNP, TRACP-5b, and CTX in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the levels of BALP, PⅠNP, TRACP-5 b, CTX, TNF-α, and IL-17 in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). Conclusion Jintiange Capsules combined with Alfacalcidol Soft Capsules has clinical curative effects in treatment of postmenopausal osteoporosis, can alleviate the symptoms related to osteoporosis, improve the quality of bone, and reduce the level of inflammatory factors in blood, which has a certain clinical application value.
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[基金项目]
陕西省教育厅专项科研计划项目(17JK08)