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| 地仲强骨胶囊治疗骨质疏松症的安全性和疗效研究 |
| Study on the safety and efficacy of Dizhongqianggu capsule in the treatment of osteoporosis |
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| DOI：10.3969/j.issn.1006-7108.2019.10.019 |
| 中文关键词: 骨质疏松 骨密度 地仲强骨胶囊 阿仑膦酸钠 |
| 英文关键词:osteoporosis bone mineral density dizhongqianggu capsule alendronate sodium |
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| 中文摘要: |
| 目的 探索地仲强骨胶囊治疗骨质疏松症的安全性和疗效。方法 选取132例绝经后骨质疏松症患者随机分为治疗组(n=66)和对照组(n=66)。对照组给予阿仑膦酸钠治疗，治疗组给予地仲强骨胶囊治疗，为期治疗12个月。检测治疗前后两组患者股骨颈及腰椎的骨密度及VAS评分改变，同时测定血清骨代谢指标：I型胶原羧基端肽β特殊序列(β-CTX)和I型胶原氨基端延长肽(PINP)的水平，记录两组治疗总有效率和药物不良反应。结果 治疗组的治疗总有效率为84.85%，而对照组为77.27%，两组比较差异有统计学意义(P＜0.05)。治疗12个月，两组股骨颈及腰椎密度都有不同程度的升高，VAS评分都有不同程度降低，其中治疗组骨密度和VAS评分变化更明显，和对照组比较有明显的统计学意义(P＜0.05)。同时，治疗组血清β-CTX水平均降低，PINP水平均升高，而对照组β-CTX和PINP水平均降低，两组比较有明显的统计学意义(P＜0.05)。两组患者治疗均未发现明显药物不良反应。结论 地仲强骨胶囊治疗骨质疏松症安全有效。 |
| 英文摘要: |
| Objective To explore the safety and efficacy of Dizhong Qianggu Capsule in the treatment of osteoporosis. Methods 132 postmenopausal osteoporosis patients were randomly divided into treatment group (n=66) and control group (n=66). The control group was treated with alendronate. The treatment group was given Dizhongqianggu Capsule for 12 months. Bone mineral density (BMD) of femoral neck and lumbar spine, VAS scores, and the levels of serum bone metabolism index including type I collagen beta C-terminal telopeptide (β-CTX) and type I collagen amino-terminal propeptide (PINP) in the two groups were measured before and after treatment, and the total effective rate of the two groups and adverse drug reactions were recorded. Results The total effective rate of the treatment group was 84.85%, whereas the total effective rate of the control group was 77.27%, there was significant difference between the two groups (P<0.05). After 12 months of treatment, hip and lumbar spine bone mineral density increased to some extent in both groups, and the VAS scores decreased to some extent. Bone mineral density and VAS score of the treatment group changed more obviously, which were significantly different from those of the control group (P<0.05). In the treatment group serum β-CTX level decreased and PINP level increased, whereas in the control group both β-CTX and PINP levels decreased, there were significant statistical differences between the two groups (P<0.05). No adverse drug reactions were recorded for all patients during treatment. Conclusion Dizhong Qianggu Capsule is a safe and effective method for the treatment of osteoporosis. |
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