摘要
目的:观察青娥丸治疗绝经后骨质疏松症肾虚血瘀证的临床疗效。方法:选取2014年9月至12月华中科技大学同济医学院附属协和医院骨质疏松症专病门诊确诊的绝经后骨质疏松症肾虚血瘀证患者48例,根据就诊顺序编号并按随机数字表法分为青娥丸治疗组和青娥丸模拟剂对照组,每组24例。两组均给予碳酸钙D3片作为基础治疗,青娥丸治疗组服用青娥丸,青娥丸模拟剂对照组服用青娥丸模拟剂,每次1丸,每日3次。疗程为24周。基线和治疗24周后对两组有效性评价指标和安全性评价指标进行检测和比较,随时记录不良事件。结果:青娥丸能显著降低绝经后骨质疏松症肾虚血瘀证患者腰背疼痛VAS评分、主要临床症状计分、中医证候总计分、腰背疼痛和腰膝酸软症状程度,并能显著降低血清β-CTX水平(P<0.05);下肢痿弱、步履艰难、耳鸣症状程度无明显改善;腰椎L2-L4及股骨颈骨密度值无明显增加。青娥丸模拟剂对照组腰椎L2-L4及股骨颈骨密度值与基线比较明显降低(P<0.01,P<0.05)。青娥丸治疗组总有效率(75.00%)优于青娥丸模拟剂对照组(29.17%)(P<0.01)。结论:青娥丸能显著改善绝经后骨质疏松症肾虚血瘀证患者腰背疼痛和腰膝酸软症状,显著降低β-CTX水平。
Objective： To observe the clinical effect of Qing＇e Pills in the treatment of postmenopausal osteoporosis with syndrome of kidney deficiency and blood stasis. Methods： Forty-eight cases of postmenopausal osteoporosis patients with syndrome of kidney deficiency and blood stasis who were diagnosed in the Union Hospital, Tongji Medical College, Huazhong University of Science and Technology between September 2014 and December 2014 were divided into treatment group and control group randomly and equally. Both two groups were treated with calcium as basic treatment, and the treatment group was treated with Qing＇e Pills while the control group was treated with simulation medicinal preparation of Qing＇e Pills. The treatment lasted for 24 weeks. Two groups of efficacy evaluation indicators and safety evaluation indicators were detected and compared at baseline and after treatment for 24 weeks. Recording adverse events at any time. Results： Qing＇e Pills could reduce the back pain VAS score, the clinical symptoms score, the TCM syndrome total score and the 13 -CTX level significantly （P〈0.05）. Meanwhile, it could improve the symptoms of low back pain and the soreness of waist and knee significantly （P〈0.05）. However, there was no statistically significant difference on the improvement of the weakness in limbs, the difficulty gaiting and the tinnitus. There was no significant increase in BMD of lumbar spine L2-L4 and the femoral neck. In the control group, there was a significant decrease in BMD of the lumbar spine L2-L4 and the femoral neck compared with the baseline, and the difference was statistically significant （P〈0.01, P〈0.05）. The total effective rate of treatment group （75.00%） was better than that of cortrol group （29.17%） （P〈0.01）. Conclusion： Qing＇e Pills can improve the symptoms of low back pain and the soreness of waist and knee significantly, and reduce the 13 -CTX levels significantly in the treatment of postmenopausal osteoporosis with syndrome of kidney deficiency and blood stasis.
出处
《中华中医药杂志》
CAS
CSCD
北大核心
2018年第1期308-312,共5页
China Journal of Traditional Chinese Medicine and Pharmacy
基金
国家自然科学基金项目(No.81473492)~~
关键词
青娥丸
绝经后骨质疏松症
肾虚血瘀证
疗效观察
Qing＇e Pills
Postmenopausal osteoporosis
Syndrome of kidney dificiency and blood stasis
Clinical observation
