六味地黄丸防治肾阴虚型绝经后骨质疏松的临床疗效评价

李伦莘; 吴连国; 梁博程; 许超; 史晓林; 韦冰; 李琰华; 李敏

doi:10.16766/j.cnki.issn.1674-4152.002605

六味地黄丸防治肾阴虚型绝经后骨质疏松的临床疗效评价

doi: 10.16766/j.cnki.issn.1674-4152.002605

1.
浙江中医药大学第二临床医学院，浙江杭州 310053
2.
浙江中医药大学附属第二医院骨伤科，浙江杭州 310005
3.
浙江中医药大学附属第二医院全科医学科

基金项目:

浙江省中医药科学研究基金计划项目 2019ZQ026

浙江省中医药科学研究基金计划项目 2021ZB144

详细信息

通讯作者:
李敏, E-mail: liminist@163.com

中图分类号: R681
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出版历程
- 收稿日期: 2021-06-07
- 网络出版日期: 2022-09-26

Evaluation of the preventive and curative effects of Liuwei Dihuang Pills on the postmenopausal osteoporosis with the type of kidney-yin deficiency

1.
The Second Clinical Medical College of Zhejiang Chinese Medical University, Hangzhou, Zhejiang 310053, China

摘要

摘要: 目的评价六味地黄丸治疗肾阴虚型绝经后骨质疏松症患者对骨密度、骨转换标志物和生活质量的影响。方法纳入2019年1—6月于浙江中医药大学附属第二医院就诊的120例肾阴虚型绝经后骨质疏松症患者，按照随机数表法分为六味地黄丸组(60例)和对照组(60例)，治疗1年。检测治疗前后骨转换标志物血清Ⅰ型原胶原氨基末端前肽(P1NP)和Ⅰ型胶原羧基端肽β特殊序列(β-CTX)的表达水平和腰髋部骨密度。应用SF-36量表评估，对比治疗前后患者生活质量改善情况。结果治疗后，2组患者血清P1NP、β-CTX及腰椎、髋部骨密度均较入组时明显改变，2组组间血清P1NP、β-CTX及腰椎、髋部骨密度的平均百分比变化差异均有统计学意义(P1NP：t=-12.902，P＜0.001；β-CTX：t=-3.646，P＜0.001；腰椎：t=13.814，P＜0.001；髋部：t=21.606，P＜0.001)，六味地黄丸组优于对照组。入组时，六味地黄丸组和对照组SF-36量表评分差异无统计学意义(P>0.05)；治疗后，2组SF-36量表评分均较治疗前升高(均P＜0.001)，六味地黄丸组SF-36量表评分[(122.60±3.25)分]高于对照组[(115.62±2.96)分，t=11.743，P＜0.001]。结论六味地黄丸不仅能够有效降低肾阴虚型绝经后骨质疏松女性骨转换标志物水平，提升腰髋部骨密度，且能明显改善患者的生活质量。
- 六味地黄丸 /
- 骨质疏松症 /
- 生活质量 /
- 血清Ⅰ型原胶原氨基末端前肽 /
- Ⅰ型胶原羧基端肽β特殊序列
Abstract: Objective To evaluate the effects of Liuwei Dihuang Pills on the bone density, bone turnover markers and quality of life in the postmenopausal osteoporosis patients with the type of kidney yin deficiency. Methods One hundred and twenty patients with postmenopausal osteoporosis characterized by kidney yin deficiency were involved in the present study, which were collected from January 2019 to June 2019 in the Second Clinical Medical College of Zhejiang Chinese Medical University. The 120 cases of patients were randomly divided into Liuwei Dihuang Pills group and the control one, with 60 cases in each group. The patients in every group were treated for 1 year, followed by the examination of serum N-terminal propeptide of type Ⅰ collagen(P1NP), β crosslinked C-telopeptide of type Ⅰ collagen(β-CTX), and bone mineral density of lumbar and hip before and after treatment. Meantime, SF-36 scale was used to evaluate the effects of treatment on the quality of life of patients in each group. Results Remarkable change was observed in the serum P1NP, β-CTX and the bone mineral density of the lumbar spine and hip of the patients in both groups after treatment, and there were significantly statistical differences in the average percentage changes in serum P1NP, β-CTX, and bone mineral density of the lumbar spine and hip between the two groups (P1NP: t=-12.902, P < 0.001; β-CTX: t=-3.646, P < 0.001; lumbar spine: t=13.814, P < 0.001; hip: t=21.606, P < 0.001). There was no significant difference on the basic SF-36 scores between the two groups (P>0.05). Interestingly, it was observed that the SF-36 scale score in the Liuwei Dihuang Pills group was higher than that in the control group [(122.60±3.25) points vs. (115.62±2.96) points, t=11.743, P < 0.001)]. Conclusion The treatment with Liuwei Dihuang Pills can result in the significant decrease in the serum levels of bone turnover markers, increase in the bone mineral density of the waist and hip, and improvement of quality of life in the postmenopausal osteoporosis patients characterized by the type of kidney yin deficiency.
- Liuwei Dihuang Pills /
- Osteoporosis /
- Quality of life /
- N-terminal propeptide of type Ⅰ collagen /
- β crosslinked C-telopeptide of type Ⅰ collagen

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表 1 2组绝经后骨质疏松症患者基线特征比较

Table 1. Comparison of baseline characteristics between two groups of postmenopausal osteoporosis patients

组别	例数	年龄(x±s，岁)	身高(x±s，cm)	体重(x±s，kg)	BMI(x±s)	绝经时间(x±s，年)	饮酒情况[例(%)]
六味地黄丸组	60	59.25±2.37	161.23±2.65	55.54±2.85	21.38±1.37	8.20±2.54	15(25.00)
对照组	60	59.15±2.42	160.23±3.03	55.95±2.11	21.82±1.33	9.07±2.89	13(21.67)
统计量		0.229^a	1.923^a	-0.898^a	-1.774^a	-1.747^a	0.186^b
P值		0.820	0.057	0.371	0.079	0.083	0.666
注: ^a为t值，^b为χ²值。

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表 2 2组绝经后骨质疏松症患者骨转换标志物及骨密度比较(x ±s)

Table 2. Comparison of bone turnover markers and bone mineral density between two groups of postmenopausal osteoporosis patients(x ±s)

组别	例数	血清P1NP水平(ng/mL)		血清β-CTX水平(ng/mL)		髋部骨密度(g/cm²)		腰椎骨密度(g/cm²)
组别	例数	入组时	治疗后	入组时	治疗后	入组时	治疗后	入组时	治疗后
六味地黄丸组	57	56.98±4.16	52.41±4.13^a	0.59±0.05	0.44±0.06^a	0.77±0.02	0.78±0.02^a	0.66±0.03	0.67±0.03^a
对照组	53	58.00±4.67	54.50±4.67^a	0.58±0.05	0.45±0.51^a	0.77±0.02	0.77±0.02^a	0.66±0.02	0.66±0.02^a
t值		-1.217	-2.487	1.397	-0.915	0.217	2.400	0.403	1.139
P值		0.226	0.014	0.165	0.362	0.829	0.018	0.688	0.257
注：与治疗前比较，^aP＜0.001。

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表 3 2组绝经后骨质疏松症患者治疗1年后骨转化标志物和骨密度平均百分比变化比较(x ±s，%)

Table 3. Comparison of bone transformation markers and mean percentage changes of bone mineral density in postmenopausal osteoporosis patients after 1 year of treatment (x ±s, %)

组别	例数	血清P1NP水平	血清β-CTX水平	腰椎骨密度	髋部骨密度
六味地黄丸组	57	-8.05±0.83	-25.40±6.17	1.32±0.22	1.79±0.31
对照组	53	-6.08±0.77	-22.06±3.04	0.79±0.18	0.68±0.23
t值		-12.902	-3.646	13.814	21.606
P值		＜0.001	＜0.001	＜0.001	＜0.001

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表 4 2组绝经后骨质疏松症患者生活质量评分比较(x ±s，分)

Table 4. Comparison of quality of life scores of postmenopausal osteoporosis patients between two groups (x ±s, scores)

组别	例数	入组时	治疗后	t值	P值
六味地黄丸组	57	108.65±2.84	122.60±3.25	-25.186	＜0.001
对照组	53	109.06±2.69	115.62±2.96	-12.964	＜0.001
t值		-0.770	11.743
P值		0.443	＜0.001

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