补肝强肾壮骨方治疗肝肾亏虚型原发性骨质疏松症的临床研究

杨军; 范续

doi:10.16766/j.cnki.issn.1674-4152.003596

补肝强肾壮骨方治疗肝肾亏虚型原发性骨质疏松症的临床研究

doi: 10.16766/j.cnki.issn.1674-4152.003596

杨军^,,
范续

天台县人民医院骨科，浙江台州 317200

基金项目:

浙江省中医药科技计划项目 2023ZL201

详细信息

通讯作者:
杨军，E-mail: 326095393@qq.com

中图分类号: R681 R243
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- 被引次数: 0
出版历程
- 收稿日期: 2024-03-18
- 网络出版日期: 2024-09-05

Study on the treatment of primary osteoporosis of liver and kidney deficiency type with Bugan Qiangshen Zhuanggu Formula

YANG Jun^,,
FAN Xu

Department of Orthopedics, Tiantai County People ' s Hospital, Taizhou, Zhejiang 317200, China

摘要

摘要: 目的探讨使用补肝强肾壮骨方治疗肝肾亏虚型原发性骨质疏松症患者的临床效果。方法纳入2020年4月—2023年10月天台县人民医收治的130例肝肾亏虚型原发性骨质疏松症患者，采用随机数表法分为对照组(65例)和观察组(65例)。对照组予以阿仑膦酸钠片及碳酸钙D₃片口服治疗，观察组患者在此基础上增加补肝强肾壮骨方治疗。比较2组患者中医证候疗效水平，检测治疗前后骨密度值及血清骨代谢指标变化，比较VAS评分和SF-36评分差异，观察药物不良反应。结果观察组中医证候总有效率(93.85%，61/65)高于对照组(69.23%, 45/65), 差异有统计学意义(P＜0.001)。观察组治疗12周VAS评分[(2.47±0.63)分]低于对照组[(3.29±0.72)分，P＜0.001]，而SF-36评分[(85.73±6.49)分]高于对照组[(74.65±6.27)分，P＜0.001]。观察组治疗12周后腰椎L_2~4、右股骨颈和左桡骨远端骨密度值均高于对照组(P＜0.001)。观察组治疗12周后血清骨特异性碱性磷酸酶(BALP)、Ⅰ型前胶原氨基端前肽(P1NP)均高于对照组，而血清Ⅰ型胶原交联C端肽(CTX)、Ⅰ型胶原交联氨基末端肽(NTX)均低于对照组(P＜0.001)。2组药物不良反应发生率比较差异无统计学意义(P>0.05)。结论在阿仑膦酸钠、碳酸钙D₃基础上，增加补肝强肾壮骨方治疗肝肾亏虚型原发性骨质疏松症，可有效改善患者中医症候，缓解疼痛，提高生活质量，其作用机制可能与增强患者骨密度，调节骨骼代谢功能相关。
- 原发性骨质疏松症 /
- 肝肾亏虚型 /
- 补肝强肾壮骨方 /
- 阿仑膦酸钠 /
- 碳酸钙D₃ /
- 临床疗效
Abstract: Objective To explore the clinical effect of Bugan Qiangshen Zhuanggu Formula in treating primary osteoporosis (liver and kidney deficiency type). Methods A total of 130 patients with primary osteoporosis (liver and kidney deficiency type) admitted to Tiantai County People ' s Hospital from April 2020 to October 2023 were studied, and were divided into control group (65 cases) and observation group (65 cases) randomly. The control group were given alendronate sodium tablets and calcium carbonate D₃ tablets, while the observation group received additional treatment with Bugan Qiangshen Zhuanggu Formula. The therapeutic effect level of traditional Chinese medicine syndrome in patients were evaluated, the changes in bone density and serum bone metabolism indicators were detected, the differences in VAS score and SF-36 score were compared, and the adverse drug reactions were observed. Results The overall effective rate of traditional Chinese medicine syndromes in observation group (93.85%, 61/65) was higher than control group (69.23%, 45/65, P < 0.001). After 12 weeks of treatment, the bone density values of the lumbar spine L_2-4, right femoral neck, and left distal radius in the observation group were higher than the control group (P < 0.001). The VAS score of observation group (2.47±0.63) was lower than control group (3.29±0.72, P < 0.001), while the SF-36 score (85.73±6.49) was higher than control group (74.65±6.27, P < 0.001). The levels of serum bone-specific alkaline phosphatase (BALP) and type Ⅰ procollagen amino terminal peptide (P1NP) in observation group was higher than control group, but the levels of serum cross-linked type 1 collagen C-terminal peptide (CTX) and N-telopeptide of type Ⅰ collagen (NTX) were lower than control group (P < 0.001). The incidence of adverse reactions between the two groups was no difference (P>0.05). Conclusion Bugan Qiangshen Zhuanggu Formula combined with alendronate sodium and calcium carbonate D₃ can effectively improve traditional Chinese medicine symptoms, alleviate pain reactions, and improve quality of life in patients with primary osteoporosis of liver and kidney deficiency type. Its mechanism of action is closely related to enhancing patient bone density and regulating bone metabolism function.
- Primary osteoporosis /
- Liver and kidney deficiency type /
- Bugan Qiangshen Zhuanggu Formula /
- Alendronate sodium /
- Calcium carbonate D₃ /
- Clinical efficacy

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表 1 2组原发性骨质疏松症患者中医证候疗效比较[例(%)]

Table 1. Comparison of TCM syndrome efficacy between two groups of patients with primary osteoporosis[cases (%)]

组别	例数	痊愈	显效	有效	无效	总有效
观察组	65	6(9.23)	25(38.46)	30(46.15)	4(6.15)	61(93.85)
对照组	65	0	19(29.23)	26(40.00)	20(30.77)	45(69.23)
注：2组总有效率比较，χ²=13.092，P＜0.001。

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表 2 2组原发性骨质疏松症患者VAS和SF-36评分比较(x ±s，分)

Table 2. Comparison of VAS and SF-36 scores between two groups of patients with primary osteoporosis (x ±s, points)

组别	例数	VAS		SF-36
组别	例数	治疗前	治疗12周	治疗前	治疗12周
对照组	65	7.43±1.15	3.29±0.72^b	53.47±5.91	74.65±6.27^b
观察组	65	7.61±1.04	2.47±0.63^b	52.96±5.84	85.73±6.49^b
统计量		0.936^a	16.852^c	0.492^a	21.416^c
P值		0.351	＜0.001	0.596	＜0.001
注：^a为t值，^c为F值；与同组治疗前比较，^bP＜0.05。

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表 3 2组原发性骨质疏松症患者不同位置骨密度比较(x ±s，g/cm²)

Table 3. Comparison of bone mineral density at different positions between two groups of patients with primary osteoporosis (x ±s, g/cm²)

组别	例数	腰椎L_2~4均值		右股骨颈		左桡骨远端
组别	例数	治疗前	治疗12周	治疗前	治疗12周	治疗前	治疗12周
对照组	65	0.69±0.06	0.78±0.08^b	0.64±0.03	0.72±0.06^b	0.65±0.05	0.73±0.05^b
观察组	65	0.70±0.07	0.86±0.09^b	0.63±0.04	0.79±0.08^b	0.64±0.04	0.79±0.07^b
统计量		0.874^a	13.287^c	1.612^a	15.634^c	1.259^a	15.926^c
P值		0.682	＜0.001	0.614	＜0.001	0.210	＜0.001
注：^a为t值，^c为F值；与同组治疗前比较，^bP＜0.05。

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表 4 2组原发性骨质疏松症患者骨代谢指标比较(x ±s)

Table 4. Comparison of bone metabolism indexes between two groups of patients with primary osteoporosis (x ±s)

组别	例数	BALP(U/L)		P1NP(μg/L)		CTX(mg/L)		NTX(mg/L)
组别	例数	治疗前	治疗12周	治疗前	治疗12周	治疗前	治疗12周	治疗前	治疗12周
对照组	65	35.28±3.39	47.68±4.25^b	46.74±4.46	58.62±5.16^b	0.88±0.10	0.72±0.08^b	3.47±0.64	2.64±0.34^b
观察组	65	34.96±3.51	59.87±4.93^b	46.39±4.53	70.49±5.74^b	0.89±0.09	0.51±0.06^b	3.58±0.61	2.11±0.32^b
统计量		0.529^a	31.648^c	0.444^a	24.506^c	0.599^a	28.361^c	1.003^a	22.374^c
P值		0.672	＜0.001	0.605	＜0.001	0.723	＜0.001	0.563	＜0.001
注：^a为t值，^c为F值；与同组治疗前比较，^bP＜0.05。

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