仙茅-淫羊藿对药治疗老年肾阳虚型骨质疏松症临床研究
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R681.1

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杭州市医药卫生科技项目(B20200520)


Clinical Study on Curculiginis Rhizoma-Epimedii Folium Herbal Pair for Osteoporosis of Kidney Yang Deficiency Type in Senile Patients
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    摘要:

    目的:观察仙茅-淫羊藿对药治疗肾阳虚型老年骨质疏松症(OP) 的临床效果。方法:选取90例 肾阳虚型老年OP患者为研究对象,随机分为A组、B组、C组,各30例。所有患者均按医嘱完成治疗,无剔 除病例。A组给予基础治疗,B组在基础治疗上给予对药1号方(低剂量) 治疗,C组在基础治疗上给予对药 2号方(高剂量) 治疗。治疗24周后,比较3组临床疗效、中医证候评分、疼痛视觉模拟评分法(VAS) 评分、 骨密度、骨代谢指标[Ⅰ型前胶原氨基末端前肽(PⅠNP)、β-胶原羧基端肽(β-CTX)、血清钙、血清磷]、炎 症因子指标[血清白细胞介素-1β(IL-1β)、白细胞介素-6(IL-6)、肿瘤坏死因子-α(TNF-α) ]水平、安全性 及不良反应发生率。结果:治疗后,C组临床总有效率为96.67%,高于A组(66.67%)、B组(80.00%),差异 均有统计学意义(P<0.05)。治疗12、24周,3组中医证候评分、VAS评分均较治疗前降低(P<0.05),且C 组相同时间点的中医证候评分、VAS评分均低于A组、B组(P<0.05)。治疗24周,3组股骨颈、L2~4骨密度T 值均较治疗前提高(P<0.05),B组、C组股骨颈、L2~4骨密度T值均高于A组(P<0.05),而B组、C组比较 差异无统计学意义(P>0.05)。治疗12、24周,3组PⅠNP水平较治疗前均提高(P<0.05),且B组、C组 PⅠNP水平高于A组(P<0.05);3组β-CTX水平较治疗前均降低(P<0.05),且B组、C组β-CTX水平低于A 组(P<0.05);B组、C组相同时间点的PⅠNP、β-CTX水平比较,差异无统计学意义(P>0.05)。3组血清 磷、钙水平治疗前后比较,差异均无统计学意义(P>0.05)。治疗12、24周,3组血清IL-1β、IL-6、TNF-α 水平均较治疗前降低(P<0.05),且呈降低趋势(P<0.05);C组上述各项炎症指标水平在相同时间点均低于 A组、B组(P<0.05)。治疗期间,A组、B组未见不良反应病例,C组出现口干5例、便秘4例,不良反应发 生率为30.00%;3组不良反应发生率比较,差异有统计学意义(P<0.05)。结论:仙茅-淫羊藿对药治疗老年 OP肾阳虚型疗效显著,其中对药2号方(高剂量) 能进一步提高疗效,促进症状体征缓解,在改善骨密度、 骨代谢指标及减轻机体炎症反应方面更有优势,且不影响机体血清磷钙代谢,但因药物剂量过大而易引发口 干、便秘等不良反应。

    Abstract:

    Abstract:Objective:To observe the clinical effect of Curculiginis Rhizoma-Epimedii Folium herbal pair on osteoporosis (OP) of kidney yang deficiency type in senile patients. Methods:A total of 90 senile patients with OP of kidney yang deficiency type were selected as the study subjects, and randomly divided into Groups A,B and C,with 30 cases in each group. All included patients completed the prescribed treatment, with no cases being culled. Group A was given basic treatment, based on which the Group B was additionally given Herbal Pair Prescription 1 (low dose) for treatment,and Group C was additionally treated with Herbal Pair Prescription 2 (high dose). After 24 weeks of treatment, the clinical effects, traditional Chinese medicine syndrome scores,scores of Visual Analogue Scale (VAS) of pain,bone mineral density, the levels of bone metabolism [procollagenⅠN-terminal propeptide (PⅠNP),β carboxyl-terminal propeptide (β -CTX), serum calcium and phosphorus], and inflammatory factors [serum interleukin-1β (IL-1β), interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α)],safety and incidence of adverse reactions were compared between the two groups. Results:After treatment,the total clinical effective rate was 96.67% in Group C, higher than that of 66.67% and 80.00% in Group A and Group B, respectively, differences being significant (P<0.05). After 12 and 24 weeks of treatment,the traditional Chinese medicine syndrome scores and VAS scores in the three groups were decreased when compared with those before treatment (P<0.05),and the above two scores in Group C at the same time point were lower than those in Groups A and B (P<0.05). After 24 weeks of treatment,the bone mineral density T values of femoral neck and L2-4 in the three groups were increased when compared with those before treatment (P<0.05);the bone mineral density T values of femoral neck and L2-4 in Groups B and C were higher than those in Group A (P<0.05), and there was no significant difference being found in the comparisons of the bone mineral density T values of femoral neck and L2-4 between Groups B and C (P>0.05). After 12 and 24 weeks of treatment,the PⅠNP levels in the three groups were increased when compared with those before treatment (P<0.05),and the PⅠNP levels in Groups B and C were higher than those in Group A (P<0.05);the β-CTX levels in the three groups were decreased when compared with those before treatment (P<0.05), and the β-CTX levels in Groups B and C were lower than that in Group A (P<0.05);there was no significant difference being found in the comparisons of levels of P ⅠNP and β-CTX at the same time point between Groups B and C (P< 0.05). There was no significant difference being found in the comparisons of levels of serum phosphorus and calcium in the three groups before and after treatment (P>0.05). After 12 and 24 weeks of treatment, the levels of serum IL-1β, IL-6 and TNF- α in the three groups were decreased when compared with those before treatment (P<0.05),and suggested a decreased tendency (P<0.05);the levels of the above inflammatory factors in Group C at the same time point were lower than those in Groups A and B (P<0.05). During the treatment, there was no adverse reaction in Groups A and B; there were five cases of dry mouth and four cases of constipation in Group C,with the incidence of adverse reactions being 30.00%; there was significant difference in the comparison of incidence of adverse reactions between the three groups (P<0.05). Conclusion: Curculiginis Rhizoma-Epimedii Folium herbal pair has a significant curative effect on senile patients with OP of kidney yang deficiency type in senile patients. Herbal Pair Prescription 2 (high dose) can enhance the curative effect, promote the mitigation of symptoms and vital signs, have more advantages in improving the bone mineral density and bone metabolism indexes,and in reducing the inflammatory responses of the body,and does not affect the serum phosphorus and calcium metabolism of the body. However, it is easy to cause such adverse reactions as dry mouth and constipation due to excessive dose.

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余晓蓉,王桂飞,余杭英,汪美霞,徐威,方百瑞,陈专心.仙茅-淫羊藿对药治疗老年肾阳虚型骨质疏松症临床研究[J].新中医,2024,56(12):80-85

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  • 在线发布日期: 2024-06-28
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