壮骨方煮散对脾肾两虚夹瘀型绝经后低骨量人群的防治疗效评价

Evaluation of Zhuanggufang Decoction Powder’s curative effect on spleen-kidney deficiency with static blood syndrome of postmenopausal low bone mass population

目的:观察壮骨方煮散(剂量相当于饮片半量)治疗脾肾两虚夹瘀型绝经后低骨量人群的临床疗效及安全性。方法:将150例脾肾两虚夹瘀型绝经后低骨量患者随机分为壮骨方煮散组、壮骨方饮片组、西药组、壮骨方煮散+西药组、壮骨方饮片+西药组,每组30例,干预6个月后进行疗效评价,评定中医证候积分,检测腰椎羟基磷灰石密度、25-羟维生素D[25-(OH)D]、骨钙素(OC)、总Ⅰ型胶原N-端前肽(P1NP)、β-Ⅰ型胶原C-末端交联肽(β-CTX),并评价用药安全性。结果:壮骨方煮散+西药组、壮骨方饮片+西药组腰椎羟基磷灰石密度较治疗前均显著升高(P<0.05),且优于其他3组(P<0.05);壮骨方煮散组、壮骨方饮片组、壮骨方煮散+西药组、壮骨方饮片+西药组中医证候积分、OC、P1NP、β-CTX水平较治疗前均显著降低(P<0.01),且作用优于西药组(P<0.01)。结论:壮骨方煮散可改善脾肾两虚夹瘀型绝经后低骨量患者的临床症状,联合阿法骨化醇软胶囊与碳酸钙D3片治疗可以提高骨量,作用与饮片相当,其机制可能在于抑制骨吸收、减缓骨量丢失。

Objective: To observe the clinical efficacy and safety of Zhuanggufang Decoction Powder in treating postmenopausal low bone mass population with spleen-kidney deficiency with static blood. Methods: One hundred and fifty cases of postmenopausal low bone mass patients with spleen-kidney deficiency with static blood syndrome were randomly divided into Zhuanggufang decoction powder group, Zhuanggufang Decoction slice group, western medicine group, Zhuanggufang decoction powder+western medicine group, Zhuanggufang decoction slice+western medicine group, 30 cases in each group. After 6 months of intervention, TCM symptom score was evaluated, lumbar quantitative CT(QCT) and serum 25-hydroxyvitamin D [25-(OH) D] were detected. Serum osteocalcin(OC), total type Ⅰ collagen N-terminal propeptide(P1 NP) and serum type beta-Ⅰcollagen C-terminal cross-linking peptide(β-CTX) were measured, and the drug safety was evaluated. Results: The density of lumbar vertebral hydroxyapatite in the Zhuanggufang decoction powder+western medicine group and the Zhuanggufang decoction slice+western medicine group were significantly higher than those before treatment(P<0.05). The effect of the two groups was similar, and the effect was better than the other three groups(P<0.05). The symptoms score, OC, P1 NP, β-CTX in the Zhuanggufang decoction powder group, the Zhuanggufang Decoction slice group, the Zhuanggufang decoction powder+western medicine group and the Zhuanggufang decoction slice+western medicine group were significantly lower than those before treatment(P<0.01), and the effect was better than the western medicine group(P<0.01). Conclusion: Zhuanggufang Decoction Powder could improve the clinical symptoms of postmenopausal low bone mass patients with spleen-kidney deficiency with static blood, combination of Alfacalcidol Soft Capsules and Calcium Carbonate D3 Tablets could improve bone mass, and the effect is equivalent to that of decoction pieces. The mechanism may be inhibiting bone absorption and slow down bone loss.