关键词: 骨质疏松症, 骨代谢标志物, 益肾固疏方, 中医药, 临床疗效, 随机对照试验

Abstract: BACKGROUND: With the variation of disease treatment modes and the in-depth research on senile osteoporosis in recent years, increasing studies have confirmed that traditional Chinese medicine has a significant effect on the prevention and treatment of senile osteoporosis.
OBJECTIVE: To investigate the effect of Yishen Gushu Formula on bone metabolic markers in patients with osteoporosis of kidney deficiency and blood stasis type.
METHODS: 102 patients with senile osteoporosis of kidney deficiency and blood stasis type who were treated at Ruikang Hospital Affiliated to Guangxi University of Traditional Chinese Medicine from July 2020 to March 2022 were enrolled, including 32 males and 70 females, aged 71-93 years. All patients were randomly divided into two groups, with 51 patients in each group. The control group was treated with calcium carbonate D3 granules and sodium alendronate tablets, while the treatment group was treated with Yishen Gushu Formula beyond the control group. Treatments in each group lasted 3 months. Bone mineral density of the L1-4 lumbar vertebrae and left femoral neck, visual analog scale score, and serum levels of osteocalcin, osteopontin, type I collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were measured before and 3 months after treatment. Traditional Chinese medicine syndrome score and therapeutic efficiency were also assessed.
RESULTS AND CONCLUSION: After 3 months of treatment, the bone mineral density of the lumbar vertebrae (L1-4) and left femoral neck was significantly increased in both two groups (P < 0.05), and the bone mineral density of the lumbar vertebrae (L1-4) and left femoral neck was significantly higher in the treatment group than the control group (P < 0.05). The visual analog scale scores of both groups after 3 months of treatment were lower than those before treatment (P < 0.05), and the visual analog scores of the treatment group after 3 months of treatment were lower than those of the control group (P < 0.05). After 3 months of treatment, the serum levels of osteocalcin, osteopontin, type I collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were significantly improved in both two groups, while compared with the control group, the serum levels of osteocalcin and osteopontin were significantly higher (P < 0.05) and the serum levels of type I collagen cross-linked C-terminal peptide and tartrate resistant acid phosphatase were significantly lower in the treatment group (P < 0.05). After 3 months of treatment, the Traditional Chinese medicine syndrome scores were decreased in both two groups, while the Traditional Chinese medicine syndrome scores in the treatment group were lower than those in the control group. After 3 months of treatment, no significant adverse reactions occurred in both groups. The total effective rate was 88.2% and 70.6% in the treatment and control groups respectively, and there was a significant difference between the two groups (P < 0.05). To conclude, Yishen Gushu Formula combined with anti-osteoporosis drugs can significantly improve the clinical symptoms of patients with senile osteoporosis of kidney deficiency and blood stasis type and prevent disease progression by regulating bone metabolism, increasing bone mineral density, and relieving pain.

Key words: osteoporosis, bone metabolic marker, Yishen Gushu Formula, traditional Chinese medicine, clinical efficacy, randomized controlled trial