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.