Clinical study of Jingang Pill combined with calcitriol in treating elderly osteoporosis with kidney-yang deficiency pattern
Objective To investigate the clinical efficacy and safety of Jingang Pill combined with calcitriol in treating elderly osteoporosis with kidney-yang deficiency pattern.Methods A total of 72 elderly patients with kidney-yang deficiency osteoporosis treated in the outpatient department of the Hospital of Hunan Academy of Chinese Medicine were randomized into control group(treated by calcitriol)and treatment group(treated by Jingang Pill combined with calcitriol)by stratified randomization method,with 36 participants in each group.The treatment lasted for 8 weeks.The clinical efficacy,visual analogue scale(VAS)scores,bone mineral density,bone metabolism index,osteogenesis-related gene levels,inflammatory factor levels,quality of life,and TCM pattern scores and safety were compared between the two groups.Results The overall efficacy rate in the treatment group was 91.7%,significantly higher than 69.4%in the control group(P<0.05);compared with the control group,VAS score in the treatment group decreased(P<0.05);bone mineral density in the whole hip,lumbar spine,and femoral neck increased(P<0.05);bone morphog-enetic protein 2(BMP2)RNA expression level,bone alkaline phosphatase(BALP)osteocalcin(BGLAP)content,and scores of health status questionnaire(36-item short-form,SF-36)increased(P<0.05);levels of tartrate-resistant acid phosphatase 5b(TRACP-5b),miR-133aRNA expression level,serum tumor necrosis factor-α(TNF-α),and interleukin-6(IL-6),and TCM pattern scores all decreased(P<0.05).Conclusion Jingang Pill combined with calcitriol may improve bone mineral density,bone metabolism,inflammatory status,and quality of life by up-regulating BGLAP,miR-133a,and down-regulating TRACP-5b,BMP2,TNF-α,and IL-6 levels,thereby effectively improving the treatment efficacy of elderly osteoporosis with kidney-yang deficiency pattern.