ObjectiveIn this study,the positive drug xianling gubao capsule was used as the control to preliminarily evaluate the clinical efficacy of hugu capsule in the treatment of primary osteoporosis with kidney essence deficiency.methodsA randomized,single-blind,and positive-drug controlled clinical study was conducted to screen 50 patients with primary osteoporosis of renal deficiency type according to the inclusion and exclusion criteria.Parallel design was conducted in 1:1 groups,with 25 patients in each group and 1 subject in the treatment group dropping out midway.The control group was given xianling gubao capsule.The treatment group was given oral bone capsule.The treatment course of the two groups was 12 weeks.After the treatment,statistical comparison was made before and after the treatment according to relevant efficacy indicators,and the efficacy indicators were observed,including height,pain score(VAS),TCM syndrome quantitative score,bone density value(BMD),serum alkaline phosphatase(ALP),and SF-36 scale score.resultsBefore treatment,the basic data of subjects in the treatment group and the control group were compared,including basic information such as gender,age and course of disease.There was no significant difference in basic data between the two groups(P>0.05),which was comparable.(1)height:there was no significant difference in height between the two groups before and after treatment(P>0.05);(2)VAS pain scores in the lower back and lower limbs:the VAS pain scores in the lower back and lower limbs of the two groups were significantly decreased after treatment(P<0.05),and the VAS pain scores in the lower back and lower limbs of the treatment group were significantly lower than those of the control group after drug intervention(P<0.05).(3)quantitative scoring of TCM syndromes:after treatment,the quantitative scoring of TCM syndromes in both groups was significantly improved(P<0.01);The quantitative score of TCM symptoms in the treatment group after drug intervention was significantly different from that in the control group(P<0.05).(4)BMD:there were no significant differences in lumbar vertebral density,trochanteric BMD and femoral neck BMD between the two groups before and after treatment(P>0.05).The BMD of wards in both groups was improved after treatment(P<0.05),and the BMD of wards in both groups was not significantly different after treatment(P>0.05).(5)serum alkaline phosphatase:there was no significant difference in serum alkaline phosphatase(ALP)between the two groups before and after treatment(P>0.05)·(6)sf-36 scale qol score:qol scores in all dimensions of the two groups were improved to a certain extent,and there were significant differences in physiological function,social function and physical pain among the three dimensions groups(P<0.05),and the physiological function of the control group was significantly improved compared with that before treatment(P<0.05).After treatment,there was no significant difference between each dimension and the control group(P>0.05).ConclusionHugu Capsule can significantly improve the clinical symptoms of primary osteoporosis(kidney deficiency deficiency syndrome),and can improve the bone density of patients to some extent,and has anti-osteogenesis. |