The Clinical Trial Study Of Buzhengxugu Pills In The Treatment Of Kidney-yang Deficiency Type Osteoporosis

Purpose:Based on the clinical application and experimental study of Buzheng Xugu Pill for many years,the clinical efficacy and safety of Buzheng Xugu Pill in the treatment of osteoporosis of kidney-yang deficiency type were observed,which provided theoretical basis for the expansion of clinical application and further promotion of Buzheng Xugu Pill.Material and method:A multicenter,blind,randomized,parallel controlled clinical trial was conducted.Sixty eligible subjects from two hospitals were randomly divided into experimental group and control group.The experimental group(n = 30)was treated with basic therapy + Buzheng Xugu pill,and the control group(n = 30)was treated with basic therapy + Gushukang capsule.The curative effect was counted after 30 days,60 days and 90 days of treatment,and the follow-up was carried out on the 90 th day after the end of treatment.The therapeutic effects were evaluated by Tinetti scale,Visual Analogue Scale/Score(VAS)and quantitative data such as specific sequence of beta-collagen(?-CTX)and type I procollagen amino terminal peptide(P1NP)before and after the experiment.CRF table was used to manage clinical data,and SPSS18.0 statistical software was used for statistical analysis.Results:1.Screening 60 subjects who met the criteria of enrollment,including 30 in the experimental group and 30 in the control group.One of the subjects was not included in the experimental study and analysis because of the fact that one of the subjects was separated from the group by himself and did not take drugs.A total of 59 cases were included in the study,including 30 cases in the experimental group and 29 cases in the control group.2.There was no significant difference in sociodemographic data and general information such as age,sex,bone mineral density and vital signs between the two groups(P > 0.05),indicating that the two groups were comparable.3.The VAS score and Tinetti scale score of the two groups had statistical significance(P <0.05),indicating that both groups had curative effect.There was no significant difference in VAS score and Tinetti scale score between the experimental group and the control group(30,60,90 days before treatment).The results showed that the two groups had the same therapeutic effect.4.There were significant differences in the levels of P1 NP and ?-CTX between the two groups before and after treatment(P < 0.05).There was no significant difference in the levels of P1 NP and ?-CTX between the two groups(P > 0.05),indicating that there was no significant difference in regulating bone metabolism between the experimental group and the control group.5.After the end of the experiment,there was no significant difference in the follow-up indicators(VAS score,Tinetti scale)between the two groups(P > 0.05).Conclusion:1.Both Buzheng Xugu Pill and Gushukang Capsule can regulate bone metabolism index,relieve pain symptoms and improve daily activity of patients with primary osteoporosis.2.Buzheng Xugu Pill can be used to treat osteoporosis of kidney-yang deficiency type.3.Buzheng Xugu Pill has a long-term effect on osteoporosis of kidney-yang deficiency type.4.During the clinical trial,there were no obvious adverse reactions before and after treatment,which indicated that Buzheng Xugu Pill had good safety and was worthy of further clinical application and promotion.