Clinical Optimization And Experimental Study On Prescriptions Of "Warming Kidney And Removing Obstruction In Channels To Relieve Pain" For Osteoporosis

Objective:The goal of this study was to build the foundation of research of prescriptions of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain" to treat Primary Osteoporosis (POP) for further research and development. Firstly wee deeply analyzed the relationship between the Primary Osteoporosis (POP) and TCM constitution by conducting the investigation of TCM constitution under the guidance of TCM theory. Next in order to screen out the best prescription we observed and evaluated the clinical efficacy and safety of three clinically effective prescriptions of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain" for osteoporosis. Finally we verify the efficacy of prescriptions of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain" for osteoporosis by using animal experiments and explored its mechanism.Methods:The study included three parts:Part one:Investigation of TCM constitution for osteoporosis80 POP patients from outpatient and inpatient department of Jiangsu Province Hospital of TCM were selected and evaluated their TCM constitution by using TCM constitution Scale. To identify the constitutional tendencies of these patients we used the statistical analysis of data of TCM constitution Scale and analysis of the correlation between osteoporosis and TCM constitution to determine therapeutic methods to modulate TCM constitution. We established the diagnosis and treatment plan based on TCM constitution types, and tried to improve individual pathological condition of osteoporosis patients and find the best prescriptions for the treatment of osteoporosis by improving the TCM constitution.Part two:Clinical optimization of prescriptions of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain"This was a randomized active control trial. A total of 75 participants with POP who met the inclusion criteria were randomly assigned to three groups of A, B and C. Each group contained 25 cases. Group A received therapy ofprescription A, group B received prescription B and group C received prescription C. All cases were followed clinically for a minimum of 2 months and the main observe clinical symptoms, the BMD and biochemical markers of bone metabolism for clinical efficacy and routine blood, urine and stool examination, liver and kidney function, ECG and other safety indicators were recorded. The data was statistical analyzed in the end. The prescription screened out as best clinical efficacy and application security would be put into study next.Part three:Experimental efficacy study of prescription of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain"After pre-clinical trials, we screened out the best prescription of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain". The next animal experiments were set to verified its efficacy and explored its mechanism. These experiments provided the basis for further research and development. Detail experiments included: ① analgesic effect test (acetic acid writhing test);② anti-inflammatory effect test (xylene inflammation test);③ BMD test; ④ histological observation.⑤ tests of biochemical markers of bone metabolism.Results:Through investigation of TCM constitution for osteoporosis Yang constitution, we found that the most popular TCM constitution for osteoporosis was Yang deficiency, followed by Qi deficiency, Yin deficiency and blood stasis. That was osteoporosis related mostly to yang deficiency, followed by Qi deficiency, Yin deficiency and blood stasis. By analyzing the data we concluded that the features of TCM constitution for osteoporosis were Kidney deficiency and blood stasis. Through clinical superiority screening of prescriptions of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain", we found that prescription A, B and C all showed effective in the treatment of osteoporosis. All of them could improve clinical symptoms, without any adverse reactions and can effectively prevent and treated osteoporosis. Optimal screening of prescriptions suggested that prescription B had better effective/price ratio and should be used as the preferred prescription in the next experimental studies. Experimental efficacy study of prescription of "Warming Kidney and Removing Obstruction in Channels to Relieve Pain" proved that the analgesic and anti-inflammatory effects of prescription B were significant. The main mechanism for its anti-osteoporosis included reducing IL-6, RANKL levels in serum, improving OPG, reducing the ratio of RANKL/OPQ which inhibited osteoclast activity and restored the bone tissue structure to improve bone density.