The Research On Clinical Effectiveness Evaluation Of PMOP With Integrated Project In TCM Based On The Growth Model And The Mixed Effects Proportional Odds Model

With the arrival of aging society, the ratio of postmenopausal osteoporosis(PMOP) increasing has become an urgent need to address global public health problems. The most serious complication of osteoporosis is fracture. The fracture incidence is far more than lung cancer, stroke and heart disease incidence, which bring the family and community serious health and economic pressure.There are many researches show that the pain is the most common and the most important symptoms of PMOP. The diagnosis of bone mineral density(BMD) has been recognized as the gold standard of the diagnostic criteria. Are there any relationship between the symptoms and BMD; any relationship between syndromes and BMD, whether if it can be used as one of the early diagnosis or the determine reference which can judge the extent of bone loss.Currently, the treatment for PMOP, bone resorption inhibitor and bone formation promoting are used in Modern Medicine. there are difficult to control the Dose of the Biological agents, even there are certain side effects with long-term use. Therefore based on the syndrome, we carry out a demonstration study of the integrated project in the community and exploratory the research on clinical effectiveness evaluation of PMOP with integrated project in TCM.1 ObjectivesStudy the relationship which between symptoms of PMOP and bone mineral density; study the relationship which between syndromes of PMOP and bone mineral density. Carry out a demonstration study of the integrated project in the community and exploratory the research on clinical effectiveness evaluation of PMOP with integrated project in TCM based on the growth model and the mixed effects proportional odds model.2 Methods2.1 There are 245 patients were enrolled in the community,then we collected,inputed clinical datas and established databases. Using chi-square test and Logistic regression to observe the the relationship between clinical symptoms and bone mineral density; between syndromes and bone mineral density.2.2 Design a prospective quasi-experimental which treat PMOP in the community. By SAS9.1.3 software, the ratio of the experimental group (20 cases) and control group (20 cases)is 1:1, the baseline of the two groups are consistent. Experimental group received an integrated project which include traditional chinese medicine,sports and diet; the control group received Caltrate D600. Two groups were observed for 6 months. Evaluation standards for the visual analog pain score (VAS), clinical symptoms and bone density. Clinical Evaluation Methods:the Growth model and mixed effects proportional odds model.3 Resulets3.1 clinical symptoms, syndromes associated with bone mineral density at different stages of research3.1.1 245 cases of abnormal bone mass in postmenopausal patients, according to T-bone mineral density values were divided into three stages:bone loss, osteoporosis, severe osteoporosis. According to symptom scores:weak waist (598 points), pain (516 points), lower limb Spasm (502 points), aversion to cold (474 points), score higher. There is a certain relationshipat spasm and bone mineral density at different stages of lower limb, and there is significant difference (P<0.05). Waist and knee weakness, bone pain, aversion to cold, forgetfulness associated with different stages of bone mineral density was not statistically significant (P>0.05).3.1.2 245 cases of patients with the syndrome factors in accordance with the deficiency, Kidney Yin Deficiency, blood.stasis syndrome was classified. Logistic regression analysis through the orderly, the results show that three kinds of syndromes and bone mineral density at different stages of factors correlated, with statistical difference (P <0.01). The bone mineral density values of Kidney yang deficiency patients is less than yin deficiency and blood stasis syndrome of bone mineral density in different parts, and there is significant difference (P<0.01). Patients with blood stasis are majority (76.6%) at bone loss stage; Patients with deficiency (49.1%) and blood stasis (33.3%) in kidney yin deficiency syndrome (17.6%) are less at osteoporosis stage; at severe osteoporosis stage, the majority of patients with kidney yang deficiency syndrome (80%), with statistical difference (P<0.05).3.2 Traditional comprehensive intervention program evaluation results3.2.1 Experimental group compared to control group, VAS scores decreased an average outcome scores more, and an additional drop of 0.23 points was significantly different (P<0.05); TCM symptom score, the average outcome score dropped more additional 0.78 points decline, with significant difference (P<0.05)., There is a certain relieve at spasm of the lower limb group, aversion to cold, bone pain, weak waist in the two groups, but the experimental group was better than the control group, the estimated parameters. better than the control group were 0.55,0.40,0.32,0.25 with significant difference (P<0.05); Experimental group on heel pain, night sweats, less gas lazy words, forgetfulness and other symptoms has improved, while the control group had no improvement, the two groups were statistically different (P<0.05).3.2.2 For the slow decline in bone mineral density, experimental group was better than the control group, with statistical difference (P<0.05). For the lumbar spine bone mineral density improvement in the experimental group was better than the control group, with statistical difference (P <0.05). For the femoral neck, femoral trochanter, greater trochanter, Wards triangle bone mineral density improvement, although the two sets of results were not statistically different (P>0.05), but from the description that the test statistics can increase the value of bone mineral density in patients relatively large, while in patients with reduced bone mineral density than the control group also has some clinical significance. 4 Conclusions4. IThere are the relationship between leg cramps and BMD, leg cramps can be the reference indicator of early diagnosis. There are a certain correlation between the different syndromes of PMOP and BMD. Most people of bone loss showed blood stasis syndrome, most people of osteoporosis or severe osteoporosis showed deficiency syndrome. Different Syndromes can be one of the reference indicator of degree of bone loss.4.2 In the community, the forward-looking of quasi-experiment is an appropriate design method during the clinical trials;with the traditional comprehensive intervention program, the pain relief, the symptoms improvement of the patients are better than with only Calcium. Slow decline in bone mineral density, also and even improve bone density values also have a certain effect.4.3 The growth model and the mixed effects proportional odds model is applicable to evaluate the clinical efficacy with repeated measurements data.In this study, Innovation presence the treatment method of PMOP with the comprehensive intervention program; the conduct of the the forward-looking of quasi-experiment in the communities; the evaluate method of the repeated measurements data with the growth model and the mixed effects proportional odds model...