| Background:Osteoporosis (Osteoporosis, OP) is a systemic bone mass and bone structure change, accompanied by osteopsathyrosis increase and the fracture of the disease. Osteoporosis bone mineral composition and characteristics for bone matrix of proportion reduce, bone damage of microstructure, the bone cortex become thinner, and bone trabeculae number and size are reduced. Clinical classified into the primary and secondary, the former has two types: type I is postmenopausal osteoporosis (PMOP), occurred in the spine and distal radial, type II is senile osteoporosis, occurred more often in vertebrae and hip. With the development of our social economy and the improvement of living standards, our country has been an aging society, the prevalence of primary osteoporosis has also been increasing year by year. The old osteoporosis rates of61%in men,90%in women, and of whose mainly is postmenopausal women in our country.Traditional Chinese medicine treatment for chronic disease have a unique advantage, especially for postmenopausal osteoporosis. Take Traditional Chinese Medicine theory as the guide, this article summaried the experimental research results and evaluated clinical effect, in order to screen effective Chinese medicine, which has good social meaning and realistic significance.Objective:We aims to carry out demonstration research on Chinese Traditional Medicine intervention for PMOP patients in the community, in order to valid efficacy and safety of Bushenhuoxue Granule, further provide an effective TCM treatment for the PMOP and evidence-based medical basis. Method:3.1In Beijing Dongcheng district community, we have recruited postmenopausal osteoporosis patients, the group of80patients and collected the relevant clinical data, then logged the data. The independent sample t-test and chi-square test are choosed to verify efficacy and safety of Bushenhuoxue Granule treatment for PMOP.3.2A randomized, double-blind, placebo-controlled study is designed in communities PMOP treatment of clinical research. Patients for40cases in experimental group and40cases in control group. The experimental group is activating blood group kidney TCM Granule called Bushenhuoxue Granule, composed of prescriptions for barrenwort, drynaria fortunei, medlar, Danshen. The control group is the placebo, two groups are observed for six months. Clinical effect evaluation index include visual simulation pain score (VAS), pain, TCM symptoms and bone mineral density values.Result:4.1Bushenhuoxue Granule to the improvement of the painBushenhuoxue Granule group drops more an average of VAS pain score compared to placebo group. Bushenhuoxue Granule group dropped by an average of3.92cm, and the placebo group grew by an average of0.32cm, a statistically significant difference (P<0.05).4.2Bushenhuoxue Granule to the improvement of the kidney-yang deficiency symptomsBushenhuoxue Granule group which improves patients with TCM symptoms in total score, lumbar debility, lower extremities, lower limb cramps symptoms compared to placebo group is obvious (P<0.05). Although there was no statistically significant difference in chillynees and night urination increasing symptoms between groups(P>0.05), Bushenhuoxue Granule group shows the greater trend.4.3Bushenhuoxue Granule to the improvement of bone mineral densityBushenhuoxue Granule group improving lumbar1,2,3,4bone mineral density is the same as the placebo group, but there was no statistically significant difference (P>0.05). Femoral neck bone mineral density difference compared, Bushenhuoxue Granule group improving more obvious than placebo group, there was no statistically significant difference (P>0.05). Femoral trochanter bone mineral density difference compared, two groups of comparisons are no statistically significant difference (P>0.05). greater trochanter of femur bone bone mineral density difference compared, Bushenhuoxue Granule group improving bone mineral density more obvious than placebo group, but there was no statistically significant difference (P>0.05).4.4Safety evaluation of Bushenhuoxue GranuleAccording to the outcomes of safety evaluation, patients taking Bushenhuoxue Granule have no obvious abnormity in blood and urine routine examination and liver and kidney function, no adverse events either.Conclusion:Bushenhuoxue Granule treating postmenopausal osteoporosis, can significantly reduce patients’pain and lumbar debility, lowering limbs weakness and limb cramps and kidney-yang deficiency symptoms, delaying the lumbar spine, femoral neck, femoral trochanter, greater trochanter of femur bone mineral density dropped. As far as clinical application is concerned, Bushenhuoxue Granule is secure. |
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