Clinical Research Of PO Treatment With Bone Density Promotion Pills By Parallel Randomized Control

Research Background:Primary osteoporosis(PO) is a kind of commonly-seen metabolic bone disease characterized by osteopenia, destruction of micro-structure of bone tissues, increased fragility and relatively high tendency to fracture, with osteopenia per unit volume but roughly normal ratio between minerals and base materials as its histopathological characters. In terms of treatment concerning modern Western Medicine, emphasis is often laid on endocrine regulation or intervention of Calcium salt metabolism. Main effective drugs usually include basic treatment drugs, bone absorption inhibitors and bone generation promotors. The above-mentioned three should be used in collaboration, in spite of higher costs and so many side effects. What’s more, lacking of recognition and intervention of general hypofunction and decreased kinetism by aging often lead to ineffective treatment. The core elements in treating this disease should be relied on holism and syndrome differentiation. Traditional Chinese Medicine have gained so much clinical experience in improving motion capabilities and delaying senility, thus providing a broad prospect of PO treatment.Objective:As to Traditional Chinese Medicine theories, the kidney, viewed as the root of acquired constitution, has the functions of storing essence and generating marrow and bones. For the aged, mutual depletion of spleen and kidney often result in insufficiency of both qi and blood. Mutual generation of essence and blood is jeopardized, leading to the failure of marrow filling and nourishment of bones. Long-standing pain also has something to do with flaccidity, which demonstrates the close relations between kidney and bones. Kidney essence serves as most important component governing growth and development of the human body, and the maturity of bones depends on the filling of marrow and the nutrient it provides. The abundance of kidney essence adds vitality to generation, transformation and nourishment. Otherwise, osteoporosis is developed. The physician applied homemade “bone density promotion pills” to the curing of PO, thus safety and sound efficacy were experienced during clinical practice, thanks to its unique treating principles and prescriptions. In order to have a more penetrating understanding of the pills on its effect concerning decreased general functions, motor ability and bone density caused by growth of age and to explore the kind of more stable medicinal that is safer and effective in improving life quality, we carried out this research.Methods:120 cases of PO, outpatient and hospitalized, were selected in the research in He Bei Yiling Hospital from January,2013 to Semptember,2014. Parallel randomized control was applied in this clinical trial between the experimental group and the control group. 120 patients were evenly divided into the groups, with their indicators having no significant differences, such as age, gender, duration, height, weight, distribution of TCM syndromes, bone density detection and 6-minute walk test, urine HOP/Cr, urine Ca/Cr, bone gla-containing protein, serum Ca, serum P and other security ones. The experimental group was given bone density promotion pills of warm water taking 0.5-1 hour after breakfast and dinner, with the frequency of 4 pieces each time, 2 times a day. The basic drugs were Caltrate D pills(calcium carbonate pills) with the method of one tablet each time, 1 times a day. The control group was only given basic drugs. 2 periods of treatment(6 months) were examined.Results:The clinical effects of experimental group at the end of 1st and 2nd course of treatment were better than control group, in terms of Syndrome curative effect, effects on bone density and 6-minute walk test(P<0.05),Changes of difference value between the mentioned two groups after 2 courses of treatment had significant difference, such as Single syndrome integral, bone density test, and 6-minute walk test(P<0.05),Changes of difference value between the mentioned two groups after 2 courses of treatment also had significant difference, such as urine HOP/Cr, urine Ca/Cr, bone gla-containing protein, serum Ca, serum P and ALP(P<0.05).Conclusion:The experiment has demonstrated satisfying curative effect in the treatment of PO with the help of bone density promotion pills, which has testified the important significance of the principle of “supplementing kidney and filling essence to nourishing yin and invigorating yang” and the strategy of multi-channel and multi-layer treatment of PO.Based on conventional efficacy evaluation indexes, the research has added a new type of indicator: activity of daily living scale, which could evaluate the impact of the life and survival qualities of the patients in a more comprehensive and more human-oriented way.Bone density promotion pills provides a safe and effective Chinese Medicine preparation, with the advantages of partial remission and improving life and survival qualities.