Experiment And Clinical Research On Treatment On Necrosis Of The Femoral Head By Using TongLuShengGu Capsule

Objective: 1. To study the two-way regulation actions of TongLuoShengGuCapsules regulating osteoblast and the lipoblast of mesenchymal stem cells,to approach the mechanism of action and provide the experiment evidence forclinical medication. 2. To explore the effects of the Traditional ChineseMedicine upon the collapse in the early stage osteonecrosis of the femoralhead.Methods: (1). MSCs were acquired by adhesive screening from SD rats and Theadherent and fibroblast-Shaped cells were in good growth state, which wereplated at 2X10~9/ml and cultured in DMEM medium supplemented with 10% fetalbovine serum and placed in37℃, 5%CO2 incubator. The MSCs were also undergoneosteogenic, lipoblast and the two-way regulation of mesenchymal stem cellsang induction with the traditional Chinese medicine. Their morphologicalcharacteristics were examined under microscope and cytochemical andmolecular biology detection verifying their multipotential. (2). Naturalhistory group was retrospectively matched according to the age, etiology,stage, and size of the lesion to a group of all patients who did not underwenttreated. After matching of the two groups, There were 44 hips of 43 patientsin TongLuoShengGu Capsules (herb group), 17 hips were in stageⅠ(ARCO stagesystem), 27 hips were in stageⅡ. one hip was less than 15% in lesion ofosteonecrosis of the femoral head, 23 hips were 15%-30%, 17 hips were 30%-60%3 hips were more than 60%. There were 48 hips of 38patients in natural historygroup, 21 hips were in stageⅠ, 27 hips were in stageⅡ. Two hips were lessthan 15% in lesion of osteonecrosis of the femoral head, 22 hips were 15%-30%,19 hips were 30%-60% 5 hips were more than 60%. In herb group, patients took12 TongLuoShengGu Capsules everyday during 6～12 monthes and were restrictedto take weigth-bearing. A prospective case-controlled study of the two groups,with a mean duration of follow-up of four years. The study of two groups criterion were that Radiographic Progression. The assessment standard adoptedthe instruction principle of clinical research about the traditional Chinesemedicine and new drug. The curative effect about imageology was based oncomparative evaluation of radiographic progression.Results: (1) The cells which were induced by the traditional Chinese medicineand the contrast cells are to run RT-PCR. Then the RT-PCR product run gelelectrophoresis and EBdyeing. The specific PCR amplification was scanned andanalyzed by gelatum imagine system to prove the relationship of growth anddecline of osteoblast and lipoblast and to demonstrate further the pathologicchanges of the stem cell that control mechanisms of oeteoblst andlipoblast.The mechanisms are to supposed to be the etiopathogenesis ofosteonecrosis of the femoral head. The TongLuShengGu Capsules have conspicuousregulating actions of oeteoblst and lipoblast. (2) there were 9 hips(20.4%)with Radiographic Progretssion and 5 hips(11.3%) with depression collapseof＞2mm in the herb group, and there were 23 hips(47.9%) with RadiographicProgression and 21 hips(54.7%) with depression collapse of＞2mm in thenatural history group. There was significant difference between two groups(P＜0.001).Conclusion: The study demonstated the two-way differentiation, correlatedand inversus relationship characteristics of oeteoblst and lipoblast throughcell culture, and also provided the experimental evidence for treatment ofOsteonecrosis of the femoral head by use of TongLuShengGu Capsules.TongLuShengGu Capsules have been proved to treat early stage ofosteonecrosis of the femoral head with the Weight-bearing control method, toprevent the collapse of the femoral head and the radiographic progression ofhip.