The Experimental And The Related Clinical Study Of Combination Of Folium Cajani And Bone Marrow Derived Mesenchymal Stem Cells As Treatment For Osteonecrosis Of The Femoral Head

Osteonecrosis of the femoral head (ONFH) is a progressively debilitating lesion, which iscommon in clinics and ultimately to lead to the collapse of the femoral head and thedestruction of the hip joint in patients between 20 and 50 years of age (mean age atpresentation, 38 years).The development of osteonecrosis can have a major impact on anindividual's lifestyle, we can know that there is no consensus on the best method forpreserving the femoral head because of lack of large sample or long term follow-upresearch, different evaluation criterion, different statistics method.The Tong Luo Sheng Gu Capsules(TLSGC), which main component is Folium Cajani, isrecipe made for treating osteonecrosis of the femoral head by Professor Yuan Hao. It hashealed a lot of patients single or associated with operation from 1982. The long termclinical practice has proved that the medicine is effective for ONFH. The experimentalstudy would observe the effect and influence of combination of Folium Cajani (FC) andbone marrow derived mesenchymal stem cells(BMSC) as treatment for osteonecrosis of thefemoral head in the rat, and analyze the mechanism of the treatment. The clinical studywould observe the effect and influence of combination of TLSGC, the Abuducted WeightCarrying and Movement Moulding Exercise Method and the Traction as treatment forosteonecrosis of the femoral head, and provide the better theoretical basis for moreextensive clinical application.The methods of the experimental study including:32 SD rats were randomly divided into four groups, the control group(n=8), the FC group(n=8), the BMSC group(n=8), thecombination of FC and BMSC group(n=8). The model of osteonecrosis of the femoralhead made by liquid nitrogen. The BMSC group, the combination of FC and BMSC groupwere injected BMSC into the femoral head. The FC group and the combination of FC andBMSC group were injected FC everyday. In 30 days, alt rats were killed respectively, bloodserum and bone specimen were collected from every rat. Serum was sampled to observechanges of Ca, P. Bone specimen were sampled to observe changes of VEGF withimmunohistochemical studies, and analyze results.The clinical study evaluated 62 patients(85 hips) with TLSGC, the Abuducted WeightCarrying and Movement Moulding Exercise Method and the Traction for ONFH fromJanuary 2000 to February 2007. There were 32 male and 30 female patients, with a meanage of 48.9 years, range from 20 to 73 years. The average treatment follow-up period was2.4 years, range from 1 to 7 years. We evaluated the effect with hip scores on function andevaluation of the radiograph.By light microscopy, in the control group, the trabeculae of bone became thinner andsparse and accompanied with bone resorption, proliferation and hypertrophythis of the fatcells were obviously, empty osteocyte lacuna in the trabeculae were increased. The FCgroup, the BMSC group(n=8) and the combination of FC and BMSC group(n=8) werebetter than the control group.Serum P concentration of the FC group, the BMSC group, the combination of FC andBMSC group were higher than that of the control group (p＜0.05, p＜0.01). Serum Caconcentration of the combination of FC and BMSC group was higher than that of thecontrol group (p＜0.05).Following the formation of tissues, in which cartilage cells,vascular endothelial cells expressed VEGF. And expression of VEGF in the FC group,the BMSC group, the combination of FC and BMSC group were higher than that of thecontrol group (p＜0.05, p＜0.01).Follow-up according to the hip scores, 34 hips were excellent(40.0%), 43 hipsgood(50.6%),7 hips fair(8.2%),1 hips bad(1.2%).Good rate of stageⅠwas 100%, that ofstageⅡwas 100%, that of stageⅢwas 92%, that of stageⅣwas 71.4%. According to evaluation of the radiograph, 74 hips were excellent(87.0%),10 hips good(11o8%),1 hipsfair(1.2%).Good rate of stageⅠwas 100%,that of stageⅡwas 100%,that of stageⅢwas98%,that of stageⅣwas 100%.The combination of FC and BMSC as treatment for osteonecrosis of the femoral headcan increase serum P and Ca concentration and expression of VEGF. It is one of themachanism promoting recovery of necrosis with FC and BMSC that might partly increaseexpression of VEGF and vascular growth. The combination of TLSGC, the AbuductedWeight Carrying and Movement Moulding Exercise Method and the Traction as treatmentfor osteonecrosis of the femoral head can improve function of hips, promote recovery ofnecrosis and maintain a congruent hip. It provides the better theoretical basis for moreextensive clinical application.