Clinical Research Of ShiShenHuoGu Decoction Treating For Early And Middle Stage Non Traumatic Osteonecrosis Of Femoral Head

Objective:To observe the effectiveness and safety of Shishen-Huogu Decoction in the treatment of early and middle stage of Non-Traumatic Osteonecrosis of The Femoral Head,which is a syndrome of Liver-Kidney Deficiency Syndrome(Yang Deficiency Type),and preliminary studying of the connotation of Chinese Medicine Theory of Kidney Dominating The Bone Theory and the Shishen-Huogu Decoction ’s treatment mechanism for this disease.Methods:64 cases of patients,who are 1)in early-and mid-phase of Non-traumatic necrosis of the femoral head 2)met the research criteria in the orthopedic clinic,and 3)receiving treatment from Affiliated Hospital of Shandong University of Traditional Chinese Medicine from January 2017 to January 2019,were participate to the study.Patients were randomly divided and assigned to a control(n=32)or an observation(n=32)group.The observation group received treatment of Shishen-Huogu Decoction,while the control group received the treatment of Compound Eucommia Bone Granules.The Harris hip score,VAS score,and hip imaging data of the patients were provided to participants at the first,third,and sixth months after treatments start in order to record and ensure that the liver and kidney function indicators were detected before and after treatment.Results:1.VAS score and Harris hip score.The VAS scores and Harris hip scores of the two groups of patients at 1st month,3rd months,and 6th months were compared with the score before treatment,the statistically significant differences(P<0.05)were found.There was no significant difference in VAS scores and Harris hip scores between the two groups of patients in the treatment on the 1st month(P=0.215、P=0.900).The comparison of VAS scores between the 3rd and 6th month of treatment in the two groups has statistically significant difference(P<0.05),and the VAS scores of the observation group were lower than those of the control group.The comparison of Harris hip score between the 3rd and 6th month of treatment in the two groups has statistically significant difference(P<0.05),and the Harris hip of the observation group were higher than those of the control group.2.Femoral Head Collapse.After 6 months of treatment,both the observation group(54 hips)and the control group(51 hips)had 8 hips collapsed>2mm.The collapse rate in the observation group was 14.81%and the collapse rate in the control group was 15.69%.The difference between the two groups was not statistically significant(P=0.980).3.Safety index.Compared to the pre-treatment results,there was no significant difference in ALT,AST,BUN,and SCr in the two groups patients after 6 months of treatment(P>0.05).Conclusion:To a certain extent,Shishen-Huogu Decoction can improve the symptoms of cold pain and hidden pain in the hips of patients,who has Liver-Kidney Deficiency Syndrome(Yang Deficiency Type)in the early and middle stage of Non-Traumatic Osteonecrosis of The Femoral Head,and provide relative beneficial conditions for patients to retain the hip function.