| Background:Femoral head necrosis,as a chronic and difficult treatment in orthopedics department of traditional Chinese medicine,has always been an urgent problem.Regardless of the etiology,the clinical manifestations and pathological process of femoral head necrosis are basically the same,and are mainly characterized by hip pain,mobility restriction and lameness.If not treated in time,60%of patients will develop progressive collapse of the femoral head,and then narrow the hip space,forming hip joint osteoarthritis,which seriously affects the quality of life of patients.The disease has a high rate of advanced disability,poor quality of life and can only be treated with artificial joint replacement.Therefore,early active and effective treatment is particularly critical for the prognosis of femoral head necrosis.Traditional Chinese medicine has played its characteristic advantage in the nonoperative treatment of femoral head necrosis in the early and middle stages,and formed various theories and prescriptions in the long-term clinical practice,all of which have achieved clear curative effect.Jianpi Huogu formula is an important prescription for the treatment of early necrosis of the femoral head.Clinical practice shows that this method can relieve the pain of the affected hip,improve the function of the affected hip joint,slow down the progression of necrosis of the femoral head and delay or avoid hip joint replacement.Previous relevant clinical observation and biological studies have shown that this method has definite clinical efficacy in the treatment of femoral head necrosis,but the evaluation content of image manifestations is insufficient,the changes of specific image manifestations are not clear,the scientific connotation of the efficacy scoring criteria is not sufficiently explored,and the correlation between the evaluation results and the changes of bone structure and bone density in the necrotic area has not been studied.Objective:1.To summarize the clinical efficacy and imaging manifestations of Jianpi Huogu formula in the treatment of patients with early and middle stage non-traumatic femoral head necrosis syndrome of phlegm-stasis obstruction,and provide evidence for the efficacy of Jianpi Huogu formula in the treatment of early and middle stage non-traumatic femoral head necrosis.2.Select the cases of imaging necrotic lesions that conform to the repair law of "focal radiolucency-focal mixture of radiolucency and sclerosis-focal sclerosis",and use the hip CT image 3D reconstruction simulation to study the bone structure analysis method,explore the correlation between the changes of bone structure parameters and the image repair law of the lesion area,and explore the scientific connotation of the evaluation criteria of TCM image efficacy.Methods:1.Study on the curative effect of Jianpi Huogu Formula in treating early non-traumatic necrosis of femoral head with phlegm-stasis blocking collateral-collateral syndromeIn this part,the method of single-center exploratory follow-up study was adopted to analyze the effects of Jianpi Huogu prescription treatment for 6 months in the Third Affiliated Hospital of Beijing University of Chinese Medicine from September 2020 to February 2023.Clinical efficacy of 202 hips of 129 patients with early femoral head necrosis who were followed up twice 6 months and 12 months after the completion of treatment and had 3 times before and after hip x-rays.Hip pain intensity,hip flexion function,walking distance score included in clinical efficacy Evaluation Criteria of Traditional Chinese Medicine for Femoral Head Necrosis(2019 Edition)and Evaluation of Radiographic Outcomes after Core Decompression were used for Osteonecrosis of the Femoral Head:The Beijing University of Chinese Medicine X-ray Evaluation In Method,three image performance evaluation indexes,including femoral head morphology,necrotic focus density and hip osteoarthritis degree,were used as outcome indexes to evaluate the efficacy of Jianpi Huogu formula in the treatment of early femoral head necrosis.2.Based on CT 3D reconstruction,the changes of imaging manifestations of Jianpi Huogu formula in treatment of femoral head necrosis were studiedIn this part,13 patients with necrotic lesion density consistent with the repair rule of"clear density-clear sclerotic mixed density-sclerotic density" at 3 time points before and after treatment were screened out in the previous part of the study.A total of 39 hips corresponding to hip joint CT image data were obtained at each time point,and the team adopted the 3D reconstruction simulation method of hip joint CT image to study bone structure analysis.Mimics Medical 21.0 software,a medical image processing workstation,was used to optimize the operation steps of the reconstruction process,reconstruct the sclerotic bone and soft tissue structure in the femoral head,and measure the bone mineral density of the femoral head by means of mesh division and material assignment,and analyze and calculate the similarities and differences of different bone structure volumes and related indexes at 3 time points before and after treatment.To explore the changes of bone structure indexes in the early stage of treatment.Results:1.Study on the curative effect of Jianpi Huogu Formula in treating early non-traumatic necrosis of femoral head with phlegm-stasis blocking collateral-collateral syndromeA total of 202 hips of 129 patients with femoral head necrosis were included in this study,including 141 hips of 87 males and 61 hips of 42 females.The mean age was 44.76±12.56 years old(range 20-69 years old).There were 129 cases of lateral incidence:left side 25 cases,right side 31 cases,bilateral 73 cases;The ARCO stages of 202 hips were 5 hips in stage Ⅰ,112 hips in stage Ⅱ,85 hips in stage Ⅲ,and 0 hips in stage Ⅳ.The interval of follow-up point 1 was 204.54 ± 59.90 days,with an average of 6.8 months.The interval of follow-up at point 2 was 426.08 ± 90.74 days,with an average of 14.2 months.The results showed that the hip pain intensity scores were 4(3)and 2(2)before and 6 months after treatment(P<0.01),and the hip flexion angles were 90～99° and 110～119°[scores 4(1),2(1)](P<0.01).Hip pain intensity scores of 6 months and 12 months after treatment were 2(2),2(1)(P<0.05),hip flexion angles of 110～119° and 120～129°[scores 2(1),2(1)](P<0.01);Hip pain intensity scores before treatment and 12 months after treatment were 4(3),2(1)(P<0.01),hip flexion angles 90～99°,120～129°[scores 4(1),2(1)](P<0.01);The mean walking distance at 12 months after treatment was 900 m[score 1(0)].Comparing the image performance evaluation before and after treatment,the results showed that:Femoral head morphology scores before treatment and 6 months after treatment were 0(1),0(1)(P>0.05),necrotic focus density scores were 2(1),2(0)(P<0.01),osteoarthritis scores were 0(0),0(0)(P<0.01),total imaging efficacy was 3(2),2(1.25)(P<0.01).Femoral head morphology score 0(1),0(1)(P>0.05)at 6 and 12 months after treatment,femoral head necrosis density score 2(0),1(1)(P<0.01),osteoarthritis score 0(0),0(0)(P<0.01),The total score of image performance was 2(1.25)and 2(2)(P<0.01);Femoral head morphology scores before treatment and 12 months after treatment were 0(1),0(1)(P<0.05),necrotic focus density scores were 2(1),1(1)(P<0.01),osteoarthritis scores were 0(0),0(0)(P<0.01),and total imaging findings were 3(2),2(2)(P<0.01).2.Based on CT 3D reconstruction,the changes of imaging manifestations of Jianpi Huogu formula in treatment of femoral head necrosis were studiedA total of 13 hips of 10 patients with femoral head necrosis were included in this study,including 5 males with 7 hips and 5 females with 6 hips.The mean age was 28.92 ± 6.06 years old(ranging from 20 to 39 years old).The 10 patients were classified as left side(5 cases),right side(2 cases)and bilateral(3 cases).ARCO stage of 13 hips:1 hip in stage ⅡA,5 hip in stage ⅡB,5 hip in stage ⅡC,and 2 hip in stage ⅢA.By comparing the overall situation indicators of the reconstructed model before and after treatment,the results showed that:The volume of femoral head before and 6 months after treatment was 34178.36±6382.32,34647.39±6078.89 mm3(P>0.05),the mean CT value was 395.25 ± 42.59,410.01 ± 52.86 HU(P<0.01).Femoral head bone mineral density 670.22 ± 63.99,715.38 ± 55.73 g/L(P<0.01);The volume of femoral head at 6 months and 12 months after treatment was 34647.35 ± 6078.89,35102.91± 6175.25 mm3(P>0.05),and the mean CT value was 410.01± 52.86,435.56 ± 40.19 HU(P<0.01).Femoral head bone mineral density 715.38± 55.73,756.86±56.84 g/L(P<0.01);Femoral head volume before and 12 months after treatment was 34178.36± 6382.32,35102.91± 6175.25mm3(P>0.05),average CT value was 395.25±42.59,435.56± 40.19 HU(P<0.01).Bone mineral density of femoral head was 670.22 ± 63.99,756.86 ± 56.84 g/L(P<0.01).By comparing the related indexes of sclerotic bone reconstructed in the model before and after treatment,the results showed that:The volume of sclerotic bone was 2194.15 ± 1294.42 and 4048.75 ± 1637.11 mm3 before treatment and 6 months after treatment(P<0.01),and the proportion of sclerotic bone was 6.57 ± 3.61,10.39 ± 5.09%(P<0.01).The mean CT values of sclerosed bones were 760.97 ± 19.87 and 780.51 ± 20.15 HU(P<0.01).The volume of sclsclicated bone at 6 months and 12 months after treatment was 4048.75 ± 1637.11,5180.27± 1890.53 mm3(P<0.01),and the proportion of sclsclicated bone was 10.39 ± 5.09,13.59 ±5.52%(P<0.01).The mean CT values of sclerosed bones were 780.51 ± 20.15 and 799.40 ±27.63 HU(P<0.01).The volume of sclerotic bone before and after treatment was 2194.15 ±1294.42,5180.27 ± 1890.53 mm3(P<0.01),and the proportion of sclerotic bone was 6.57 ±3.61,13.59± 5.52%(P<0.01).The mean CT values of sclerosed bones were 760.97 ± 19.87 and 799.40±27.63 HU(P<0.01).By comparing the soft tissue related indexes of the reconstructed model before and after treatment,the results showed that:The soft tissue volume was 4237.63±1996.07 and 4427.63± 2142.07 mm3 before treatment and 6 months after treatment(P>0.05),and the proportion of soft tissue was 12.37±5.82 and 12.84 ± 6.55%(P>0.05).The mean CT values of soft tissue were 153.89 ± 19.67 and 153.12 ± 17.81 HU(P>0.05).The soft tissue volume at 6 months and 12 months after treatment was 4427.63±2142.07,3767.03± 2339.55 mm3(P>0.05),and the soft tissue accounted for 12.84±6.55,10.32 ± 5.63%(P>0.05).The mean CT values of soft tissue were 153.12 ± 17.81 and 154.72 ± 17.62 HU(P>0.05).The soft tissue volume was 4237.63± 1996.07 and 3767.03 ± 2339.55 mm3 before treatment and 12 months after treatment(P>0.05),and the proportion of soft tissue was 12.3 7 ± 5.82 and 10.32 ± 5.63%(P>0.05).The mean CT values of soft tissue were 153.89 ± 19.67 and 154.72± 17.62 HU(P>0.05).According to the Logistic regression analysis results,the volume of sclerotic bone in reconstructed femoral head model was a significant correlation factor for image focus density score(P<0.05).Conclusion:1.Jianpi Huogu Formula has positive clinical efficacy and imaging manifestations of traditional Chinese medicine in treating patients with early and middle stage non-traumatic femoral head necrosis syndrome of phlegm-stasis blocking collateral-collateral syndrome,and has therapeutic effects of relieving pain,improving joint function and repairing necrotic bone.2.After the treatment of early femoral head necrosis with Jianpi Huogu formula,the image focus density score decreased step by step.The changes of bone structure in patients followed the overall law of the gradual increase of sclerotic bone volume,femoral head bone density and the maintenance of soft tissue volume.The increase of sclerotic bone volume and femoral head bone density was the key to the decrease of image focus density score. |
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