| Osteonecrosis of the Femoral head(ONFH)is one of the refractory diseases in orthopedic department.Osteonecrosis of femoral head is developing rapidly.Once collapse occurs,most patients have to carry out artificial joint replacement.Preventing femoral head collapse is very important for the treatment of this disease.At present,there is no definite treatment to prevent the collapse of femoral head,and how to prevent or delay the process of collapse effectively is a difficult and hot spot in the industry.Objective:A retrospective cohort study was used to compare the efficacy of patients with nontraumatic femoral head collapse treated with Jianpi Bushen Prescription and protective weight-bearing therapy alone and prevention of necrotic femoral head collapse with simple protective weight-bearing therapy To compare the efficacy of To explore the efficacy and safety of Jianpi Bushen Prescription in preventing the collapse of femoral head necrosis,and to provide the basis for clinical application of Jianpi Bushen Prescription.Method:According to the criteria of inclusion and exclusion,40 cases of adult non-traumatic femoral head necrosis(phlegm and stasis obstruction syndrome)were selected as Steinberg staging ?-? stage,20 cases in Jianpi Bushen Prescription group and 20 cases in control group,which were followed up for two years up to December 2017.Jianpi Bushen Prescription group was given Jianpi Bushen Prescription combined with protective load,while the control group was only treated with progressive protective weight loading,both groups were treated with hip joint function exercise.The femoral head collapse,hip function and adverse reaction were compared between the two groups during the follow-up,and the effect of spleen tonifying was evaluated by using every 3 months as a follow-up node.Efficacy and safety of Jianpi Bushen Prescription.(1)Femoral head collapse:according to hip position and frog position X-ray to evaluate the two groups of femoral head collapse.(2)Hip function evaluation:according to the changes of Harris score after treatment,the hip function in both groups was evaluated.(3)Safety evaluation:the general situation,liver and kidney function,adverse events were compared between the two groups,and their safety was evaluated.(4)The survival time before collapse of femoral head was evaluated by Kaplan-Meier survival analysis.(5)we analyzed the factors of age,sex,single/bilateral onset and onset time,so as to find out whether it was related to collapse.Result:The study included 40 eligible cases(57 hips),20 cases(14 males and 6 females)in the treatment group and 29 hips(12 males and 8 females)in the control group.The average age of treatment group was 39.30 ± 9.90 years old,and that of control group was 43.25 ±11.58 years old.There were 22 hips in Steinberg stage ? and 6 hips in stage ? in treatment group,and 4 hips in stage II in control group.In the treatment group,there were 14 hips of hormone,11 hips of alcohol,3 hips of other factors,15 hips of hormone,7 hips of alcohol and 7 hips of other factors in the control group.Follow-up in both groups there was no significant difference in pre-Steinberg staging(P=0.682).Before follow-up,Harris score was 86.79 ±7.56 in the treatment group and 87.83 ±5.26 in the control group.There was no significant difference in Harris score between the two groups before follow-up(P=0.948).(1)There was no collapse of femoral head in both groups before treatment.After treatment,5 hips collapsed in treatment group and 20 hips in control group.The survival rate of the treatment group was 82.14%and that of the control group was 31.03%.The difference was statistically significant between the treatment group and the control group(P=0.000).(2)In terms of hip function,the Harris score before treatment was 86.79 ±7.56 in the treatment group,and the Harris score was 91.93 ± 7.69 at the end of follow-up.The difference was statistically significant(P=0.04),and the score after treatment was higher than that before treatment.The Harris score before treatment was 87.83 ±5.26 in the control group,and the Harris score after treatment was 68.96 ±14.07.There was significant difference before and after treatment(P=0.000).The pre-treatment score was lower than that at the end of follow-up.The Harris score was significantly different between the two groups at the end of follow-up(P=0.000).The treatment group was superior to the control group.(3)In terms of safety,there was one case with abnormal liver function in the treatment group,and no adverse events such as abnormal liver and kidney function were recorded in the control group.There was no significant difference between the two groups in the occurrence of adverse events(P=1.000).(4)The survival time of the femoral head in the two groups was analyzed by Kaplan-Meier,and the estimated survival time of the femoral head in the control group was 10 months.The survival time of the femoral head in the treatment group was right censored,that is,the expected survival time of the femoral head in this group was greater than the follow-up time(2 years),and the Log Rank test(P=0.000,P<0.05,)The difference between the two groups was statistically significant,and the survival time of the treatment group was longer than that of the control group.(5)Analysis of influencing factors of collapse in treatment group:The causes of collapse of treatment group were compared with that of male(19.05%)and female(14.29%)(P=0.000,P<0.05).Compared with age group,the age of 25-45 was 19.05%,the age of 45 was 14.29%,there was no significant difference(P= 0.000,P<0.05).There was no significant difference in the collapse rate between the two sides(25%),the left side(16.67%)and the right side(0.00%),and there was no significant difference between the two sides(P=0.393 P>0.05).The collapsing rate among different stages was 7.14%of hormone,28.57%of non-hormone,The difference was not statistically significant(P=0.326 P>0.05).The collapse rate in different stages was higher than that in stage ?(13.63%)and stage ?(33.33%).The difference was not statistically significant(P=0.285 P>0.05).The collapsing rate between different types was 21.74%for the lateral column,but not for the lateral 0.00%.The difference was not statistically significant(P=0.550 P>0.05).The three columns involved 18.14%and the non-three columns involved 16.67%.The difference was not statistically significant(P=1.000 P>0.05).Conclusion:1.Invigorating spleen and tonifying kidney can effectively prevent and delay the occurrence of avascular necrosis of femoral head in the early stage of collapse.2.Invigorating the spleen and tonifying the kidney can relieve the clinical symptoms of the patients with necrosis of the femoral head and improve the hip function of the patients.3.The side effect of Jianpi Bushen prescription is less,and clinical application is relatively safe. |
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