Clinical Study On The Treatment Of Early And Middle Stage Femoral Head Necrosis By Sanqi Jiegu Pill Combined With Fibular Column Support

Objective:The clinical effects of Sanqi Jiegu pill combined with fibula column support for early and middle femoral head necrosis were observed,hopefully to provide a clinical basis for optimizing the clinical treatment of femoral head necrosis and improving the treatment effect.Methods:According to the inclusion criteria of the subject,53 patients(58 hips)were selected from femoral head necrosis patients treated in Luoyang orthopedic hospital of Henan province from October 2016 to January 2018.All patients underwent SPECT/CT fusion imaging in addition to X-ray and MRI before surgery.Patients who met the inclusion criteria were numbered according to the order of hospitalization,and were randomly divided into the treatment group and the control group by the random number table method.Results showed that there were 27 patients in the control group(29 hips in total),and 26 patients in the treatment group(29 hips in total).Ruled out of surgery contraindications,complete removal of necrotic tissue in necrotic lesions,autologous iliac cancellous bone granule implantation and allograft peroneal column implantation were performed in the treatment group,and then at the second day after surgery,oral administration of the Sanqi Jiegu pill,manufactured uniquely by Luoyang Orthopaedic and Trumotology hospital,was started(6 g/time,3 times/day,take with warm water before meals),2 months for a period of treatment,drug use 3period of treatment.The patients in the control group were treated with the same surgical method.After the surgery,this drug was not taken.The other treatments were the same as those in the treatment group.Intravenous drip antibiotics were used to fight infection(no more than 2 days),intravenous drip was used to promote blood circulation and blood stasis,reduce swelling and promote water retention,and bone healing drugs were used together with physical therapy of both lower limbs.Postoperative wounds were regularly sterile dressing dressing(once every 2 days)until stitches were removed.The baseline data of the two groups of patients were observed and recorded preoperatively,and the patients in all two groups were followed up for at least 12 months postoperatively.Observe and record the two groups of patients in the preoperative Harris hip function score,NRS-11 hip pain score,and Bone metabolic markers and biochemical laboratory examination indicators reflecting osteogenesis ability and the state of total serum collagen typeⅠextended amino acid peptide(P1NP)measurements and determination of N-MID serum osteocalcin numerical results.The NRS-11 digital pain score and the progress of femoral head necrosis and collapse as shown by X-ray radiography at 3,6,9 and 12 months of postoperative follow-up were recorded respectively in the two groups.Harris scores at6,9,and 12 months of postoperative follow-up and the nuclide concentration values measured by SPECT/CT fusion images were recorded for each of the two groups.Respectively,bone metabolic markers in serum total extendedⅠtype collagen amino acid peptide measurements and N-MID serum osteocalcin numerical test results were also recorded for each of the two groups.The data obtained from the above research were used to establish a database.SPSS22.0 statistical software was used for statistical analysis of the data in the database.Results:When the success rate of"head preservation"treatment for femoral head necrosis was evaluated by X-ray radiography,the power of treatment composition was96.55%at the follow-up of 12 months,while the success rate of"head preservation"treatment in the control group was 89.66%.Statistical comparison analysis found that:(1)At the last postoperative follow-up(12 months after surgery),Harris score and NRS-11 pain score of the two groups were significantly different from those before surgery(Harris:t=10.548 P<0.01 in the control group,Harris:t=14.483 P<0.01 in the treatment group,NRS-11:t=10.722 P<0.01 in the control group,and NRS-11:t=12.640 P<0.01 in the treatment group).Harris score and NRS-11 score in the treatment group were both better than those in the control group at the last follow-up(12 months after surgery),(Harris score:t=2.094 P=0.041,NRS-11 score:t=3.300P=0.002).In addition,compared with the difference in preoperative efficacy between the two groups,the Harris score and NRS-11 score at the last follow-up were significantly better in the treatment group than in the control group(Harris difference:t=2.090 P=0.042,NRS-11 difference:t=2.433,P=0.019).Harris score and NRS-11pain score in the control group at 12 months of postoperative follow-up were not statistically significant compared with those at 9 months of follow-up(P=>0.05),but however,under the same comparison condition,the Harris score and NRS-11 pain score of the patients in the treatment group at 12 months after surgery were still better than those of the patients in the 9-month follow-up.(2)The differences in preoperative SPECT/CT fusion imaging nuclide concentration between the two groups were not statistically significant(t=0.835,P=0.407).At 6 months(t=2.274 P=0.027)and 12months(t=4.833,P<0.01),the SPECT concentration in the treatment group was significantly higher than that in the control group,but at 9 months(t=0.769,P=0.445).Compared with control group,the SPECT/CT fusion imaging rate was statistically significant(X~2=6.870,P<0.05).(3)Treatment group patients were followed up for 6months after surgery,and serum total at the time of follow-up after extendedⅠtype collagen amino acid peptide and N-MID serum osteocalcin content was better than the control group patients serum levels(P<0.01).Conclusion:This clinical study found that compared with the control group treated only with the removal of necrotic bone in focus area and the foreign body fibula column implantation,the treatment group treated with the traditional chinese medicine Sanqi Jiegu pill after the surgery presented obvious advantages in terms of efficacy,and this combination therapy is effective in improving the function of the affected hip,alleviating pain,enhancing the osteogenic ability in the patient and improving the prognosis of femoral head necrosis treatment.However,femoral head collapse and secondary hip arthritis still occurred in the treatment group after surgery,and they were still forced to receive total hip replacement.In this clinical study,it was found that Sanqi Jiegu pills,a traditional Chinese medicine for promoting blood circulation and removing blood stasis,and tonifying kidney,bone and marrow,could increase the content of total type 1 collagen amino acid prolonging peptide and n-mid osteocalcin in the serum of patients,which was beneficial to the formation of human bone.