The Standardized Research On Indications Of Herb Therapeutic And Symptoms Of Traditional Chinese Medicine Of Femoral Head Necrosis

The clinical research in this article is divided into two parts, in the first part, we will aim the standardized research on syndrome type and symptoms characteristics of traditional Chinese medicine(TCM) of femoral head necrosis, the second part will aim the standardized research on indications and effect evaluation of herb therapeutic of femoral head necrosis.Part1The standardized research on syndrome type and symptoms characteristics of traditional Chinese medicine of femoral head necrosisObjectiveTo filter characteristic clinical syndrome points outside of the common syndrome in the use of the clinical epidemiological investigation from the patients suffered from femoral head necrosis, combined with statistical methods, to establish the TCM syndrome and syndrome type system of scientific and practical.MethodsFrom July2008to October2011,532patients whose suffered from femoral head necrosis were collected complete information from department of orthopaedics in First Affiliated Hospital of Guangzhou University of TCM, including458cases retrospective analysis,74cases prospective analysis, the average age of42.31±12.03years, to investigate the cases according to 'clinical cases questionnaire of TCM syndrome epidemiological', and take the blood from74cases prospective study of patients for laboratory tests, to get the syndrome distribution characteristics of femoral head necrosis, and extract relevant data, after statistically, initial screening of the different indicators between the different syndrome types, adopting Person correlation analysis and logistic regression analysis, according to the size of the P-value as a measure standard of syndromes with primary and secondary, establishing diagnostic model of symptoms of TCM, finally, using assessment method of diagnostic tests to verify the model predictive ability. To provide a dialectical basis for diseases and syndromes contemporary treatment of femoral head necrosis.ResultsAccording to original diagnostic criteria of syndrome type, the epidemiol-ogical survey results show that the male to female ratio was2.67.(1)Qi stagnation and blood stasis type:105cases, common in50to59years, semi-manual workers, a higher distribution proportion in traumatic femoral head necrosis,'No obvious sclerosis and uneven density of femoral head' is the main performance of the X-ray,'two grade joint effusion'is the main performance of the MRI. By Person correlation analysis and logistic regression analysis, Joint pain, The main performance of the X-ray, Dark tongue, Joint sting, Petechiae at the edge of the tongue, The main performance of the MRI are the main syndrome of the Qi stagnation and blood stasis type(P<0.01). Sore fixed, Limited joint mobility, Inguinal tenderness, Upset, Pulse string, White fur are the secondary syndrome of the Qi stagnation and blood stasis type(P <0.05). Prediction accuracy rate was91.9%, Youden's index is0.684.(2) Deficiency of the kidney and blood stasis type:222cases, common in16to29years,≥70years, semi-manual workers, a higher distribution proportion in Steroid-induced femoral head necrosis, FPS-R mainly shows C-level pain,'Continuous sclerosis of femoral head'is the main performance of the X-ray,'Zero/two grade Bone marrow edema and Zero/one/three grade joint effusion' are the main performance of the MRI. Serum200/S,30/S,3/S, Arbe and EPT index count value are higher than the other two syndrome type, there was considered statistically significant. By Person correlation analysis and logistic regression analysis, Joint pain,'Continuous sclerosis of femoral head'of the X-ray, fatigue,'two grade Bone marrow edema'of the MRI, White fur, Hot flushes and night sweats, Pulse breakdown are the main syndrome of the Deficiency of the kidney and blood stasis type (P<0.01). Joint heavy, Insomnia, lumbar acid,'three grade joint effusion'of the MRI, Serum3/S t,200/S t are the secondary syndrome of the Deficiency of the kidney and blood stasis type(P<0.05). Prediction accuracy rate was79.7%, Youden's index is0.581.(3)Phlegm and Stasis Accumulation type:205cases, common in40to69years, manual and mental workers, a higher distribution proportion in Alcohol-induced femoral head necrosis, FPS-R mainly shows D-level pain,'sclerosis and cystic of femoral head'is the main performance of the X-ray,'One/three grade Bone marrow edema and one/three grade joint effusion'are the main performance of the MRI. Serum CHOL, TG, ApoB and ApoA, HDL, contrast to the Qi stagnation and blood stasis type and ApoA, HDL contrast to the Deficiency of the kidney and blood stasis type, there was considered statistically significant.By Person correlation analysis and logistic regression analysis, Joint pain, Walking fatigue, Joint heavy, Tongue pale, Greasy fur,'sclerosis and cystic of femoral head'of the X-ray,'three grade Bone marrow edema'of the MRI are the main syndrome of Phlegm and Stasis Accumulation type (P<0.01). Upset, Slippery pulse,'one grade joint effusion'of the MRI, slow pulse, Serum ApoB↑, HDL↓are the secondary syndrome of Phlegm and Stasis Accumulation type (P<0.05). Prediction accuracy rate was82.5%, Youden's index is0.630.ConelusionUse of clinical epidemiology survey and statistical research methods, initial filter characteristic clinical syndrome points of femoral head necrosis. Including the performance of the imaging and characteristics indicators of laboratory tests. Combined with four diagnostic content of TCM of femoral head necrosis. Establishing diagnostic model of symptoms of TCM which combined with macro and micro indicators for improving the accuracy of the diagnosis and treatment and laiding the foundation for an accurate assessment of the clinical efficacy. Part2The standardized research on indications and effect evaluation of herb therapeutic of femoral head necrosisObjectiveThe aim of this study was to evaluate the clinical efficacy of herb therapeutic of femoral head necrosis and analyse the influence of prognostic factors for femoral head survival.MethodsIn this retrospective study the follow-up of91patients with133osteonecrotic femoral heads treated with herb was assessed between Jule2009and May2011. The average age at the time of the treatment was38.81±11.99years.All patients were available for follow-up at a mean of14.04±6.77months. Including31cases Qi stagnation and blood stasis type,37cases Deficiency of the kidney and blood stasis type and23cases Phlegm and Stasis Accumulation type; According to the ARCO classification system,11hip had stage-Ⅰ disease,43hips had stage-Ⅱ disease(Based on the existence of the subchondral fracture from CT,31hips had stable-stage-Ⅱ and12hips had unstable-stage-Ⅱ disease),58hips had stage-Ⅲ disease and21hips had stage-Ⅳ disease;Outcome measures that were used included a FPS-R score,a limb-specific score (Harris hip score), SF-36score, radiographic outcome measures, and survivorship analysis with femoral head collapse)4mm as the end point. Multivariate analysis was performed with use of the Cox proportional hazards model with censoring to identify the independent prognostic factors associated with clinical and radiographic failure for exploring the indications of herb therapeutic of femoral head necrosis.ResultsSeven hips were converted to a surgery at an average of14.04±6.77months (range, two to twenty-nine months) after treatment with herb.(1) Total evalu-ation of three syndrom types:The mean FPS-R within the survivor group after treatment with herb decreased post-treatment during follow-up from2.51±1.95to1.03±0.99(there was considered statistically significant, P<0.01)(2) Total evaluation of three syndrom type:The mean HHS within the survivor group after treatment with herb increased post-treatment during follow-up from81.04±13.79to88.61±8.91(P<0.01). Independent evaluation of three syndrom type:The mean SF-36score within the survivor group after treatment with herb contrast to post-treatment, there was considered statistically significant (P<0.01).(3) Radiographic progression occurred in49cases59hips after treatment with herb.6cases7hips showed progression on the pre-treatment (54hips without collapse) radiographs, including4cases4hips with collapsed <4mm,2cases3hips with collapse≥4mm;43cases52hips showed progression on the pre-treatment(79hips with collapse) radiographs, including19cases 24hips with collapse<4mm,22cases28hips with collapse≥4mm.①Pain time<12months,3hips (7.5%) showed progression on the pre-treatment (40hips without collapse) radiographs,16hips (51.6%) showed progression on the pre-treatment (31hips with collapsed) radiographs;≥12months,4hips (28.6%) showed progression on the pre-treatment(14hips without collapse) radiographs,36hips (75.0%) showed progression on the pre-treatment(48hips with collapse) radiographs.②Necrosis shape of central type,9hips showed no progression on the radiographs; Necrosis shape of Peripheral type,7hips (15.6%) showed progression on the pre-treatment(45hips without collapse) radiographs,52hips (65.8%) showed progression on the pre-treatment (79hips with collapse) radiographs.③Necrosis area(necrotic zone volume ratio)≤30%,1hips (3.3%) showed progression on the pre-treatment(30hips without collapse) radiographs,6hips (46.2%) showed progression on the pre-treatment(13hips with collapse) radiographs;30～40%,1hips (5.9%) showed progression on the pre-treatment(17hips without collapse) radiographs,23hips (63.9%) showed progression on the pre-treatment(36hips with collapse) radiographs;≥40%,5hips (71.4%) showed progression on the pre-treatment (7hips without collapse) radiographs,23hips (76.7%) showed progression on the pre-treatment (30hips with collapse) radiographs.④ARCO classification stage-Ⅰ,11hips showed no progression on the radiographs; stable-stage-Ⅱ,3hips (9.7%) showed progression on the pre-treatment (31hips) radiographs;unstable-stage-Ⅱ,4hips (33.3%) showed progression on the pre-tr eatment(12hips) radiographs; stage-Ⅲ,41hips (70.7%) showed progression on the pre-treatment(58hips) radiographs;stage-Ⅳ,11hips (52.4%) showed progression on the pre-treatment(21hips) radiographs.⑤JIC classification A type,3hips showed no progression on the radiographs;B type,1hips (4.2%) showed progression on the pre-treatment(24hips) radiographs;CI type,3hips (15.8%) showed progression on the pre-treatment(19hips without collapse) radiographs,30hips (62.5%) showed progression on the pre-treatment(48hips with collapse) radiographs;C2type,3hips (37.5%) showed progression on the pre-treatment (8hips without collapse) radiographs,22hips (71.0%) showed progression on the pre-treatment (31hips with collapse) radiographs.(4) Survivorship analysis with femoral head(collapsing>4mm as the end point): there were26cases31hips with collapsing≥4mm, The average failure time at the final follow-up was13.58±7.01months (range, two to twenty-eight months). The estimated survival rates were76.7%at final follow-up for hips, The average survivor time at the final follow-up was22.99±0.86months. The Cox proportional-hazards model revealed that Pain time,necrotic zone volume ratio and ARCO classification were prognostic factor related to Radiographic progression(collapsing≥4mm). The Kaplan-Meier survivorship curve revealed the results, as follows:①The survival rates were100%at painless,83.3%at≤three months,80.0%at three～six months,66.7%at six～twelve months and66.1%at≥twelve months. The log-rank test performed x2=22.69, P<0.01.②necrotic zone volume ratio, the survival rates were91.8%at≤30percents,77.4%at30～40percents, and56.8%at≥40percents. The log-rank test performed x2=13.68, P<0.01.③ARCO classification, the survival rates were100%at Stage-Ⅰ,96.8%at stable-stage-Ⅱ,75.0%at unstable-stage-Ⅱ,67.2%at stage-Ⅲ and61.9%at stage-IV. The log-rank test performed x2=20.13, P<0.01.④JIC classification, the survival rates were100%at A type,95.8%at B type,76.1%at C1type and64.1%at C2type. The log-rank test performed x2=15.95, P<0.01.⑤Necrosis shape, the survival rates were100%at central type and75.0%at Peripheral type. The log-rank test performed x2=3.95, P<0.05.ConclusionWe believe that this method can be suitable for right patients.The herb therapeutic of femoral head necrosis can resolve the pain, improve the functi-on and the quality of life. The indications of herb therapeutic of femoral head necrosis is:①Prerequisite for this method is FPS-F is a Class B or below, at the same time, Harris score is excellent, good or moderate.②Absolute indications:Necrosis shape of central type, JIC A/B type, or ARCO Stage-Ⅰ with painless, there is no significant relationship was found between the clinical efficacy and such factors as Pain time, Necrosis area, ARCO classification and Necrosis shape.③ARCO stable-stage-Ⅱ, the patients stopped to use of corticosteroids after suffered from femoral head necrosis, if painless, there is no significant relationship was found between the clinical efficacy and such factors as necrosis area, pain time, JIC classification and necrosis shape;if pain, it should be seen as unstable-stage-Ⅱ.④Relative indications:unstable-stage-Ⅱ, stage-Ⅲ and stage-Ⅳ, at the same time, necrotic zone volume ratio)<40%, Pain time<12months, JIC Cl type.