The Research On Constructing The Multidimensional Assessment System Of Curative Effect In Treating SLE With Traditional Chinese Medicine

ObjectivesThis project used the international efficiency ICF system to establ-ish a multidimensional assessment system of curative effect in treating SLE with traditional Chinese medicine (TCM) including the SLE diseae activity index (SLEDAI),The MOS 36item short-form health survey (SF-36), fatigue severity scale(FSS), traditional Chinese medical symptom score (TCMSS), glucocrticosteroid dosage score(GCS), glucocrticosteroid side effect score(GCSES). At the same time, this RCT trail using LangchuangⅡCapsule to cure the active lupus selected and optimized the multidimensional assessment system of curarive effect from a multi-time points and multi-effect points which can manifest the characteristic and the advantage of Chinese medicine in treating SLE. This study would verify the advantage of Chinese medicine of curing SLE so that it can play a more important role in the combined treatment of SLE and make up for the inefficiency of evaluating Chinese medicine in treating SLE. Also, this trail has the realistic meaning of popularizing the Chinese medicine in treating SLE. Through the analysis of the multidimensional assessment, the study seeks for the regulation of using Chinese medicine to decrease even cease the use of glucocrticosteroid (GC) and is trying to use GCS to directly evaluate the effect and influence of using combining TCM treatment to decrease the side effect of GC.Methods1. according to the results of literature and the review of the design of the clinical trails of SLE all over the world, evaluate the advantage and disadvantage of the worldwide SLE active index scale systematically. The SLE multidimensional assessment system of curative effect should include the following scales:SLEDAI, GCS, GCSES, FSS, SF-36 and TCMSS scale.2. Through the prospective, multi-center, randomized controlled trails to verify the assessment System of TCM effect, the trail has recruited 66 active SLE patients(Chinese medicine combine GC group had 33patients and the basic treatment group had 33patients) and discuss the scale and the corresponding evaluating time point of different outcome evaluating level. After recruiting, different researchers would evaluate all the above scales repeatedly at different point. There are 7 time points which are before the treatment and 4,8,12,16,20,24 weeks after the treatment.3. According to the results and through the clinical trail of multi-dimensional, multi-time points Assesssment System for TCM Effect, w e analyzed all the data (All the data has been analyzed by SPSS13.0.) and selected the indexes。The principle of the selection is to pay mo re attention to the importance, sensitivity, representativeness and t he certainty of the indexes and at the same time, we should also cons ider the operability and acceptability. We used the activity analysis, Correlation Coefficient analysis, Principal constituent Analysis and F actor analysis and combined these analysis with the professional know ledge. Finally, we verified the index of the assesssment System of TC M effect and formed the multidimensional assesssment System of TCM ef feet in curing SLE.ResultThis multi-center randomized controlled clinical trail evaluated the effect of "LangchuangⅡCapsule" in curing the mild and moderate active SLE using SLEDAI, TCMSS, GCS, GCSES, FSS, SF-36 scale. The results of all scores of different scale before and after the treatment at the different time point and the overall effect between two groups have no statistical significance (P>0.05), which is probably related to the small specimen. According to the tendency chart, it revealed that long term of taking "LangchuangⅡCapsule" has advance in improving the SLEDAI score, TCMSS score and stabling the patients among the mild and moderate active SLE compared with western medicine group. Under the condition of same dosage of GC in two groups, the TCM group has the tendency to decrease the side effect of GC. At the same time, the trail showed that two groups are accordant in GC dosage of mild or moderate active SLE patients. The change of GC dosage adjusted depending the patients'condition and the decrease of the score revealed the validity of the treatment. Therefore, there is the conclusion that it is necessary to discuss the relationship between other scales and the glucocrti-costeroid score which is the index reflecting the change of disease in the assesssment System and also can provide the evidence of the assesssment System.The trail did the Responsiveness Analysis with rank test through the subject contrast of two isolated groups at different time points before and after the treatment. The results showed that in the TCM group:①responsiveness of SLEDAI is more sensitive at 4-8 weeks after the treatment;②TCMSS is more sensitive at 4-12weeks after the treatment;③SF-36 is more sensitive at 16-24 weeks after the treatment④GCS has good sensitivity during 4-24 weeks of the treatment；⑤GCSES only has good responsiveness at 4 weeks after the treatment and the responsiveness of FSS is only has good responsiveness at 24 weeks after the treatment (P<0.05).Through the multiple linear regression and the standardized regret-ssion coefficient analysis of the GCS at different time points, the results showed that the scales relative with the GCS at different time points in the TCM group are:before the treatment is SLEDAI and FSS;4 weeks after the treatment is TCMSS;12 weeks after the treatment:SLEDAI, FSS, SF-36;16 weeks after the treatment is SLEDAI, FSS, SF-36; 20 weeks after the treatment is SLEDAI, GCSES, SF-36; 24 weeks after the treatment is SLEDAI, TCMSS, SF-36(all the standardized regression coeficien are P<0.05). Make the standardized regression coefficient as the weight standard of influence on GCS and sequence the weight standard at the same time point of each scale. The correlativity of all the weight standard of influence on GCS at each time point are sequenced from much to litte:4 weeks after treatment:TCMSS;8 weeks after treatment:SESCT, FSS, TCMSS; 12-16 weeks after treatment;SLEDAI, SF-36, FSS; 20 weeks after treatment: SLEDAI, SF-36, GCSES; 24 weeks after treatment:SLEDAI, SF-36, TCMSS.Based on the evaluation scale we selected from each time point in the TCM group, we do the further analysis to discuss the important items which influence the change of the TCM treatment in the scale. Through the Pearson correlation analysis and the exploratory factor analysis of all the items and the total score in the scale, we got the following results:among the evaluation scales at each time point before and after the treatment, the main items which influencing the different total scores change in the different scales are TCMSS scale:dry mouth and sore throat, fatigue, limp aching lumbus and knees, vexing heat in the five hearts, macule and arthralgia; SLEDAI scale:hematuria, proteinuria, pyuria, leukocyte-openia and hypocomplementemia; GCSES scale:hairy, Moon face, buffalo back, acne, hypertension and osteoporosis; the main territories of SF-36 scale which influencing the total score of SF-36 are:emotional role, vitality, physical role and physical function; the sensitive time point of each item before and after the treatment in the FSS has great relation-ship with the composition of the total score. The Pearson correlation coefficient between the above items and the total score of the scales is above 0.4(P<0.05) which indicates the great correlativity.Conclusion:1. The initial construction of the E assessment system:The clinical trails using TCM to treat the mild and moderate active SLE should choose the different evaluation index system depending on different object and time. At the valuation study about short-term effect(4-8 weeks):we can choose SLEDAI scale as the evaluation index to observe the active change of the clinical symptoms; TCMSS can be the evaluation index to observe the change of the TCM patterns so that it can be the alternative index of the effect at 4-12 weeks after the treatment of the mild active SLE. GCSES can be the evaluation index while observing the side effect and complications of GC on the 8th week. At the Evaluation study about Medium-term effect(12-16 weeks):SLEDAI can be the evaluation index to observe the active change of the clinical symptoms and SF-36 can be the evaluation index of living quality. At the Evaluation study about long-term effect(20-24 weeks):Moderate SLE can choose SLEDAI scale as the evaluation index to observe the active change of the clinical symptoms; SF-36 as the evaluation index to observe the change of the patients'living quality, its emotional role, vitality, physical role and physical function are the important evaluation points. FSS can be the evaluation index to observe the condition of fatigue in the 24th week, the GCSES can be the evaluation index to observe the side effece of the GC in the 20th week. Mild active SLE had better choose SF-36 to be the evaluation index which can reflect the change of living quality.2. Adjusting the dosage of GC according to the change of total scores of evaluation index of effect:mild and moderate active SLE patients:we should adjust the dosage of GC according to the change of the score of SLEDAI or TCMSS combining the score of GCSES at 4-8 weeks after the treatment, and according to the change of the score of SF-36 combining the GCSES at 12-24 weeks after the treatment, moderate active SLE patients: should adjust the dosage of GC according to the change of total score of SLEDAI, and should adjust the dosage of GC according to the change of total score of TCMSS at 4 weeks after the treatment.3. Primary Conponent Analysis of each scale:based on Analysis, all the main items of different scales are related with the subjective f eeling and physiological sensation, therefore, we can deduce that in the assesssment System of treating mild and moderate active SLE with TCM, the relative items reflecting the patients'subjective feeling and physiological sensations are the major parts of the assesssment S ystem of TCM effect.In this trail, the main items influencing the composition and cha nge of the SLEDAI score includes hematuria, proteinuria, pyuria, hypo complementemia and leukocytopenia. Combining the change of TCMSS, th e major items are macule and arthralgia. Therefore, it is deduced tha t in the yin deficiency and inner heat pattern of mild and moderate a ctive SLE patients, kidney damage, immunology, blood system, macule a nd arthralgia are related with the condition of the disease according to whose change of score we can adjust the glucocrticosteroid dosage.