A Clinical Research On The Treatment Of Psoriasis Vulgaris In Stationary Stage Blood Dryness Syndrome,Blood Stasis Syndrome With Calm-the-Mind-And-Relieve-Itching Formula

Objective:This study adopt random,double blind,placebo controlled method,used internationally recognizedPASI,Psoriasis patients life quality scale(PQOLS scale)and evaluate Calm-the-Mind-and-Relieve-Itching Formula treating efficacy and safety of psoriasis vulgaris in stationary stage of blood dryness syndrome and blood stasis syndrome.Methods:1.Research methods:Using SAS statistical software according to experimental group and the control group 2:1 ratio produce drugs were blind coded with random number table,drug in accordance with code for distribution packaging,the blind end of the cross by the hospital GCP center save and has nothing to do with the test of hospital GCP Center staff completed knitting blind and emergency letters drugs preparatory work,including drug by the random coding and blind after the number of drugs is a random number.According to the random number table of random coding and blind to the drugs,researchers and patients from beginning to end in the blind state.2.Therapeutic method:The test group of blood dryness syndrome takes NO.1 recipel,including Raw Os Draconis 30g,Calcined Concha Osterae 30gConcha Margaritifear 30g,Magentitum 30g,Petiolus Trachycarpi30g,Radix Sanguisorbae 30g,Radix Angelica Sinensis 10g,Radix Rehmanniae Preparata 10g.The control group of blood stasis syndrome takes N0.2recipel including Raw Os Draconis 30g.Calcined Concha Osterae 30gConcha Margaritifear 30g,Magentitum 30g,Petiolus Trachycarpi30g,Radix Sanguisorbae 30g,Common Burreed Rhizome 10g,Rhioxma Curcumae Aeruginosae 10g.The control group is zedoary,simulation agent,main components of maize starch,dextrin,pigment,bitters,there was no difference in appearance,shape,taste,smell,packaging with test group and no therapeutic effects and side effects on psoriasis vulgaris.Two groups were treated with boiling water about 400ml a day,2 times/day,use of 200ml.after meals,for 12 weeks.3.Observation methods:the patients after the first diagnosis and treatment of 4 weeks,8 weeks,12 weeks respectively,fill out the observation records,records of psoriasis area and lesion severity index(PASI score),psoriatic patients quality of life scale(PQOLS scale),TCM syndrome scale for patients with psoriasis,ask medication adherence and record adverse reactions.4.Efficacy was evaluated by investigator observation and patientself-assessment before and after the therapy.Efficacy criteria refer to PASI score,evaluation of quality of life refer toPQOLS scale and TCM syndrome scale for patients with psoriasis.5.Safety was evaluated by recording patients' blood,urine,liver and kidney function,safety class and the occurrence of adverse reactions.6.Statistical methods:Using SAS6.12 Statistical software,P<0.05 means significant.Result:1.The PASI score improvement:experimental group and control group after treatment of 4 weeks.PASI score is no significant difference.P>0.05;8 weeks after the PASI score comparison have significant difference.P<0.05;After 12 weeks after treatment PASI score has a very significant difference.P<0.01;Comparison(and 0 weeks)in the group,experimental group 4 weeks after treatment,PASI score was no significant difference,P>0.05,8 weeks after the PASI score comparison have significant difference.P<0.05;After 12 weeks after treatment PASI score has a very significant difference,P<0.01.Subgroup analysis different TCM syndrome types each visit viewpoints PASI score changes,blood dryness syndrome,blood stasis group 4 weeks,8 weeks,12 weeks after treatment there was no significant difference PASI score,P>0.05).Group comparison(and 0 weeks),blood dryness syndrome groups 8 weeks after treating PASI score comparison have significant difference,P<0.05;12 weeks after treatment PASI score comparison has a very significant difference,P<0.01;Blood stasis group 8 weeks,12 weeks after treatment PASI score comparison,there are significant difference,P<0.05).2.PQOLS score improvement:experimental group PQOLS score comparison of experimental group comparing different dimension PQOLS score and PQOLS scores before and after treatment,there are significant difference,P<0.05,suggesting that the town of mind method from physical,psychological,illness,three dimensions to improve symptoms and quality of life of patients with psoriasis vulgaris.PQOLS score comparison,control group before and after treatment only psychological dimensions have significant difference,P<0.05,the experimental group and control group at 0,4 weeks,comparing different dimension PQOLS score and total score no significant difference.P>0.05.in weekly intra-articular 8 dimensions PQOLS score and total score comparison,there are significant difference,P<0.05,in the 12th weekly intra-articular dimension,disease dimension PQOLS score and total score,there are significant differences.P<0.05).Comparison group,experimental group weekly intra-articular 8 dimensions,psychological dimension PQOLS score and total score compared with 0 weeks,there are significant difference,P<0.05,12 weeks each dimension PQOLS score and total score compared with 0 weeks,there are significant difference.P<0.05).Subgroup analysis,blood dryness syndrome and blood stasis group at 0,4 weeks,8 weeks,12 weeks PQOLS score and total score to compare different dimensions,no significant difference,P>0.05).Within the group to compare(compared with 0 weeks),blood dryness syndrome in different dimensions 8 weeks,12 weeks PQOLS score and total score comparison have significant difference,P<0.05;Blood stasis in 8 weeks psychological dimension PQOLS score and total score comparison have significant difference,P<0.05;Comparing different dimension PQOLS score and total score in 12 weeks have significant difference,P<0.05.3.Improvement of syndromes:blood dryness syndrome of TCM syndrome integral,experimental group and control group in 8 weeks after treatment of TCM syndrome integral comparison have significant difference,P<0.05;After 12 weeks after treatment of TCM syndrome integral comparison has a very significant difference,,P<0.01.With the passage of time,the experimental group with various syndromes are improved to varying degrees,especially in dry itchy,scaly,GanYan dry mouth to improve is most obvious.4 weeks,8 weeks itch integral improvement have significant difference,P<0.05,12 weeks itching integral improvement has a very significant difference,P<0.01;Dry scales,GanYan dry mouth in 4 weeks,8 weeks of integral improvement have significant difference,P<0.05).Blood stasis of TCM symptoms integral,experimental group and control group in 8 weeks after treatment of TCM syndrome integral comparison have significant difference,P<0.05;After 12 weeks after treatment of TCM syndrome integral comparison has a very significant difference,,P<0.01.With the passage of time,the experimental group with various syndromes are improved to varying degrees,especially in the itching,skin hypertrophy improved significantly.4 weeks,8 weeks itch integral improvement have significant difference,P<0.05,12 weeks itching integral improvement has a very significant difference,P<0.01;Skin hypertrophy in 8 weeks improved integral have significant difference,P<0.05,12 weeks to improve has very significant difference,P<0.01).4.The total effective rate comparison:with evaluation method for the Calm-the-Mind-and-Relieve-Itching Formula the overall efficacy of treatment for 12 weeks with psoriasis vulgaris,the result shows:the treatment group 81 examples,the 12 patients,47 cases were markedly effective,improvement in 29 cases,12 cases ineffective,the total effective rate was 85.19%;Control group 40 cases,1 case,16 cases were markedly effective,6 cases,18 cases ineffective,the total effective rate was 25.00%.Two groups total effective comparative difference was very significant difference,P<0.01).Each visit viewpoints efficient compared two groups,two groups of 4 weeks,8 weeks after treatment curative effect of comparative differences are statistically significant(P<0.05.Comparing different TCM syndrome types efficiently,blood dryness syndrome groups:experimental group 44 patients with,including the 7 cases,15 cases were markedly effective,improvement in 16 cases,6 cases ineffective,the total effective rate was 86.34%;Control group 20 cases,1 case,2 cases had marked effect,improvement in 3 cases,14 cases ineffective,the total effective rate was 30.00%,two groups of curative effect comparison difference was statistically significant,P<0.05).37 cases of patients with blood stasis syndrome group:test group,of which the more base in 5 cases,12 cases were markedly effective,improvement in 14 cases,6 cases ineffective,the total effective rate was 83.78%;Control group 20 cases,0 cases,1 case had marked effect,improvement in 3 cases,16 cases,the total effective rate was 30.00%,two groups of curative effect comparison difference was statistically significant,P<0.05).In addition,the visit to view different TCM syndrome types efficiently,blood dryness syndrome and blood stasis group in 4 weeks,8 weeks,12 weeks of efficient comparative differences were not significant,P<0.05).Conclusion:Calm-the-Mind-and-Relieve-Itching Formula treating psoriasis vulgaris in stationary stage of blood dryness syndrome and blood stasis syndrome is effective,and the security is high,worthy of further research and promotion.Innovative Points:Innovation proposed the etiology and pathogenesis of psoriasis vulgaris for hyperactivity of heart fire,mind disorders.Put forward the principle of treating psoriasis vulgaris----Suppress-The-Heart-and-Calm-The-Mind Method.This study adopt random,double blind,placebo controlled method,used internationally recognizedPASI,Psoriasis patients life quality scale(PQOLS scale)and evaluate Calm-the-Mind-and-Relieve-Itching Fonnula treating Psoriasis vulgaris in stationary stage of blood dryness syndrome and blood stasis syndrome.