Experimental Research Of YinXieLing Capsule With Orthogonal Design And Clinical Scoutingtest

BackgroundPsoriasis is a common, genetic, inflammatory, multisystem, T-cell interaction disease with pathognesis has not been completely defined. Nowadays without any drug can cure Psoriasis completely. It is objectivity neeed to find some safey drugs witch may confer less rik and side sffects. Traditional Chinese Medicine (TCM) with longterm effectiveness, but less side sffects and toxicity,can improve patient's quality of life. TCM has widely application prospect.ObjectiveTo find the best formulation composition of Yinxieling Capsule. Research into the relevance of syndrome type of TCM with sverity and stag of psoriasis. Understand the distribution of syndrome type of TCM in the population, in order to offer reference of using the optimize of Yinxieling Capsule.Evaluate the safety and efficacy of the optimize of Yinxieling Capsule.Methods1. Experimental research:Establish different segments or pathology model, such as itching animal model and mouse tail model for doing optimization operations. To made model of pruritus by the method of inducing endogenous histamine releasing in the using of dextran-40, To observe the time (latent time) of the first time scratching after giving dextran-40 in Jimpy mice and frequency of scratching in 30min. To give histamine phosphate by endermic injection at the same time giving yiwensi physiologic saline to dye skin of Jimpy mice' hypogastric zone, to cut blue-stain skin and to survey areas. Used a mouse tail model, to counter the number of scales which contained the granular cell in lines consecutively 100 scales. Arrange experiments with the orthogonal design. Tweleve experiments were carried out by L12 (211) orthogonal design. Screening the best optimization named The Optimization of YinXieLing Capsule. Then verification its effect with YinXieLing Capsule.2. The clinical epidemiological investigation:TO study the 280 psoriasis vulgaris patients'questionnaires with cross-section survey method. The questionnaires make up with 3 parts:common conitions, pysician-assessed outcomes and patient-reported outcomes. SPSS13.0 for windows Chi-square test, Rank sum test, ANOVA test and multiple logistic regression analysis, Bivariate Correlations were used in this research.3. Clinical scoutingtest:A descriptive research study design was used in this study.22 patients with psoriasis vulgaris were bring into this study. The observation has been lasting 2 months. Record PASI DLQI and adverse event every month after The Optimization of YinXieLing Capsule treatment.Results1. Experimental research:1.1 Latent time of yinxieling Capsule group in low,middle or high dose are obviously longer than blank group, but frequency of scratching obviously decrease (p<0.01) among the total, There are not obviously difference among yinxielingpian group in middle or high dose and chlorphenamine group, wheal area of dyeing skin of Jimpy mice'hypogastric zone in high group obviously decrease than blank group(p<0.05), but not obviously difference between high dose and chlorphenamine group. Latent time,frequency of scratching and wheal area all outstrip yindipian.1.2 There were highly statistically significant compared each dosage of YinXieLing Capsule with negative control group(P<0.01). Compared the Methotrexate group, no statistically significant difference was found with the highest, higher and medium dosage groups. Also the Diyin film group compared with medium and lower dosage groups (P>0.05). Even more scales were found by the highest, higher and medium dosage groups than Diyin Capsule group (P<0.01). And compared with each dosage of YinXieLing Capsule, the highest, higher and medium dosage groups were highly statistically significant with the lower dosage group(P<0.01). But no statistically significant difference in themselves(P>0.05). 1.3 The Optimization of YinXieLing Capsule is made into Raix Paeoniae Rubra,Fructus Mume,Rhizoma Curcumae,Glabrous Greenbrier Rhizome,Radix Paeoniae Rubra,Chloranthus spicatus (Thunb.) Makino, Radix Glycyrrhiza.1.4 There were highly statistically significant compared YinXieLing Capsule and The Optimization one with negative control group(P<0.01). Compared YinXieLing Capsule group, no statistically significant difference was found with The Optimization one(P>0.05).2. The clinical epidemiological investigation:Laws of poriasis vulgaris patients with diseases card type of traditional Chinese medicine in the distribution of the results of this survey:blood stasis syndrome and the stationary phase of psoriasis vulgaris is the most common, with 69% and 58%. different syndrome types of traditional Chinese medicine(TCM) has different outcomes. Correspondence analysis has been taking into Syndrome types of TCM and the phase of psoriasis vulgaris. blood stasis syndrome has relationship with the stationary phase. Wind-heat with development phase, and blood-dryness with fade phase.3. Clinical scoutingtest:3.1 Intention to treat analysis:22 patients finish the test, according to the enquiry and the patients'getting records,95% of the statistics Intention to treat analysis well.3.2 Treatment Efficacy:14% of the patients achived PASI-75 after one month treatment, and PASI-50 is 43%,28% average improved.10% of the patients achived PASI-75 after one month treatment, and PASI-50 is 30%,12% average improved. There were highly statistically significant compared after 1 month and 2 months treatment with before (P≤0.05). After I month treatment 10% improved in DLQI and 12% after 2 months.3.3 Safety Evaluation:The experiment has not been observed in all cases of sickness, diarrhea and vomiting have no adverse events, preliminary showed good Safety.ConclusionYinxieling Capsule have better alleviating itching effect. The formation of granular cell of mouse tail was significantly promoted by each dosage group of YinXieLing Capsule. The Optimization of YinXieLing Capsule has less drug but same effects. According to The clinical epidemiological investigation:Blood stasis syndrome and the stationary phase of psoriasis vulgaris is the most common, with 69% and 58%. different syndrome types of TCM has different outcomes. Correspondence analysis has been taking into Syndrome types of TCM and the phase of psoriasis vulgaris. blood stasis syndrome has relationship with the stationary phase. Wind-heat with development phase, and blood-dryness with fade phase.In this 2 months study the Optimization of YinXieLing Capsule reulted in significant improvements in clinical end points in patients with this study.