| Objective:to evaluate the curative effect and the safety generally on clinical studies for psoriasis vulgaris with ku bi chun xiao yin fang.Method:1. divide patients into two groups of test team (ku bi chun xiao yin fang) and control team (capsule of compound recipe Qingdai) in successively order.2. therapeutic method:36 cases in test team take 100ml juice orally which coming from ku bi chun xiao yin fang for two times everyday at morning and night; 36 cases in control team take four capsules for three times everyday. Both teams take medicine in half hours after meals. The course of treatment is eight weeks, return visit for every two weeks, to observe and record index.. Neither medicine whose effect is similar to those in research nor other correlated therapy can be put into practice in treatment period. 3.observation index: observation of curative effect include lesion part and limit, erythema , scale,infiltrative degree and the changes after therapy. safe index: all cases have to take routine examination at the first and the last including blood,urine,liver and renal function, adverse reaction will be recorded in detail.4.cost analysis.5. Standard of curative effect judgment is in accordance with guide principle for new traditional Chinese drugs on clinical studies.Result:1. Comparison about PASI Score between two groups has statistical significance (P<0.01), that one between groups at post-treatment have no statistical significance (P>0.05), the difference show that ku bi chun xiao yin fang has therapeutic equivalence with capsule of compound recipe Qingdai on PASI Score.2. General effect Comparison between test team and control group has no statistical significance, which show ku bi chun xiao yin fang has therapeutic equivalence with capsule of compound recipe Qingdai on general effect. 3. Comparison on safety:patients in test team have no abnormalities in routine of blood and urine, also in liver and kidney function test took at prior treatment and post-treatment.4. Comparison of adverse reaction:one case had diarrhea in test team, eight cases had untoward reaction in the way of diarrhea, abdominal pain and abdominal distention.5. cost analysis:economic cost of capsule of compound recipe Qingdai is nine times of that of ku bi chun xiao yin fang, which show the last is economic clinical medicine.Conclusion:ku bi chun xiao yin fang has certain curative effect on psoriasis vulgarism, it can improve erythematic,scale and degree of soakage, decrease lesion size. It has good safety and economic cost. he mechanism of action of ku bi chun xiao yin fang may be to restrain tumor grow and need further confirmation. |