| Objective:①To observe the clinical curative effect and safety of the Xiao Yin Ointment for the treatment of Blood-heat Psoriasis, and observe the effect of Xiao Yin Ointment for single symptom of Ps(such as erythema, scale, infiltration, pruritus and the area of lesion).②To approach that if B ultrasound can appraise objectiveiy the psoriatic lesion's state and the efficacy of therapy.③To approach if thermalvideosystem(TVS)can be regard as an objective index for TCM differentiation of symptom and signs,also a therapentic effect evaluation indicator for the occurrence,development and prognosis of the psoriasis.Methods:We evaluated the safety and effeciancy of the Xiao Yin Ointment objectively by trabantal, controlled methods.Three groups of patients had taken KeYinYiFang orally for 8 weeks.The thickness of epidermis and dermis were detected by B ultrasonic while the change of temperature were detected by far-infrared rays.Results:99 patients were distributed into three groups:33 patients in treated group, and 33 patients in control group while the other 33 patients in blank group.There was no statistical difference in three groups of age, gender and the time of disease, dermal leisure degree before treating (P>0.05) .Using ITT data to statise and analyze the results, before treatment, treated group and controlled group was no statistic difference (P=0.868), but the scores of both two were higher than blank group, which showed statistical difference (P<0.01) .When the research was over, the score of the three group were lower than before the severity of dermal leisure between the treated group and controll group/blank group showed significant statistic difference (P=0.0.047,0.003), while there was no statistical difference between contrasted and blank group(P=0.286).The analysis of the curative effect of the three groups(ITT):the healing rate, excellent efficiency rate, efficiency rate, and the total effective rate of the treatedgroup were 12.1%, 24.2%, 57.6%, and 93.9% respectively;while the healing rate, excellence efficiency rate, efficiency rate, and the total effective rate of the controll group were 0, 21.2%, 57.6%, and78.8%;while the rate of blank group were 0,9.1%, 36.4% and 45.5% and the invalid rate was 54.5%.In rank-sum test, the result of the three groups showed significant difference in curative effect (P=0.000), there was significant statistic difference between the healing group and the controll group (P=0.038);But compared to the blank group, the forth two groups had good curative effect (PO.Ol) .The degree of erythema and pruritus between healing group and controll group showed no statistic difference (P>0.05) , but the scores of scale and infiltration indicated significant difference (PO.05) .there was significant difference in the degree of erythema, pruritus, scale and infiltration between healing group and blank group (P<0.01) .The degree of erythema between contrasting group and blank group showed no statistic difference (p>0.05).The degree of scale, infiltration and pruritus had significant difference between controll group and blank group (P<0.01) .The score of the area of lesion among the three groups showed no statistic difference (P>0.05) .All of these indicated that the curative effect of healing group and controll group were better than blank group while there were the same curative effect between the forth two groups.The comparation of the time when effect was detected among the three groups:The duration of erythema showed significant difference (p=0.026) while scale, infiltration, pruritus, and the area of lesion between healing group and controll group showed no statistic difference (P=0.330, 0.767, 0.872, 0.226) .While the duration of erythema ,infiltration,pruritus, and the area of lesion between controll group and blank group gave significant statistic difference(P =0.035 , 0.001,0.006,0.01 l).But the time of scale indicated no difference (P=0.490) .The duration of erythema, infiltration, pruritus, and the area of lesion between healing group and blank group showed significant difference (P=0.000, 0.002, 0.0007,0.002) while the forth two groups had no statistic difference at the time when the effect of scale manifested (p=0.117) .Comparing among the three groups, the regression time of erythema among the three groups showed no statistic difference (P.0.05), the regression time of scale, infiltration and pruritus showed no difference(P=0.315, 0.338, 0.230) between healing group and controll group;Between controll group and blank group,the regression time of scale and infiltration also showed no statistic difference (p=0.072, 0.323) while the pruritus's had statistic difference(P=0.032);But the regression time of scale,infiltration,pruritus showed significant statistic difference(P=0.009, 0.041, 0.002)beween healing group and blank group;Otherwise, 4 cases in the treated group the lesion had recovered entirely, such case can't be found in the other groups.One patient feeled flash lightly, because of stimulus at the beginning of using ShiDu ointment.After 1 week, the adverse feeling disappeared.Healing group and blank group have no adverse event.With regard to the recurrence:for 10 patients whose score less than 4 after treatment, we carried out Foliow-Up in the forth week and the third month after treatment.The result was that 2 out of 8 cases were recurrent in healing group, and 1 out of 2 cases in controll group.To observe the transmutation of dermatic thickness of the psoriastic lesion in pretherapy and post-treatment by B ultrasound, the result showed that the thickness of epidermis and dermis of psoriastic lesion was higher than normal skin around. Applying pared-t test (both side), the comparison between the thickness of epidermis of psoriastic lesion and normal epidermis showed statistic difference before therapy (t=4.680, P=0.000), meanwhile thickness of dermis of psoriastic lesion and normal dermis showed significant difference (t=5.157, P=0.000).The thickness of epidermis and dermis of psoriastic lesion and normal skin in post-treatment were thinner than before.applying pared-t test(both side), thickness of epidermis and dermis of psoriastic lesion and normal dermis still existed statistic difference in after treatment(t=2.911, P=0.007;t=6.180, P=0.000) .The temperature of psoriastic lesion and normal skin measured by extreme infra-red ray.The result showed that temperature of psoriastic lesion of blood-heat psoriasis had transmutation.the temperature between lesion and normal showed significant difference (t=7.313, P=0.000) .When we compared the temperature index, the main trendency is lower .But the cases are not enough and didn't for pared-t test.Conclusions:The total curative effect of XiaoYinRuanGao obviously superior to ShiDuRuanGao (P=0.038) .After taking KeYinYiFang,total respinder rate reached to 93.9%.For the effect of lowering PASI score,XiaoYinRuanGao was better than ShiDuRuanGao in eliminating scale and infiltration.Although the two medicine had no difference on the effect of lightening erythema and relieving itchingjXiaoYinRuanGao was fast than ShiDuRuanGao on the time when the effect was detected for lightening erythema.All these proved adding the dosagei,the effect of of QinDa's anti-hyper-proliferation of epidermic cells and T-cell were strengthened.and its removing heat to cool blood was faster.Objective evidence showed that XiaoYinRuanGao can improve symptom of psoriatic blood-heat syndrome, lower racurrence and had no evident side effect.When lesion improved,The comparison of thickness of psoriastic lesion index showed that both epidermis and dermis incrassated exponent were lower than which in pretherapy. Compare situation of pretherapy and post-treatment,epidermis incrassated exponent had no statistic difference(t= 1.337, P=0.192), but dermis incrassated exponent showed significant difference(t=3.076, P=0.005).All of above results further suggested that the incrassation of dermis was the important pathobiological manifestation of psoriatic.There may be two possible reasons.One was that neovascularization in dermis and inflammatory cell infiltration in the acute stage, swell beneath epidermis, rarefaction of corium papilla;On the other hand, the thicken of dermis related to collagenoblast proliferation in the quiescent period andparacmasis stage of psoriasis.The result confirmed that B ultrasound can appraisethe psoriatic lesion's state and the efficacy of therapy.The result of TVS unified differentiation of symptoms and signs for classification of syndrome of TCM for psoriasis,and can be demonstrated inflammation of psoriatic lesion.The result of our research suggested that the thermalvideosystem can be regard as an objective index for TCM differentiation of symptom and signs,also a therapentic effect evaluation indicator for the occurrence^evelopment and prognosis of the psoriasis.The temperature of the exterior lesion of inflammation dermatosis can change along with the state of the illness.The better lesion become, the lower the tendency of the temperature is .But the data of XiaoYinRuanGao in this research showed no statistic difference, and researching on the lesion's temperature of psoriasis may be a direction in future. |
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