From The Blood On The Treatment Of Psoriasis Clinical Repeated Measures Analysis And Safety Evaluation

ObjectiveTo evaluate the clinical effect and safety of treating psoriasis vulgaris by solving disorders of blood system.Applying repeated measures design and analysis for this trail,and in order to evaluate more roundly dynamical trends and the effecting characteristics of clinical effectiveness by the treating of solving disorders of blood system.Further more to analysis the advantages of TCM in treating psoriasis vulgaris,and to accumulate the experience of evaluation of Traditional Chinese Medical treatments for psoriasis vulgaris based on syndrome differentiation.ContentIn this study,we made an observation from the patients(n=145) of psoriasis vulgaris with disorders of blood system.And the repeated measures design and analysis was be used in this trail to evaluate the effect of the treatment by solving the disorders of blood system. According to the differentiated syndromes(TMDS),the patients were divided into three groups:blood heat syndrome group(n=83),blood dryness syndrome group(n=32) and blood stasis syndrome group(n=30).Based on the syndrome differentiation,the blood heat syndrome group was given the herb of keyinyifang,blood dryness syndrome group was given keyinerfang and the blood stasis syndrome group was given the herb of taohongsiwutang,8 weeks was considered as a course of treatment,while we observe the symptom in the clinical once 2 weeks.Using the internationally scores of Psoriasis Area and Severity Index(PASI) to measure the skin lesions,the scores of erythema,scale,the degree of infiltration and lesion size were assessed at baseline,the 2 weeks,4 weeks,6 weeks and 8 weeks in treating time,for each time point,the changes of the lesions were compared.Applying the repeated measures analysis of variance of the multi-method,we want to reveal the time trend of the condition of the lesion with treating in TCM.In addition,the safety of the treatment was evaluated,we made close observation about the adverse events with the patients,30 patients were selected randomly for the safety inspection (including:blood and urine routine examination,stool test,electrocardiographic examination,liver function test,renal function test) at the baseline and the finish time.Result145 cases of patients was include in this study,valid 127 cases alt,shed off 18 cases,while, in the blood heat syndrome group,there are 71 cases completely finished the course of treatment;in the blood dryness syndrome group there are 32 cases and in the blood stasis syndrome group there were 24cases.114(90%) cases were effectual,13(10%) cases were unfruitful.In the blood heat syndrome group,4 patients(6%) were cured,15 patients(21%) were effected excellently,44patients (62%) has effective results and 8(11%) patients ineffective.In blood dryness syndrome group,the rate of cure,excellently effective,effective and ineffective is 3 patient(9%),6 patient(19%),21 patients(66%),2 patients(6%).In the in the blood stasis syndrome group, 1 patients(4%) were cured,2 patients(13%) were effected excellently,18 patients(60%) has effective results and 8(13%).The total effective rates of the three groups are 89%,94%, 87%.Applying the repeated measures analysis,the lesions score of blood heat syndrome group has a much stable and obvious downward trend and the acting time is much early,after treating 2 weeks,the lesions score was significant different to that at the baseline.Mean while downward trend of the lesions score in the blood dryness syndrome group is not obvious as the blood heat syndrome group.Except for score of lesion size,the other scores had remarkable descend after treating 2 weeks.But the downward trend of the lesion size is much more slowly,its acting time is between 2 weeks and 4 weeks.The lesions score of blood stasis syndrome group has a gentle decline and its acting time is later:for example,the acting time of sores of erythema,scale,are always at 4 weeks,the acting time of scores of infiltration is at 6 weeks,only the total score of PASI has a significant difference among the 5 time points.There are no diarrhea,allergies and other adverse events among the patients in treating time.There are 6 patients have abnormal items among 30 patients who were selected randomly for the safety inspection at the baseline and the finish time.Among them,2 patients have abnormal items in blood and urine routine examination before treating,and then became normal when finished the treatment;2 female patients has abnormal items in urine routine examination before and after treating,because they are in menses;lpatient' liver function test is abnormal,but alter treating the abnormal items disappeared;1 patient has a high level of white blood cell in treating,we conclude that may had a connection with the upper respiratory infection.ConclusionThis study proved once again that there is a good curative effectiveness of treating psoriasis vulgaris by solving disorders of blood system,and among the three groups the effectiveness of the blood heat and the blood dryness group are much better than the blood stasis group. Further more,applying the repeated measures analysis,we definitude the changing characteristics and trends of the lesions in treating,made a dynamic description of relevance between the disease severity and the treatment time,and gained experience for future allied research.