The Evaluation On Long-term Effect Of Integrated Treatment Of Yin Deficiency Heat SLE

BackgroundSystemic Lupus Erythematosus (SLE) belongs to autoimmune disease and the cause of SLE is still uncovered. The morbidity and recurrence rate both stay high until today. SLE can damage human organs and systems then threaten health and life seriously. SLE shows chronic-recurrent pathological process and there is no perfect method to cure it yet. The means of mainstream medicine are to adopt adrenocortical hormone and immunosuppressant to treat SLE. Recently, with the wide application of western medicine such as hormone, it is effective to control or delay the damage of organs caused by SLE and decrease the fatality. Unfortunately, long-term glucocorticoid application will result in hemorrhage of upper digestive tract, osteoporosis, ischemic necrosis of femoral head, hypertension, diabetes and infection. Immunosuppressant also can lead to fatal toxic reaction of blood system, hepatic injury and serious secondary infection. The second infection caused by side effects of medicine abuse has become the very first death cause of SLE. As a result, the focus of SLE clinic research is to explore the ideal ways and methods of enhancing clinic efficacy and decreasing those side effects. The Traditional Chinese Medicine (T. C. M) is playing an important role in this field.Though there is no obvious record of SLE in the T. C. M material, the great amount of reference has proved that it was certain that SLE has been studied by T. C. M doctor in different dynasties. It has a lot of chinical experience on treating and preventing those side effect.Especially in the field of reduce the amount of adrenocortical hormone and the side effect of hormone, it shows a clear advantage. The pathological mechanism of SLE is Yin Deficiency Inner Heat. Yin Deficiency can inherit from parents body or result from invasion Ying and Blood by heat and toxic; Inner Hear will be produced by Five-Zang damage, exterior-affection or mood trend change. Traditionally, SLE treatments with T. C. M method are mainly related to integration of Disease and Pattern Differentiation then manipulating with replenishing kidney nourishing Yin, clearing heat and toxic.After more than ten years theory study and clinic observation, the nation famous professor Xuanguowei has put forward that Replenishing Kidney, Nourishing Yin and Clearing Heat are the primary rules to treat SLE on the base of Yin Deficiency Inner Heat Pattern as far as the basic pathological mechanism of SLE is concerned. The Prescription of LangChuangII capsule works as the supplementary medicine to treat the patients with SLE and the prophase clinic observation showed a great efficacy. The project focused on proving academic ideas of professor Xuanguowei in terms of reference and evaluated the safety and effectiveness of LangChuangIIcapsule treating active SLE of Yin Deficiency inner heat pattern objectively by random double blind control test.PurposeThe prescription is on the basic of pass, using including SLEDAI scale and TCMSS scale to evaluate the long-term effect of LangChuangⅡCapsule and glucocorticoid on Yin Deficiency Heat SLE. Actively seeking advantage points of integrated treatment of Yin Deficiency Heat SLE. The efficacy target is to work combined with western medicine, decrease dose of western medicine and lessen the side or toxic effect. There still exit some shortcomings and problems as far as the SLE clinic research just like irrational clinic design and unreasonable adoption of efficacy index are concerned. The research and the result are hard to be accepted by both domestic and international academy. There is short of index of T. C. M pattern to show advantage of T. C. M, so we try to find the inherent relationship between the two scales.MethodsUse SLEDAI and TCMSS scales to evaluate. Prospective, multicenter, randomized control test was adopted to carry out the clinic trial. Divided 66 cases with mild active SLE into A and B groups (33 cases each), A group (Treatment Group) treated with LangChuangⅡCapsule and glucocorticoid, B group (Control Group) treated with placebo and glucocorticoid. The treatment course was 24 weeks. Specific determination of time were before treatment, after 4,8,12,16,20,24 weeks treatment。ResultThe outcomes showed:After 24 week treatment, the two treatment group showed obvious difference compare with untreated;There was obvious significance on the base of scores of T. C. M symptoms.Trends showed that long-term use LangChuangⅡCapsule to treating on Yin Deficiency Heat SLE can make a stable condition and trend to better efficacy. There was no obvious difference between groups (p>0.05); There was no obvious significance between groups in term of SLEDAI and TCMSS scores (p>0.05). Considerating the sample size is too small. SLEDAI and TCMSS preliminary exploration shows correlation between the two scales, scales exist between the part of the entry corresponding to the relationship.ConclusionLong-term effect of integrated treatment of Yin Deficiency Heat SLE showed a better resule than simple to use hormone therapy. These findings suggest that there is no statistically significant between the two groups, considering the lack of correlation with the sample. SLEDAI and TCMSS preliminary exploration shows correlation between the two scales, scales exist between the part of the entry corresponding to the relationship. The next step needs to continue to increase sample and try to filter out some representative entries to form a Chinese Characteristics Scale.