| Objective: Systemic lupus erythematosus (SLE) is a kind of autoimmunity chronic inflammational connective tissue disease. Research data show that the incidence of this disease has an ascensive trend year after year, and this disease is repeating, the state of an illness is complex, the range of the pathological changes is comprehensive, the course of disease is lasting. At present, it has not a method of effect a radial heal, it belongs to one of fatal difficult disease. The research evaluate the clinical curative effect and quality of life (QOL) to the SLE patients treated by the synthetical project of qingyangtoujie method under the theory of epidemic febrile diseases, expecting to establish a suit of synthetical project of trustworthily in the clinic, and the synthetical project has more curative effect, the less poisonous and side-effect,the more obvious improve the quality of life of SLE patients.Method: The research includes two parts: literature research and clinical research. In the literature research, we have a detailed management and summarization from actuality and evolvement of Western medicine to Traditional Chinese Medicine in SLE, from actuality and evolvement treated by the theory of epidemic febrile diseases to quality of life for the SLE patients. In the clinical research, we take the familiar syndromes (yinxueneire,yurebizu,ganshenyinxu ) of SLE as research object. We selected cases according the methods of big sample,more centers,preceding,half randomization,single blind and controlled method, and according the recognized criteria of diagnostic criteria,inclusive criteria,exclusive criteria by the internal and international, we separate the 118 eligible patients into treatment group (81 cases) and contrast group (37 cases) according to ratio of 2:1 in half randomization. Treatment group was adapted by the qingyangtoujie method synthetical project which is composed of taking care of Chinese medicine, allopathy, routine Chinese patent medicine(lingdanpian), treated by Chinese medicine and less dose adrenocortical horrnone; and contrast group was adapted by the routine west medicine synthetical project which is composed of general publicize and educate, allopathy, placebo, adrenocortical hormone or (and) immunosuppressant. The period of treatment are 3 months(one month is a period), observing the clinical symptom and testing the laboratory indexes, at the same time observing and tracing continuously quality of life of the two groups SLE patients for 18 months by the two forms (SF-36 and Chinese medicine symptom form) which have been used in international and national. In the end, we input all the data into computer, and analysis dynamic the clinical symptom,laboratory indexes,the scores of diseases,curative effect in the near future and at a specified future date, security index and quality of life, etc.Result: There are no statistical significance in sex,age,marriage,course of diseases,scores of diseases,distribution of symptom,clinical symptom,laboratory indexes,dose of adrenocortical hormone,side-effect,quality of life, etc (P>0.05).1,Compare the total curative effect of two groups after treated The curative effect of disease and symptom after intervention in treatment group are higher than contrast group, there is statistical significance (P<0.05). Total efficiency of treatment group is 98.77%, and contrast group is 91.89%. There is no statistical significance in the scores of SLEDAI (P>0.05).2,Observe security of two groups dynamic before and after intervention: Observation security indicated that there are no statistical significance in hemanalysisand urinalysis (P>0.05), it maybe related to the short period of treatment and observation. There is a little influence to the function of liver and kidney, but it is no negative effect, and needs to observe continually.Observation dynamic: The indexes of two groups in hemanalysis,kidney function and liver function are fluctuated in well-balanced, there are better stability, the trend of urinalysis is descend, but there is more fluctuation, in particular, the degree of contrast group is higher, there is much more stability, it indicates more security in two groups. 3,Observe curative effect and analysis dynamic(1) Clinical symptoms: Compare before to after intervention, two groups have improved in different degree in all symptoms, and the radio of symptom disappear in treatment group is higher than contrast one, especially in Raynaud phenomenon,lose hair,lack of power,perturbed,nausea and vomit,edema,emmeniopathy, there are statistical significance (P<0.05), however, there are no statistical significance in fever,ulcerin mucous membrane,arthralgia,heart-throb (P>0.05).(2)Observe and analysis dynamic: Two kinds of treatment subject have been obtained better curative effect in the symptom offever,arthralgia,lose hair,lack of power,nausea and vomit,edema, and the curative effect has more stability following the time: the degree of decline in treatment group is more stability, but contrast group has less stabilization in the symptom of erythema in face,lose hair,perturbed,nausea and vomit, emmeniopathy, and has more undulatory property, it maybe related to the side-effect of Western medicine。4,Compare and analysis dynamic immunity index(1) Compare immunity index: it indicates that two kinds of treatment subjects have been improved in correlation immunity indexes, treatment group is more significant than contrast group. In treatment group before and after intervention, there are statistical significance in IgG,CH50 and C4 (P<0.05), there are remarkable statistical significance in ESR,C3 and ANA (P<0.01). In contrast group before and after intervention, there are statistical significance in IgG (P<0.05), there are remarkable statistical significance in CH50,C4 and ANA (P<0.01), there are no statistical significance in ESR and C3 (P>0.05)(2) Indicated by observe and analysis dynamic: There are remarkable and stabile curative effect in two groups in reducing ESR, furthermore the curative effect are getting more and more intensity following time little by little. There is up trend of two groups in CH50, but treatment group is relatively stability: C3 and C4 of two groups are fluctuated under the normal lower line, the up-trend of treatment group is higher than contrast one, but degree is less. ANA of two groups indicated up-trend little by little; ds-DNA indicated down-trend, in the former period, treatment group has more stability and less fluctuation than contrast one.5,Scale and size of adrenocortical hormone's dose: There are no statistical significance in scale of adrenocortical hormone's dose of before intervention with both groups (P>0.05). After intervention, treatment group has higher degree decrease than contrast group, there are statistical significance of scale and size of adrenocortical hormone's dose (P<0.05). It maybe related to perfect in the treatment group.6,Compare the times of disease repeating and syndrome after treated: Times of disease repeating in treatment group are less than contrast one after intervention, there is statistical significance (P<0.05). The syndrome of treatment group is less than contrast one after intervention, such as emmeniopathy,amenorrhea,sight faintness,hypertension,diabetesmellitus or femoral head necrosis, etc., there is statistical significance (P<0.05).7,Quality of life:(1) It indicated with SF-36 that the scores of quality of life in two groups are improved with different degree, the scores of contrast group in Bodily Pain (BP),General Health (GH),Vitality (VT),Social Functioning (SF),Mental Health (MH),Reported Health Transition (HT)are higher than contrast group, there are statistical significance (P<0.05), there are no statistical significance in Physical Functioning (PF),Role-Physical (RP) and Role-Emotional (RE) (P>0.05). There are statistical significance in difference of two groups before and after intervention in Bodily Pain (BP),Vitality (VT) and Mental Health (MH) (P<0.05), There is remarkable statistical significance in Reported Health Transition (HT) (P<0.01), however, there are no statistical significance in Physical Functioning (PF),Role-Physical (RP),General Health (GH),Social Functioning (SF) and Role-Emotional (RE) (P>0.05). Result of intervention: The evaluations of patients and doctors in treatment group are higher than contrast group, there are statistical significance (P<0.05).(2) It indicated with Chinese symptoms form that the scores of quality of life in two groups are improved with different degree, the scores of contrast group in appetite,stool,piss,soma and emotion are higher than contrast one, there are statistical significance (P<0.05), but there are no statistical significance in energy,pain and sleep (P>0.05). The difference of treatment group before and after intervention in pain,stool,sleep,soma and emotion are bigger than contrast one, and have shown statistical significance (P<0.05), there are no statistical significance in other areas(P>0.05)(3) Indicated by observe and analysis dynamic: Before and after intervention, there are up-trend little by little in Physical Functioning (PF),Role-Physical (RP),Bodily Pain (BP),Role-Emotional (RE) and Mental Health (MH) between treatment and contrast groups, and treatment group is more relatively stability than contrast one; it indicated down-trend in Reported Health Transition (HT) and result of intervention, and the degree of contrast group is bigger than treatment one. It indicated with Chinese symptoms form in two groups that there are up-trend in energy,pain,appetite,soma,emotion, and treatment group has higher up-degree and lower fluctuation than contrast one.Conclusion: The total curative effect of treatment group treated by the dialectic and synthetical methods directed by the theory of Epidemic Febrile Disease is not only better than contrast group, but also more remarkable improve the clinical symptom, decrease the dose of adrenocortical hormone and side-effect, reduce repeating times, and obvious stable the disease, prolong release period, at the same time obvious improve the SLE patients' quality of life, It indicated by observe and analysis dynamic that the curative effect of treatment group is more stability than contrast group. In a word, it indicated the synthetical subject is feasible one in fact,more significant curative effect,less side-effect,furthermore improved remarkably SLE patients' quality of life, it is worth to spreading and using in clinic.
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