| BackgroundRefractory nephritic syndrome (RNS) is primary nephrotic syndrome (primary nephrotic syndrome, PNS) that is treated with large doses of prednisone (lmg/kg/1.73m2d) for 8 weeks, have no effect (Steroid resistant) or partial effect and often relapse and steroid dependence. The steroid resistant nephritic syndrome for use with standard dose of prednisone therapy, urinary protein decreased, or reduce but not yet out of NS; steroid partial effect is reduction in proteinuria after standard hormone therapy, but24 h protein≥ 2g/1.73m2. Frequently relapsing nephrotic syndrome (NS) is the PNS which remission within half year recurrence more than2, lyears more than 3times after standard dose hormone therapy after. The steroid dependant is hormone reduction process or withdrawal in January forced relapse, prolonged use of hormone.Western medicine treatment of RNS preferred hormones, such as steroids or dependence, treatment is very difficult. Cyclophosphamide (CTX), nitrogen mustard, such as azathioprine therapy, some patients can improve the remission rate, but the RNS overall treatment effect is not satisfactory, and immunosuppressive agents are often more severe complications than hormone. In recent years, new immunosuppressive agents tacrolimus (FK506), cyclosporin A, mycophenolate mofetil available for intolerance, hormone therapy or hormone inactive patients a glimmer of hope, but its exact curative effect for multi-center, large sample of evidence-based research. And expensive, some patients economy hard to bear.Chinese medicine treatment of RNS has more reports. Some of the treatment based on syndrome differentiation and typing, such as RNS, water swelling period and non edema period for syndrome differentiation and treatment of edema period, Yang deficiency of spleen and kidney, Qi deficiency of spleen and kidney yin deficiency, blood stasis, hot water cross resistance, pathogenic wind passage, cold, and exogenous; non edema period, kidney deficiency, spleen deficiency of Qi and yin deficiency of two. Some changes to the amount of hormone for foundation treatment at different stages, the hormone using large dose of patients with stage of hyperactivity of Yang due to yin deficiency and damp-heat pathogen of flow of two types, treatment should be nourishing Yin, clearing heat and removing dampness, cooling blood detoxification; maintain volume and reduction stage patients with Qi deficiency of spleen and kidney yang deficiency treatment is even, the spleen qi, tonifying kidney yang. Some of the unilateral, treatment. Some in the Chinese traditional medicine combined with western medicine treatment based on. Traditional Chinese medicine therapy to slow the progression of RNS, reduce the recurrence, remission and improve the patient’s symptoms and thus reduce the application of corticosteroids and cytotoxic drugs side effects caused by all have certain curative effect.Combined Chinese and Western Medicine in RNS although has certain curative effect, but the respective syndrome differentiation, some water swelling period and the edema stage; some type four, type five, type six, type seven or type ten differ, some portion of this standard is false; some by hormone use in different stages to phases of treatment, some a main square dialectical addition and subtraction, what type and several of the most appropriate? The use of Western medicine, prednisone, some day 30mg quantities; some continued to decrease to zero, no small dose and the maintenance of the platform; some in small dose and maintenance stages for 3 months, more than prednisone usage is not standard. Some CTX with prednisone together to start with, some in the prednisone reduction stage RNS was relieved when used; some day some of the 0.2goral intravenous; some 8-12mg/Kg/day, half a month with 2 days; some per square metre per monthO.5g-0.8g, gross thinks there are some that are 6g. When RNS started using CTX? The method best? In general, RNS lacks a standardized treatment plan optimization.ObjectivePreliminary evaluation the efficacy and safety of RNS in integrated traditional Chinese and Western medicine treatment, evaluation the side effects of reduce steroid and immunosuppressant on RNS in traditional Chinese medicine.Method1 Experimental design: Adoping multi-center, randomized, double blind, controlled clinical trial program.2 Clinical resources:From September 2011 to March 2012, all the observed cases were collected from hospitalized patients or outpatients in the Center of Southern Medical University March in Zhujiang Hospital, First Hospital of Guangzhou University of Chinese Medicine, Weihai Hospital of traditional Chinese medicine, Heilongjiang Academy of Traditional Chinese Medicine, the first hospital of Guangxi Traditional Chinese Medical University, Southern Medical University affiliated Beijiao Hospital, Southern Medical University, of integrated traditional Chinese and Western Medicine Hospital. According to the main indicators of efficacy for 24 hours protein quantitative efficacy evaluation the minimum sample size for 120 patients, using a random interval stochastic methods, combination of Chinese traditional and Western medicine 80 cases in the treatment group, placebo control group of 40 cases. As a result of this study is not the end, as of March 2012, were collected effectively complete the cases of combination of traditional Chinese and Western medicine in 45 cases,30 cases in the treatment group, placebo control group of 15 cases.3 Treatment methods: all patients were treated by high quality low protein diet, standard glucocorticoid 8-12 week, cyclophosphamide (CTX) intravenous injection, ACEI/ARB preparation, anticoagulation and antiplatelet drug based therapy, and under the condition to diuresis detumescence, resistance to infection, correction of electrolyte disturbance symptomatic treatment. On this foundation, combining traditional Chinese and Western medicine treatment group were given traditional Chinese medicine granule, the main drugs including Qi xu(Beiqi 60g, Baishu 12g, Duzhong 15g, batch number:J110804), Yin xu (Qianshi 30g, Taiziseng 15g, Nvzhengzi 10g. Batch number:J110805), Shi re (Yumixu60g, Xiaoyeshiwei 15g. Batch number:J110806), Xue yu (Shuizhi 5g, Yi muchao 15g, Shanzha20g. Batch number:J110904), and according to TCM syndrome differentiation treatment given superimposed delivery, warm water,3 times a day. The control group was given the corresponding placebo. Treatment for 12 weeks.4 Examination contents:4.1 The primary efficacy evaluation index:24 hours urine protein quantity efficiency.4.2 The secondary efficacy index:plasma albumin determination, TCM efficacy, blood lipids (total cholesterol, glycerin three greases, high density lipoprotein, low density lipoprotein), coagulation/fibrinolysis (fibrinogen, D-two dimers, thrombin time, kaolin partial thromboplastin time).4.3 Safety of treatment:blood, urine, stool, electrolytes, liver function, kidney B ultrasound, ECG, adverse reactions, end event.5 Examination criteria of therapy effects:5.1 24 hour urine protein quantitative efficacy evaluation for valid effect, effect and invalid effect three class. Valid effect:urine protein quantitative<0.20g/24h, determined to complete remission; effect:urine protein quantitative 0.21--3.5g/24h or baseline decrease is greater than or equal to 50%, judged to be partially effective; invalid effect:urine protein quantity is greater than or equal to 3.5G/24h, decision invalid.5.2 TCM efficacy evaluation clinical cure:clinical symptoms, physical signs disappeared, TCM total score than before treatment decreased more than 95%. Valid effect:clinical symptoms, signs were improved, TCM total score than before treatment decreased more than 70%,< 95%. Effect: clinical symptoms, signs have improved, TCM total score than before treatment decreased more than 30%,< 70%. Invalid effect:clinical symptoms, signs were not obvious change for the better, or even aggravate, TCM total score than before treatment decreased< 30%.6 Statistic analysis:All values are expressed as the mean±standard deviation(x±s). Statistial analysis was performed using the statistical package SPSS for Windows Ver 13.0. Results of prior-treatment and post-treatment in the group were analyzed using paired t test. Independ two-sample t test was used for the comparion of the two groups before and after treatment.. Count data was analysed by pearson χ2 and wilcoxon Wtest. P<0.05 was considered to be statistically significant.Results1 Comparison of general effects of each group:the 24 hour urine protein quantitative indicators for the evaluation of the efficacy of standard, the treatment group14 cases, effective in 11 cases,5 cases are invalid; the control group3 cases, effective in 4 cases,8 cases are invalid. Comparison between two groups had significant difference (Z=-2.405, P= 0.016).2 Comparison of the integral change in TCM syndrome and the effect of TCM after treatment The symptom scores of the treatment group and the control group significantly decreased after treatment, had significant difference (P< 0.05) compared with before treatment; and the treatment group better than in control group (P= 0.001). According to the Chinese medicine symptom effect assessment of TCM efficacy, the total efficiency of 86.7% in the treatment group,46.7% in control group, the treatment group compared with the control group with significant difference (Z=-2.523, P= 0.012). Tips for integrated traditional Chinese and Western medicine can better improve the syndromes of traditional Chinese medicine.3 Comparison of biochemical in each group after treatment Comparison of serum albumin, total cholesterol, triglyceride after treatment, was significantly different (P= 0). plasma albumin had no statistical significance (P= 0.927) in The control group, while the other indexes had statistical significance (P< 0.05). After treatment between the two groups was significant (P24hUpr= 0.019, PAlb= 0.022, PChol= 0.001, PTG = 0.001).4 Comparison of liver and kidney function in each group after treatment There was significant difference in blood urea nitrogen (P=0.01) within each group before and after treatment; There were no significant difference in creatinine and COMT(P>0.05). After treatment in the two groups were compared, urea nitrogen change has significant difference (P= 0.001), creatinine and COMT change had no significant difference (P> 0.05).5 Comparison of coagulation/fibrinolysis indexes in each group after treatment There were significant difference in fibrinogen, D-2dimer, APTT, PT of the treatment group after treatment (P< 0.05); the control group after treatment fibrinogen decreased (P= 0.004), while D-2, APTT, PT dimer changes obviously, no statistical significance (P> 0.05). After treatment in the two groups were compared, the index had significant difference (P < 0.05).6 Comparison of Routine blood test in each group after treatment There were no significant difference in red blood cell, hemoglobin, platelet in each group after treatment (P> 0.05); There was significant difference in blood cells of the treatment group after treatment (P< 0.05). After treatment between the two groups, each index showed no significant difference (P> 0.05).7 Comparison of other safety indexes in each group after treatment There were no significant difference in stool routine, electrocardiogram, kidney B ultrasound in each group after treatment (P>0.05).8 Comparison of side effects observed during in each group after treatment There were significant difference in side effects observed during in each group after treatment (x 2= 4.849, P= 0.028). The treatment group side reaction incidence rate was 53.3%, compared to the control group side reaction incidence rate was 86.7%. ConclusionsThe basic treatment of Western medicine, integrated traditional Chinese and Western medicine treatment regimens were capable of reducing RNS of urinary protein, elevated plasma albumin, improve clinical symptoms; and the combination of TCM and Western medicine WM foundation scheme is better than the treatment regimen, and can improve the high coagulation state, reducing the hormone, cytotoxic drug side effects. Traditional Chinese medicine on hormone, cytotoxic drugs have synergistic attenuation. |
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