| Background:IgAN is a primary pathological manifestation of primary glomerulonephritis with mesangial IgA immune complex deposition.The clinical manifestations are gross or microscopic hematuria and may be accompanied by different degrees of protein Urinary,nephrotic syndrome.In China,IgAN accounts for 45.26%of primary glomerular diseases and is a clinical refractory disease.At present,the KDIGO guidelines mainly recommend RAS inhibitors and immunosuppressive agents,but clinical efficacy is not satisfactory.There are problems such as low clinical complete remission rate,easily recurring conditions,and deterioration of renal function.How to effectively control IgAN onset and disease progression is currently Problems to be solved.The pathogenesis of IgAN is not completely clear,and many scholars generally believe that when the mucosal immune system is related to the mucosal immune system,immune tolerance to common pathogens or digestive components may be the key factor triggering IgAN.Mucosal infections such as respiratory tract and gastrointestinal tract can also activate the autoimmune system and exacerbate the clinical manifestations of IgAN patients.If paroxysmal gross hematuria occurs,mucosal injury gradually becomes a hot spot in the research field of kidney disease.The upper respiratory tract infection,especially chronic pharyngitis and tonsillitis,is closely related to the attack of IgAN.It is an important factor to induce IgAN,and it is also the key factor affecting the improvement of the curative effect.In clinical reports,64%of the patients with IgAN had chronic pharyngitis and tonsillitis,and the tonsils of IgAN patients were significantly different from those without IgAN.Many evidence shows that tonsillitis are closely related to IgAN.The mucous injury of the pharynx also has a continuous pathogenicity to IgAN,but whether the tonsillectomy can improve the prognosis of IgAN is still controversial.We observed that in some patients after the tonsillectomy,chronic pharyngitis is still very prominent,which may be the reason for the failure of tonsillectomy to achieve satisfactory results.Relieving the inflammation of pharynx and reduction of immune system disorders caused by pharyngeal mucosal injury may be the key to control the progress of IgAN and improve the curative effect A multi-center,randomized,parallel-controlled clinical trial showing that Yiqi Zishen recipe has a good effect in reducing proteinuria,hematuria,and improving patient symptoms.Thallium treatment is a traditional treatment for chronic pharyngitis and tonsillitis by Chinese medicine.The operation of the tonsils using the Tincture Therapy method has advantages in retaining tonsillar tissue and reducing crypt content accumulation than surgical removal of tonsils.After our preliminary clinical observation,Yiqi Yangyin Liyan recipe combined with pharyngeal fistula treatment has certain advantages for the clinical treatment of IgAN patients.A large number of studies have reported the existence of immune disorders in IgAN patients.The main manifestations are the imbalance of Th1/Th2 cytokines and the therapeutic effect of glucocorticoids on renal diseases.It is realized by inhibiting APC,up regulating Th2,down regulating Thl cytokine,inhibiting the Thl cell immune axis and mediating its shift to Th2.Domestic studies found that IgAN patients peripheral blood T lymphocyte imbalance,mainly manifested as the decline of Treg,while Chinese medicine treatment has its immunomodulatory effect.Yu Renhuan and other T lymphocyte subsets in peripheral blood of patients with nephrotic disease were observed.The results showed that the changes of T lymphocyte subsets in peripheral blood of different glomerular diseases were different,and the maladjustment of T lymphocyte subsets was significantly improved in the cases of effective hormone or traditional Chinese medicine.Chen Xiaojuan et al.By analyzing the changes of Thl,Th2 and CD4+CD25+Treg levels in IgAN patients before and after treatment,it was found that the expression of Thl was down regulated after treatment with Chinese medicine.Therefore,we hypothesized that the regulatory effect of Chinese medicine on T lymphocytes in IgAN patients may be the mechanism of its therapeutic effect.Objective:To evaluate the efficacy and safety of the new method combining Yiqi Yangyin Liyan recipe and pharynx pecking by randomized clinical trial,and to explore the possible mechanism of its therapeutic effect.To provide new clinical evidence for IgA nephropathy.Methods:In this clinical trial,the combination of Yiqi Yangyin Liyan recipe and pharynx pecking treatment was used,and the prospective randomized control study method was used.Ninety patients were divided into two groups:oral treatment group(45 cases)and irbesartan group(45 cases).All the patients were examined with blood routine test,urine analysis,24 hours urine protein quantification,liver and kidney function,blood lipid and TB lymphocyte subsets to evaluate the score of pharynx symptoms.Blood routine examination,liver and kidney function,blood lipids and TB lymphocyte subsets were tested before and after 24 weeks follow up,urine analysis,24 hours urine protein quantitative test every 4 weeks,and pharynx symptom score every 4 weeks.The treatment time was 12 weeks and the follow-up time was 24 weeks.Results:(1)90 patients were included in the study,including 45 cases in the treatment group,45 cases in the control group,5 cases in the control group,2 cases in the treatment group and 3 cases in the control group.The baseline data of IgAN patients before treatment included age,sex,course of disease,pathological grade,24 hour urinary protein quantification,hypertension and hematuria,etc.There was no significant difference between the two groups(P>0.05).(2)The 24 hour urine protein in the treatment group was significantly lower than that in the control group P<0.05.The total effective rate of the treatment group was 72.1%at 24 weeks,and the average decrease was 46.2%compared with that of the control group.The total effective rate of the control group was 45.2%,which was decreased by 16.2%compared with that of the group.(3)Compared before and after the treatment of pharynx symptoms,the effective rate of the treatment group was 93%,the control group was 21.4%,and the treatment group was significantly better than the control group(P<0.01).(4)Urine red blood cell counts in two groups showed a downward trend.The treatment group decreased by 67.9%on average and the control group decreased by 56.9%on average.Compared with the control group,the treatment group decreased significantly at twentieth weeks and 24 weeks(P<0.05).(5)After 24 weeks,CD4 +,CD4 + +/CD8 + decreased significantly(P<0.05)in the treatment group compared with the control group(P<0.05).(6)There were no adverse events such as abnormal liver function and serum creatinine deterioration in the two groups.Before treatment and after 24 weeks follow-up,the vital signs of the patients were stable and good,and no drug side effects were reported.Conclusion:(1)Yiqi Yangyin Liyan recipe combined with pharyngeal pecking can reduce hematuria and proteinuria in patients with IgAN and relieve chronic pharyngitis and tonsillitis.(2)For IgAN patients with normal renal function and 24 urine protein ration less than 3 g,the combination of Yiqi Yangyin Liyan recipe and pharynx pecking method has better clinical effect than that of ACEI/ARB routine treatment.(3)Yiqi Yangyin Liyan recipe combined with pharyngeal pecking can regulate peripheral blood T cells in patients with IgAN.(4)Yiqi Yangyin Liyan recipe combined with pecking method has higher safety in clinical treatment of IgAN patients.(5)The mechanism of Yiqi Yangyin Qingyan prescription combined with pecking therapy may be related to controlling pharynx inflammation,reducing antigen stimulation,restoring the immune regulation function of patients,and improving the clearance of IgA immune complex. |
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