1.Clinical Observation of Yingliu Mixture Combined with Methimazole for Treatment of Graves’ Disease
Hua YANG ; Hong TANG ; Xiaojuan BI ; Juanhua ZENG ; Tengfei WU ; Yilei CONG
Journal of Guangzhou University of Traditional Chinese Medicine 2014;(5):706-711
Objective To observe the effect of Yingliu mixture combined with methimazole on autoantibodies and traditional Chinese medical syndromes of patients with Graves’ disease ( GD) . Methods A randomized, paralleled and controlled trial was carried out in 92 GD patients. The patients were evenly randomized into treatment group and control group, and were separately treated with Yingliu mixture combined with methimazole, and methimazole. The treatment for both groups lasted 12 weeks, and forty patients in each group completed the whole treatment. The changes of thyroid function, thyroid autoantibodies, and traditional Chinese medical syndrome scores were observed before and after treatment, and the clinical efficacy was also evaluated. Results (1) After treatment for 12 weeks, serum levels of thyroid peroxidase antibody (TPOAb), thyroglobulin antibody ( TGAb) and thyrotrophin receptor antibody ( TRAb) were decreased, and thyroid stimulating hormone ( TSH) was increased obviously in both groups after treatment ( P<0.01 compared with those before treatment) . The treatment group has better effect on improving TGAb and TRAb than the control group ( P<0.05). ( 2) Compared with those before treatment, the total scores of clinical symptoms and signs were decreased in the two groups at different time points of treatment course ( P<0.001) , and the decrease value in the treatment group was larger than that in the control group ( P<0.05) . ( 3) The total effective rate of the treatment group was 92.50%, higher than 82.50% of the control group ( P<0.05) . Conclusion Yingliu mixture combined with methimazole is effective on improving thyroid function, decreasing autoantibodies levels and relieving clinical symptoms and signs, and has better effect than methimazole alone for the treatment of GD.
2.Oxidative Stress of Qidan Tangshen Granules (芪丹糖肾颗粒) in Treatment of 95 Patients with Early Diabetic Kidney Disease with Qi Deficiency,Blood Stasis,and Kidney Deficiency Syndrome:A Double-Blind,Double-Simulated,Randomized Controlled Trial
Jie ZHANG ; Yilei CONG ; Tengfei WU ; Qin LIU ; Yue YUAN ; Shilei CUI ; Hua YANG
Journal of Traditional Chinese Medicine 2025;66(7):695-703
ObjectiveTo evaluate the clinical efficacy and safety of Qidan Tangshen Granules (芪丹糖肾颗粒, QTG) in the treatment of early diabetic kidney disease (DKD) with qi deficiency, blood stasis, and kidney deficiency syndrome, and to explore its mechanism. MethodsA double-blind, double-simulated method was used to enroll 200 patients with early DKD and qi deficiency, blood stasis, and kidney deficiency syndrome. Patients were randomly assigned in a 1∶1 ratio to the treatment group (100 cases) and the control group (100 cases). The treatment group received QTG plus a valsartan capsule simulant, while the control group received valsartan capsules plus a QTG simulant, both for 12 weeks. The primary outcome was the urinary albumin-to-creatinine ratio (UACR). Secondary outcomes included estimated glomerular filtration rate (eGFR), fasting blood glucose (FBG), 2-hour postprandial blood glucose (PBG), glycated hemoglobin (HbA1c), and traditional Chinese medicine (TCM) syndrome scores (including individual symptom scores for fatigue, dull complexion, soreness and weakness of the waist and knees, headache and chest pain, irritability, spontaneous sweating, thirst and polydipsia, polyphagia, polyuria, numbness of the limbs, and the total TCM syndrome score). Oxidative stress markers including serum 8-hydroxy-2'-deoxyguanosine (8-OHDG), 3-nitrotyrosine (3-NT), and superoxide dismutase (SOD) were also assessed. Clinical efficacy and TCM syndrome efficacy were evaluated after treatment, and routine blood tests, urinalysis, and liver function tests were conducted and adverse reaction during the tria was recorded to assess safety. ResultsA total of 191 patients completed the study (95 in the treatment group and 96 in the control group). The treatment group showed significant reductions in UACR, FBG, PBG, and HbA1c levels after treatment (P<0.05 or P<0.01). The single TCM symptom scores except for polyphagia and total TCM syndrome scores significantly decreased (P<0.05 or P<0.01). Compared to the control group, the treatment group had signi-ficantly lower UACR, FBG, PBG levels, and total TCM syndrome scores, sinlge symptoms scores except for polyphagia and limb numbness (P<0.05 or P<0.01). Among 40 randomly selected patients (21 cases in the treatment group and 19 cases in the control group) for oxidative stress analysis, there were no significant differences in SOD, 3-NT, and 8-OHDG levels before and after treatment within or between groups (P>0.05). The overall effective rate in the treatment group was 64.2% (61/95) and 39.6% (38/96) in the control group, while the TCM syndrome efficacy rates were 80.0% (76/95) and 24.0% (23/96), respectively, with the treatment group showing superior efficacy (P<0.01). No significant differences were observed in routine blood tests, urinalysis, or liver function indices before and after treatment in either group (P>0.05). The incidence of adverse reactions was 8.4% (8/95) in the treatment group and 9.4% (9/96) in the control group, with no statistically significant difference (P>0.05). ConclusionQTG can effectively reduce UACR and blood glucose levels, alleviate clinical symptoms, and improve clinical efficacy in patients with early DKD with qi deficiency, blood stasis, and kidney deficiency syndrome. The treatment is well-tolerated and safe, with no significant impact on oxidative stress markers.