ABSTRACT
Objective:To observe the clinical efficacy as well as anti-inflammatory and anti-fibrosis mechanism of Yishen Tongluo decoction in the treatment of chronic glomerulonephritis （CGN） with spleen and kidney Qi deficiency and blood stasis syndrome. Method:According to the random number table method， one hundred and twenty patients were divided into control group （60 cases） and observation group （60 cases）. The two groups were given oral valsartan capsules， 160 mg/time， 1 time/day， and dipyridamole tablets orally， 50 mg/time， 3 times/day. Patients in control group additionally took Wubi Shanyao pills orally， 9 g/time， 2 times/day， while patients in observation group additionally took Yishen Tongluo decoction orally， 1 dose/day. Both groups were treated continuously for four months. Before and after treatment， 24 h urine total protein （24 h UTP）， creatinine （SCr）， urea nitrogen （BUN）， serum cystatin C （CysC）， tumor necrosis factor-<italic>α</italic> （TNF-<italic>α</italic>）， interleukin-6 （IL-6）， IL-17， interferon-<italic>γ</italic> （IFN-<italic>γ</italic>）， transforming growth factor-<italic>β</italic><sub>1</sub> （TGF-<italic>β</italic><sub>1</sub>）， connective tissue growth factor （CTGF）， matrix metalloproteinase-9 （MMP-9）， tissue inhibitor of metalloproteinases （TMP-1） and hypoxia inducible factor-1<italic>α </italic>（HIF-1<italic>α</italic>） levels were detected in both groups. The scores of spleen and kidney Qi deficiency and blood stasis syndrome were graded. Urine protein， and urine red blood cells （urinary RBC） were monitored. Result:The 24 h UTP， SCr， BUN and CysC levels of the observation group were lower than those of the control group （<italic>P</italic><0.01）. The score of spleen and kidney Qi deficiency and blood stasis syndrome in the observation group was lower than that in the control group （<italic>P</italic><0.01）. The levels of TNF-<italic>α</italic>， IL-6， IL-17 and IFN-<italic>γ </italic>in the observation group were lower than those in the control group （<italic>P</italic><0.01）. The levels of TGF-<italic>β</italic><sub>1</sub>， CTGF， TMP-1 and HIF-1<italic>α</italic> in the observation group were lower than those in the control group （<italic>P</italic><0.01）. While MMP-9 level was higher than that in control group （<italic>P</italic><0.01）. The clinical effective rate was 88.33% （53/60） in the observation group， higher than 73.33% （44/60） in the control group （<inline-formula><alternatives><mml:math xmlns:mml="http://www.w3.org/1998/Math/MathML" id="M2"><mml:msup><mml:mrow><mml:mi>χ</mml:mi></mml:mrow><mml:mrow><mml:mn mathvariant="normal">2</mml:mn></mml:mrow></mml:msup></mml:math><graphic specific-use="big" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/155A9E27-C0C9-44b4-96FF-AF947372054E-M002.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic><graphic specific-use="small" xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="alternativeImage/155A9E27-C0C9-44b4-96FF-AF947372054E-M002c.jpg"><?fx-imagestate width="3.30200005" height="3.64066648"?></graphic></alternatives></inline-formula>=4.356， <italic>P</italic><0.05）. Conclusion:On the basis of conventional Western medicine treatment， Yishen Tongluo decoction in the treatment of CGN patients with spleen and kidney Qi deficiency and blood stasis syndrome can reduce proteinuria， and improve traditional Chinese medicine （TCM） syndromes， with anti-inflammatory and anti-kidney fibrosis effects. Thereby， it plays a role in protecting renal function and delaying the malignant progression of renal function， with high clinical efficacy and value of clinical use.
ABSTRACT
Objective:To observe the clinical efficacy of Erxian Shengbai decoction combined with Huangqi Huang soup for leucopenia (deficiency of spleen and kidney Qi) after chemotherapy, and to investigate the regulatory effect on immune function and cytokines. Method:One hundred and fifty patients were randomly divided into control group（75 cases） and observation group （75 cases）by random number table. Patients in group got batilol tablets by oral administration for 6 weeks, 60 mg/time, 3 times/day. And the patients at stage Ⅲ or Ⅳ additionally received recombinant human granulocyte colony stimulating factor injection (rhG-CSF) for subcutaneous injection,2-5 μg·kg-1·d-1, until the count of neutrophils recovered to 5.0×109个/L (10.0×109个/L for white blood cell). In the control group shengbaikang granules were taken orally,1 bag/time,3 times/day.Patients in observation group additionally received Erxian Shengbai decoction combined with Huangqi Huangshan soup for 6 weeks, 1 doses/day. Number of peripheral blood leukocytes (WBC) and neutrophils (NEUT), time to recovery, number of infections, duration of using antibiotics, dose and duration of rhG-CSF, red blood cell (RBC) count, hemoglobin (Hb), platelets (PLT) and rate of completed chemotherapy were recorded. Scores of traditional Chinese medicine（TCM）syndrome and karnofsky performance scale (KPS) were graded before and after treatment. Levels of T lymphocyte subsets (CD3+, CD4+, CD8+ and CD4+/CD8+) , natural killer cell (NK), interleukin-2 (IL-2), IL-6, and tumor necrosis factor-α (TNF-α) were all detected. Result:In the analysis of rank sum test, to the efficacy for leucopenia in observation group was better than that in control group (Z=2.057, P<0.05). Levels of WBC, NEUT, RBC, Hb and PLT were higher than those in control group (P<0.01). Time to recovery, number of infections and duration of using antibiotics, dose and duration of rhG-CSF were all less than those in control group (P<0.01). After treatment, the recovery rate of WBC and NEUT as well as completed chemotherapy were 76.12% (51/67), 73.13% (49/67) and 92.54% (62/67) in observation group, higher than 57.35% (39/68), 52.94% (36/68) and 79.41% (54/68) in control group (P<0.01). Levels of NK, CD3+, CD4+, CD4+/CD8+ and IL-2 were all higher than those in control group (P<0.01), while levels of CD8+ , IL-6 and TNF-α were lower than those in control group (P<0.05). Conclusion:Erxian Shengbai decoction combined with Huangqi Huangshan soup can promote the recovery of WBC and NEUT, stabilize the immune function, regulate cytokines, improve the microenvironment of bone marrow hematopoiesis, improve the completion rate of chemotherapy, reduce the number of infections and the amount of rhG-CSF, relieve clinical symptoms, and stabilize the quality of life in patients with leukopenia after chemotherapy (deficiency of spleen and kidney Qi).
ABSTRACT
Objective:To discuss the efficacy and safety of Shenwu Yishenpian on stage 4-5 chronic kidney disease-nondialysis （CKD） with deficiency of spleen and kidney Qi， and the effect on renal interstitial fibrosis （RIF） and microinflammation. Method:One hundred and twenty patients were randomly divided into observation group and control group. A total of 58 patients in control group completed the treatment （including 2 patients falling off or lost）. And 58 patients in observation group completed the treatment （including 1 patient was falling off or lost visit， and 1 eliminated）. Both groups got comprehensive treatment of western medicine. Patients in control group got simulated medicine of Shenwu Yishenpian， 4 pieces/time， 3 times/day. Patients in observation group got Shenwu Yishenpian， 4 pieces/time， 3 times/day. The treatment lasted for 6 months until the renal replacement therapy， and the 6-month follow-up was recorded. For every month， blood creatinine （SCr） was detected， and glomerular filtration rate （eGFR） were calculated. The 12-month renal replacement （dialysis or kidney transplantation）， progress （CKD4 to CKD5） and mitigation （CKD5 to CKD4 or CKD4 to CKD3） were recorded. Before and after treatment， levels of urea nitrogen （BUN）， hemoglobin （HB）， plasma albumin （ALB）， urine protein quantity （24 hUp） and blood uric acid （UA） levels were detected， deficiency of spleen kidney Qi was scored， and transforming growth factor-β1 （TGF-β1）， connective tissue growth factor （CTGF）， serum Klotho， tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6）， interleukin-1 （Lkn-1） and interleukin-12 （IL-12） were detected. And the safety was evaluated. Result:At the 3th and 6th after treatment， SCr in two groups increased （P<0.01）， while eGFR decreased （P<0.01）. Compared with control group， SCr was less than that in control group （P<0.01）， whereas eGFR was higher than that in control group （P<0.01）. During 12 months of observation， the reduction rate of CKD was 13.79% （8/58）， which was higher than 1.72% （1/58） in control group. The progress rate of CKD was 11.43% （4/35）， which was lower than 31.58% （12/38） in control group （P<0.05）. Levels of BUN， 24 hUp and UA were lower than those in control group （P<0.01）， while levels of Hb and ALB were higher than those in control group （P<0.01）. Effect in observation group was better than that in control group （Z=2.051， P<0.05）. And levels of TGF-β1， CTGF， TNF-α， IL-6， Lkn-1 and IL-12 were lower than those in control group （P<0.01）， and level of Klotho was higher than that in control group （P<0.01）. There was no adverse reaction relating to Shenwu Yishen Pian. Conclusion:Shenwu Yishenpian can delay the progress of renal function and CKD， reverse the progress of renal function in some patients， reduce the risk factors of disease progress， reduce the state of micro inflammation and resist RIF， and protect or improve renal function. Its clinical effect is better than placebo， and it is safe to use.