3.A Clinical Multicenter Randomized Controlled Study on JianpiQinghua Decoction in Treating Stage 3 Chronic Kidney Disease with A Syndrome Type of Dampness-heat due to Spleen Deficiency.
Ke-Na YU ; Zhao-Hui NI ; Nian-Song WANG ; Wen PENG ; Yi WANG ; Chang-Ming ZHANG ; Li-Qun HE
Acta Academiae Medicinae Sinicae 2016;38(6):686-695
Objective To evaluate the clinical effectiveness of JianpiQinghua decoction in treating stage 3 chronic kidney disease (CKD3) with syndrome type of dampness-heat due to spleen deficiency. Methods A multicenter, randomized, controlled, prospective, double-blind, and double-simulation study was undertaken. A total of 270 CKD3 patients with syndrome type of dampness-heat due to spleen deficiency from the outpatient departments of six general hospitals were randomly divided into telmisartan+analog traditional Chinese medicine (TA) group, traditional Chinese medicine+analog telmisartan (TCMA) group, and telmisartan+traditional Chinese medicine (TTCM) group, in which the corresponding treatment was applied in addition to basic treatment. Six months later, changes in the traditional Chinese medicine (TCM) clinical symptom scores and renal functions before and after treatment were compared among these three groups. Results Of these 270 CKD3 patients who had been enrolled in this study, 30 cases lost to follow-up. The baseline data were comparable among these three groups. After treatment, the TCM clinical symptom scores of both syndrome of spleen-qi deficiency and dampness-heat in TA group were significantly higher than those in TCMA group and TTCM group (P<0.001). With the treatment time prolonged, the TCM clinical symptom scores showed similar descending trends in TCMA group and TTCM group but were different from that in TA group. After treatment, abnormal creatinine rate decreased (P=0.003), and these three treatments and their interactions with each visit had no effect on serum urea nitrogen value (P=0.270, P=0.520); with prolonged treatment, the estimated glomerular filtration rates in three groups tended to be relatively stable after the first rise. The liver function and abnormal serum potassium rate were not statistically significant before and after treatment (P>0.05). Conclusions JianpiQinghua decoction can improve clinical symptoms of TCM in CKD3 patients with syndrome type of dampness-heat due to spleen deficiency and thus improve the quality of life and prognosis. The clinical efficacy of JianpiQinghua decoction alone or combined with telmisartan is superior to telmisartan monotherapy.
Benzimidazoles
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therapeutic use
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Benzoates
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therapeutic use
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Double-Blind Method
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Drugs, Chinese Herbal
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therapeutic use
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Humans
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Medicine, Chinese Traditional
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Phytotherapy
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Prospective Studies
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Quality of Life
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Renal Insufficiency, Chronic
;
drug therapy
4.Clinical study on treatment of early diabetic nephropathy by tangshenling combined with telmisartan.
Jian-ping LI ; Xue-lin HE ; Qun LI
Chinese Journal of Integrated Traditional and Western Medicine 2006;26(5):415-418
OBJECTIVETo study the effects and the possible mechanism of Tangshenling (TSL) combined with telmisartan on early diabetic nephropathy (DN). Methods Eighty-one patients with early DN were randomly assigned into the control group (n=40) treated by telmisartan alone and the treated group (n=41) treated by TSL combined with telmisartan, and the conventional western therapy was given to all patients in both groups. Changes before and after treatment in symptoms and levels of urine albumin excretion rate (UAER), urine transforming growth factor beta1 (TGF-beta1), retinol binding protein (RBP) and beta2-microglobulin (beta2-MG), fasting blood glucose (FBG), serum creatinine (SCr), blood lipids, plasma atrial natriuretic peptide (ANP), serum collagen type IV (Col-IV) and TGF-beta1 were observed.
RESULTSBefore treatment, no significant difference was shown in all these indexes between the treated group and the control group. After 8 weeks of treatment, the effective rates in symptoms improvement were higher in the treated group than those in the control group (P < 0.05 or P < 0.01); UAER, urine RBP, beta2-MG and TGF-beta1, serum TC, TG, Col-IV and TGF-beta1, and blood pressure were significantly lowered in both groups after treatment (P < 0.05 or P < 0.01); and the treated group showed a better effect than the control group in improving all the above-mentioned indexes except the blood pressure (P < 0.05); but there was no significant difference in the changes of FBG, SCr and blood pressure between the 2 groups (P > 0.05); after treatment, plasma ANP significantly lowered in the treated group (P < 0.01), while there was no significant change of that in the control group (P > 0.05). Conclusion Combination of TSL and telmisartan has a better effect than telmisartan on DN in early stage. Its mechanism might be related to the decrease of ANP and TGF-beta1 and improvement of lipids metabolism and renal tubular interstitial pathological changes.
Adult ; Aged ; Benzimidazoles ; therapeutic use ; Benzoates ; therapeutic use ; Diabetic Nephropathies ; drug therapy ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Phytotherapy
5.Korean Guideline for Iron Chelation Therapy in Transfusion-Induced Iron Overload.
Jun Ho JANG ; Je Hwan LEE ; Sung Soo YOON ; Deog Yeon JO ; Hyeoung Joon KIM ; Jooseop CHUNG ; Jong Wook LEE
Journal of Korean Medical Science 2013;28(11):1563-1572
Many Korean patients with transfusion-induced iron overload experience serious clinical sequelae, including organ damage, and require lifelong chelation therapy. However, due to a lack of compliance and/or unavailability of an appropriate chelator, most patients have not been treated effectively. Deferasirox (DFX), a once-daily oral iron chelator for both adult and pediatric patients with transfusion-induced iron overload, is now available in Korea. The effectiveness of deferasirox in reducing or maintaining body iron has been demonstrated in many studies of patients with a variety of transfusion-induced anemias such as myelodysplastic syndromes, aplastic anemia, and other chronic anemias. The recommended initial daily dose of DFX is 20 mg/kg body weight, taken on an empty stomach at least 30 min before food and serum ferritin levels should be maintained below 1000 ng/mL. To optimize the management of transfusion-induced iron overload, the Korean Society of Hematology Aplastic Anemia Working Party (KSHAAWP) reviewed the general consensus on iron overload and the Korean data on the clinical benefits of iron chelation therapy, and developed a Korean guideline for the treatment of iron overload.
Anemia, Aplastic/therapy
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Benzoates/therapeutic use
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Blood Transfusion/*adverse effects
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Chelation Therapy/*methods
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Humans
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Iron Chelating Agents/*therapeutic use
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Iron Overload/*therapy
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Myelodysplastic Syndromes/therapy
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Pyridones/therapeutic use
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Republic of Korea
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Triazoles/therapeutic use
6.Efficacy observation of treating diabetic nephropathy by shenshuaining granule combined telmisartan tablet.
Bai-yun LI ; Hui PENG ; Dong-lin XIONG ; Jing YI ; Huan CHEN
Chinese Journal of Integrated Traditional and Western Medicine 2015;35(2):142-146
OBJECTIVETo observe the effect of Shenshuaining Granule (SG) combined telmisartan on serum creatinine (SCr) levels and urinary albumin contents in diabetic nephropathy (DN) patients, and to explore its efficacy.
METHODSTotally 204 DN patients were recruited, and further assigned to 3 groups, i.e., the early DN group, the clinical stage of DN with normal renal function group, the clinical stage of DN with insufficient renal function group. Patients in the same group were randomly allocated to the telmisartan treatment group, the SG treatment group, and the combination of SG and telmisartan treatment group, 68 in each group. Patients in the telmisartan treatment group took telmisartan tablet, 80 mg per day, once daily. Those in the SG treatment group took SG, 5 g each time, 3 times per day. Those in the combination of SG and telmisartan treatment group took telmisartan tablet (80 mg per day, once daily) and SG (5 g each time, 3 times per day). The therapeutic course for all was 3 successive months. SCr levels, serum urea nitrogen (BUN),24 h urine microalbumin (24 h U-MA) were detected before and after treatment. Results In three different treatment groups, 24 h U-MA decreased after treatment in the telmisartan treatment group; SCr and BUN decreased after treatment in the SG treatment group; and 24 h U-MA, SCr and BUN decreased after treatment in the combination of SG and telmisartan treatment group (P<0.05). In the clinical stage of DN with insufficient renal function group, SCr obviously increased after treatment in the telmisartan treatment group (P <0. 05). In the 3 DN stages, SCr and 24 h U-MA obviously decreased in the combination of SG and telmisartan treatment group, when compared with the telmisartan treatment group and the SG treatment group (P<0.05). Compared with the telmisartan treatment group, SCr and BUN obviously decreased in the SG treatment group, but 24 h U-MA quantitation obviously increased (P<0.05). BUN obviously decreased in the combination of SG and telmisartan treatment group (P<0. 05).
CONCLUSIONThe combination of SG and telmisartan could decrease urinary albumin, and stabilize SCr levels.
Adult ; Albumins ; metabolism ; Antihypertensive Agents ; therapeutic use ; Benzimidazoles ; therapeutic use ; Benzoates ; therapeutic use ; Diabetic Nephropathies ; drug therapy ; Drugs, Chinese Herbal ; administration & dosage ; therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Phytotherapy ; Tablets
7.Efficacy and safety of deferasirox in aplastic anemia patients with iron overload: a single arm, multi-center,prospective study in China.
Jun SHI ; Hong CHANG ; Li ZHANG ; Yinqi SHAO ; Neng NIE ; Jing ZHANG ; Jinbo HUANG ; Li ZHANG ; Xudong TANG ; Richeng QUAN ; Chunmei ZHENG ; Haiyan XIAO ; Dengming HU ; Lingyan HU ; Feng LIU ; Yongming ZHOU ; Yizhou ZHENG ; Fengkui ZHANG
Chinese Journal of Hematology 2016;37(1):1-6
OBJECTIVETo explore the efficacy and safety of deferasirox in aplastic anemia (AA)patients with iron overload.
METHODSA single arm, multi- center, prospective, open- label study was conducted to evaluate absolute change in serum ferritin (SF)from baseline to 12 months of deferasirox administration, initially at a dose of 20 mg·kg(-1)·d(-1), and the safety in 64 AA patients with iron overload.
RESULTSAll patients started their deferasirox treatment with a daily dose of 20 mg · kg(-1) ·d(-1). The mean actual dose was (18.6±3.60) mg · kg(-1)·d(-1). The median SF decreased from 4 924 (2 718- 6 765)μg/L at baseline (n=64) to 3 036 (1 474- 5 551)μg/L at 12 months (n=23) with the percentage change from baseline as 38%. A median SF decrease of 651 (126-2 125)μg/L was observed at the end of study in 23 patients who completed 12 months' treatment, the median SF level decreased by 1 167(580-4 806)μg/L [5 271(3 420-8 278)μg/L at baseline; 3 036(1 474-5 551)μg/L after 12 months' treatment; the percentage change from baseline as 42% ] after 12 months of deferasirox treatment. The most common adverse events (AEs) were increased serum creatinine levels (40.98%), gastrointestinal discomfort (40.98%), elevated liver transaminase (ALT: 21.31%; AST: 13.11%)and proteinuria (24.59%). The increased serum creatinine levels were reversible and non-progressive. Of 38 patients with concomitant cyclosporine use, 12(31.8%)patients had two consecutive values >ULN, 10(26.3%)patients had two consecutive values >1.33 baseline values, but only 1(2.6%)patient's serum creatinine increased more than 1.33 baseline values and exceeded ULN. For both AST and ALT, no patients experienced two post- baseline values >5 ×ULN or >10 × ULN during the whole study. In AA patients with low baseline PLT count (less than 50 × 10(9)/L), there was no decrease for median PLT level during 12 months' treatment period.
CONCLUSIONSAA patients with iron overload could achieve satisfactory efficacy of iron chelation by deferasirox treatment. The drug was well tolerated with a clinically manageable safety profile and no major adverse events.
Anemia, Aplastic ; drug therapy ; Benzoates ; therapeutic use ; Blood Transfusion ; China ; Ferritins ; blood ; Humans ; Iron ; blood ; Iron Chelating Agents ; therapeutic use ; Iron Overload ; drug therapy ; Liver ; Prospective Studies ; Triazoles ; therapeutic use
8.Efficacy and tolerability of a single-pill combination of telmisartan/hydrochlorothiazide 80/25 mg in Chinese and Korean patients with moderate to severe hypertension: a subgroup analysis of a randomized, double-blind, active-controlled trial.
Ding-Liang ZHU ; Ping-Jin GAO ; Shao-Wen LIU ; Myung Ho JEONG ; Michaela MATTHEUS ; Voelker BIRGIT
Chinese Medical Journal 2013;126(21):4072-4077
BACKGROUNDHypertension is an important issue in Asia, responsible for up to 66% of cardiovascular disease cases. This randomized controlled trial subgroup analysis compared telmisartan 80 mg (T80)/hydrochlorothiazide 25 mg (H25) singlepill combination with T80 monotherapy, specifically in Chinese and Korean patients.
METHODSPatients with grade 2/3 hypertension were randomized to receive telmisartan 40 mg (T40)/hydrochlorothiazide 12.5 mg (H12.5) combination or T40 monotherapy for one week, before uptitrating the dose to T80/H25 or T80, respectively, for the remaining 6 weeks. The primary endpoint was systolic blood pressure (SBP) mean change from baseline. Secondary endpoints included mean diastolic blood pressure (DBP) change from baseline, and blood pressure (BP) goal achievement. Adverse events were recorded.
RESULTSOf a total 888 patients who were treated, efficacy analyses for Chinese and Korean patients included 127 patients treated with T80/H25 and 54 patients treated with T80. At week 7, mean SBP reductions from baseline were -37.5 mmHg (1 mmHg = 0.133 kPa) and -26.9 mmHg in the T80/H25 and T80 groups (adjusted mean difference, -10.6 mmHg; 95% confidence interval (CI), -15.6 to -5.7). Mean DBP reductions were -19.0 and -14.1 mmHg in the T80/H25 and T80 groups (adjusted mean difference, -4.9 mmHg; 95% CI, -8.0 to -1.8). In total, 56.7% of patients receiving T80/H25 achieved BP goal (<140/90 mmHg) compared with 35.2% receiving T80. SBP goal attainment (<140 mmHg) and DBP goal attainment (<90 mmHg) were also higher in the T80/H25 group compared with the T80 group (SBP: 69.3% vs. 48.1%; DBP: 62.2% vs. 46.3%). A small number of treatment-related adverse events were observed in both T80/H25 (nine patients, 6.9%) and T80 monotherapy (two patients, 3.6%) groups.
CONCLUSIONSIn Chinese and Korean patients with moderate-to-severe hypertension, treatment with T80/H25 provided large reductions in mean SBP and DBP, and high BP goal attainment rates. This once-daily combination is effective and well tolerated in this patient group.
Adult ; Aged ; Antihypertensive Agents ; Benzimidazoles ; therapeutic use ; Benzoates ; therapeutic use ; Blood Pressure ; drug effects ; Double-Blind Method ; Female ; Humans ; Hydrochlorothiazide ; therapeutic use ; Hypertension ; drug therapy ; Male ; Middle Aged ; Treatment Outcome
9.Effect of telmisartan and pyridoxamine on oxidative stress in brain tissue of spontaneously hypertensive rats.
Feng HUANG ; Peng-Li ZHU ; Fan LIN ; Hong LIN
Chinese Journal of Applied Physiology 2012;28(4):342-345
OBJECTIVETo explore the effect of telmisartan and pyridoxamine on oxidative stress in brain tissue of spontaneously hypertensive rats.
METHODSTwenty-four spontaneously hypertensive rats were randomly divided into four groups (n = 6): hypertensive control group (HC group), telmisartan group (T group ), pyridoxamine group (P group ), telmisartan and pyridoxamine group (TP group). Wistar-Kyoto (WKY) rats of the same age were served as a normal control group (NC group). Drug treatment lasted for 16 weeks the level of hyde (MDA) in rat brain tissue, as well as superoxide dismutase (SOD) activity and nicotinamide adenine dinucleotide phosphate(NADHP) oxidase p47phox mRNA expression were observed in this study.
RESULTSThe MDA level in brain in HC group were higher than that in NC group and the SOD activity were lower (P < 0.05). T group, P group and TP group had lower MDA level and higher SOD activity than HC group (P < 0.05). The NADPH mRNA in brain in HC group were significantly higher than that in NC group (P < 0.01). T group and TP group had decreased levels of NADPH mRNA (P < 0.01), there was no significant difference between HC group and P group (P > 0.05).
CONCLUSIONThe brain tissue of spontaneous hypertensive rats had been under the status of oxidative stress. Single application of either telmisartan or pyridoxamine could inhibit oxidative stress of brain tissue. However, compare with single treatment of telmisartan, no beneficial effects were observed in combined use of telmisartan and pyridoxamine.
Animals ; Benzimidazoles ; pharmacology ; therapeutic use ; Benzoates ; pharmacology ; therapeutic use ; Brain ; drug effects ; metabolism ; Hypertension ; drug therapy ; metabolism ; Male ; NADPH Oxidases ; metabolism ; Oxidative Stress ; drug effects ; Pyridoxamine ; pharmacology ; therapeutic use ; Rats ; Rats, Inbred SHR ; Rats, Inbred WKY ; Superoxide Dismutase ; metabolism
10.Maintenance of efficacy and its predictors after discontinuation of eltrombopag in adults with primary immune thrombocytopenia.
Hui Ping SUN ; Jian Hua YOU ; Qiu Sheng CHEN ; Jin WANG ; Jun Min LI
Chinese Journal of Hematology 2023;44(1):32-37
Objective: To determine the efficacy of eltrombopag for primary immune thrombocytopenia (ITP) in adults and the predictive factors for treatment-free response (TFR) . Methods: Clinical data of adults with ITP who received eltrombopag from June 14, 2013 to May 31, 2021 in the Hematology Department of Ruijin Hospital affiliated with Shanghai Jiao Tong University Medical College were retrospectively analyzed. The initial dose of eltrombopag was 25 mg/d, and the maximum dose was 75 mg/d; the dose was adjusted to maintain the platelet count to within 50-150×10(9)/L. Treatment was discontinued according either to the protocol, on the patient's wishes or doctor's judgment (prescription medication), or based on clinical trials. The efficacy of eltrombopag and factors for TFR among patients who achieved complete response and those who discontinued treatment were analyzed. Results: Overall, 106 patients with ITP (33 men and 73 women) were included in the study. The median age of patients was 50 (18-89) years. There were 2, 10, and 94 cases of newly diagnosed, persistent, and chronic ITP, respectively. The complete response rate was 44.3% (47/106), the response rate was 34.0% (36/106), and the overall response rate was 78.3% (83/106). Meanwhile, 83 patients who responded to treatment discontinued eltrombopag; of these, 81 patients were evaluated. Additionally, 17 patients (21.0%) achieved TFR. The median follow-up duration of patients who achieved TFR was 126 (30-170) weeks. The recurrence rate was 17.6% (3/17), and the relapse-free survival rate was 76.5%. The results of univariate analysis revealed that non-recurrence after discontinuation of other treatments for ITP (P=0.001), and platelet count and eltrombopag dose of ≥100×10(9)/L (P=0.007) and ≤25 mg/d (P=0.031), respectively, upon discontinuation of eltrombopag were predictors of TFR; these effects were attributed to prolonged effective duration of eltrombopag. Multivariate analysis showed that there was a correlation between non-recurrence and prolonged effective duration after discontinuation of other treatments for ITP (P=0.002) . Conclusion: Eltrombopag is effective for patients with ITP as it can result in TFR. Predictors for TFR include non-recurrence after discontinuation of concomitant ITP treatment, and platelet count and eltrombopag dose of ≥100 × 10(9)/L and ≤25 mg/d upon discontinuation of treatment, respectively.
Male
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Humans
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Adult
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Female
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Middle Aged
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Aged
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Aged, 80 and over
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Purpura, Thrombocytopenic, Idiopathic/diagnosis*
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Retrospective Studies
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Treatment Outcome
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China/epidemiology*
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Benzoates/therapeutic use*