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Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.
Hu, K, Guan, WJ, Bi, Y, Zhang, W, Li, L, Zhang, B, Liu, Q, Song, Y, Li, X, Duan, Z, et al
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2021;:153242
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Abstract
BACKGROUND Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza. PURPOSE To determine the safety and efficacy of LH capsule in patients with Covid-19. METHODS We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery. RESULTS We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported. CONCLUSION In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.
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Effects of Kudiezi Injection on Serum Inflammatory Biomarkers in Patients with Acute Cerebral Infarction.
Liu, X, Jin, X, Chen, B, Liu, X, Liang, X, Fang, X, Wu, H, Fu, X, Zheng, H, Ding, X, et al
Disease markers. 2018;:7936736
Abstract
BACKGROUND Kudiezi injection is a traditional Chinese medicine for acute cerebral infarction, but the exact mechanisms are poorly understood. OBJECTIVE To investigate the mechanisms of Kudiezi injection on the inflammatory response in the treatment of acute cerebral infarction. METHODS This was a prospective study of patients with acute cerebral infarction within 48 h of onset and treated between July 2012 and July 2016 at three hospitals in China. The patients were randomized to routine treatments (control group) versus routine treatments and Kudiezi injection (Kudiezi group). The National Institutes of Health Stroke Score was assessed on days 1, 3, 5, 7, and 14. The patients were tested for serum levels of pro- and anti-inflammatory cytokines (S100 calcium-binding protein B, neuron-specific enolase, interleukin-6, interleukin-10, interleukin-18, and matrix metaloproteinase-9; by enzyme-linked immunosorbent assay) immediately after admission and on days 3, 5, and 14. RESULTS Stroke scores were improved in both groups from days 1 to 14. On days 5 and 7, stroke scores in the Kudiezi group were lower than in the control group (P < 0.05). Compared with controls, the Kudiezi group had lower serum S100 calcium-binding protein B on day 14; higher interleukin-6 and interleukin-10 on day 3; lower interleukin-6 and interleukin-18 on day 5; and lower interleukin-18 and matrix metaloproteinase-9 on day 14. CONCLUSION Kudiezi injection could lead to early reduction of interleukin-6, interleukin-18, matrix metaloproteinase-9, neuron-specific enolase, and S100 calcium-binding protein B levels and increases of interleukin-10 levels in patients with acute ischemic stroke. This trial is registered with ClinicalTrials.gov NCT01636154.
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THE THERAPEUTIC EVALUATION AND MECHANISM ON TREATING BRONCHIAL HYPER-RESPONSIVENESS COUGH BY ZIYINQINGRE PRESCRIPTION.
Zhang, Y, Dan Li, S, Zhang, JX, Liu, Y, Cui, YX, Yang, MH
African journal of traditional, complementary, and alternative medicines : AJTCAM. 2016;(5):190-194
Abstract
OBJECTIVE Discussing the effects of Ziyinqingre prescription on the level of airway resistance (Rrs), airway response threshold (Dmin), airway conductance (sGrs) and the level of inflammatory cytokines interleukin-4 (IL-4) and interferon-γ (IFN-γ) of the bronchial hyper-responsiveness (BHR) cough patients. METHOD 84 subjects diagnosed as BHR were randomly divided into 42 Chinese Traditional medicine group and 42 control group. The Chinese Traditional Medicine group received Ziyinqingre prescription twice a day and the control group received 10mg Montelukast Sodium tablets once a day for two weeks. Observe the clinical symptoms improvement and the changes of the level of the Rrs, Dmin, sGrs and IL-4, IFN-γ. RESULTS After receiving the medicine, the symptoms of the Chinese medicine group were obviously alleviated, the outcome was more satisfied than that of the control group. Compared with the control group, the level of Dmin increased and sGrs level decreased more obviously (P<0.05); the level of IL-4 decreased and IFN^level increased more obviously in the Chinese medicine group (P<0.05). CONCLUSION Ziyinqingre prescription can not only improve BHR patients' symptoms, but reduce the level of bronchial responsiveness, which proved a better curative effect of Chinese medicine. The mechanism is probably due to relieving the airway inflammation by keeping the balance between Th1 and Th2 cells.
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Effects of Hedan Tablet () on lipid profile, proprotein convertase subtilisin/kexin type 9 and high-density lipoprotein subfractions in patients with hyperlipidemia: A primary study.
Xu, RX, Wu, NQ, Li, S, Zhang, Y, Li, XL, Guo, YL, Zhu, CG, Liu, G, Dong, Q, Li, JJ
Chinese journal of integrative medicine. 2016;(9):660-5
Abstract
OBJECTIVE To investigate the effects of Hedan Tablet () on serum lipid profile, proprotein convertase subtilisin/kexin type 9 (PSCK9) and high-density lipoprotein (HDL) subfractions in patients with hyperlipidemia. METHODS Thirty-seven patients with hyperlipidemia were randomized to treatment with Hedan Tablet 4.38 g/day as Hedan group (18 cases) or placebo (19 cases) as control group for 8 weeks. The lipid profile, PCSK9 and HDL subfractions were determined at day 0 and week 8 in both groups respectively. RESULTS Hedan treatment for 8 weeks mildly decreased serum low-density lipoprotein cholesterol (LDL-C) levels, while no changes were found in total cholesterol (TC), triglycerides (TG) and PCSK9 concentrations. Furthermore, Hedan treatment increased the concentration of large high-density lipoprotein cholesterol (HDL-C) and the percentage of large HDL subfraction, while decreased the concentration of small HDL-C and the percentage of small HDL subfraction without changing serum HDL-C levels in patients with hyperlipidemia. CONCLUSION Hedan treatment of 4.38 g per day for 8 weeks could confer a favorable effects on serum LDL-C concentration as well as HDL subfractions.
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[Treating ischemic stroke patients of deficiency of qi and yin syndrome and static blood obstructing collaterals syndrome by Yangyin Yiqi Huoxue Recipe: a clinical study of therapeutic effect].
Wan, HT, Bie, XD, Yao, Z, Xu, B, Liu, H, Yang, JH, Zhang, Y, He, Y, Zhou, HF
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2015;(3):281-6
Abstract
OBJECTIVE To observe the clinical effect of Yangyin Yiqi Huoxue Recipe (YYHR, the basic recipe of Yangyin Tongnao Granule) in treatment of ischemic stroke patients of deficiency of qi and yin syndrome (DQYS) and static blood obstructing collaterals syndrome (SBOCS). METHODS Totally 312 patients were assigned to the control group (86 cases) and the treatment group (226 cases) using strati- fied randomized allocation method. Patients in the treatment group were treated with modified YYHR, while those in the control group took Xueshuan Xinmaining. The treatment course was 4 weeks for all. Constituent ratios of the acute stage and the recovery stage of DQYS and SBOCS and their complicated syndromes were observed in the two groups. Changes of the clinical curative effect, clinical symptoms integral, whole blood viscosity ratio, plasma viscosity ratio, hematocrit, erythrocyte sedimentation rate (ESR), total cho- lesterol (TC), triglyceride (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) were detected in the two groups before and after treatment. RESULTS There was statistical difference in constituent ratios of the acute stage and the recovery stage of DQYS SBOCS and its complicated syndromes between the two groups (P < 0.01). DQYS and SBOCS was basic syndrome types of the two groups. The cured and markedly effective rate was 71.24%(161/226) in the treatment group and 43.02% (37/86) in the control group. The total effective rate was 91.15% (206/226) in the treatment group, higher than that of the control group (76.74%, 66/86) with statistical difference (P < 0.01). There was statistical difference in the clinical symptoms integral, whole blood viscosity ratio, plasma viscosity ratio, hematocrit, ESR, TC, TG,HDL-C, and LDL-C (P < 0.05, P < 0.01). CONCLUSIONS Symptoms of ischemic stroke patients could be improved by modified YYHR. Indices such as the whole blood viscosity, plasma viscosity ratio, hematocrit, ESR, abnormal metabolism of blood lipids were also significantly improved. Pathological changes of blood stasis induced by qi-yin deficiency exist in ischemic stroke patients, and DQYS and SBOCS were basic syndrome types.
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Study on the efficacy and safety of Jinlida in patients with inadequately controlled type-2 diabetes and dyslipidemia under life style intervention (ENJOY LIFE Study).
Zhang, Y, Wang, W, Ning, G
Journal of diabetes. 2015;(2):268-9
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A multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the effects of qili qiangxin capsules in patients with chronic heart failure.
Li, X, Zhang, J, Huang, J, Ma, A, Yang, J, Li, W, Wu, Z, Yao, C, Zhang, Y, Yao, W, et al
Journal of the American College of Cardiology. 2013;(12):1065-1072
Abstract
OBJECTIVES The purpose of this study was to assess the effects of qili qiangxin capsules in patients with chronic heart failure (CHF). BACKGROUND Qili qiangxin capsules are a traditional Chinese medicine that has been approved in China for the treatment of CHF, but the evidence supporting its efficacy remains unclear. METHODS A total of 512 patients with CHF were enrolled and randomly assigned to receive the placebo or qili qiangxin capsules in addition to their standard medications for the treatment of CHF. The primary endpoint was the reduction or percent change in the plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) level during 12 weeks of treatment. RESULTS At the 12-week follow-up, a significant reduction in the NT-proBNP level from baseline was observed in both groups, but the qili qiangxin capsule group demonstrated a significantly greater reduction than the placebo group (p = 0.002); 47.95% of patients in the qili qiangxin capsule group demonstrated reductions in NT-proBNP levels of at least 30% compared with 31.98% of patients in the placebo group (p < 0.001). Treatment with qili qiangxin capsules also demonstrated superior performance in comparison to the placebo with respect to New York Heart Association functional classification, left ventricular ejection fraction, 6-min walking distance, and quality of life. CONCLUSIONS On a background of standard treatment, qili qiangxin capsules further reduced the levels of NT-proBNP. Together, our data suggest that qili qiangxin capsules could be used in combination therapy for CHF.
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[Treatment of chronic heart failure by shencao tongmai granule: a multi-centered, double-blinded, randomized, parallel controlled trial].
Wang, C, Zhang, Y, Gong, LH
Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine. 2012;(5):612-5
Abstract
OBJECTIVE To assess the clinical effects and safety of Shencao Tongmai Granule (STG) in treatment of patients with chronic heart failure (CHF) (NYHA functional class II - III) of qi deficiency blood stasis and water retention syndrome (QDBSWRS). METHODS This was a multi-centered, double blinded, randomized, and placebo parallel controlled study. A total of 280 CHF patients of QDBSWRS were randomly assigned to the trial group and the control group in the ratio of 1:1. All patients received Western medicine (WM) treatment such as ACEI, diuretics, Digoxin Elixirs, and so on. Additionally, patients in the trial group took STG while those in the control group took the placebo. The therapeutic course for all was twelve weeks. The NYHA functional classification, Chinese medicine (CM) syndrome integral, and left ventricular ejection fraction (LVEF) were compared between the two groups. The safety assessment was also carried out. RESULTS Totally 265 patients completed this trial (138 cases in the trial group and 127 cases in the control group). The effective rate of NYHA functional classification and CM syndrome integral were obviously higher in the trial group than in the control group (94.20% vs 55.90%, 97.83% vs 70.08% respectively), showing statistical difference (P < 0.01). There was no statistical difference in LVEF between the two groups before treatment (P > 0.05). The LVEF both increased in the two groups when compared with before treatment (P < 0.05). The post-treatment increment of LVEF was obviously higher in the trial group than in the control group (6.55% +/- 6.23% vs 3.14% +/- 4.99%, P < 0.05). The rate of adverse reaction was 0.71% in the two groups (1/140). CONCLUSION STG showed good therapeutic effectiveness and safety in treating CHF patients of QDBSWRS.
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The treatment of non-small cell lung cancer by interstitial I-125 seeds implantation combined with chemotherapy and Chinese medicine.
Feng, Y, Xiao, YY, Li, SD, Lin, MX, Zhang, Y, Wang, HM, Li, M, Zhang, X, Cao, K, Ye, YF, et al
Chinese journal of integrative medicine. 2012;(9):663-9
Abstract
OBJECTIVE To investigate the effects of brachytherapy with computed tomography-guided percutaneous radioactive I-125 seeds interstitial implantation (ISI) synchronized chemotherapy and Chinese medicine (CM) for the treatment of advanced stage of non-small cell lung cancer (NSCLC). METHODS Ninety patients diagnosed with NSCLC by biopsy were randomly assigned to three groups: the synchronized therapy group (A), the chemotherapy plus CM-treated group (B), and the chemotherapy-treated group (C); a 2-month course of treatment was administered to them all. The effectiveness of treatment was evaluated based on tumor size, tumor markers (carcinoembryonic, squamous cell carcinoma-associated antigen, and cytokeratin 19 fragment), clinical symptoms, and quality of life (QOL) in patients. RESULTS The total effective rates of Groups A to C were 83.33%, 46.67%, and 43.33%, respectively. The tumor markers were reduced obviously in Group A, showing signifificant difference compared with those in the other two groups. Additionally, QOL was elevated and cancer-related symptoms were alleviated more signifificant in Group A than those in Group C (all P<0.05). CONCLUSION The synchronized therapy of I-125 implantation with chemotherapy and CM was a safe therapeutic method and can be regarded as a new mode for treatment of advanced-stage NSCLC.
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[Therapeutic effect of Rabdosia rubescens aqueous extract on chronic pharyngitis and its safety].
Ma, Z, Hu, C, Zhang, Y
Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences. 2011;(2):170-3
Abstract
OBJECTIVE To evaluate the clinical therapeutic effect of Rabdosia rubescens aqueous extract on chronic pharyngitis and its safety. METHODS One hundred and two patients suffered from chronic pharyngtis were randomly divided into an interventional group (n=51) and a placebo group (n=51). These volunteers were given 220 mL test materials once a day double-blindly for 30 days. All patients took routine physical examinations, and their throat symptom and pharynx signs were observed before and after the experiment. RESULTS After the patients had consumed Rabdosia rubescens aqueous extract and the placebo for 30 days, the improvement rates of main clinical symptom and signs in the interventional group were 67.31% and 61.54%, while those in placebo group were 19.23% and 11.54%, with significant difference (P<0.05). Before the experiment, the integral of main clinical symptom and signs between the two groups did not show significant difference (P>0.05). But after 30 days, the integral of main clinical symptom and signs in the interventional group significantly decreased (P<0.05), compared with itself before the experiment and the placebo group. CONCLUSION Rabdosia rubescens aqueous extract is safe and effective for patients with chronic pharyngitis.