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BACKGROUND: In a randomized trial, Lianhuaqingwen (LHQW) capsule was effective for accelerating symptom recovery among patients with coronavirus disease 2019 (COVID-19). However, the lack of blinding and limited sample sizes decreased the level of clinical evidence. OBJECTIVES: To evaluate the efficacy and safety of LHQW capsule in adults with mild-to-moderate COVID-19. METHODS: We conducted a double-blind randomized controlled trial in adults with mild-to-moderate COVID-19 (17 sites from China, Thailand, Philippine and Vietnam). Patients received standard-of-care alone or plus LHQW capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the median time to sustained clinical improvement or resolution of nine major symptoms. RESULTS: The full-analysis set consisted of 410 patients in LHQW capsules and 405 in placebo group. LHQW significantly shortened the primary endpoint in the full-analysis set (4.0 vs. 6.7 days, hazards ratio: 1.63, 95% confidence interval: 1.39-1.90). LHQW capsules shortened the median time to sustained clinical improvement or resolution of stuffy or runny nose (2.8 vs. 3.7 days), sore throat (2.0 vs. 2.6 days), cough (3.2 vs. 4.9 days), feeling hot or feverish (1.0 vs. 1.3 days), low energy or tiredness (1.3 vs. 1.9 days), and myalgia (1.5 vs. 2.0 days). The duration to sustained clinical improvement or resolution of shortness of breath, headache, and chills or shivering did not differ significantly between the two groups. Safety was comparable between the two groups. No serious adverse events were reported. INTERPRETATION: LHQW capsules promote recovery of mild-to-moderate COVID-19 via accelerating symptom resolution and were well tolerated. Trial registration ChiCTR2200056727 .
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COVID-19 , Medicamentos de Ervas Chinesas , Adulto , Humanos , Método Duplo-Cego , Medicamentos de Ervas Chinesas/uso terapêutico , Resultado do TratamentoRESUMO
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide and characterized by emphysema, small airway remodeling and mucus hypersecretion. Citrus peels have been widely used as food spices and in traditional Chinese medicine for chronic lung disease. Given that citrus peels are known for containing antioxidants and anti-inflammatory compounds, we hypothesize that citrus peel intake can suppress oxidative stress and inflammatory response to air pollution exposure, thereby alleviating COPD-like pathologies. This study aimed to investigate the efficacy of citrus peel extract, namely Guang Chenpi (GC), in preventing the development of COPD induced by diesel exhaust particles (DEPs) and its potential mechanism. DEP-induced COPD-like lung pathologies, inflammatory responses and oxidative stress with or without GC treatment were examined in vivo and in vitro. Our in vivo study showed that GC was effective in decreasing inflammatory cell counts and inflammatory mediator (IL-17A and TNF-α) concentrations in bronchoalveolar lavage fluid (BALF). Pretreatment with GC extract also significantly decreased oxidative stress in the serum and lung tissue of DEP-induced COPD rats. Furthermore, GC pretreatment effectively reduced goblet cell hyperplasia (PAS positive cells) and fibrosis of the small airways, decreased macrophage infiltration as well as carbon loading in the peripheral lungs, and facilitated the resolution of emphysema and small airway remodeling in DEP-induced COPD rats. An in vitro free radical scavenging assay revealed robust antioxidant potential of GC in scavenging DPPH free radicals. Moreover, GC demonstrated potent capacities in reducing ROS production and enhancing SOD activity in BEAS-2B cells stimulated by DEPs. GC treatment significantly attenuated the increased level of IL-8 and MUC5AC from DEP-treated BEAS-2B cells. Mechanistically, GC treatment upregulated the protein level of Nrf-2 and could function via MAPK/NF-κB signaling pathways by suppressing the phosphorylation of p38, JNK and p65. Citrus peel extract is effective in decreasing oxidative stress and inflammatory responses of the peripheral lungs to DEP exposure. These protective effects further contributed to the resolution of COPD-like pathologies.
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Citrus , Enfisema , Doença Pulmonar Obstrutiva Crônica , Ratos , Animais , Emissões de Veículos/toxicidade , Citrus/metabolismo , Remodelação das Vias Aéreas , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Pulmão , Estresse Oxidativo , Antioxidantes/farmacologia , Antioxidantes/metabolismo , Líquido da Lavagem Broncoalveolar/química , Enfisema/metabolismoRESUMO
BACKGROUND: Recent studies suggest that routine laboratory tests are not required within 1 day after partial knee arthroplasty. In this study, we evaluated the utility of routine postoperative laboratory tests after initial unilateral total knee arthroplasty (TKA) in an Asian population. In addition, we explored risk factors associated with abnormal test results. METHODS: Clinical data of patients who underwent original unilateral TKA between 2015 and 2020 were retrospectively analyzed. Patient characteristics and laboratory test results were recorded. Multivariate binary logistic regression analysis was performed to identify risk factors associated with 3 abnormal laboratory results. RESULTS: A total of 713 patients, who underwent relevant laboratory tests within 3 days of TKA surgery, were enrolled. Among them, 8.1%, 9.9%, and 3.4% patients with anemia, hypoalbuminemia, and abnormal serum potassium levels required clinical intervention after surgery. Binary logistic regression analysis revealed that preoperative hemoglobin levels, estimated blood loss, and age were independent risk factors of postoperative blood transfusion in TKA patients. On the other hand, preoperative albumin levels, intraoperative blood loss, and operation time were risk factors associated with postoperative albumin supplementation. In addition, lower body mass index (BMI) and preoperative hypokalemia were potential risk factors of postoperative potassium supplementation. CONCLUSION: Considering that more than 90% of abnormal postoperative laboratory tests do not require clinical intervention, we believe that routine laboratory tests after surgery have little significance in patients with primary unilateral TKA. However, postoperative laboratory testing is necessary for patients with established risk factors.
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Artroplastia do Joelho , Albuminas , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/métodos , Perda Sanguínea Cirúrgica , Humanos , Potássio , Estudos RetrospectivosRESUMO
The development of anti-COVID-19 drugs has become the top priority since the outbreak of the epidemic, and Traditional Chinese medicine plays an important role in reducing mortality. Here, hesperidin and its glycosylation product, glucosyl hesperidin were selected to determine their antiviral activity against SARS-CoV-2 due to their structural specificity as reported. To be specific, their binding ability with ACE2, M, S, RBD and N proteins were verified with both in silico and wet lab methods, i.e., molecular docking and binding affinity tests, including biolayer interferometry assay (BLI) and isothermal titration calorimetry assay (ITC). Moreover, systematic pharmacological analysis was conducted to reveal their pharmacological mechanism in treating COVID-19. Finally, their antiviral activity against SARS-CoV-2 was determined in vitro in a biosafety level 3 (BSL3) laboratory. The results demonstrated their outstanding binding affinity with ACE2, M, S and RBD proteins, while showed barely unobserved binding with N protein, indicating their key roles in influencing the invasion and early replication phase of SARS-CoV-2. In addition, both hesperidin and glucosyl hesperidin were shown to have a great impact on immune, inflammation and virus infection induced by COVID-19 according to the systematic pharmacological analysis. Moreover, the IC50s of hesperidin and glucosyl hesperidin against SARS-CoV-2 were further determined (51.5 [Formula: see text]M and 5.5 mM, respectively) with cell-based in vitro assay, suggesting their great anti-SARS-CoV-2 activity. All in all, present research was the first to verify the binding ability of hesperidin and glucosyl hesperidin with SARS-CoV-2 proteins with both in silico and wet-lab methods and proposed the possibility of applying hesperidin and glucosyl hesperidin to treat COVID-19.
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Tratamento Farmacológico da COVID-19 , Hesperidina , Antivirais/farmacologia , Biologia Computacional , Glucosídeos , Hesperidina/análogos & derivados , Hesperidina/farmacologia , Humanos , Simulação de Acoplamento Molecular , SARS-CoV-2 , Glicoproteína da Espícula de Coronavírus/química , Glicoproteína da Espícula de Coronavírus/metabolismoRESUMO
ObjectiveTo observe the effect of Liuwei Dihuangtang (LWDHT) on depression-like behaviors of rats with diabetes mellitus and depression (DD) and explore its mechanism. MethodThe diabetes mellitus (DM) model was induced by the high-fat diet and tail vein injection of low-dose streptozotocin (STZ) in 50 male Sprague-Dawley rats of SPF grade. Then the DD model was induced by chronic unpredictable mild stress (CUMS) for 28 days in DM rats. Fifty DD rats were randomly divided into model group, fluoxetine group (10 mg·kg-1·d-1), and low-, medium-, and high-dose LWDHT groups (3.375, 6.75, 13.5 g·kg-1·d-1), with 10 rats in each group. Another 10 healthy rats were assigned into a control group and received normal saline by gavage. After four weeks of drug intervention, the forced swimming assay was carried out to assess the depression-like behaviors of rats. The expression levels of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-4 (IL-4), and interleukin-10 (IL-10) in the anterior cingulate cortex (ACC) were detected by enzyme-linked immunosorbent assay (ELISA). Immunofluorescence was used to detect the expression of myelin basic protein (MBP) in ACC and the co-localization of ionized calcium-binding adapter molecule 1 (Iba1) with intracellular microtubule-associated protein 1 light chain 3 (LC3). The protein expression levels of MBP, myelin proteolipid protein (PLP), myelin oligodendrocyte glycoprotein (MOG), Beclin-1, LC3, p62, and microglia (MG) phenotypic protein-related inducible nitric oxide synthase (iNOS), and arginase 1 (Arg1) were detected by Western blot. ResultCompared with the control group, the model group showed shortened swimming time and prolonged immobility time (P<0.01). Compared with the model group, the medium- and high-dose LWDHT groups showed reduced immobility time (P<0.05, P<0.01). Compared with the control group, the model group showed decreased protein expression of MBP, PLP, and MOG in the ACC region (P<0.01). Compared with the model group, the fluoxetine group and the medium- and high-dose LWDHT groups showed up-regulated protein expression of MBP, PLP, and MOG (P<0.05, P<0.01). Compared with the control group, the model group showed decreased MBP fluorescence intensity in the ACC region (P<0.01). Compared with the model group, the fluoxetine group and the medium- and high-dose LWDHT groups showed increased MBP fluorescence intensity in the ACC region (P<0.05, P<0.01). Compared with the control group, the model group showed increased expression of iNOS (P<0.01) and slightly increased Arg1 protein expression. Compared with the model group, the medium- and high-dose LWDHT groups and the fluoxetine group showed down-regulated iNOS expression and up-regulated Arg1 protein expression (P<0.05, P<0.01), but there was no significant difference between the fluoxetine group and the medium-,high-dose LWDHT groups. Compared with the control group, the model group showed increased expression levels of proinflammatory factors IL-1β and TNF-α in the ACC region (P<0.01) and slightly increased expression levels of anti-inflammatory factors IL-4 and IL-10. Compared with the model group, the fluoxetine group, and the medium- and high-dose LWDHT groups showed down-regulated expression of IL-1β and TNF-α (P<0.05, P<0.01) and up-regulated expression of IL-4 and IL-10 (P<0.05, P<0.01). Compared with the control group, the model group showed reduced expression levels of Beclin-1 and LC3Ⅱ (P<0.01) and increased expression level of p62 (P<0.01). Compared with the model group, the fluoxetine group and the medium- and high-dose LWDHT groups showed up-regulated Beclin-1 and LC3Ⅱ expression (P<0.01) and down-regulated p62 expression (P<0.01). Compared with the control group, the model group showed decreased LC3+Iba1+ cells in the ACC region (P<0.01). Compared with the model group, the fluoxetine group and the medium- and high-dose LWDHT groups showed increased LC3+Iba1+ cells (P<0.05, P<0.01). ConclusionLWDHT can alleviate the depression-like behaviors in DD rats presumedly by promoting MG autophagy, regulating MG phenotypic changes, and increasing MG clearance of myelin sheath fragments. Meanwhile, MG phenotypic transformation also inhibits ACC inflammation in DD rats, improves the local microenvironment of oligodendrocyte proliferation and differentiation, and ultimately promotes the repair and remyelination of damaged myelin sheath.
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Pulmonary hypertension (PH) is a severe pathophysiological condition characterized by pulmonary artery remodeling and continuous increases in pulmonary artery pressure, which may eventually develop to right heart failure and death. Although newly discovered and incredible treatment strategies in recent years have improved the prognosis of PH, limited types of effective and economical drugs for PH still makes it as a life-threatening disease. Some drugs from Chinese materia medica (CMM) have been traditionally applied in the treatment of lung diseases. Accumulating evidence suggests active pharmaceutical ingredients (APIs) derived from those medicines brings promising future for the prevention and treatment of PH. In this review, we summarized the pharmacological effects of APIs derived from CMM which are potent in treating PH, so as to provide new thoughts for initial drug discovery and identification of potential therapeutic strategies in alternative medicine for PH.
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Medicamentos de Ervas Chinesas , Hipertensão Pulmonar , Materia Medica , China , Humanos , Hipertensão Pulmonar/tratamento farmacológico , Medicina Tradicional ChinesaRESUMO
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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Tratamento Farmacológico da COVID-19 , Reposicionamento de Medicamentos , Medicamentos de Ervas Chinesas/uso terapêutico , Adulto , Idoso , Cápsulas , China , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do TratamentoRESUMO
Chronic cough is very common in respiratory clinics, and no effective drugs are available. Schisandra chinensis (Turcz.) Baill. (S. chinensis), an important traditional Chinese medicine, has been extensively prescribed for patients with a persistent cough. Preliminary research indicated that 95% ethanol extracts (EE) of S. chinensis showed remarkable antitussive activity in guinea pigs exposed to cigarette smoke (CS). To find out the antitussive ingredients of S. chinensis, EE was divided into four fractions according to the polarity: petroleum ether extract (PEE), ethyl acetate extract (ECE), n-butyl alcohol extract, and residue extract. The antitussive, antioxidant, and anti-inflammatory effects of the four fractions were evaluated in a guinea pig model of cough hypersensitivity induced by CS exposure. Eighteen main constituents of the two effective fractions, PEE and ECE, were identified using ultra-high-pressure liquid chromatography electronic spray ion time-of-flight mass spectrometry. The cough inhibition activities of compound 1, 3, 9, 10, 17 were evaluated on citric acid induced acute cough guinea pigs. The results showed that the antitussive activity of EE was almost all contained in PEE and ECE. The 16 major peaks in PEE were identified as 15 lignans (1-12 and 14-16) and 1 triterpene (compound 13), and 3 major peaks (1, 17, and 18) in ECE were also identified as lignans. Three doses of five compounds brought about a significant decrease in number of cough efforts (P < .01), and the cough inhibition rates were between 40.9% and 85.1%. Therefore, lignans are the antitussive ingredients of S. chinensis.
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Antitussígenos , Lignanas , Schisandra , Animais , Cromatografia Líquida de Alta Pressão , Tosse/induzido quimicamente , Tosse/tratamento farmacológico , Cobaias , Humanos , Lignanas/análiseRESUMO
Pulmonary hypertension (PH) is a severe pathophysiological condition characterized by pulmonary artery remodeling and continuous increases in pulmonary artery pressure, which may eventually develop to right heart failure and death. Although newly discovered and incredible treatment strategies in recent years have improved the prognosis of PH, limited types of effective and economical drugs for PH still makes it as a life-threatening disease. Some drugs from Chinese materia medica (CMM) have been traditionally applied in the treatment of lung diseases. Accumulating evidence suggests active pharmaceutical ingredients (APIs) derived from those medicines brings promising future for the prevention and treatment of PH. In this review, we summarized the pharmacological effects of APIs derived from CMM which are potent in treating PH, so as to provide new thoughts for initial drug discovery and identification of potential therapeutic strategies in alternative medicine for PH.
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Humanos , China , Medicamentos de Ervas Chinesas , Hipertensão Pulmonar/tratamento farmacológico , Materia Medica , Medicina Tradicional ChinesaRESUMO
Aflatoxin B1 (AFB1) is a toxic secondary metabolite produced by toxigenic Aspergillus spp. (such as A. flavus and A. parasiticus) with carcinogenic,teratogenic and mutagenic effects. Studies have shown that AFB1 is widely found in crops,food,feed and traditional Chinese medicine,which poses a serious safety hazards to humans healthy. The establishment of a rapid detection technique that is suitable for AFB1 in different matrices has a great significance in preventing contamination,controlling food and medicines safety and ensuring human health. With the continuous improvement of small-molecule immune technology,various rapid immunoassays of AFB1 have been developed and utilized in recent years. This review systematically summarized current relevant standards for the detection of AFB1 in China and the maximum recommended levels for the application of aflatoxins in Chinese herbal medicines in some regions and countries. These standards are mainly applicable for aflatoxins in food,feed and some easily contaminated samples of Chinese herbal medicines. Some studies have shown that except the Chinese herbal medicines specified with the maximum recommended levels,some medicinal herbs and their products were also contaminated by aflatoxins. In addition,this paper reviewed the preparation technology of antigen and antibody for AFB1,and the rapid detection methods based on the specific recognition ability between antigen and antibody, including enzyme-linked immunosorbent assay,immunochromatographic assay,fluorescence immunoassay,chemiluminescence immunoassay,and novel immunosensor method, were also summarized and compared. This review aims to provide the reference for rapid,accurate,and sensitive technical standards for the detection of AFB1 in traditional Chinese medicine during the agricultural planting,distribution, trade and quality supervision and for the market, pharmacies and hospitals,so as to ensure the quality and safety of the traditional Chinese medicines.
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BACKGROUND: In COPD, functional status is improved by pulmonary rehabilitation (PR) but requires specific facilities. Tai Chi, which combines psychological treatment and physical exercise and requires no special equipment, is widely practiced in China and is becoming increasingly popular in the rest of the world. We hypothesized that Tai Chi is equivalent (ie, difference less than ±4 St. George's Respiratory Questionnaire [SGRQ] points) to PR. METHODS: A total of 120 patients (mean FEV1, 1.11 ± 0.42 L; 43.6% predicted) bronchodilator-naive patients were studied. Two weeks after starting indacaterol 150 µg once daily, they randomly received either standard PR thrice weekly or group Tai Chi five times weekly, for 12 weeks. The primary end point was change in SGRQ prior to and following the exercise intervention; measurements were also made 12 weeks after the end of the intervention. RESULTS: The between-group difference for SGRQ at the end of the exercise interventions was -0.48 (95% CI PR vs Tai Chi, -3.6 to 2.6; P = .76), excluding a difference exceeding the minimal clinically important difference. Twelve weeks later, the between-group difference for SGRQ was 4.5 (95% CI, 1.9 to 7.0; P < .001), favoring Tai Chi. Similar trends were observed for 6-min walk distance; no change in FEV1 was observed. CONCLUSIONS: Tai Chi is equivalent to PR for improving SGRQ in COPD. Twelve weeks after exercise cessation, a clinically significant difference in SGRQ emerged favoring Tai Chi. Tai Chi is an appropriate substitute for PR. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02665130; URL: www.clinicaltrials.gov.
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Terapia por Exercício , Doença Pulmonar Obstrutiva Crônica/reabilitação , Tai Chi Chuan , Adulto , Idoso , Idoso de 80 Anos ou mais , Humanos , Pessoa de Meia-Idade , Força Muscular , Testes de Função Respiratória , Inquéritos e Questionários , Resultado do TratamentoRESUMO
Endogenous toxic components have become an important topic in the field of traditional Chinese medicines (TCMs). Since the endogenous toxic components in TCMs are often used as clinical effective components, the safety and effectiveness of endogenous toxic substances has become an important part of the research of TCMs. In this paper, the classification and evaluation criteria of toxic Chinese medicinal materials are described, and the analytical methods of endogenous components in TCMs are summarized and expounded base on with the techniques of chromatography, spectroscopy, immunoassay, and so on. On this basis, the problems in terms of endogenous toxic components are analyzed and discussed. This paper could provide ideas and methods for the evaluation of the validity and safety of TCMs containing endogenous toxic components.
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Medicamentos de Ervas Chinesas , Medicina Tradicional ChinesaRESUMO
ETHNOPHARMACOLOGICAL RELEVANCE: Schisandra chinensis (Turcz.) Baill. (S. chinensis), locally known as "Wuweizi", has been used in the treatment of chronic cough as prescription medications of Traditional Chinese Medicine for thousands of years. However, the components of antitussive activity of S. chinensis and the mechanism are poorly understood. AIM OF THE STUDY: This study aims to investigate the antitussive activity of polysaccharides extracted from S. chinensis. MATERIALS AND METHODS: S. chinensis fruit polysaccharide-1 (SCFP-1) was extracted by 95% ethanol and distilled water successively, and then the water extraction was isolated with chromatographic columns. The preliminary characterization of SCFP-1 was analyzed by gel permeation chromatography (GPC), gas chromatography-mass spectrometry (GC-MS) and some other recognized chemical methods. Antitussive potential of SCFP-1 was estimated at dose of 250, 500, and 1000mg/kg respectively by peroral administration in a guinea pigs model with cough hypersensitivity induced by cigarette smoke (Chronic cough model) or acute cough guinea model induced by citric acid (Acute cough model). Also, the time-dependent antitussive effect of SCFP-1 were evaluated with acute cough model, and compared with codeine. RESULTS: The molecular of SCFP-1 was 3.18×104Da, mainly being composed of glucose and arabinose (66.5% and 29.4%, respectively). Peroral administration of SCFP-1 at 250, 500, and 1000mg/kg showed remarkable suppressive effects respectively on cough in both of chronic cough model and acute cough model. Meanwhile, inflammatory cell in BALF and some typical characteristics of nonspecific airway inflammation in animals exposed to CS was significantly attenuated after pretreatment with SCFP-1. The cough suppression of SCFP-1 (500 mg/kg) stablly lasted during the whole 5 h of time-dependent experiment, while no positive effect was observed after 300 min of oral administration of codeine. CONCLUSIONS: SCFP-1 is one of the antitussive components of S. chinensis.
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Antitussígenos/farmacologia , Extratos Vegetais/farmacologia , Schisandra/química , Animais , Cromatografia em Gel , Cromatografia Gasosa-Espectrometria de Massas , Cobaias , MasculinoRESUMO
BACKGROUND: Ban-Lan-Gen (BLG) is a traditional Chinese herbal medicine. It has been used for the prevention and treatment of virus-related respiratory diseases such as influenza virus infection. BLG contains some antiviral compounds, but few evidence-based clinical studies have been conducted to assess its efficacy against influenza. We assessed the effects of BLG (including efficacy and safety) on the treatment of seasonal influenza in an evidence-based clinical trial. METHODS/DESIGN: We conducted a randomized, double-blinded, oseltamivir- and placebo-controlled, parallel-design clinical trial. A total of 177 subjects are going to be recruited after satisfying the criteria: (i) 18 to 65 years of age; (ii) illness onset within 36 h; (3) axillary temperature ≥38.0°C; and (iv) positive influenza (type A/B) virus test. Subjects will be assigned randomly into three groups in equal proportions: oseltamivir treatment, BLG granule treatment, and placebo treatment. Each group receives 5-day treatment and is followed up 1, 3, 5, 7 and 21 days later. Symptoms and patient compliance are recorded, and virus/serum viral antibodies tested. We will use the primary outcome, secondary outcome, and safety indicators to evaluate the efficacy and safety of BLG granules in the treatment of seasonal influenza. DISCUSSION: We have described the first clinical trial for treatment using a single herb against influenza A and B viruses in China. We will hold a large-scale clinical trial to comprehensively evaluate the effectiveness and safety of BLG against influenza infection based on the results of this pilot study. And this clinical trial will serve as an example for the study of other traditional herbal medicines in evidence-based clinical trials. TRIAL REGISTRATION: This study has been registered at ClinicalTrials.gov: NCT02232945 (3 September 2014).
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Antivirais/uso terapêutico , Influenza Humana/terapia , Medicina Tradicional Chinesa , Oseltamivir/uso terapêutico , Fitoterapia , Adulto , Protocolos Clínicos , Método Duplo-Cego , Humanos , Influenza Humana/tratamento farmacológico , Pessoa de Meia-IdadeRESUMO
Schisandra chinensis (S. chinensis) is a traditional Chinese medicine commonly used in prescription medications for the treatment of chronic cough. However, the material basis of S. chinensis in relieving cough has not been completely elucidated yet. This study established a guinea pig model of cough hypersensitivity induced by 14 days of cigarette smoke (CS) exposure, to evaluate the antitussive, antioxidant, and anti-inflammatory effects of three S. chinensis extracts. And then the function of four lignans in reducing expression of TRPV1 and TRPA1 was examined using A549 cells induced by cigarette smoke extract (CSE). The results demonstrated that both ethanol extract (EE) and ethanol-water extract (EWE) of S. chinensis, but not water extract (WE), significantly reduced the cough frequency enhanced by 0.4M citric acid solution in these cough hypersensitivity guinea pigs. Meanwhile, pretreatment with EE and EWE both significantly attenuated the CS-induced increase in infiltration of pulmonary neutrophils and total inflammatory cells, as well as pulmonary MDA, TNF-α, and IL-8, while remarkably increased activities of pulmonary SOD and GSH. According to H&E and immunofluorescence staining assays, airway epithelium hyperplasia, smooth muscle thickening, inflammatory cells infiltration, as well as expression of TRPV1 and TRPA1, were significantly attenuated in animals pretreatment with 1g/kg EE. Moreover, four lignans of EE, including schizandrin, schisantherin A, deoxyschizandrin and γ-schisandrin, significantly inhibited CSE-induced expression of TRPV1, TRPA1 and NOS3, as well as NO release in A549 cells. In conclusion, S. chinensis reduces cough frequency and pulmonary inflammation in the CS-induced cough hypersensitivity guinea pigs. Lignans may be the active components.