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1.
J Nanobiotechnology ; 22(1): 266, 2024 May 18.
Article in English | MEDLINE | ID: mdl-38762451

ABSTRACT

The detection of carcinoembryonic antigen (CEA) holds significant importance in the early diagnosis of cancer. However, current methods are hindered by limited accessibility and specificity. This study proposes a rapid and convenient Cas12a-based assay for the direct detection of CEA in clinical serum samples, aiming to address these limitations. The protocol involves a rolling machine operation, followed by a 5-min Cas12a-mediated cleavage process. The assay demonstrates the capability to detect human serum with high anti-interference performance and a detection limit as low as 0.2 ng/mL. The entire testing procedure can be accomplished in 75 min without centrifugation steps, and successfully reduced the limit of detection of traditional DNA walking machine by 50 folds. Overall, the testing procedure can be easily implemented in clinical settings.


Subject(s)
Biosensing Techniques , CRISPR-Cas Systems , Carcinoembryonic Antigen , DNA , Limit of Detection , Carcinoembryonic Antigen/blood , Humans , Biosensing Techniques/methods , DNA/chemistry , Endodeoxyribonucleases , Nucleic Acid Amplification Techniques/methods , CRISPR-Associated Proteins , Bacterial Proteins/genetics
2.
J Dairy Sci ; 2024 Apr 10.
Article in English | MEDLINE | ID: mdl-38608956

ABSTRACT

Staphylococcus aureus (S. aureus) is a pathogenic bacterium-contaminating milk and dairy foods causing food poisoning and foodborne pathogens. In this work, a smartphone-enabled enzyme cascade-triggered colorimetric platform was constructed using cascade bio-nanozyme formed by immobilized glucose oxidase (GOx) on the Fe3O4@Ag for rapid detection of S. aureus. Benefiting from reasonable experimental design, a bio-nanozyme cascade-triggered reaction was achieved through H2O2 produced by GOx oxidation of glucose, followed by in situ catalysis of 3,3',5,5'-tetramethylbenzidine (TMB) by the inherent peroxidase-like activity of Fe3O4@Ag to produce color signals. S. aureus detection could be performed through naked-eye observation and smartphone measurement, the developed assay can achieve quantitative and qualitative detection of S. aureus. The on-site nanoplatform had satisfactory specificity and sensitivity with a low detection limit of 6.9 cfu·mL-1 in 50 min. Moreover, the nanoplatform has good practicality in the detection of S. aureus in milk samples. Therefore, the assay has potential application prospects in food safety inspection.

3.
Food Chem ; 440: 138196, 2024 May 15.
Article in English | MEDLINE | ID: mdl-38104450

ABSTRACT

The total bacterial count is an important indicator of food contamination in food safety supervision and management. Recently, the CRISPR/Cas12a system integrated with nucleic acid amplification has increasingly shown tremendous potential in microorganism detection. However, a general quantification strategy for total bacteria count based on the CRISPR/Cas12a system has not yet been developed. Herein, we established a sensitive bacterial quantification strategy based on the CRISPR/Cas12a system combined with magnetic covalent organic frameworks (MCOFs) and hybridization chain reaction (HCR). MCOFs acted as a carrier, adsorbing the ssDNA as HCR trigger sequence through π-π stacking. Then, the HCR circuit produces DNA duplexes containing the PAM sequences that activate the trans-cleavage activity of Cas12a for further signal amplification. Under the optimal conditions, the proposed method can quantify total bacteria in 50 min with a minimum detection concentration of 10 CFU/mL. The successful applications in food samples confirmed the feasibility and broad application prospects.


Subject(s)
Biosensing Techniques , Metal-Organic Frameworks , CRISPR-Cas Systems , Nucleic Acid Hybridization , Bacteria/genetics , Magnetic Phenomena
4.
Polymers (Basel) ; 15(6)2023 Mar 14.
Article in English | MEDLINE | ID: mdl-36987208

ABSTRACT

Regenerated cellulose packaging materials can alleviate the environmental pollution and carbon emissions caused by conventional plastics and other chemicals. They require regenerated cellulose films with good barrier properties, such as strong water resistance. Herein, using an environmentally friendly solvent at room temperature, a straightforward procedure for synthesizing these regenerated cellulose (RC) films, with excellent barrier properties and doping with nano-SiO2, is presented. After the surface silanization modification, the obtained nanocomposite films exhibited a hydrophobic surface (HRC), in which the nano-SiO2 provided a high mechanical strength, whereas octadecyltrichlorosilane (OTS) provided hydrophobic long-chain alkanes. The contents of the nano-SiO2 and the concentrations of the OTS/n-hexane in regenerated cellulose composite films are crucial, as they define its morphological structure, tensile strength, UV-shielding ability, and the other performance of these composite films. When the nano-SiO2 content was 6%, the tensile stress of the composite film (RC6) increased by 41.2%, the maximum tensile stress was 77.22 MPa, and the strain-at-break was 14%. Meanwhile, the HRC films had more superior multifunctional integrations of tensile strength (73.91 MPa), hydrophobicity (HRC WCA = 143.8°), UV resistance (>95%), and oxygen barrier properties (5.41 × 10-11 mL·cm/m2·s·Pa) than the previously reported regenerated cellulose films in packaging materials. Moreover, the modified regenerated cellulose films could biodegrade entirely in soil. These results provide an experimental basis for preparing regenerated-cellulose-based nanocomposite films that exhibit a high performance in packaging applications.

5.
Front Cardiovasc Med ; 10: 1287434, 2023.
Article in English | MEDLINE | ID: mdl-38259313

ABSTRACT

Background: The number of models developed for predicting major adverse cardiovascular events (MACE) in patients undergoing percutaneous coronary intervention (PCI) is increasing, but the performance of these models is unknown. The purpose of this systematic review is to evaluate, describe, and compare existing models and analyze the factors that can predict outcomes. Methods: We adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 during the execution of this review. Databases including Embase, PubMed, The Cochrane Library, Web of Science, CNKI, Wanfang Data, VIP, and SINOMED were comprehensively searched for identifying studies published from 1977 to 19 May 2023. Model development studies specifically designed for assessing the occurrence of MACE after PCI with or without external validation were included. Bias and transparency were evaluated by the Prediction Model Risk Of Bias Assessment Tool (PROBAST) and Transparent Reporting of a multivariate Individual Prognosis Or Diagnosis (TRIPOD) statement. The key findings were narratively summarized and presented in tables. Results: A total of 5,234 articles were retrieved, and after thorough screening, 23 studies that met the predefined inclusion criteria were ultimately included. The models were mainly constructed using data from individuals diagnosed with ST-segment elevation myocardial infarction (STEMI). The discrimination of the models, as measured by the area under the curve (AUC) or C-index, varied between 0.638 and 0.96. The commonly used predictor variables include LVEF, age, Killip classification, diabetes, and various others. All models were determined to have a high risk of bias, and their adherence to the TRIPOD items was reported to be over 60%. Conclusion: The existing models show some predictive ability, but all have a high risk of bias due to methodological shortcomings. This suggests that investigators should follow guidelines to develop high-quality models for better clinical service and dissemination. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=400835, Identifier CRD42023400835.

6.
Phytomedicine ; 107: 154458, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36152591

ABSTRACT

BACKGROUND: Scutellaria baicalensis, a medicinal herb belonging to the Lamiaceae family, has been recorded in the Chinese, European, and British Pharmacopoeias. The medicinal properties of this plant are attributed to the total flavonoids of Scutellaria baicalensis (TFSB), particularly the main component, baicalin. This study provides a systematic and comprehensive list of the identified TFSB components and their chemical structures. The quality control process, pharmacokinetics, clinical application, and safety of Scutellaria baicalensis are discussed, and its pharmacological effect on cardiovascular diseases (CVDs) is detailed. Finally, the future research trends and prospects of this medicinal plant are provided. METHODS: The Chinese and English papers related to TFSB were collected from the PubMed and CNKI databases using the relevant keywords. To highlight the pharmacological mechanism, clinical application, and safety of TFSB, the collected articles were screened and classified based on their research content. RESULTS: TFSB contains at least 100 different kinds of flavonoids, of which baicalin, baicalein, wogonin, wogonoside, scutellarin, and scutellarein are the main active ingredients. The preparation process of TFSB is relatively well established, and the extraction rate can be significantly increased by enzymatic pretreatment and ultrasonication. The low oral availability of TFSB may be effectively enhanced using nanoformulations. The available pharmacokinetic data show that flavonoid glycosides and aglycones with the same parent nucleus may be converted to structures that are conducive to absorption in vivo. Moreover, TFSB can protect against CVDs by inhibiting apoptosis, regulating oxidative stress response, participating in inflammatory response, protecting against myocardial fibrosis, inhibiting myocardial hypertrophy, and regulating blood vessels. In terms of clinical application and animal safety, the available studies show that TFSB can be applied in a wide range of clinical treatments and is safe to use is animals. CONCLUSION: This article systematically reviews the therapeutic effect and underlying pharmacological mechanism of TFSB against CVDs. The available studies clearly suggest that TFSB has great potential for the treatment of CVDs and is worthy of in-depth research and development.


Subject(s)
Cardiovascular Diseases , Flavanones , Plants, Medicinal , Animals , Cardiovascular Diseases/drug therapy , Flavanones/analysis , Flavonoids/analysis , Flavonoids/pharmacology , Flavonoids/therapeutic use , Glycosides/analysis , Plant Roots/chemistry , Plants, Medicinal/chemistry , Scutellaria baicalensis/chemistry
7.
Magn Reson Imaging ; 94: 18-24, 2022 12.
Article in English | MEDLINE | ID: mdl-35921982

ABSTRACT

OBJECTIVE: To investigate the characteristics of fat content and component in IFP using hydrogen proton MR spectroscopy (1H-MRS), and to explore the correlation with the severity of OA, Hoffa-synovitis, and knee pain. MATERIALS AND METHODS: 80 volunteers were enrolled. Subjects were grouped based on Kellgren-Lawrence (K-L) grading. Fat fraction (FF) and unsaturation index (UI) of IFP were measured using 1H-MRS. Hoffa-synovitis was evaluated based on the MRI Osteoarthritis Knee Score system (MOAKS). Knee pain was assessed by a self-administered Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire. One-way ANOVA or Kruskal-Wallis test and Spearman's correlation tests were applied for statistical analysis. RESULTS: After matching BMI, waistline, and K-L grade, a total of 64 knees were included and divided into 23 normal, 25 mild OA, and 16 advanced OA. The mean values were 76.79% ± 7.24%, 70.35% ± 7.42%, and 58.29% ± 10.32% for FF in the healthy controls, mild OA, and advanced OA group, and 6.36 ± 1.19%, 6.08 ± 1.35%, and 5.69 ± 1.78% for UI, respectively, the statistical difference was found for FF (p < 0.01). A good negative correlation was observed between the FF and the severity of OA, Hoffa-synovitis (r = -0.625, -0.758, respectively, p < 0.0001), and a weak inverse correlation with knee pain. CONCLUSION: FF alteration in IFP is associated with the severity of OA, Hoffa synovitis, and knee pain, and has the potential to be a new quantitative imaging biomarker in knee OA.


Subject(s)
Osteoarthritis, Knee , Synovitis , Humans , Osteoarthritis, Knee/diagnostic imaging , Protons , Proton Magnetic Resonance Spectroscopy , Hydrogen , Adipose Tissue/diagnostic imaging , Biomarkers , Pain
8.
Materials (Basel) ; 15(13)2022 Jun 21.
Article in English | MEDLINE | ID: mdl-35806503

ABSTRACT

In order to study the influence of brace failure on the seismic response of concentrically braced frames and the improvement of the residual structure's resistance to collapse due to reserve capacity, a series of concentrically braced frame prototypes with different story numbers is designed. A matrix of six finite-element concentrically braced-frame (CBF) models is established, which is varied by the number of stories and the level of reserve capacities. Accuracy of the numerical model is verified by comparing the responses of the shaking-table test of the concentrically braced frames, under 10 different working conditions. Then, a nonlinear time-history analysis, considering brace failure in one specified story, is carried out. The results show that the story-drift angle of the failure story as well as its adjacent stories increases greatly in the ideal pinned model. The above phenomenon is particularly serious, when the failure occurs at the top or bottom of the structure. With the reserve capacity brought by column continuity, and the semi-rigid rotation capacity of the beam-to-column and column-to-base connections are taken into consideration, the increase in story-drift angle caused by the brace failure is effectively reduced. However, the inherent reserve capacity has little influence on the dynamic characteristics of concentrically braced frames in the elastic stage.

9.
J Periodontal Res ; 57(5): 969-976, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35848007

ABSTRACT

OBJECTIVE: The aim of this study was to investigate the association between periodontitis and total serum cholesterol level in patients with type 2 diabetic nephropathy (T2DN). BACKGROUND: Periodontitis is now recognized as the sixth complication of diabetes and can also affect other complications of diabetes, including nephropathy and coronary artery diseases. Studies have considered dyslipidemia as a risk factor for exacerbation of periodontitis. METHODS: A total of 119 T2DN patients with chronic periodontitis were included in this observational study. Participants were stratified into the Normal (serum total cholesterol <5.17 mmol/L, n = 89) and the Dyslipidemia groups (serum total cholesterol ≥5.17 mmol/L, n = 30). Participants completed a validated questionnaire that collected information on oral hygiene behaviors and knowledge of oral health and underwent a clinical oral examination. The number of remaining teeth, probing depth (PD), clinical attachment level (CAL), and bleeding index (BI) was recorded. Physical examination and laboratory tests (fasting plasma glucose, serum glycosylated hemoglobin (HbA1c), total cholesterol, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), triglyceride, and high-sensitivity C-reactive protein levels) were performed. RESULTS: Means of CAL and BI were significantly higher in the Dyslipidemia group compared with the Normal group. In the Dyslipidemia group, PD and percent of sites with PD ≥4 mm were positively correlated with urinary albumin/creatinine ratios; PD and percent of sites with PD ≥4 and PD ≥5 mm were positively correlated with HbA1c level; a number of remaining teeth were negatively correlated with serum LDL-C level. After adjusting for age, gender, body mass index, smoking, FPG, and serum HbA1c and triglyceride levels, BI was found to be positively associated with dyslipidemia in T2DN patients with periodontitis. CONCLUSION: T2DN patients with chronic periodontitis had a 2.355-fold higher risk of developing dyslipidemia, implying an important relationship between periodontitis and blood lipid control among T2DN patients.


Subject(s)
Chronic Periodontitis , Diabetes Mellitus, Type 2 , Diabetic Nephropathies , Dyslipidemias , Cholesterol, LDL , Chronic Periodontitis/complications , Cross-Sectional Studies , Diabetes Mellitus, Type 2/complications , Diabetic Nephropathies/complications , Dyslipidemias/complications , Glycated Hemoglobin/analysis , Humans , Triglycerides
10.
Front Cardiovasc Med ; 9: 875327, 2022.
Article in English | MEDLINE | ID: mdl-35600478

ABSTRACT

Background: Heart failure with preserved ejection fraction (HFpEF) is associated with a high risk of mortality and frequent hospitalization. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have favorable cardiovascular protective effect and could decrease the risk of mortality and hospitalization in patients with heart failure with reduced ejection fraction. However, the effect of SGLT2 inhibitors for HFpEF has not been well studied. Purpose: The aim of this meta-analysis is to systematically assess the effects of SGLT2 inhibitors in patients with HFpEF. Methods: MEDLINE, EMBASE, Ovid, Cochrane Library, Chinese National Knowledge Infrastructure Database, VIP database, Chinese Biomedical Database, and Wanfang Database were searched from inception to November 2021 for randomized controlled trials (RCTs) of SGLT2 inhibitors for HFpEF. Risk bias was assessed for included studies according to Cochrane handbook. The primary outcome was the composite of first hospitalization for heart failure (HHF) or cardiovascular mortality. First HHF, cardiovascular mortality, total HHF, all-cause mortality, exercise capacity, ventricular diastolic function, and adverse events were considered as secondary endpoints. PROSPERO registration: CRD42021291122. Results: A total of 12 RCTs including 10,883 patients with HFpEF (SGLT2 inhibitors group: 5,621; control group: 5,262) were included. All included RCTs were at low risk of bias. Meta-analysis showed that SGLT2 inhibitors significantly reduced the composite of first HHF or cardiovascular mortality (HR:0.78, 95% CI: [0.70, 0.87], P< 0.00001, I 2 = 0%), first HHF (HR:0.71, 95% CI: [0.62, 0.83], P < 0.00001, I 2 = 0%), total HHF (RR:0.75, 95% CI: [0.67, 0.84], P<0.00001, I 2 = 0%), E/e' (MD: -1.22, 95% CI: [-2.29, -0.15], P = 0.03, I 2 = 59%) and adverse events (RR:0.92, 95% CI: [0.88, 0.97], P = 0.001, I 2 = 0%). No statistical differences were found in terms of cardiovascular mortality, all-cause mortality, NT-proBNP, BNP and 6-min walk test distance. Conclusion: SGLT2 inhibitors significantly improve cardiovascular outcomes with a lower risk of serious adverse events in patients with HFpEF. However, these findings require careful recommendation due to the small number of RCTs at present. More multi-center, randomized, double-blind, placebo-controlled trials are needed. Systematic Review Registration: [https://www.crd.york.ac.Uk/prospero/], identifier [CRD42021291122].

11.
Front Pharmacol ; 13: 854292, 2022.
Article in English | MEDLINE | ID: mdl-35600859

ABSTRACT

Aims: The objective of this study was to assess the efficacy and potential mechanisms of Chinese herbal medicine (CHM) for treating coronary heart disease (CHD) patients with anxiety or depression. Methods: A systematic literature search was performed. Screening studies, extracting data, and assessing article quality were carried out independently by two researchers. The active ingredients of CHM for the treatment of CHD with anxiety or depression were analyzed by the network pharmacology, and the main potential mechanisms were summarized by the database of Web of Science. Results: A total of 32 studies were included. The results showed that compared with the blank control groups, CHM was more beneficial in treating anxiety or depression in patients with CHD [anxiety: OR = 3.22, 95% CI (1.94, 5.35), p < 0.00001, I2 = 0%; depression: OR = 3.27, 95% CI (1.67, 6.40), p = 0.0005, I2 = 0%], and the efficacy of CHM was not inferior to that of Western medicine (WM) [anxiety: OR = 1.58, 95%CI (0.39, 6.35), p = 0.52, I2 = 67%; depression: OR = 1.97, 95%CI (0.73, 5.28), p = 0.18, I2 = 33%,]. Additionally, CHM also showed a significant advantage in improving angina stability (AS) in CHD patients with anxiety or depression compared with blank groups [anxiety: SMD = 0.55, 95%CI (0.32, 0.79), p < 0.00001, I2 = 0%; depression: p = 0.004] and WM groups [anxiety: SMD = 1.14, 95%CI (0.80, 1.47), p < 0.00001, I2 = 0%; depression: SMD = 12.15, 95%CI (6.07, 18.23), p < 0.0001, I2 = 0%]. Angina frequency (AF) and electrocardiogram (ECG) analysis after using CHM demonstrated similar trends. Based on the network pharmacology, quercetin, kaempferol, luteolin, beta-sitosterol, puerarin, stigmasterol, isorhamnetin, baicalein, tanshinone IIa, and nobiletin were most closely and simultaneously related to the pathological targets of CHD, anxiety, and depression. The main underlying mechanisms might involve anti-damage/apoptosis, anti-inflammation, antioxidative stress, and maintaining neurotransmitter homeostasis. Conclusion: CHM exhibited an obvious efficacy in treating CHD patients with anxiety or depression, especially for improving the symptom of angina pectoris. The most active compounds of CHM could simultaneously act on the pathological targets of CHD, anxiety, and depression. Multiple effective components and multiple targets were the advantages of CHM compared with WM.

12.
Eur Radiol ; 32(7): 4718-4727, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35141779

ABSTRACT

OBJECTIVES: To investigate the efficacy of fat fraction (FF) and T2* relaxation based on DIXON in the assessment of infrapatellar fat pad (IFP) for knee osteoarthritis (KOA) progression in older adults. METHODS: Ninety volunteers (age range 51-70 years, 65 females) were enrolled in this study. Participants were grouped based on the Kellgren-Lawrence grading (KLG). The FF and T2* values were measured based on the 3D-modified DXION technique. Cartilage defects, bone marrow lesions, and synovitis were assessed based on a modified version of whole-organ magnetic resonance imaging score (WORMS). Knee pain was assessed by self-administered Western Ontario and McMaster Osteoarthritis Index (WOMAC) questionnaire. The differences of FF and T2* measurement and the correlation with WORMS and WOMAC assessments were analyzed. Diagnostic efficiency was analyzed by using receiver operating characteristic (ROC) curves. RESULTS: A total of 60 knees were finally included (n = 20 in each group). The values were 82.6 ± 3.7%, 74.7 ± 5.4%, and 60.5 ± 14.1% for FF is the no OA, mild OA, and advanced OA groups, and were 50.7 ± 6.6 ms, 44.1 ± 6.6 ms, and 39.1 ± 4.2 ms for T2*, respectively (all p values < 0.001). The WORMS assessment and WOMAC pain assessment showed negative correlation with FF and T2* values. The ROC showed the area under the curve (AUC), sensitivity, and specificity for diagnosing OA were 0.93, 77.5%, and 100% using FF, and were 0.86, 75.0%, and 90.0% using T2*, respectively. CONCLUSIONS: FF and T2* alternations in IFP are associated with knee structural abnormalities and clinical symptoms cross-sectionally and may have the potential to predict the severity of KOA. KEY POINTS: • Fat fraction (FF) and T2* relaxation based on DIXON imaging are novel methods to quantitatively assess the infrapatellar fat pad for knee osteoarthritis (KOA) progression in older adults. • The alterations of FF and T2* using mDIXON technique in IFP were associated with knee structural abnormalities and clinical symptoms. • FF and T2* alternations in IFP can serve as the new imaging biomarkers for fast, simple, and noninvasive assessment in KOA.


Subject(s)
Cartilage, Articular , Osteoarthritis, Knee , Adipose Tissue/diagnostic imaging , Adipose Tissue/pathology , Aged , Cartilage, Articular/diagnostic imaging , Cartilage, Articular/pathology , Female , Humans , Knee Joint/diagnostic imaging , Knee Joint/pathology , Magnetic Resonance Imaging/methods , Osteoarthritis, Knee/diagnostic imaging , Osteoarthritis, Knee/pathology , Protons
13.
Materials (Basel) ; 15(1)2021 Dec 27.
Article in English | MEDLINE | ID: mdl-35009325

ABSTRACT

Several experiments are conducted to investigate the seismic behavior of composite shear walls because of their advantages compared to traditional reinforced concrete (RC) walls. However, the numerical studies are limited due to the complexities for the steel and concrete behaviors and their interaction. This paper presents a numerical study of composite shear walls with stiffened steel plates and infilled concrete (CWSC) using ABAQUS. The mechanical mechanisms of the web plate and concrete are studied. FE models are used to conduct parametric analysis to study the law of parameters on the seismic behaviour. The finite element (FE) model shows good agreement with the test results, including the hysteresis curves, failure phenomenon, ultimate strength, initial stiffness, and ductility. The web plate and concrete are the main components to resist lateral force. The web plate is found to contribute between 55% and 85% of the lateral force of wall. The corner of web plate mainly resists the vertical force, and the rest of web plate resists shear force. The concrete is separated into several columns by stiffened plates, each of which is independent and resisted vertical force. The wall thickness, steel ratio, and shear span ratio have the greatest influence on ultimate bearing capacity and elastic stiffness. The shear span ratio and axial compression ratio have the greatest influence on ductility. The test and analytical results are used to propose formulas to evaluate the ultimate strength capacity and stiffness of the composite shear wall under cyclic loading. The formulas could well predict the ultimate strength capacity reported in the literature.

14.
Medicine (Baltimore) ; 99(33): e21593, 2020 Aug 14.
Article in English | MEDLINE | ID: mdl-32872012

ABSTRACT

INTRODUCTION: Unstable angina pectoris is an acute exacerbation secondary to coronary artery occlusion. In routine clinical treatment, patients with unstable angina pectoris are prone to recurrence or aggravation of symptoms. Based on the traditional Chinese medicine (TCM) theory, phlegm, and blood stasis are one of the main pathological factors of unstable angina pectoris. The treatment of unstable angina pectoris with phlegm-blood stasis syndrome by Gualou Danshen granules (GLDS) has been the focus of many clinical trials. However, there is no evidence to prove the safety or clinical efficacy of GLDS. METHODS AND ANALYSIS: In this study, we will conduct a 4-week randomized, controlled feasibility study, with participants recruited from Guang'anmen Hospital, Chinese Academy of Traditional Chinese Medicine. Sixty subjects are to be diagnosed as having phlegm-blood stasis syndrome and randomly divided into a treatment group (GLDS) and placebo group in a 1:1 ratio. Result measurements will include therapeutic indicators (Clinical Symptom Rating Scale, Phlegm-Blood Stasis Syndrome Scale, and Seattle Angina Questionnaire) and safety indicators (blood routine, urine routine, electrocardiogram, liver function, and kidney function). The clinical data management system (http://www.tcmcec.net/) will be used to collect and manage data. Quality control will be implemented according to good clinical practice. DISCUSSION: Previous TCM clinical trials have investigated if adding GLDS to standard routine treatment can improve the therapeutic effect in patients with unstable angina pectoris. This study focuses on the safety and efficacy of GLDS on unstable angina pectoris of phlegm-blood stasis type, in order to obtain relevant clinical evidence. TRIAL REGISTRATION: This study is approved by the Ethics Committee of Guang'anmen Hospital of the China Academy of Chinese Medical Sciences (no. 2019-187-KY-02) and is registered with chictr.org (registration number ChiCTR2000031780).


Subject(s)
Angina, Unstable/drug therapy , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional/methods , Adult , Aged , Angina, Unstable/therapy , Double-Blind Method , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Female , Humans , Male , Middle Aged , Salvia miltiorrhiza
15.
Article in English | MEDLINE | ID: mdl-31485250

ABSTRACT

To evaluate the safety and clinical efficacy of Yangxue Qingnao (YXQN) granules in the treatment of chronic cerebral circulation insufficiency (CCCI), electronic databases-PubMed, Embase, CNKI, VIP, and Wangfang-were searched for randomized controlled trials (RCTs) published up to January 2019. GRADE and RevMan 5.3.0 were used for grading and analysis, respectively. Fifteen trials involving 1211 CCCI patients were included. Subgroup analysis was performed owing to study heterogeneity. Compared to nimodipine plus routine treatment, YXQN granules plus routine treatment were more effective in increasing basilar artery (BA) blood flow velocity (mean difference (MD) = 3.34, 95% confidence interval (CI) = [2.31, 4.37], P < 0.00001), vertebral artery (VA) blood flow velocity (MD = 0.52, 95% CI = [0.27, 0.76], P < 0.0001), and internal carotid artery (ICA) blood flow velocity (MD = 7.46, 95% CI = [2.01, 12.90], P=0.007). In improving the clinical efficacy of traditional Chinese medicine (TCM) for symptoms such as headache, dizziness, and insomnia, YXQN granules plus routine treatment were shown to be superior to the following control treatments: nimodipine plus routine treatment (mean difference (M-H) = 4.21, 95% CI = [2.49, 7.12], P < 0.00001), flunarizine plus routine treatment (mean difference (M-H) = 3.92, 95% CI = [1.36, 11.29], P=0.01), troxerutin plus routine treatment (mean difference (M-H) = 4.79, 95% CI = [2.20, 10.42], P < 0.00001), and routine treatment (mean difference (M-H) = 6.13, 95% CI = [1.48, 25.34], P=0.01). Risk of bias was assessed in 15 trials. One analysis was graded using GRADE and showed poor results. Adverse events were not reported explicitly in all but one trial. Thus, this meta-analysis suggests that YXQN granules may be beneficial for patients with CCCI. However, owing to the poor quality of the clinical trials and small sample sizes, a definite conclusion on the efficacy and safety of YXQN granules cannot be drawn from existing information.

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