This study aims to investigate the safety of Shu-Xue-Ning injection (SXNI) in real-world clinical applications.
A prospective, multi-center, large-sample intensive monitoring method was used to ...monitor the use of SXNI in several medical institutions across China while collecting patients' dosing and adverse event information. Patients who suspected as adverse reactions made comparisons with patients who did not report adverse reactions to calculate the correlation between relevant risk factors and suspected adverse reactions. Statistical analysis software SAS 9.1 was used for data analysis.
A total of 48 hospitals participated in this intensive monitoring study of SXNI, and 30,122 patients were monitored from July 2015 to December 2018. A total of 1,908 adverse events were reported during the use of SXNI, with an adverse event rate of 6.33% and a 95% confidence interval (CI) of 6.06%-6.61%. Association assessment showed that 54 cases presented with SXNI-related adverse reactions with an incidence of 0.18% and a 95% CI of 0.13%-0.23%, thereby indicating that the incidence of SXNI-related adverse reactions was occasional. SXNI-related adverse reactions involved 9 systems-organs with 20 clinical manifestations, and the most common adverse reactions were rash, pruritus, and other damages of skin and its appendages. No serious adverse reactions were observed; 27.78% of the adverse reactions occurred within 30 min of drug administration and more than half of them occurred within 2 h of drug administration; 96.3% of the adverse reactions were cured or improved. Causal analysis showed that women, long dispensing time, and slow dripping speed rate were considered as risk factors.
The incidence of SXNI-related adverse reactions in real-world clinical applications is occasional and in a reasonable range with a good prognosis.
Since its outbreak in December 2019, a series of clinical trials on coronavirus disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical ...outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) Handbook: Version 1.0, a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine (TCM), evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (www.chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019 novel coronavirus (2019-nCoV) reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.
With the development of traditional Chinese medicine (TCM) syndrome knowledge accumulation and artificial intelligence (AI), this study proposes a holistic TCM syndrome differentiation model for the ...classification prediction of multiple TCM syndromes based on deep learning and accelerates the construction of modern foundational TCM equipment.
We searched publicly available TCM guidelines and textbooks for expert knowledge and validated these sources using ten-fold cross-validation. Based on the Bidirectional Encoder Representations from Transformers (BERT) and Convolutional Neural Networks (CNN) models, with the classification constraints from TCM holistic syndrome differentiation, the TCM-BERT-CNN model was constructed, which completes the end-to-end TCM holistic syndrome text classification task through symptom input and syndrome output. We assessed the performance of the model using precision, recall, and F1 scores as evaluation metrics.
The TCM-BERT-CNN model had a higher precision (0.926), recall (0.9238), and F1 score (0.9247) than the BERT, TextCNN, Long Short-Term Memory (LSTM) of Recurrent Neural Network (RNN), and attention mechanism-based LSTM (LSTM-attention) models and achieved superior results in model performance and predictive classification of most TCM syndromes. Symptom feature visualization demonstrated that the TCM-BERT-CNN model can effectively identify the correlation and characteristics of symptoms in different syndromes with a strong correlation, which conforms to the diagnostic characteristics of TCM syndromes.
The TCM-BERT-CNN model proposed in this study is in accordance with the TCM diagnostic characteristics of holistic syndrome differentiation and can effectively complete diagnostic prediction tasks for various TCM syndromes. The results of this study provide new insights into the development of deep learning models for holistic syndrome differentiation in TCM.
Background As a bioactive metabolite preparation widely used in acute ischemic stroke (AIS), the efficacy and safety of Panax notoginseng saponins injections (PNSI) in patients with AIS after ...intravenous thrombolysis remain to be evaluated. Methods This study included randomized controlled trials published before 26 April 2024 in 8 databases. AIS patients who received intravenous thrombolysis were included. The control group receiving conventional treatment and the treatment group receiving additional PNSI. Primary outcomes were selected as mortality, disability, and adverse events. Secondary outcomes were selected as all-cause mortality, improvement of neurological deficit, quality of life, and cerebral injury indicators. The revised Cochrane Risk of Bias tool was used to assess risk of bias. Risk ratio (RR) and mean differences (MD) were calculated for binary variables and continuous variables, respectively, based on a 95% confidence interval (CI). Results A total of 20 trials involving 1,856 participants were included. None of them reported mortality or disability. There was no significant difference in the adverse events RR: 1.04; 95% CI: 0.60 to 1.81 and hemorrhagic transformation RR: 0.99; 95% CI: 0.36 to 2.70 between the two groups. Compared to the control group, the treatment group had a better effect in neurological improvement assessed by National Institutes of Health Stroke Scale MD: −2.91; 95% CI: −4.76 to −1.06, a better effect in activities of daily living changes in Barthel Index MD: 9.37; 95% CI: 1.86 to 16.88, and a lower serum neuron-specific enolase level MD: −2.08; 95% CI: −2.67 to −1.49. Conclusion For AIS patients undergoing intravenous thrombolysis, the use of PNSI improved neurological deficits and enhanced activity of daily living in the short term without increasing the occurrence rate of adverse events. However, due to the moderate to very low certainty of evidence, it is advisable to conduct high-quality clinical trials to validate the findings of this study. Systematic Review Registration https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=466851 , Identifier CRD42023466851
Integration of Chinese medical drugs (CMD) and western medicine (WM) has been widely used in the treatment of Coronavirus Disease 2019 (COVID-19). This systematic review aimed to evaluate the ...efficacy and safety of CMD for COVID-19.
A literature search was performed in six databases from injection to June 2020. Both randomized controlled trials (RCTs) and quasi-RCTs were considered as eligible. The quality of included RCTs were assessed by Cochrane Risk of Bias Tool, and Review Manager 5.3 software was used to do meta-analysis.
Eleven studies with 1259 patients were included in this study. CMD included herbal decoction and Chinese patent medicine. The methodological quality was evaluated as generally unclear. The results of meta-analysis showed that the integration of CMD and WM had better efficacy than WM in number of patients turned to severe and critical type (RR = 0.47, 95% CI=0.32, 0.69, P < 0.0001), length of hospital stay (MD= -7.95, 95% CI=-14.66, -1.24, P = 0.02), defervescence time (MD= -1.20, 95% CI=-2.03, -0.38, P = 0.004), cough resolution rate (RR = 1.37, 95% CI=1.15, 1.64, P = 0.0004), fatigue resolution rate (RR = 1.37, 95% CI=1.02, 1.83, P = 0.04), and tachypnea resolution rate (RR = 2.20, 95% CI=1.11, 4.39, P = 0.02). As for safety, there was no significant difference between two groups.
CMD may bring potential benefit to patients suffered from COVID-19. However, the quality of included trials is not good enough. High quality study with core outcome set are still required.
Squama Manitis (pangolin scale) has been used in traditional Chinese medicine for thousands of years. However, its efficacy has not been systematically reviewed. This review aims to fill the gap.
We ...searched six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure Database (CNKI), WanFang Database and SinoMed from inception to May 1, 2020. Search terms included “pangolin”, “Squama Manitis”, “Manis crassicaudata”, “Manis javanica”, “Malayan pangolins”, “Manis pentadactyla”, “Ling Li”, “Chuan Shan Jia”, “Shan Jia”, “Pao Jia Zhu”, “Jia Pian” and “Pao Shan Jia”. The Cochrane Risk of Bias (RoB) assessment tool and Newcastle-Ottawa Scale (NOS) were used to evaluate the risk of bias of the included randomized controlled trials (RCTs) and case control studies (CCSs).
After screening, 15 articles that met the inclusion criteria were finally included. There were 4 randomized controlled trials, 1 case control study, 3 case series and 7 case reports. A total of 15 different diseases were reported in these studies, thus the data could not be merged to generate powerful results. Two RCTs suggested that Squama Manitis combined with herbal decoction or antibiotics could bring additional benifit for treating postpartum hypogalactia and mesenteric lymphadenitis. However, this result was not reliable due to low methodological quality and irrational outcomes. The other two RCTs generated negative results. All the non-RCTs did not add any valuable evidence to the efficacy of Squama Manitis beacause of small samples, incomplete records, non-standardized outcome detection. In general, currently available evidence cannot support the clinical use of Squama Manitis.
There is no reliable evidence that Squama Manitis has special medicinal value. The removal of Squama Manitis from Pharmacopoeia is rational.
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•The overall performance of three common UF processes was evaluated in a pilot scale.•Ultrafiltration process significantly improved effluent water quality.•Extending the pretreatment ...process enhanced the control of ultrafiltration membrane fouling.•The suitable post-treatment process was evaluated for the ultrafiltration process.
Despite the rapid proliferation of ultrafiltration (UF) membranes in drinking water treatment, the long-term operational performance of various hybrid UF processes remains inadequately understood. Herein, three typically applied hybrid UF processes were directly compared on a pilot scale, focusing on effluent quality, fouling control and subsequent disinfection performance. Water quality analysis revealed that the direct UF process exhibited significant removal of high molecular weight and hydrophobicity fractions, while the integration of UF with conventional water treatment processes further enhanced the removal of medium molecular weight and transition fractions, as well as fluorescent organic matter. The augmentation of pretreatment processes resulted in the hybrid UF process featuring enhanced anti-fouling properties, characterized by decreased reversible and irreversible resistances under the constant flux condition. This improvement was attributed to reduced interaction between the membrane and foulants. Furthermore, the subsequent disinfection performance of hybrid UF processes was evaluated using chlorine and chlorine dioxide as disinfectants. The chlorine decay rate and disinfection by-product formation indicated that chlorine dioxide was more suitable for the UF process, whereas chlorine was better for the hybrid UF process with low organic matter content in the effluent. These comprehensive comparisons offer valuable insights for making informed decisions in adopting suitable hybrid UF processes for practical water treatment applications.
Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates low-density lipoprotein (LDL) homeostasis and plays a key role in acute coronary syndrome (ACS). The cardioprotective effect of PCSK9 ...inhibition extends beyond LDL cholesterol reduction, involving regulation of platelet function by not yet unraveled mechanisms. Oxidized-LDL (ox-LDL) is increased during ACS and induces platelet activation via binding to platelet surface. We will evaluate serum PCSK9 and its correlation with platelet reactivity and platelet-ox-LDL binding in Chinese ACS patients.
In this pilot cross-sectional study, we will enroll 115 Chinese participants aged 30 to 75 years with ACS. Blood sample will be obtained after the first maintenance dose of aspirin and clopidogrel during morning time. Serum PCSK9 will be measured by an enzyme-linked immunoadsorbent assay. Platelet reactivity will be assessed by; Platelet activation (P-selectin and GPIIbIIIa expression using flow cytometry) and; Platelet aggregation using light transmission aggregometry in response to various stimuli. On-treatment platelet reactivity is measured by adenosine diphosphate-induced platelet aggregation. Binding of ox-LDL to platelet will be evaluated by flow cytometry. Spearman correlations will be used to determine association of serum PCSK9 with platelet functional parameters and platelet-ox-LDL binding. Additionally, continuous PCSK9 levels will be categorized into tertiles of equal size to investigate its association with on-treatment platelet reactivity.
This study will reveal possible relationship between serum PCSK9 and platelet reactivity in the setting of ACS which may shed light on therapeutic potential in platelet inhibition by targeting PCSK9. The study will also explore the association of serum PCSK9 and platelet-ox-LDL binding, an important mechanism for platelet-LDL interplay, to provide mechanistic insight into PCSK9-mediated regulation of platelet reactivity.
Ginkgo biloba is a traditional Chinese medicine extracted from the Ginkgophyta and is commonly used in the treatment of cardiovascular diseases in China. Clinical trials have demonstrated the ...clinical benefits of Ginkgo biloba extract (GBE) preparations for patients with unstable angina pectoris (UAP).
The efficacy of different GBE preparations in treating UAP may vary, leading to a lack of guidance for physicians when choosing GBE preparations. How to make choices among different GBE preparations is a topic worthy of investigation. In order to clarify the efficacy differences among different GBE preparations, provide a reference for their optimal use conditions, this study was conducted.
This study included literature from eight databases from inception to November 2023. It included UAP patients, with the control group receiving conventional treatment and the treatment group receiving different GBE preparations in addition to conventional treatment. Angina efficacy, electrocardiogram (ECG) improvement, and frequency of angina were chosen as outcomes. This study employed a systematic review and Bayesian network meta-analysis, and the surface under the cumulative ranking (SUCRA) curve was used for estimating the efficacy ranking.
A total of 98 studies involving 9513 patients and 9 interventions were included. Compared with conventional treatment, GBE preparations combined with conventional treatment had better efficacy in angina symptoms and ECG improvement. According to the SUCRA ranking, Shuxuening injection was most effective in improving angina symptoms and reducing the frequency of angina. Among oral GBE preparations, Ginkgo tablets had the best performance in improving angina symptoms and ECG manifestations, and reducing the frequency of angina. There was no significant difference in the incidence of adverse events between the treatment group and the control group, and all adverse events were mild and self-limiting. Compared with oral preparations, the incidence of adverse events for injections was higher.
GBE preparations may alleviate angina symptoms and myocardial ischemia in the treatment of UAP with favorable safety. Shuxuening injection may be the most effective among all GBE preparations in improving angina symptoms, while Ginkgo tablets may perform best among oral formulations. The optimal use of GBE injection may be for rapidly alleviating angina symptoms and myocardial ischemia in patients with UAP, and oral formulation of GBE may be more suitable for the long-term treatment of patients with milder symptoms.
https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022361487, ID: CRD42022361487.
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