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.
Tongue diagnosis is one of the four diagnostic methods of traditional Chinese medicine (TCM), which has important value in clinical disease diagnosis and efficacy evaluation. The change in tongue ...coating is a comprehensive cause of multi-dimensional changes such as color, texture, and substance. However, the color tongue image contains less spectral information, which may lead to the lack of key information in tongue diagnosis. Hyperspectral images can obtain reflection information of tongue images in hundreds of spectral bands. Unlike traditional color images, the rich spectral information can more accurately and sensitively describe and classify tongue coating, and has been widely applied in biomedical images. In this paper, we conducted feature extraction and analysis on hyperspectral images of different tongue coatings, and proposed a spectral-spatial feature deep learning framework to classification and quantitative recognition the tongue coating based on hyperspectral image features. Firstly, 360 hyperspectral images of tongue body were collected, and clinicians were identify all tongue coatings and divided them into 6 different grades. The hyperspectral features of each tongue coating area were extracted respectively. In order to reduce noise interference, singular spectrum analysis was used to preprocess the hyperspectral curve features. Considering the actual situation of tongue coating, a depth learning model was established to analyze the spectral and spatial feature of the hyperspectral tongue image to identified the grading of tongue coating. The experimental results showed that tongue coating with different quantization levels had different hyperspectral features, and the recognition rate of tongue coating quantization level can reach 87.21% using the spatial-spectral features.
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
Traditional Chinese medicine (TCM) has been widely used in the treatment of coronavirus disease 2019 (COVID-19). Tongue features should be referred for diagnosis and treatment of diseases in TCM. ...Therefore, it is necessary to analyze the tongue features of the patients suffered from COVID-19.
COVID-19 Symptom Database (established by Evidence-based Medicine Center of Tianjin University of TCM) was searched for eligible tongue pictures. The tongue pictures were assessed by TCM experts to extract the data of tongue color, coating color, tongue body shape and coating proper feature. The relationship between tongue features and patient’s condition was analyzed.
Patients diagnosed as mild and moderate COVID-19 commonly had light red tongue and white coating. Severe patients had purple tongue and yellow coating. The proportion of critical patients with tender tongue increased to 75%. Greasy coating was a significant characteristic of patients with COVID-19. The proportions of greasy coating were 53.3%, 73.3%, 83.6% and 87.5% in disease category of mild, moderate, severe and critical. In addition, the thick coating proportion increased from mild (24.9%) to critical (50.0%).
Tongue features have certain relationship with the category of COVID-19. Tongue features can serve as potential indicators for the evaluation of patient’s condition and prognosis. Further studies are needed to enhance the quantification of tongue features and develop standards.
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.
To explore the influence of concrete thermal parameters on the hydration heat temperature and thermal stress of mass concrete, four feature positions of a dam foundation were chosen to analyze the ...changing process of temperature and stress by varying the thermal parameters, including the thermal conductivity, specific heat, surface heat diffusion coefficient, temperature rise coefficient, solar absorption coefficient, and thermal expansion coefficient. Some conclusions were obtained as follows. Increasing the thermal conductivity and reducing the specific heat and temperature rise coefficient of concrete can effectively reduce the maximum temperature of the central concrete structure. Increasing the solar absorption coefficient, specific heat, and thermal expansion coefficient and reducing the thermal conductivity, surface heat diffusion coefficient, and temperature rise coefficient of concrete can reduce the maximum principal tensile stress in the structure to a certain extent. The maximum principal tensile stress at different positions of the structure has a linear functional relationship with the thermal conductivity, specific heat, and thermal expansion coefficient and has a quadratic function relationship with the surface heat diffusion coefficient, temperature rise coefficient, and solar absorption coefficient. Besides, this study also proposed a series of related anticracking measures. This study was expected to provide a theoretical reference for the design, construction, and cracking disease prevention of mass concrete structures.
Objective:
To evaluate the efficacy and safety of Zhibitai (ZBT) in the treatment of patients with hyperlipidemia (HLP).
Methods:
A search of 8 electronic databases was conducted to find randomized ...controlled trials (RCTs), to evaluate the efficacy and safety of ZBT for the treatment of HLP. The risk of bias in randomized controlled trials was assessed by using the Cochrane Collaboration Risk of Bias tool for randomized controlled trials 2.0 (RoB 2.0). The primary outcomes were the levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). The total effective rate served as the secondary outcome. The incidence of adverse events was considered the safety outcome. Review Manager 5.4 was used to conduct meta-analyses. Data were pooled by random-effects or fixed-effects model to obtain the mean difference (MD), risk ratio (RR), odds ratio (OR), and 95% confidence interval (CI).
Results:
There were 28 eligible RCTs with a total of 2,952 participants. Overall, we verified that ZBT plus conventional therapy (CT) was superior to CT for the treatment of HLP TC: MD = −0.50, 95% CI (−0.80, −0.19); TG: MD = −0.38, 95% CI (−0.49, −0.27); LDL-C: MD = −0.50, 95% CI (−0.69, −0.31); HDL-C: MD = 0.17, 95% CI (0.11, 0.24); total effective rate: OR = 4.26, 95% CI (2.28, 7.95). There were no significant differences in the primary outcomes between ZBT alone vs. CT (
p
> 0.05). For safety, the ZBT group (with CT or alone) outperformed the CT group ZBT alone: RR = 0.51, 95% CI (0.32, 0.81); ZBT plus CT: RR = 0.51, 95% CI (0.30, 0.89). For each outcome, the subgroups and the sensitivity analysis matched the overall results.
Conclusion:
ZBT may be safe and beneficial to HLP patients, especially for serum lipid management. ZBT can be used along with CT for the treatment of HLP. However, it is necessary to conduct more rigorous RCTs to confirm these findings.
Systematic Review Registration
:
https://www.crd.york.ac.uk/PROSPERO/
, identifier CRD42022316251.
This paper focuses on the transient stability of a hydro-turbine governing system with three kinds of tailrace tunnels. As the transfer coefficients change with operation conditions, the dynamic ...transfer coefficients which can describe the transient characteristics of the hydro-turbine governing system are introduced. Then, the transient stability of the hydro-turbine governing system is analysed. The global bifurcation diagrams for the three kinds of tailrace tunnels are respectively presented to investigate the effects of the tailrace tunnels on the stability of the hydro-turbine governing system. Theoretical analysis which proves the validity of simulation results is provided to explain the effects of the flow inertia and water level fluctuation. The influence of the tailrace tunnel gradient on the transient stability is also studied. More importantly, these methods and research results provide theoretical guidance for the arrangement of the tailrace tunnel and the operation of the hydropower station.
This study focuses on the fault diagnosis of a hydroelectric generation system with hydraulic‐mechanical‐electric structures. To achieve this analysis, a methodology combining Bayesian network ...approach and fault diagnosis expert system is presented, which enables the time‐based maintenance to transform to the condition‐based maintenance. First, fault types and the associated fault characteristics of the generation system are extensively analyzed to establish a precise Bayesian network. Then, the Noisy‐Or modeling approach is used to implement the fault diagnosis expert system, which not only reduces node computations without severe information loss but also eliminates the data dependency. Some typical applications are proposed to fully show the methodology capability of the fault diagnosis of the hydroelectric generation system.
Fault diagnosis of a hydroelectric generation system is a critical science and engineering problem to improve the safety of hydropower stations. To enable the risk quantification in the process of fault diagnosis, fault types and associated fault characteristics of a hydroelectric generation system are extensively analyzed to model a precise Bayesian Network. Noisy‐Or modeling approach is used for the implementation of fault diagnosis expert system, which not only reduces the computation of nodes probability without severe information loss but also eliminates the data dependency. A typical application is proposed to fully show the capability of the presented methodology of the HGS's fault diagnosis.
A large number of protocols for Systematic Reviews (SR) of Traditional Chinese Medicine (TCM) for coronavirus disease 2019 (COVID-19) have been registered in the International Prospective Register of ...Systematic Reviews (PROSPERO). This study aimed to analyze the innovativeness and rigorousness of the SR protocols and make recommendations for the design and implementation of future SRs on TCM for COVID-19. This effort is likely to enhance the value of the produced information and prevent the futility of the research.
PROSPERO was searched comprehensively for identifying SRs of TCM for COVID-19 from the inception of the database to August 2020. Two researchers independently screened the literature, extracted the data, and cross-checked the retrieved information for consistency. The following details were recorded: database, registration time, organizations, types of research included, participants, interventions, and outcome measures. All extracted data were analyzed by an overview. The “P - participants, I - interventions, C - controls, and O - outcomes (PICO)” included in the protocols were compared for similarity. The outcomes of the included SR protocols were compared with the newly published Core Outcome Sets (COSs).
A total of 80 protocols of SR related to TCM for COVID-19 were obtained after a primary search, and finally 71 protocols were included. The majority of the protocols were from China. Thirty-two organizations participated in the protocol registrations, including 11 hospitals and 21 universities/colleges. However, some protocols were not innovative or rigorous enough, as the PICO of some protocols were similar and non-specific, and the searched literature was incomprehensive. In addition, COS is not commonly adopted.
Registering a protocol of SR is an effective way to ensure the usefulness of the produced information, and to avoid the duplication of research and the wastage of resources. In future SR protocols, it is important to focus on and solve the methodological problems such as non-specific PICO, incomprehensive literature retrieval, and improper outcome measures.
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