scholarly journals Postmarketing Safety Surveillance and Reevaluation of Danhong Injection: Clinical Study of 30888 Cases

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Xue-Lin Li ◽  
Jin-Fa Tang ◽  
Wei-Xia Li ◽  
Chun-Xiao Li ◽  
Tao Zhao ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Drug Withdrawal ◽  
Main Type ◽  
Cerebrovascular Diseases ◽  
Incidence Rates ◽  
Joint Disease ◽  
Severe Illness ◽  
Danhong Injection ◽  
Safety Surveillance ◽  
Clinical Emergency

Traditional Chinese medicine injections (TCMIs) have played an irreplaceable role for treating some clinical emergency, severe illness, and infectious diseases in China. In recent years, the incidence rates of adverse drug reactions (ADRs) of TCMIs have increased year by year. Danhong injection (DHI) is one representative TCMI comprised of Danshen and Honghua for treating cardiovascular and cerebrovascular diseases in clinic. In present study, the postmarketing safety surveillance and reevaluation of DHI were reported. Total 30888 patients in 37 hospitals from 6 provinces participated in the study. The results showed that the ADR incidence rate of DHI was 3.50‰. Seventeen kinds of new adverse reactions of DHI were found. The main type of ADRs of DHI was type A (including sweating, dizziness, headache, flushing, vasodilation, eye hemorrhage, faintness, chest pain, palpitations, breathlessness, anxious, nausea, flatulence, vomiting, hypotension, hypertension, local numbness, dyspnea, joint disease, and tinnitus) accounting for 57.75%. The severities of most ADRs of DHI were mild and moderate reactions accounting for 25.93% and 66.67%, respectively. The main disposition of ADRs of DHI was drug withdrawal and without any treatments. The results can provide basis for amendment and improvement of the instructions of DHI, as well as demonstration and reference for the postmarketing safety surveillance and reevaluation of other TCMIs. And the rationality, scientificity, and safety of clinical applications of TCMIs could be improved.

scholarly journals Ultra-processed food intake and risk of cardiovascular disease: prospective cohort study (NutriNet-Santé)

BMJ ◽  
2019 ◽  
pp. l1451 ◽  
Author(s):  
Bernard Srour ◽  
Léopold K Fezeu ◽  
Emmanuelle Kesse-Guyot ◽  
Benjamin Allès ◽  
Caroline Méjean ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Cohort Study ◽  
Disease Risk ◽  
Saturated Fatty Acids ◽  
Cerebrovascular Diseases ◽  
Incidence Rates ◽  
Hazard Ratio ◽  
Sensitivity Analyses ◽  
Processed Foods ◽  
Processed Food

AbstractObjectiveTo assess the prospective associations between consumption of ultra-processed foods and risk of cardiovascular diseases.DesignPopulation based cohort study.SettingNutriNet-Santé cohort, France 2009-18.Participants105 159 participants aged at least 18 years. Dietary intakes were collected using repeated 24 hour dietary records (5.7 for each participant on average), designed to register participants’ usual consumption of 3300 food items. These foods were categorised using the NOVA classification according to degree of processing.Main outcome measuresAssociations between intake of ultra-processed food and overall risk of cardiovascular, coronary heart, and cerebrovascular diseases assessed by multivariable Cox proportional hazard models adjusted for known risk factors.ResultsDuring a median follow-up of 5.2 years, intake of ultra-processed food was associated with a higher risk of overall cardiovascular disease (1409 cases; hazard ratio for an absolute increment of 10 in the percentage of ultra-processed foods in the diet 1.12 (95% confidence interval 1.05 to 1.20); P<0.001, 518 208 person years, incidence rates in high consumers of ultra-processed foods (fourth quarter) 277 per 100 000 person years, and in low consumers (first quarter) 242 per 100 000 person years), coronary heart disease risk (665 cases; hazard ratio 1.13 (1.02 to 1.24); P=0.02, 520 319 person years, incidence rates 124 and 109 per 100 000 person years, in the high and low consumers, respectively), and cerebrovascular disease risk (829 cases; hazard ratio 1.11 (1.01 to 1.21); P=0.02, 520 023 person years, incidence rates 163 and 144 per 100 000 person years, in high and low consumers, respectively). These results remained statistically significant after adjustment for several markers of the nutritional quality of the diet (saturated fatty acids, sodium and sugar intakes, dietary fibre, or a healthy dietary pattern derived by principal component analysis) and after a large range of sensitivity analyses.ConclusionsIn this large observational prospective study, higher consumption of ultra-processed foods was associated with higher risks of cardiovascular, coronary heart, and cerebrovascular diseases. These results need to be confirmed in other populations and settings, and causality remains to be established. Various factors in processing, such as nutritional composition of the final product, additives, contact materials, and neoformed contaminants might play a role in these associations, and further studies are needed to understand better the relative contributions. Meanwhile, public health authorities in several countries have recently started to promote unprocessed or minimally processed foods and to recommend limiting the consumption of ultra-processed foods.Study registrationClinicalTrials.gov NCT03335644.

scholarly journals Adverse Oral Reactions Associated with Low Doses of Methotrexate

2020 ◽  
Vol 8 (4) ◽  
pp. 205-210
Author(s):  
N. V. Izmozherova ◽  
A. A. Popov ◽  
E. F. Gaysina ◽  
M. N. Dobrinskaya ◽  
V. M. Bakhtin ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Drug Withdrawal ◽  
Symptomatic Therapy ◽  
Oral Lesions ◽  
Low Doses ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Medical Specialties ◽  
Potential Development ◽  
Lichenoid Reactions ◽  
Drug Pharmacokinetics

Doctors of various medical specialties often encounter adverse drug reactions in their clinical practice. Methotrexate (MTX) can cause adverse reactions in the oral cavity, primarily erosions and ulcerations. The aim of the study was to analyse scientific literature on the prevalence, pathophysiological mechanisms, risk factors for oral lesions associated with low doses of MTX, their prevention and treatment. It was demonstrated that the most frequent oral adverse reactions associated with low doses of MTX are hard-to-heal painful necrotic and often irregularly shaped lesions of the oral mucosa (including aphthae and ulcers). The spectrum of histopathological changes ranges from nonspecific ulcerations to lichenoid reactions. Treatment of oral lesions induced by low doses of MTX consists in drug withdrawal or dose tapering. Folic acid and local symptomatic therapy can also be used, if necessary. Practitioners should be aware of the potential development of MTX-induced oral lesions, and specific aspects of the drug pharmacokinetics and pharmacodynamics in order to be able to ensure timely detection of adverse reactions and their effective treatment.

scholarly journals 215. Invasive Group A Streptococcus-Associated Hospitalizations and Risk Factors for In-Hospital Mortality Among Adults in California, 2000–2016

2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S126-S127
Author(s):  
Ellora Karmarkar ◽  
Seema Jain ◽  
Gail L Sondermeyer Cooksey ◽  
Jennifer Myers ◽  
Amanda Kamali
Keyword(s):  
Risk Factors ◽  
Group A Streptococcus ◽  
Continuous Variable ◽  
Incidence Rates ◽  
Severe Illness ◽  
Hospital Death ◽  
Discharge Data ◽  
Invasive Group ◽  
Group A ◽  
Race Ethnicity

Abstract Background Invasive group A Streptococcus (iGAS) causes severe illness and death but is not vaccine preventable or nationally notifiable. We describe the epidemiology of adult patients hospitalized with iGAS in California and risk factors for in-hospital death. Methods Using 2000–2016 California hospital discharge data, we extracted records for adults (≥18 years) with ≥1 group A Streptococcus (GAS)-associated International Classification of Diseases, Ninth or Tenth Revision discharge diagnosis code (e.g., unspecified GAS; GAS-specific pharyngitis, pneumonia, and sepsis) or known GAS-associated syndromes (e.g., acute rheumatic fever, erysipelas, scarlet fever). To identify patients hospitalized with iGAS, we selected extracted records that also had codes consistent with invasive disease (e.g., sepsis, pneumonia, intubation, or central line placement). We calculated iGAS-associated hospitalization incidence rates per 100,000 population and described patient demographics and comorbidities. We calculated the odds of in-hospital death using multivariable logistic regression (P < 0.05). Results During 2000–2016 in California, 37,532 adults were hospitalized with iGAS; 1,045 (3%) died in-hospital. Mean annual hospitalization incidence was 9.4/100,000 population, and was highest (16.3/100,000) in 2016 (Figure 1). Most patients were male (56%), aged 40–65 (45%) or ≥65 (28%) years, and white (60%); 18% were immunocompromised. The percent of patients who died in-hospital increased with age and was highest among those with comorbidities such as malnutrition, cardiovascular disease (CVD), and chronic kidney disease (CKD) (Figure 2). In a multivariable model including age as a continuous variable, sex, and race-ethnicity, the odds of in-hospital death was significantly increased for patients with diagnosis codes for malnutrition, liver disease, CVD, immunosuppression, and CKD (Figure 2); within the race/ethnicity variable Asian/Pacific Islander patients had a higher odds of death compared with white patients. Conclusion Hospitalization and subsequent in-hospital death due to iGAS is substantial in California. Adults with iGAS who have specific comorbidities are at greater risk for death when hospitalized with iGAS. Disclosures All authors: No reported disclosures.

Effects of 0.15% Ropivacaine Alone and Combination with Sufentanil on Epidural Labor Analgesia and Adverse Reactions

2021 ◽  
Vol 7 (5) ◽  
pp. 1746-1752
Author(s):  
Huanhui Zhong ◽  
Yongdong Wang ◽  
Yiqun Wang ◽  
Heng Li
Keyword(s):  
Adverse Reactions ◽  
Mode Of Delivery ◽  
Incidence Rates ◽  
Labor Analgesia ◽  
Apgar Scores ◽  
Analgesic Drugs ◽  
Vas Score ◽  
Satisfaction Degree ◽  
Group A ◽  
Group B

To compare the effects of 0.15% ropivacaine alone and combination with sufentanil on epidural labor analgesia and adverse reactions. Methods: A total of 297 eligible primiparae were randomly divided into group A (n=149, 0.15% ropivacaine + sufentanil) and group B (n=148, 0.15% ropivacaine). Visual analogue scale (VAS) scores before analgesia and 20 min after epidural medication, and maximum VAS score during labor were observed. The times of patient-controlled analgesia (PCA) pump pressing and remedial analgesia, dosage of analgesic drugs, modified Bromage score, satisfaction degree, duration of labor, mode of delivery, 1-min and 5-min Apgar scores of newborns, adverse reactions during analgesia, and fever during labor were recorded. Results: VAS score 20 min after epidural medication and maximum score during labor were significantly lower in both groups than those before labor analgesia (P<0.05), but the two groups had similar scores (P>0.05). The two groups had similar times of PCA pump pressing and remedial analgesia, dosage of analgesic drugs, modified Bromage score and satisfaction degree (P>0.05). They had similar duration of labor, mode of delivery and 1-min and 5-min Apgar scores of newborns (P>0.05). There were 13 cases (8.72%) and 0 cases of pruritus in group A and B, respectively (P<0.05). They had similar incidence rates of nausea and vomiting, urinary retention and fever during labor (P>0.05). Conclusions: The epidural labor analgesia effect of 0.15% ropivacaine is comparable to that of 0.15% ropivacaine + 0.05 ng/mL sufentanil for primiparae, but the incidence rate of pruritus plummets when ropivacaine is used alone.

Effects of Berberine on Gut Microbiota in Patients with Mild Metabolic Disorders Induced by Olanzapine

2021 ◽  
Vol 49 (08) ◽  
pp. 1949-1963
Author(s):  
Zhengping Pu ◽  
Yunying Sun ◽  
Hongxia Jiang ◽  
Qingmei Hou ◽  
Hui Yan ◽  
...  
Keyword(s):  
Metabolic Syndrome ◽  
Bipolar Disorder ◽  
Gut Microbiota ◽  
Metabolic Disorders ◽  
Adverse Reactions ◽  
Intestinal Flora ◽  
Incidence Rates ◽  
Post Treatment ◽  
Metabolic Disturbances ◽  
To Receive

Secondary metabolic disturbances in patients with schizophrenia or bipolar disorder may be attributed to olanzapine. It is important to prevent mild metabolic disorders progressing to metabolic syndrome. This study aims to investigate the effects of berberine on intestinal flora in patients with mild metabolic disorders induced by olanzapine. A total of 132 patients with schizophrenia, bipolar disorder, or schizoaffective psychosis that had been treated with olanzapine for at least 9 months were randomly assigned ([Formula: see text] = 66 each) to receive berberine or placebo tablets for 12 weeks. Metabolic assessments and intestinal flora were quantified at baseline and after 4, 8, and 12 weeks of treatment. Incidence rates of adverse reactions were recorded. FPG, FPI, HOMA-IR, HbA1, TG, BMI, and WC were significantly lower in patients who received berberine compared to placebo after 12 weeks of treatment ([Formula: see text]< 0.05). The abundance of firmicutes and coliform were significantly lower and the abundance of bacteroides significantly higher in patients who received berberine compared to placebo after 12 weeks of treatment ([Formula: see text]< 0.05). In patients who received berberine, the abundance of firmicutes was significantly decreased, and the abundance of bacteroides was significantly increased, and in patients who received placebo, the abundance of firmicutes was significantly increased post-treatment, compared to baseline (both [Formula: see text]< 0.05). In conclusions, berberine may regulate intestinal flora and metabolism in patients with schizophrenia or bipolar disorder and mild metabolic disturbances induced by olanzapine.

Stroke: cerebrovascular disease

2010 ◽  
pp. 4933-4948
Author(s):  
J van Gijn
Keyword(s):  
Coronary Heart Disease ◽  
Heart Disease ◽  
Cerebrovascular Disease ◽  
Case History ◽  
Cerebrovascular Diseases ◽  
Incidence Rates ◽  
Important Case ◽  
Small Arteries ◽  
Transient Ischaemic Attacks ◽  
Arterial Aneurysms

Case History—Four cases of headache. Cerebrovascular diseases include many pathological conditions but the principal categories are (1) infarction—through occlusion of major arteries, small arteries or venous sinuses; and (2) haemorrhage—most often through rupture of small arteries, arterial aneurysms or capillaries. Strokes are common, with annual incidence rates for subjects aged over 55 ranging from 420 to over 1000 per 100 000. They are the most important case of disability in developed Western nations and the second most frequent cause of death after coronary heart disease. About 80% of strokes are caused by cerebral infarcts, with the remainder due to haemorrhage, with 20% of these attributable to a bleeding cerebral aneurysm. The incidence of transient ischaemic attacks (TIAs) is about 50 per 100 000....

scholarly journals Occurrence of Cerebrovascular Diseases Decreased after the Great East Japan Earthquake and Tsunami of 2011

2020 ◽  
Vol 10 (3) ◽  
pp. 105-115
Author(s):  
Shinichi Omama ◽  
Nobukazu Komoribayashi ◽  
Yoshihiro Inoue ◽  
Tomohiko Mase ◽  
Kuniaki Ogasawara ◽  
...  
Keyword(s):  
Flood Damage ◽  
Cerebrovascular Diseases ◽  
Incidence Rates ◽  
Great East Japan Earthquake ◽  
Temporary Increase ◽  
Long Term Effects ◽  
Stroke Registry ◽  
Adjusted Incidence ◽  
Iwate Prefecture

<b><i>Background:</i></b> A temporary increase in the occurrence of cerebrovascular diseases (CVDs) after the Great East Japan Earthquake and Tsunami of 2011 was reported; however, no studies have been conducted to investigate long-term effects. We assessed the long-term impact of the disaster on the incidence of CVDs. <b><i>Methods:</i></b> Incidence data for CVDs from 2008 to 2017 were acquired from the population-based Stroke Registry with an inventory survey of Iwate Prefecture, Japan. Part of the coastal area in Iwate Prefecture was mildly flooded and the other part was severely flooded. Age-adjusted incidence rates of CVDs (according to the Japanese standard population) were calculated for each area. The relative risk (RR) of incidence based on the years before the disaster (2008–2010), adjusted by stratified age groups, was calculated for the year of the disaster (2011), and the years after the disaster (2012–2017) in each area. <b><i>Results:</i></b> The age-adjusted incidence rates gradually decreased in all areas, with the exception of a temporary increase among men who lived on the coast the year the disaster occurred. The adjusted RR in the disaster year were not significant in any area and those of the postdisaster years were 0.91 (95% CI 0.87–0.96) for all inland men, 0.93 (0.89–0.97) for all inland women, 0.85 (0.78–0.93) for all coastal men, 0.87 (0.81–0.94) for all coastal women, 0.88 (0.80–0.98) for men at mildly flooded coast, 0.82 (0.75–0.89) for women at mildly flooded coast, 0.79 (0.68–0.91) for men at severely flooded coast, and 0.98 (0.86–1.11) for women at severely flooded coast. <b><i>Conclusions:</i></b> The occurrence of CVDs in the flooded coastal areas did not increase in the year of the Great East Japan Earthquake and Tsunami; furthermore, it decreased for men according to the severity of flood damage in the subsequent years; this can be attributed to supportive activities for the tsunami victims and the migration of the population.

scholarly journals Effects of Tirofiban and Nicorandil on Effective Reperfusion and the Levels of IL-4 and sICAM-1 After PCI for Chronic Coronary Total Occlusion

2021 ◽  
Author(s):  
Guo-Hua Li
Keyword(s):  
Adverse Reactions ◽  
Coronary Intervention ◽  
Incidence Rates ◽  
Interleukin 4 ◽  
Intercellular Adhesion Molecule ◽  
Control Group ◽  
Cardiac Events ◽  
Intercellular Adhesion Molecule 1 ◽  
Total Occlusion

Aim: The effects of tirofiban combined with nicorandil on effective reperfusion, and the levels of interleukin-4 (IL-4)and soluble intercellular adhesion molecule-1 (sICAM-1) after percutaneous coronary intervention (PCI) for chronic coronary total occlusion (CTO) were investigated.Method: From January 1, 2017, to June 31, 2019, a total of 40 patients with CTO receiving PCI in Shandong QianfoshanHospital were randomly divided into a control group (treated with single tirofiban) and a cocktail group (treated with nicorandil combined with tirofiban). Effective reperfusion was compared between groups. In addition, differences in coronary serum IL-4 and sICAM-1 levels before and 10 min after the operation were compared between groups, and the incidence rates of adverse reactions were observed. Finally, patient follow-up occurred at 1 month and 6 months, and the total incidence rates of adverse cardiac events in both groups were assessed.Results: The levels of IL-4 and sICAM-1 in the cocktail group significantly decreased after the operation (P < 0.05).In addition, after the operation, significantly greater decreases in the IL-4 and sICAM-1 levels were observed in thecocktail group than the control group (P < 0.05). The Seattle Angina Scale (SAQ) score of the cocktail group, comparedwith the control group, showed a significant improvement after vessel opening in the patients with CTO. At the 1-month follow-up, the SAQ score of the cocktail group, compared with the control group, indicated further improvements in terms of angina attack frequency. No significant differences were observed in the incidence rates of adverse reactions between groups (P > 0.05).Conclusion: The treatment of patients with CTO undergoing PCI with nicorandil and tirofiban alleviated the inflammatoryresponse, improved the SAQ scores, and decreased the occurrence of angina pectoris in patients. Moreover, this treatment is safe and reliable, and has important clinical significance.

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