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To investigate the common specific immunoglobulin E(sIgE) in children with eczema and urticaria, compare the allergies in children with different diseases, genders and ages, and provide the scientific basis for the prevention, diagnosis and treatment. A retrospective study was conducted to analyze the children who were suspected of eczema and urticaria and tested for serum sIgE in the Tianjin Children's Hospital from December 2019 to August 2021. A total of 8 092 serum samples were tested for ten food allergens and ten inhaled allergens. The method was the enzyme-linked immune capture assay. The allergen epidemiological characteristics were statistically analyzed by Chi square test based on the children's characteristics and factors such as different sexes and ages and by the mass data. The results showed that the positive rate of eczema was 64.42%(5 213/8 092), and the urticaria was 35.58%(2 879/8 092). The positive rate of specific IgE was 66.65%(5 393/8 092), the food allergens was 61.74%(4 996/8 092), and the inhaled allergens was 34.85%(2 820/8 092). The top three positive rates of food allergens were egg 46.65%(3 775/8 092), milk 32.64%(2 641/8 092) and wheat flour 15.08%(1 220/8 092). The top three positive rates of inhaled allergens were house dust 21.40%(1 732/8 092), Alternaria 11.78%(953/8 092) and Dermatophagoides farinae 7.33%(593/8 092). The positivity of food allergens and inhaled allergens was significantly different in different age groups. The positive rates of food allergens in different age groups were 48.92%(947/1 936) in<1 year old, 72.28%(2 680/3 708) in 1-3 years old, 64.58%(919/1 423) in 4-6 years old and 43.90%(450/1 025) in>6 years old. The positive rates of inhaled allergens in different age groups were 17.67%(342/1 936) in<1 year old, 36.35%(1 348/3 708) in 1-3 years old, 46.38%(660/1 423) in 4-6 years old and 45.85%(470/1 025) in>6 years old. The top six positive rates of allergens of eczema were the same with urticaria, which were egg, milk, house dust, wheat flour, Alternaria and Dermatophagoides farinae. The allergens (greater than or equal to grade 4) differed in children with eczema and urticaria. Moreover, there were significant differences in the positive rates of Alternaria, egg, wheat flour, crab and shrimp. In conclusion, this study can reflect the epidemic characteristics of allergens in children with eczema and urticaria to a certain extent. There were significant differences in the positive rates of allergens between different age groups. It is necessary to reasonably avoid the high-risk allergens according to the epidemiological characteristics and clinical symptoms, which provide valuable information for the prevention, diagnosis and treatment of allergic diseases.
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Lactente , Criança , Humanos , Feminino , Masculino , Pré-Escolar , Farinha , Estudos Retrospectivos , Triticum , Urticária/epidemiologia , Eczema/epidemiologia , Hospitais , Imunoglobulina E , Alérgenos , PoeiraRESUMO
To investigate the common specific immunoglobulin E(sIgE) in children with eczema and urticaria, compare the allergies in children with different diseases, genders and ages, and provide the scientific basis for the prevention, diagnosis and treatment. A retrospective study was conducted to analyze the children who were suspected of eczema and urticaria and tested for serum sIgE in the Tianjin Children's Hospital from December 2019 to August 2021. A total of 8 092 serum samples were tested for ten food allergens and ten inhaled allergens. The method was the enzyme-linked immune capture assay. The allergen epidemiological characteristics were statistically analyzed by Chi square test based on the children's characteristics and factors such as different sexes and ages and by the mass data. The results showed that the positive rate of eczema was 64.42%(5 213/8 092), and the urticaria was 35.58%(2 879/8 092). The positive rate of specific IgE was 66.65%(5 393/8 092), the food allergens was 61.74%(4 996/8 092), and the inhaled allergens was 34.85%(2 820/8 092). The top three positive rates of food allergens were egg 46.65%(3 775/8 092), milk 32.64%(2 641/8 092) and wheat flour 15.08%(1 220/8 092). The top three positive rates of inhaled allergens were house dust 21.40%(1 732/8 092), Alternaria 11.78%(953/8 092) and Dermatophagoides farinae 7.33%(593/8 092). The positivity of food allergens and inhaled allergens was significantly different in different age groups. The positive rates of food allergens in different age groups were 48.92%(947/1 936) in<1 year old, 72.28%(2 680/3 708) in 1-3 years old, 64.58%(919/1 423) in 4-6 years old and 43.90%(450/1 025) in>6 years old. The positive rates of inhaled allergens in different age groups were 17.67%(342/1 936) in<1 year old, 36.35%(1 348/3 708) in 1-3 years old, 46.38%(660/1 423) in 4-6 years old and 45.85%(470/1 025) in>6 years old. The top six positive rates of allergens of eczema were the same with urticaria, which were egg, milk, house dust, wheat flour, Alternaria and Dermatophagoides farinae. The allergens (greater than or equal to grade 4) differed in children with eczema and urticaria. Moreover, there were significant differences in the positive rates of Alternaria, egg, wheat flour, crab and shrimp. In conclusion, this study can reflect the epidemic characteristics of allergens in children with eczema and urticaria to a certain extent. There were significant differences in the positive rates of allergens between different age groups. It is necessary to reasonably avoid the high-risk allergens according to the epidemiological characteristics and clinical symptoms, which provide valuable information for the prevention, diagnosis and treatment of allergic diseases.
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Lactente , Criança , Humanos , Feminino , Masculino , Pré-Escolar , Farinha , Estudos Retrospectivos , Triticum , Urticária/epidemiologia , Eczema/epidemiologia , Hospitais , Imunoglobulina E , Alérgenos , PoeiraRESUMO
OBJECTIVE: To analyze the serological positive results of brucellosis and its clinical manifestations in the key occupational population in Baotou City. METHODS: A total of 9 937 individuals from eight districts who were engaged in livestock breeding, grazing, slaughtering, processing, and selling from 2018 to 2019 in Baotou City were selected as the study subjects by a cluster sampling method. Blood samples were collected and serological tests of brucellosis were performed. The demographic characteristics and clinical manifestations of these subjects were investigated by a questionnaire. RESULTS: The seropositive rate of brucellosis in the study subjects was 2.7%(273/9 937). The average age of the individuals with serological positive reaction of brucellosis was(44±13) years. The seropositive rate of brucellosis was higher in males than females(4.8% vs 1.2%, P<0.05). In the brucellosis seropositive population, the regional distribution was the highest in Damao Qi district and the lowest in Qingshan district; the mainly occupation distribution was farmers, herdsmen and workers in beef and mutton processing plants. The exposure ways were mainly slaughtering animals and delivering lambs. The main clinical manifestations were fatigue(54.2%), followed by fever(48.7%). CONCLUSION: The characteristics of brucellosis serological positive reaction are young age, males, and farmers and herdsmen in key occupational group in Baotou City. The prevention and control of brucellosis should be focused on young male farmers and herdsmen engaged in slaughtering animals and delivering lambs.
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To screen the sensitive cell lines of active fraction from clove(AFC) on human colon cancer cells, investigate the effects of AFC on the cells proliferation and apoptosis as well as PI3 K/Akt/mTOR(phosphoinositide 3-kinase/Akt/mechanistic target of rapamycin) signaling pathways involved, and reveal the mechanism of AFC for inducing apoptosis of human colorectal carcinoma cells. Cell counting kit-8(CCK-8) assay was used to detect the cytotoxic effect of different concentrations of AFC. AFC-induced apoptosis was detected by Hoechst 33258 fluorescence staining and Annexin V-FITC/PI double staining. HCT116 cells were treated with AFC with or without pretreatment with insulin-like growth factor-Ⅰ(IGF-Ⅰ), and then the protein expression levels of caspase-3, caspase-9, poly ADP-ribose polymerase(PARP), PI3 K, p-PI3 K, Akt, p-Akt, mTOR and p-mTOR in PI3 K/Akt/mTOR signaling pathway were detected by Western blot. RESULTS:: showed that the most obvious inhibitory effect of AFC was on human colon cancer HCT116 cells, and the optimal AFC treatment time was 48 hours. After AFC treatment, typical apoptotic features such as nuclear chromatin concentration, nuclear fragmentation and apoptotic bodies appeared in a dose-dependent manner. Annexin V-FITC/PI double staining showed that as compared with the control group, 50 and 100 μg·mL~(-1) AFC groups increased the apoptosis rate of HCT116 cells significantly(P<0.001); AFC activated caspase-9, cleaved caspase-3 and cleaved PARP in a concentration-dependent manner. The protein expression levels of cleaved caspase-3/procaspase-3, cleaved PARP/PARP and caspase-9/β-actin after treatment of AFC(100 μg·mL~(-1)) were significantly different from those in the control group(P<0.001). The relative protein expression of p-PI3 K, p-Akt and p-mTOR decreased in a concentration dependent manner, while Akt and mTOR showed no significant differences among groups. The ratios of p-PI3 K/PI3 K, p-Akt/Akt and p-mTOR/mTOR in the AFC groups(50 and 100 μg·mL~(-1)) were significantly lower than those in the control group(P<0.01). Its combination with IGF-Ⅰ weakened the effect of AFC in inhibiting PI3 K/Akt/mTOR signaling pathway. The ratios of p-Akt/Akt and p-mTOR/mTOR in the AFC+IGF-Ⅰ group were significantly enhanced as compared with the AFC group(P<0.05). Apoptosis-related protein expression levels(cleaved caspase-3 and cleaved PARP) in HCT116 cells treated with AFC+IGF-Ⅰ were also down regulated. As compared with the AFC group, the ratios of cleaved caspase-3/procaspase-3 and cleaved PARP/PARP in the AFC+IGF-Ⅰ group were significantly decreased(P<0.01). In summary, AFC activated caspase-mediated cascades and induced HCT116 cells apoptosis in a dose-dependent manner, which may be associated with the inhibition of the PI3 K/Akt/mTOR signaling pathway.
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Humanos , Apoptose , Linhagem Celular Tumoral , Proliferação de Células , Neoplasias do Colo/tratamento farmacológico , Células HCT116 , Fosfatidilinositol 3-Quinases/metabolismo , Proteínas Proto-Oncogênicas c-akt/metabolismo , Transdução de Sinais , Syzygium , Serina-Treonina Quinases TOR/metabolismoRESUMO
According to the notice on revision of the instructions for traditional Chinese medicine injections(TCMIs) issued by the National Medical Products Administration(NMPA) from January 2006 to May 2020, the revised contents in the instructions for 29 varieties involved in the notice were sorted out, and the existing problems in the instructions for TCMIs were analyzed, so as to provide the basis for dynamic revision of the instructions. It was found that the revised items of instructions for 29 varieties all involved adverse reactions, contraindications and precautions, and warnings were added for 82.76% of 29 TCMIs preparations, indicating that all the revised contents were related to safety issues. In addition, 33.33% of the drugs risks mentioned in the precautions were not indicated in the adverse reactions; 82.76% instructions did not indicate drug interactions; 17.24% instructions lacked medication notes for special populations; 48.28% instructions did not indicate traditional Chinese medicine(TCM) syndromes of the main disease; 44.83% instructions did not indicate the type and stage of indication; and 86.21% instructions did not indicate the course of treatment. It could be concluded that the instructions for TCMIs have known risks of drugs that are not fully reflected in adverse reactions and the effective information is not comprehensive. The risk control measures proposed in the precautions need to have aftereffect evaluation and there is a lack of drug interactions and medications for special populations. As an important part of the full life-cycle management of drugs, the revision of instructions for TCMIs should be continuously improved to provide the basis for safe and reasonable application of TCMIs. Based on the above problems, it is proposed that the marketing license holder as the main body of the revision of instructions should actively carry out post-marketing basic and clinical research in accordance with the characteristics of TCM, combine the updated research with the guidance of TCM theory and improve the revision level of instructions for TCMIs to provide the basis for post-marketing evaluation.
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Humanos , Medicamentos de Ervas Chinesas , Injeções , Medicina Tradicional Chinesa , SíndromeRESUMO
Objective:To explore the effects of functional electrical stimulation (FES)-assisted rehabilitation cycling on motor function, cardiopulmonary fitness and activities of daily living in patients with subacute stroke. Methods:From January, 2016 to April, 2019, 60 patients with first-onset stroke at subacute stage were divided into control group (n = 30) and experimental group (n = 30). The experimental group and the control group received cycling training with or without FES based on the routine treatment for four weeks. They were assessed with Fugl-Meyer Assessment (FMA) and modified Barthel Index (MBI), and measured peak oxygen uptake (VO2peak) before and after treatment. Results:The scores of FMA and MBI, and VO2peak increased in both groups after treatment (|t| > 7.889, P < 0.001), and the scores of FMA and VO2peak increased more in the experimental group than in the control group (|t| > 3.332, P < 0.01). Conclusion:FES-assisted rehabilitation cycling could promote the recovery of motor function, cardiopulmonary fitness and activities of daily living in subacute stroke patients.
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Congchi Decoction in Zhouhou Beiji Fang is a prescription commonly used in treating light exterior wind-cold syndrome.Fistular Onion Stalk in the prescription has the effects in inducing sweat and dispelling exogenous evils and accelerating Yang Qi,and has been recorded in many medical books. In addition to be used to treat light exterior wind-cold syndrome,Fistular Onion Stalk is also used extensively and uniquely to treat restlessness after cholera,febrile disease,thoracic obstruction,Yin-Yang toxin syndrome,consumptive disease,bellyache due to spleen Qi deficiency according to Zhouhou Beiji Fang. However,there is still lack of the research on whether Fistular Onion Stalk is derived from shallot or scallion. The authors analyzed the sources of Fistular Onion Stalk in the prescription of Congchi Decoction by consulting ancient books,and studying the plant morphology of shallot,the characteristic and effect of Fistular Onion Stalk and the historical physicians' clinical application of Fistular Onion Stalk,the completion and popularity of Zhouhou Beiji Fang,the ratio of water to medicine of Congchi Decoction and the chemical ingredients of Fistular Onion Stalk. Finally,the authors concluded that Fistular Onion Stalk in the Congchi Decoction refers to Scallion bulbs.
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Humanos , Medicamentos de Ervas Chinesas , Farmacologia , Medicina Tradicional Chinesa , Cebolas , Química , Yin-YangRESUMO
BACKGROUND@#Handan Eye Study (HES), a large population-based cohort study in rural area of northern China, was one of the few studies focusing on the major eye diseases of rural Chinese population. The aim of this study was to introduce the design, methodology and to assess the data quality of the follow-up phase of HES.@*METHODS@#All participants were recruited in Yongnian county of Handan city between 2012 and 2013. Main outcomes were measured by visual quality scales and ocular examinations. We performed the Chi-square test to make comparison of categorical data among groups, One-way analysis of variance and Kruskal-Wallis test was applied to make comparison of continuous data among groups, a post-hoc test was done to make further pairwise comparison. Inter-class correlation coefficients (ICCs) and Kappa coefficients were used to evaluate the consistency between different operators. Logistic regression was used to explore the influence factors of death, odds ratio (OR) and 95% confidence interval (CI) were used to estimate the effect size of each influence factor.@*RESULTS@#The follow-up rate was 85.3%. Subjects were classified into three groups: the follow-up group (n = 5394), the loss to follow-up group (n = 929), and the dead group (n = 507), comparison of their baseline information was done. Compared with the other two groups, age of the dead group (66.52 ± 10.31 years) was the oldest (Z = 651.293, P < 0.001), male proportion was the highest (59.0%) (χ = 42.351, P < 0.001), only 65.9% of the dead finished middle school education (Z = 205.354, P < 0.001). The marriage percentage, body mass index (BMI), best-corrected visual acuity (BCVA), and intra-ocular pressure of the dead group was the lowest either. Spherical equivalent error (SER) of the dead group was the highest. Besides, history of smoking, hypertension, diabetes, and heart disease were more common in the dead group. Multivariate analysis showed that age (OR = 1.901, 95% CI: 1.074-1.108), gender (OR = 0.317, 95% CI: 0.224-0.448), and BCVA (OR = 0.282, 95% CI: 0.158-0.503) were associated with death. While between the follow-up group and the loss to follow-up group, there was only difference on age, gender, BMI, systolic blood pressure and SER. The Cronbach coefficients of all scales used in the follow-up were ≥0.63 and the cumulative variances were ≥0.61, indicating good reliability and validity. The ICCs and Kappa coefficients between different operators were ≥0.69.@*CONCLUSIONS@#HES has a high follow-up rate and a low risk of loss to follow-up bias. Age, gender, and BCVA are influence factors of death. Specifically, male subjects are at a higher risk of death than female, age is a risk factor of death while BCVA is a protective factor for death.
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Xiaoke Pills are Chinese and Western medicine compound preparations with effects of nourishing kidney and Yin,and supplementing Qi and promoting fluid. It is widely used in clinical treatment of type 2 diabetes( Qi and Yin deficiency syndrome),and continuously included in 2010,2013 and 2017 editions of Chinese prevention guide for type 2 diabetes. For the purpose of accurate positioning and rational use in clinic,it is necessary to further define the curative effect,indications,medication precautions and contraindications of Xiaoke Pills,in order to improve medication safety. This consensus was reached by reference of international clinical guidelines and expert consensus approach based on clinical evidence-based evidence,expert experience and standard specification. The evidence-based evaluation was oriented to clinical problems summarized by no less than 200 front-line clinical physicians in two rounds.GRADE system was adopted for quality classification and evaluation of the evidences,and then the nominal group method was used to form consensus recommendations or suggestions. This consensus defined the curative effect advantages,target users,dosage,administration method,contraindications and precautions of Xiaoke Pills,and provided valuable reference for the clinical use of the drug. Thisconsensus still needs to be updated and revised based on new clinical problems and evidence-based evidence in practical application in the future.
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Humanos , Consenso , Diabetes Mellitus Tipo 2/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa , Deficiência da Energia YinRESUMO
Background@#Handan Eye Study (HES), a large population-based cohort study in rural area of northern China, was one of the few studies focusing on the major eye diseases of rural Chinese population. The aim of this study was to introduce the design, methodology and to assess the data quality of the follow-up phase of HES.@*Methods@#All participants were recruited in Yongnian county of Handan city between 2012 and 2013. Main outcomes were measured by visual quality scales and ocular examinations. We performed the Chi-square test to make comparison of categorical data among groups, One-way analysis of variance and Kruskal-Wallis test was applied to make comparison of continuous data among groups, a post-hoc test was done to make further pairwise comparison. Inter-class correlation coefficients (ICCs) and Kappa coefficients were used to evaluate the consistency between different operators. Logistic regression was used to explore the influence factors of death, odds ratio (OR) and 95% confidence interval (CI) were used to estimate the effect size of each influence factor.@*Results@#The follow-up rate was 85.3%. Subjects were classified into three groups: the follow-up group (n = 5394), the loss to follow-up group (n = 929), and the dead group (n = 507), comparison of their baseline information was done. Compared with the other two groups, age of the dead group (66.52 ± 10.31 years) was the oldest (Z = 651.293, P < 0.001), male proportion was the highest (59.0%) (χ2 = 42.351, P < 0.001), only 65.9% of the dead finished middle school education (Z = 205.354, P < 0.001). The marriage percentage, body mass index (BMI), best-corrected visual acuity (BCVA), and intra-ocular pressure of the dead group was the lowest either. Spherical equivalent error (SER) of the dead group was the highest. Besides, history of smoking, hypertension, diabetes, and heart disease were more common in the dead group. Multivariate analysis showed that age (OR = 1.901, 95% CI: 1.074–1.108), gender (OR = 0.317, 95% CI: 0.224–0.448), and BCVA (OR = 0.282, 95% CI: 0.158–0.503) were associated with death. While between the follow-up group and the loss to follow-up group, there was only difference on age, gender, BMI, systolic blood pressure and SER. The Cronbach coefficients of all scales used in the follow-up were ≥0.63 and the cumulative variances were ≥0.61, indicating good reliability and validity. The ICCs and Kappa coefficients between different operators were ≥0.69.@*Conclusions@#HES has a high follow-up rate and a low risk of loss to follow-up bias. Age, gender, and BCVA are influence factors of death. Specifically, male subjects are at a higher risk of death than female, age is a risk factor of death while BCVA is a protective factor for death.
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Objective To investigate the degrees of injury severity of sepsis models made by different kinds of Escherichia coli. Methods The 152 mice were randomly divided into control group, DH5α group, 44102 group, and 25922 group, with 38 rats in each group. DH5α group, 44102 group and 25922 group were intraperitoneally injected with 300 μL of Escherichia coli DH5α, 44102 and 25922 at the concentration of 1.0 × 109CFU/kg to prepare sepsis models of different kinds of Escherichia coli. Control group was injected intraperitoneally with the same amount of normal saline. (1) After 8 h, four mice were taken from each group for peripheral blood bacterial culture . (2) After 12 h, ten mice in each group were used for measuring serum levels of TNF-α and IL-6 by enzyme-linked immunosorbent assay (ELISA). (3) Western blot assay was used to determine the serum levels of high-mobility group protein (HMGB1) in four mice of each group. (4) Ten mice in each group were used to measure serum levels of alanine transaminase (ALT), aspartate aminotransferase (AST), creatinine (CR) and blood urea nitrogen (BUN) by automatic biochemical analyzer. (5) After liver, lung and kidney tissues were fixed with formaldehyde, hematoxylin-eosin (HE) staining was performed (n=10 for each group). Results In DH5α group, 44102 group and 25922 group, bacteria, inflammatory cytokines TNF-α, IL-6 and HMGB1 protein, liver and kidney indicators ALT, AST, CR and BUN showed a sequential increasing trend (P<0.01). The severe degrees of alveolar structure damage, hepatic cell infiltration and renal glomerular atrophy were DH5α group, 44102 group and 25922 group in turn. There were no obvious damages of lung, liver or kidney tissues in control group. Conclusion Escherichia coli 25922 induces severe sepsis injury and can be used to study the animal models of the initial inflammatory phase of sepsis. Escherichia coli 44102 induces moderate damage of sepsis and can be used in animal models that do not require definitive sepsis staging experiments. Escherichia coli DH5α induces less damage of sepsis and can be used to explore immunosuppressive therapy of the animal model of sepsis.
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By retrieving domestic and foreign literatures, the authors provided a systematic review for effects of Xanthii Fructus, toxicity recorded in ancient/current literatures and relevant toxicological experience, and summarized clinical characteristics of clinical cases related to Xanthii Fructus and influencing factors. In addition to liver and kidney injuries as the major side effects of Xanthii Fructus, neurotoxicity and cardio-toxicity of Xanthii Fructus were also common clinical adverse events. However, there have been a few animal experimental studies so far. Oral administration and external application with Xanthii Fructus have often caused skin reactions, even such severe cases as exfoliative dermatitis. The authors suggested standardizing the clinical medication, avoiding to use untreated prescriptions and unprocessed herbs, ensuring the effective and safety use of Xanthii Fructus in strict accordance with the recommended dosage and usage in pharmacopeia, paying attention to the accumulation of safety signals, strengthening studies on toxic substance, toxicity mechanism, and synergy and attenuation effects.
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The authors systemically evaluated and analyzed the safety of Areca catechu from domestic and foreign literatures about the herbal origin, toxicity recorded in ancient/current documents, safety case reports of clinical A. catechu, experimental studies on toxicity in recent years, and differences of safety risk between edible and medicinal A. catechu. Subsequently, they proposed a preliminary summary about the clinical characteristics and potential risk factors of safety related cases of A. catechu and its preparations. According to the authors, although clinical adverse events of A. catechu were fewer and controllable, clinicians shall stillstrictly standardize its application, and rationally combine it with other herbs, while strengthening fundamental and clinical studies related to safety, so as to give better guidance to safety application of A. catechu in clinic.
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Through a systematic and comprehensive study of domestic and foreign literatures and information, this study aims to trace the herbal origin and the toxicity recorded in ancient and current documents, analyze the safety case reports of Psoralea corylifolia and experimental studies on toxicity in recent years, and make a preliminary summary about the clinical characteristics and potential risk factors of cases related to the safety of P. corylifolia and its preparations. The study involved 84 patients in the safety case reports of P. corylifolia. The adverse events were mainly liver damage (55.95%) and light toxic contact dermatitis (38.10%), sugguesting that P. corylifolia may lead to liver damage and photo toxicity. However, reproductive toxicity and renal damage were only reported in animal studies, but not in clinical reports. Because of its complicated ingredients, the toxic components and mechanisms of P. corylifolia have not been clear at present. Therefore, the authors proposed to strictly apply P. corylifolia in clinic, use it rationally and combine it with other medications. Besides, efforts shall be made to strength the guidance for doctors, the safety monitoring of P. corylifolia and relevant preparations, and actively carry out safety-related basic and clinical studies, so as to give a better guidance to safe medication, full exert the efficacy and avoid the medication risk.
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We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in that it enhances the pharmaceutical manufactures the ability to control enterprise risk and eliminate the negative impact on traditional Chinese medicine. With the widely used and ADR report concentrated Radix Bupleuri injection as an example, the author provide a new approach to post-marketing clinical research.
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Humanos , Bupleurum , Química , Composição de Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Medicamentos de Ervas Chinesas , Vigilância de Produtos Comercializados , Métodos , SegurançaRESUMO
By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.
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Feminino , Humanos , Masculino , Cápsulas , Economia , China , Avaliação de Medicamentos , Economia , Medicamentos de Ervas Chinesas , Economia , Marketing , Vigilância de Produtos Comercializados , EconomiaRESUMO
<p><b>OBJECTIVE</b>To investigate the relationship of carotid artery plaque and blood pressure variation and cardiovascular risk factors.</p><p><b>METHODS</b>We retrospectively analyzed clinical data of in-patients treated in the department of hypertension between April 2009 and June 2010. Information on carotid ultrasonography and other clinical date were obtained from 408 patients. All patients were monitored by ambulatory blood pressure.</p><p><b>RESULTS</b>(1) Carotid artery determined in plaque was 55.3%, there was no differences between men and women. However, the carotid artery plague was associated positively with age. Increased age was associated with a significantly increased positive rate. (2) Cardiovascular risk factors and carotid artery plaque: carotid artery plaque was associated with duration of disease, fasting blood sugar, total cholesterol, and low density lipoprotein-cholesterol. (3) 24 h ambulatory blood pressure and carotid artery plaque: the prevalence of carotid artery plaque increased with increasing coefficient of systolic variation (P = 0.001). There was no correlation between the coefficient of diastolic variation and the prevalence (P = 0.644).(4) Multivariate regression analysis indicated that carotid artery plaque was associated with duration of hypertension, 24 h mean systolic blood pressure, and coefficient of variation of 24 h blood pressure (P < 0.05).</p><p><b>CONCLUSION</b>Carotid atherosclerosis is independently associated with coefficient of variation of blood pressure, especially with coefficient of variation of systolic blood pressure.</p>
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Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pressão Sanguínea , Doenças das Artérias Carótidas , Hipertensão , Patologia , Estudos Retrospectivos , Fatores de RiscoRESUMO
<p><b>BACKGROUND</b>Pterygium is a common ophthalmic disease and an important public health problem. It may be affected by many factors such as age, gender, ultraviolet radiation exposure, and time spent outdoors. This study aimed to investigate the prevalence of pterygium and evaluate the risk factors for the development of pterygium in the aged rural population of Beijing.</p><p><b>METHODS</b>The investigation is a population-based cross-sectional study. Participants from 198 villages of 13 suburban districts, aged 55 - 85 years old, were invited to complete a medical record, and 37 067 individuals were taken external ocular and fundus photos at Beijing ocular disease survey in 2008-2009. The information was uploaded by Internet and diagnosed with stages and grades by ophthalmological specialists. The prevalence, stages and grades of pterygia were observed.</p><p><b>RESULTS</b>Of the 37 067 individuals, 1395 (3.76%) had pterygium. There was a significantly higher prevalence in male (5.13%) than in female (3.17%, P = 0.000). The prevalence rate increased obviously with ages (chi(2) = 7.939, P = 0.019) in rural Beijing. The average prevalence of 5.91% in Daxing and Fangshan districts with low latitude and low precipitation was significantly higher than that in Miyun and Huairou districts with high latitude and deep precipitation (3.17%, P = 0.000). The majority of the pterygia (43.5%) were in active stage and 46.5% pterygia involved pupil area corneas.</p><p><b>CONCLUSIONS</b>There is a statistically significant association between latitude and precipitation of habitation region and pterygium formation. Solar radiation, especially ultraviolet exposure represents a significant environment hazard to pterygium development.</p>
Assuntos
Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Distribuição por Idade , China , Epidemiologia , Pterígio , Epidemiologia , População RuralRESUMO
<p><b>OBJECTIVE</b>To explore the interactions of gene polymorphisms of cytotoxic T lymphocyte antigen 4 (CTLA-4) and programmed cell death 1 (PDCD-1) with risk environmental factors in individuals with systemic lupus erythematosus (SLE) from Han nationality female population in South of Changjiang River region of China.</p><p><b>METHODS</b>With a case-only design, a total of 258 cases were enrolled in this study, and single nucleotide polymorphisms (SNPs) of the PDCD-1 and CTLA-4 genes were determined by means of PCR-RFLP. With the aid of Poisson loglinear mode, interactions between gene-gene and gene-environment were fitted under the dominant, recessive, additive and multiple models, respectively.</p><p><b>RESULTS</b>It was found that interaction existed between GG genotype of PD1.6 and UV history under separate inherent models of the recessive mode (OR = 3.714, 95%CI: 1.235 - 11.179) and additive mode (OR = 3.199, 95%CI: 1.023 - 10.004). For CTLA-4 locus, there existed interactions between TT/TC genotype of -1722T-->C and UV history under the dominant model (OR = 4.874, 95%CI: 1.119 - 21.242), and interaction between T allele and UV history was also found under the multiple model (OR = 1.470, 95%CI: 1.047 - 2.065). While, under the additive mode for CTLA-4, it was found that interactions existed between TT genotype of -1722T-->C and UV history (OR = 4.744, 95%CI: 1.037 - 21.737), as well as between TC genotype of -1722T-->C and UV history (OR = 4.973, 95%CI: 1.110 - 22.287).</p><p><b>CONCLUSION</b>The interactions between UV history and polymorphisms of CTLA-4 and PDCD-1 gene for SLE were observed, which indicates that there may be association of their interactions with the development of SLE in Han nationality females population in the south regions of Changjiang River in China.</p>
Assuntos
Adulto , Feminino , Humanos , Pessoa de Meia-Idade , Antígenos CD , Genética , Apoptose , Proteínas Reguladoras de Apoptose , Genética , Antígeno CTLA-4 , Exposição Ambiental , Predisposição Genética para Doença , Genótipo , Lúpus Eritematoso Sistêmico , Genética , Polimorfismo de Nucleotídeo Único , Receptor de Morte Celular Programada 1 , Fatores de Risco , Raios UltravioletaRESUMO
<p><b>OBJECTIVE</b>To investigate the relationship of gene polymorphisms of programmed cell death 1 gene (PDCD1) and ultraviolet history with systemic lupus erythematosus (SLE) among the Han population in the southern region of yangtze river in China.</p><p><b>METHODS</b>With a case control design, a total of 159 SLE cases and 159 controls were enrolled in this study, and single nucleotide polymorphisms (SNPs) of the PDCD1 gene were determined by PCR-restriction fragment length polymorphism (RFLP). With the aid of the logistic regression model, the effect of gene polymorphism, environmental factor and the interaction between gene and environment were fitted under the recessive, dominant, additive and codominant mode, respectively.</p><p><b>RESULTS</b>Three models were screened as the optimal models under the additive mode and one model under the dominant mode, according to the lowest value of Akaike's Information Criteria (AIC). After the control of age and gender, it was found that the frequency of ultraviolet exposure was higher in cases than in controls with significant difference under all models (P<0.05). For the haplotypes composed of the alleles of PD1.2, PD1.5 and PD1.6, there was significantly higher frequency of G-T-A haplotype (0.1196 vs 0.0363) and lower frequency of A-C-A haplotype (0.4746 vs 0.5399) in cases than that in controls (P<0.05) under the additive mode, and the G-T-A haplotype was associated with an increased risk for SLE (OR=4.319), while A-C-A haplotype was shown as a protective factor for SLE (OR=0.571). Moreover, interaction between A-C-G haplotype and ultraviolet exposure, which was related to an increased risk for SLE (beta5=1.182, Z=2.2898, P<0.05, OR=3.261), was also found under this mode. Additionally, the frequency of G-C-G haplotype was higher in cases than that in controls (0.1287 vs 0.0361) under the dominant mode with statistically significant difference (P<0.05, OR=4.332).</p><p><b>CONCLUSION</b>Authors' results indicate that ultraviolet exposure, G-T-A or G-C-G haplotype and interaction between A-C-G and ultraviolet exposure may be associated with genetic susceptibility to SLE in Han population in the southern region of yangtze river in China under certain genetic modes.</p>