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    20 July 2018, Volume 15 Issue 7 Previous Issue    Next Issue

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    Effect of Pomegranate Peel Tannin on Migration and Invasion of Bladder Cancer T24 Cells
    ZENG Maolin, ZHOU Benhong
    2018, 15(7): 385-388. 
    Abstract ( 439 )   PDF (930KB) ( 216 )  
    Objective To investigate the effect of pomegranate peel tannin on the migration and invasion of human bladder cancer T24 cells. Methods Human bladder cancer T24 cells were used as target cells, and the effects of different concentrations of tannin on migration of T24 cells were observed by cell scratch test and Transwell migration test. Transwell invasion assay was used to determine the effect of pomegranate peel tannin on the invasion ability of T24 cells. Results The results of cell scratch test showed that the wound healing ability of T24 cells decreased significantly after pomegranate peel tannin treatment. After 48 h, the wound healing rate of blank control group was 52.04 %, 12.5 μg·mL-1 pomegranate peel tannin group was 18.21 %, and the differences were statistically significant compared with the blank control group (P <0.001). Transwell migration assay indicated that the number of T24 cells passing through the membrane was significantly decreased after treated with pomegranate peel tannin for 24 h (P <0.001). The results of Transwell invasion test showed that the number of cells in the pomegranate peel tannin group passing through the artificial basement membrane decreased significantly. It can decrease the invasive activity (P <0.001). Conclusion Pomegranate peel tannin can inhibit the metastasis of bladder cancer cells.
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    Effect of Xiaoyao Pill on Ovarian Oxidative Damage and Apoptosis in Glycosides of Tripterygium Wilfordii- induced Ovulation Obstacles Rats
    ZHOU Nan, YANG Hongmin, MA Huirong, HUI Linmin, LIU Zhenxing, DUI Huilan
    2018, 15(7): 389-392. 
    Abstract ( 414 )   PDF (867KB) ( 132 )  
    Objective To observe the effects of Xiaoyao pill (XYP) on ovarian oxidative damage and apoptosis in Glycosides of Tripterygium Wilfordii (GTW)-induced ovulation obstacles rats. Methods The rat model of ovulation caused by GTW was successfully established. One hundred and thirty-six rats were randomly divided into control group, model group, XYP high-dose group and XYP low-dose group, with 34 rats in each group. Serum and ovarian tissues levels of Tbil, Dbil and T-AOC were detected by colorimetry, and the levels of MDA were detected by penthiobarbital. Apoptosis of ovarian granulosa cells was observed by TUNEL. Results Compared with control group, serum and ovarian tissues MDA level increased(P <0.01), while Tbil, Dbil and T-AOC levels decreased in the model group (all P <0.01), the apoptosis of ovarian granulosa cells was significantly increased in model group (P <0.01). After treatment with XYP, the levels of serum and ovarian tissues Tbil and Dbil were increased (all P <0.05), while the levels of ovarian tissues MDA in those groups were lower than model group (all P <0.05). Moreover, the apoptosis of ovarian granulosa cells was significantly lower than those in model group (all P <0.01). XYP high-dose group shows the best effect. Conclusion XYP could improve follicular development and ovulation obstacles by regulating ovarian oxidative damage and apoptosis.
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    Analysis and Consideration on Safety Risk of Thiamazole Tablets
    LI Lan, XIA Dongsheng, TIAN Chunhua, PENG Lili, GAO Yunjuan
    2018, 15(7): 393-397. 
    Abstract ( 554 )   PDF (1011KB) ( 245 )  
    Objective To analyze the safety risk of thiamazole tablets in China, so as to provide reference for clinical rational drug use. Methods The individual adverse drug reaction cases in Vigibase, China adverse drug reaction database,the literatures in foreign bibliographic databases, the domestic and original drug instruction and the domestic risk management measures were analyzed. Results The risk of agranulocytosis and liver damage of thiamazole should be concerned. It is important to monitor blood test and hepatic functions regularly. Conclusion The marketing authorization holder should carry out main responsibility and amend the safety information of drug instruction constantly to guarantee the public drug safety.
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    Analysis of Granulocytopenia Induced by Thiamazole
    WEN Xiaoling, GAO Yunjuan, ZHANG Hailang, YANG Jie, LAN Shan, LI Yamei, LI Lan
    2018, 15(7): 398-403. 
    Abstract ( 691 )   PDF (819KB) ( 1951 )  
    Objective To analyze the characteristics of granulocytopenia induced by thiamazole, so as to provide reference for clinical safe and rational drug use. Methods Retrospective study was conducted on the statistical analysis of granulocytopenia induced by thiamazole that received by the national adverse drug reactions monitoring database from January 1, 2004 to June 30, 2016. Results Among 1 358 cases of granulocytopenia induced by thiamazole, the proporation of the serious adverse drug reactions(ADRs) was 48.53%, female patients were 3.93 times that of male patients, the most of patients were 15 to 44 years old, it occurred within 12 weeks accounting for 87.56%, and there may be a dose correlation in the occurrence of ADRs. Clinical manifestations were mainly the blood system damage, systemic damage and respiratory damage. Conclusion Granulocytopenia induced by thiamazole can't be ignored. The clinic should pay attention to usage and dosage. The education of patients, the blood monitoring before and after treatment should be strengthened. Doctors should actively take treatment measures to reduce the injury if it happened, so as to prevent or reduce the occurrence of serious adverse drug reactions.
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    Literature Analysis of Adverse Drug Reactions/Events Induced by Thiamazole
    PENG Lili, LIU Wei, TANG Ren, LI Lan, FAN Yan
    2018, 15(7): 404-410. 
    Abstract ( 505 )   PDF (860KB) ( 688 )  
    Objective To investigate and analyze the literatures on clinical application and ADR/ADE induced by thiamazole, so as to provide reference for its rational use in clinic. Methods The literatures for the clinical application and ADR/ADE of thiamazole were retrieved in the databases of Pubmed, Embase and CNKI, Wangfang data. The related literatures were screened out and analyzed by evidence-based medicine method and bibliometric statistical method. Results 117 available literatures were retireved; 449 adverse drug reaction cases were collected. Female patients were 4.80 times that of male patients, the most of patients were 15 to 44 years old, the serious adverse drug reactions (events) were mainly blood system damage and hepatobiliary disorders, accountiong for 48.12% and 22.26% respectively. Conclusion We should reinforce the clinical application monitoring of thiamazole, standardize and improve the drug manual, promte the rational application of drug.
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    Upgrade of EudraVigilance in the EU and Its Considerations
    WANG Tao, WANG Dan, FAN Yan, DONG Duo
    2018, 15(7): 411-413. 
    Abstract ( 755 )   PDF (840KB) ( 632 )  
    Objective To introduce the main and upgraded features of EudraVigilance, so as to provide consideration and reference for the development of our national ADR monitoring in China. Methods Based on 2017 Annual Report on EudraVigilance for the European Parliament, the council and the commission, the new and enhanced functionalities of this database were analyzed. Results The enhanced functionalities of this database were mainly focused on functionalities subject to audit, the dictionary for medicinal product information and medical literature monitoring, etc. Conclusion The adverse reaction monitoring system in China still needs to be strengthened in internationalization of data formats, expansion of data sharing and improvement of drug information database.
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    Discussion on Shelf Life and In-Use Period of Medicinal Products
    QIAN Peipei, CAO Kai, ZHAO Liang, LAN Weimin, LAN Bingxin
    2018, 15(7): 414-418. 
    Abstract ( 864 )   PDF (865KB) ( 625 )  
    Objective To review the related concepts and regulations for in-use period in China and abroad in order to propose references and suggestions for the improvement of in-use period management of medicinal products in China. Methods By literature retrieval, the related concepts and regulations for in-use period in China and abroad were introduced and classified. The differences between shelf life and in-use period were compared and analyzed. Results and Conclusion Compared with the concept of shelf life, the concept of in-use period is different in stability study type, assigning person, starting time and marking method. By now, the regulations for in-use period in China are insufficient. By contrast, international regulations for in-use period are relatively systematic, which include multi-dose packaging drugs after the first time of being opened, drugs after reconstitution or dilution, repackaged drugs and pharmaceutical compoundings. International regulations for in-use period provide beneficial references and enlightenments for the improvement of in-use period management of medicinal products in China.
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    Bayesian Network Meta-analysis of Randomized Controlled Trials Comparing Fufangdanshen Dripping Pills, Isosorbide Nitrate and Isosorbide Mononitrate in Treating Coronary Heart Disease Angina
    ZHANG Dandan, LIU Huan, CHEN Jiayin, JIN Jing, XIONG Yao, YANG Yue
    2018, 15(7): 419-428. 
    Abstract ( 536 )   PDF (1087KB) ( 274 )  
    Objective To evaluate the safety and efficacy of Fufangdanshen dripping pills, isosorbide nitrate and isosorbide mononitrate in treating angina by Bayesian network meta-analysis. Methods Randomized controlled trials comparing Fufangdanshen dripping pills, isosorbide nitrate and isosorbide ononitrate in treating angina were searched in the Cochrane Library, PubMed, EMBASE, CNKI, Wanfang and Weipu databases. Search time was as of December 10, 2017. The EndNote X8 was used to document management and deduplication. Cochrane Reviewers handbook(5.3.3) was used to evaluate quality of studies included. The risk of bias was evaluated by RevMan(V.5.0). The Gemtc package of R software(V.3.4.4) was used to carry out Bayesian network meta-analysis through the Markov chain-Monte Carlo (MCMC). Rank probabilities were used to evaluate efficacy of different treatments. Stata 14.0 draws funnel maps were used to evaluate publication bias. Direct meta-analysis was evaluated by RevMan(V.5.0). Results 41 RCTs and 4 679 patients were included. Network meta-analysis shows: ①Probability of the efficacy of Fufangdanshen dripping pills was the biggest in angina clinical efficacy(n=41), Fufangdanshen dripping pills was more effective than isosorbide nitrate and isosorbide mononitrate[OR=3.7,95%Crl(2.9,4.7), OR=4.3,95%Crl(1.7,13)], Fufangdanshen dripping pills+isosorbide nitrate is more effective than isosorbide nitrate[OR=2.5,95%Crl(1.5,4.4)], Fufangdanshen dripping pills+isosorbide mononitrate was more effective than isosorbide mononitrate [OR=3.6,95%Crl(2.4,5.5)]; ②Probability of the efficacy of Fufangdanshen dripping pills+isosorbide mononitrate was the biggest in ECG clinical efficacy(n=30), Fufangdanshen dripping pills was more effective than isosorbide nitrate[OR=2.7,95%Crl(2.2,3.3)], Fufangdanshen dripping pills+isosorbide nitrate was more effective than isosorbide nitrate[OR=2.9,95%Crl(1.8,5.1)], Fufangdanshen dripping pills+isosorbide mononitrate was more effective than isosorbide nitrate and isosorbide mononitrate[OR=6.2,95%Crl(2.3,17); OR=3.8,95%Crl(2.5,5.9)]; ③Probability of the efficacy of Fufangdanshen dripping pills was the biggest in adverse drug reaction (n=26), Fufangdanshen dripping pills are smaller than isosorbide nitrate and isosorbide mononitrate in adverse drug reactions[OR=0.036, 95%Crl(0.0061,0.093; OR=0.049, 95%Crl(0.0022, 0.40). There was no difference between the incidence of adverse reactions of Fufangdanshen dripping pills+nitrate drugs and nitrate drugs. The above results were consistent with the direct meta analysis. Conclusion Fufangdanshen dripping pills was more effective than isosorbide nitrate and isosorbide mononitrate in angina clinical efficacy and ECG clinical efficacy and adverse drug reactions. There was no difference between the incidences of adverse reactions of fangdanshen dripping pills+nitrate drugs and nitrate drugs. However, The quality of randomized controlled trials incluced were low. The study results are still supported by high-quality research.
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    Pareto Chart Analysis of Irrational Drug Use in Outpatient and Emergency of Our Hospital
    ZHAO Xuan, LIN Ping, GUO Jing, CHENG Ning, MAO Lu, ZHEN Jiancun
    2018, 15(7): 429-433. 
    Abstract ( 542 )   PDF (761KB) ( 389 )  
    Objective To analyze the outpatient and emergency prescriptions in our hospital, and to understand the situation and cause of irrational drug use, in order to find out measures to improve prescription quality and promote rational drug use. Methods By the way of combining software review and manual review, the using rationality of medicines, which were used in our hospital's outpatient and emergency in October 2017, were evaluated, and the result was analyzed, while Pareto chart analysis was used to find out the main and minor factors of irrational prescriptions in outpatient and emergency. Results There were 76 598 prescriptions used in our hospital's outpatient and emergency, while the number of irrational prescriptions was 3 706 accounting for 4.84%. Meanwhile, the number of prescriptions used in outpatient was 62 916 with 5.33% (3 354) being irrational. The main factors of drugs' misusing in outpatient were "usage or dosage disagree" and "indication mismatch", while the minor factor was "drugs' formulations or routes of administration disagree". 13 682 prescriptions were used in emergency, while 2.57% (352) of which was irrational. The main factors of drugs' misusing in emergency were "usage or dosage disagree" and "drugs' formulations or routes of administration disagree", and minor factor was "indication mismatch". Conclusion "Usage or dosage disagree", "indication mismatch" and "drugs' formulations or routes of administration disagree" were the main and minor factors of irrational drug use in our hospital's outpatient and emergency. The way to review all the prescriptions in outpatient and emergency and make Pareto chart analysis was helpful for a comprehensive understanding of current status and issues distribution in hospital's prescriptions, after that, targeted measures could be taken to effectively improve the quality of hospital's prescriptions and promote rational drug use.
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    Analysis of 56 Literature and Clinical Cases of Adverse Reactions Induced by Topiramate
    GUO Mangmang, MENG Jin, ZHUANG Jie, YANG Weili, GAO Baoqin, DENG Yaxian
    2018, 15(7): 434-439. 
    Abstract ( 383 )   PDF (781KB) ( 286 )  
    Objective Through investigating the characteristics and mechanism of adverse reactions induced by topiramate, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods The patients who experienced adverse drug reactions(ADRs) induced by topiramate and reported by the department of pharmacy in Beijing Tiantan Hospital from March 1999 to March 2018 were included. At the same time articles in the CNKI database, Wanfang database, VIP Chinese full-text database and CBM database were searched, and the patients in the references which met the inclusion criteria were extracted. Then the ADR information of the patients both from Beijing Tiantan Hospital and the literatures were analyzed together. Results Most of the reactions occurred in patients under the age of 18. The major illness was epilepsy. ADRs occurred more frequently within 1 to 3 months after topiramate treatment. Systems and organs mainly involved in adverse reactions were neurological disorders, skin and appendages disorders, etc. Cognitive disorders and hypohidrosis were the most commonly reported adverse reactions, followed by anorexia and weight decrease. There were ten serious ADRs among which skin and appendages disorders were the most common, and then urinary tract disorders. No case died because of ADRs induced by topiramate, and most ADRs were fully recovered or relieved by stopping or reducing the use of topiramate. Conclusion The family history of nephrocalcinosis and allergy history should be asked before using topiramate. Start using topiramate with a small dose and increase the dose slowly. Blood routine test、liver function、ammonia、electrolyte、urinary system ultrasound test of patients should be monitored. Once ADRs occur, diagnosis and treatment should be carried out as soon as possible to ensure the safe drug use.
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    One Case of Anaphylactic Shock Induced by Dextran Iron Injection
    CHEN Fang, CUI Min*
    2018, 15(7): 440-440. 
    Abstract ( 384 )   PDF (516KB) ( 308 )  
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    One Case of Hypoglycemia Induced by Alogliptin Combined with Metformin
    GUAN Songmei, FANG Chao
    2018, 15(7): 441-442. 
    Abstract ( 456 )   PDF (528KB) ( 457 )  
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    One Case of Allergic Purpura Induced by Ceftizoxime Sodium for Injection
    LIU Shuhong, LI Lianchun, CAO Yu
    2018, 15(7): 443-444. 
    Abstract ( 429 )   PDF (526KB) ( 520 )  
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