Archive

20 February 2018, Volume 15 Issue 2 Previous Issue    Next Issue

---

For Selected:

Download Citations EndNote Ris BibTeX

Toggle Thumbnails

Select

Long-term Toxicity of Different Extracts of Epimedium Brevicornu Maxim in Mice WANG Qin, ZHANG Pan-yang, YUAN Xiao-mei, BI Ya-nan, ZHOU Kun, ZHANG Yue 2018, 15(2): 65-69.  Abstract ( 708 )   PDF (757KB) ( 289 )   Objective To study the long-term toxicity of oral administration of different extracts of Epimedium brevicornu Maxim in mice and provide a safety reference for its clinical application. Methods 144 ICR mice were randomly divided into blank control group, high, medium and low dose groups of Epimedium brevicornu Maxim water extract and Epimedium brevicornu Maxim alcohol extract (80, 40, 20 g?kg-1). Continuous gavaging for 8 weeks, the general condition of the mice was observed during the administration, and the body weight was weighed weekly. After the last administration, relevant blood biochemical indexes, system autopsy and histopathological examination were performed. Results Four weeks after continuous administration of Epimedium brevicornu Maxim water extract and ethanol extract, the body weight of female and male mice were significantly lower than the control group(P <0.001). In addition, compared with the control group, the organ coefficient, blood indicators, serum biochemical indicators of Epimedium brevicornu Maxim water extract and ethanol extract groups had a certain degree of change(P <0.05). Conclusion Epimedium brevicornu Maxim extracts at high dose have certain toxic effects on mice for 8 weeks. References | Related Articles | Metrics

Select

Effects of Lx2-32c on Cervical Cell Hela in vitro CAI Pei, XIAO Zuo-qi, PAN Tao, OU-YANGBo 2018, 15(2): 70-72.  Abstract ( 347 )   PDF (825KB) ( 196 )   Objective To study the effects of Lx2-32c on the proliferation and apoptosis of cervical cell Hela. Methods After treated with different concentration of Lx2-32c for 24, 48, 72 h, the proliferation of cervical cell Hela was determined by MTT. Simultaneously, the apoptosis ratio of Hela by Annexin V-FITC/PI and the expression of Bcl-2 and cleaved-caspase-3 by western blotting were detected. Results Lx2-32c could effectively inhibit the proliferation of Hela in a dose-dependent and time-dependent manner. At the same time, Lx2-32c induced apoptosis and down-regulated the expression of Bcl-2 and up-regulated the expression of cleaved-caspase-3 in Hela. Conclusion Lx2-32c maybe induced apoptosis and inhibited the proliferation of Hela involving in mitochondrial pathway. References | Related Articles | Metrics

Select

Analysis of Ribavirin Utilization Based on Yinzhou Healthcare Database LIN Hong-bo, LIU Cui-li, SHEN Peng, LI Hai-long, ZHAO Hou-yu, ZHAN Si-yan 2018, 15(2): 73-77.  Abstract ( 402 )   PDF (1015KB) ( 174 )   Objective To describe the clinical utilization of ribavirin in Ningbo city, Yinzhou District. Methods We conducted a descriptive analysis of the clinical utilization of ribavirin in 3 general hospitals and 24 community health centers from 2010 to 2016 by using Yinzhou healthcare information database. Results During the study period, we found 1587 504 outpatients' prescriptions of ribavirin and 673,661 ribavirin users. Ribavirin injections accounted for 97.74% of all ribavirin prescriptions. In addition, ribavirin was mainly prescribed by primary grade medical institutions. The result showed the number of prescriptions and users of ribavirin was decreasing. Moreover, ribavirin prescriptions of children (≤14) accounted for 50.56% of the total number of ribavirin prescriptions. Among all ribavirin prescriptions, there were 68.85% recorded diagnosis of acute upper respiratory tract infection. Conclusion The results indicated that there were large amount of irrational prescriptions of ribavirin. Clinicians should adhere to the indication of ribavirin injection and pay attention to the treatment. References | Related Articles | Metrics

Select

Utilization of Ribavirin Injection Among Reproductive Population Aged 18 to 44 Years Old Based on Yinzhou District Healthcare Database LI Hai-long, ZHAO Hou-yu, LIN Hong-bo, LIU Cui-li, SHEN Peng, ZHAN Si-yan 2018, 15(2): 78-82.  Abstract ( 408 )   PDF (773KB) ( 183 )   Objective To describe the clinical utilization of ribavirin injection among reproductive population in Yinzhou district, Ningbo city. Methods A descriptive analysis of the clinical utilization of ribavirin injection among reproductive population aged 18 to 44 in 3 general hospitals and 24 community health centers from 2010 to 2016 was conducted by using Yinzhou healthcare information database. Results During the study period, it was found that there were 363 882 outpatients' prescriptions of ribavirin injection and 206 511 ribavirin users. According to the instructions, the number of ribavirin injections prescription which met the requirement of each dose and daily dose accounted for 85.59% and 90.33% of the total number of ribavirin injection prescriptions respectively. Among our study population, there were 617 patients who had a diagnosis of pregnancy within 6 months of ribavirin prescription. Conclusion The results indicated that there were large amount of irrational prescriptions of ribavirin. Clinicians should adhere to the indication of ribavirin injection and requirement of dose, and be cautious when prescript to reproductive patients. References | Related Articles | Metrics

Select

Analysis and Suggestions on Risk of Ribavirin in Children LI Qing-fang, LIU Huan, ZHANG Dan-dan, YANG Yue, ZHANG Hui-xia, XIA Xu-dong, LIU Chao 2018, 15(2): 83-89.  Abstract ( 529 )   PDF (793KB) ( 243 )   Objective Through comparatively analyzing the approval, application and instructions of ribavirin at home and abroad, to conduct the risk analysis of domestic children ribavirin clinical use based on the ribavirin's children ADR report data in a certain province, so as to provide suggestions on the modification of instructions, clinical application, regulation and so on. Methods The risk of ribavirin was analyzed by means of comparing ribavirin's approval, application and instructions at home and abroad,and analyzing ribavirin's children ADR reports collected by a certain province from January 2003 to December 2016. Results The approval and application of ribavirin were different significantly between China and abroad, the phenomenons of irrational drug combination and off-label use are common during clinical application in children. Conclusion It is suggested that regulatory authority, manufactures and healthcare providers should pay attention to unapproved indications and dosage form of ribavirin, while revising and improving instruction for more standardized application . References | Related Articles | Metrics

Select

Review and Analysis of Evaluation of FDA for Updating Fluoroquinolones Label LIU Cui-li, WU Gui-zhi, FENG Hong-yun, LI Lan 2018, 15(2): 90-93.  Abstract ( 438 )   PDF (685KB) ( 297 )   Objective To study the evaluation work of FDA updated fluoroquinolone label and to provide reference for the post-marketing evaluation of risk-benefit of drug and better management in China. Methods This article introduced the background, contents and results of the evaluation of the fluoroquinolones to analyze the regulatory thinking and methods of drug management in the United States. Results This work is not only a comprehensive evaluation of the safety of fluoroquinolones, but also carries out risk-benefit assessment for three indications, which is of great significance for the safety of fluoroquinolones. Conclusion Paying attention to the means of foreign advanced drug management can provide ideas and reference for the post-marketing evaluation of drugs in China. References | Related Articles | Metrics

Select

Revelation of French BIA 10-2474 Clinical Trials to Chinese Investigators LI Jiang-fan, XUE Wei, HU Xin, LI Ke-xin 2018, 15(2): 94-97.  Abstract ( 645 )   PDF (708KB) ( 462 )   Objective To provide some suggestions for the investigators who are engaged in phase I clinical trial First-In-Human or related clinical trials in China through making a detailed introduction to the first human trial event in phase I of French BIA 10-2474 clinical trial. Methods A case study was conducted to analyze the clinical phase I study of BIA 10-2474 in France. Results and Conclusion To the first-in-human clinical trials, investigators in China should pay attention to the design of starting dose, making correct decision to terminate the incremental rule, setting up risk control measures, guaranteeing the safety of the subjects, enhancing the overall level of clinical research. References | Related Articles | Metrics

Select

Research Progress on Small-molecule Compounds against Connective Tissue Growth Factor LIU Jun-li, ZHANG Mu-xin, LIANG Di, ZHENG Ming-xin, ZHOU Xiao-ping 2018, 15(2): 98-102.  Abstract ( 384 )   PDF (803KB) ( 170 )   Objective To provide a concise overview of small molecule connective tissue growth factor (CTGF) inhibitors. Methods A summarization of the small molecules was provided, both the approved drugs and the agents under developing with new structures, that can inhibit CTGF. Results The research on small molecule CTGF inhibitors could be mainly classified into two categories: one is based on the approved drugs or natural products, the other is the small molecule compounds with new structures. Conclusion As a very important cytokine which is only expressed in interstitial cells, CTGF, inducing the fibrosis of TGF-β, is an effective and specific target for anti-fibrosis cytokine in organism. There are only a few structural types of compounds reported, but they will also be the prelude to provide useful references for developing more potential small molecule CTGF inhibitors in the future. References | Related Articles | Metrics

Select

Comparison of Aconitum with Tripterygium in Treatment of Axial Spondyloarthritis: A Benefit-risk Assessment ZHANG Xiao-meng, LIN Zhi-jian, ZHANG Bing, LI Min 2018, 15(2): 103-109.  Abstract ( 321 )   PDF (1093KB) ( 169 )   Objective Quantitatively comparing the benefit and risk of Aconitum and Tripterygium in the treatment of axial spondyloarthritis (ax-SpA), which can provide guidance for rational use of medicines in clinic. Methods The data, which from random clinical trials (RCTs) that Aconitum or Tripterygium vernus western medicines in the treatment of ax-SpA, was extracted and merged by RevMan 5.2 software. Based on the benefit-risk assessment framework of herbs for treating ax-SpA that was built by the multi-criteria decision analysis model in Hiview 3 software, the benefit value, the risk value and the total benefit-risk value of Aconitum and Tripterygium were calculated. And the probability of difference value caused by the two therapies were conducted by Monte Carlo simulation. Results 14 RCTs of Aconitum and 7 RCTs of Tripterygium that each vernus western medicines in the treatment of ax-SpA were included. Comprehensively and quantitatively compared the benefit and risk of Aconitum and Tripterygium in the treatment of ax-SpA, the difference of efficacy between Aconitum and Tripterygium was 3[95%CI (7.39, 16.45)], which probability was 86.53%; and the difference of risk was 80[95%CI (73.24,86.48)], which probability was 100%. When benefit and risk were the same important for ax-SpA patients, the total benefit-risk value of using Aconitum was 65, while that of Tripterygium was 24, their difference was 41[95%CI(35.67,46.23)] and the probability of the former superior to the latter was 100%. The results were stable which tested by sensitivity analysis. Conclusion Based on the available evidence, the benefit-risk of Aconitum for ax-SpA patients is significantly superior to that of Tripterygium. If ax-SpA patients that cannot accept the medication risk, the application of Tripterygium is not recommended. References | Related Articles | Metrics

Select

Analysis of 890 Cases of Adverse Reactions Induced by Iohexol Injection LIN Jing-yu, ZHONG Lei, XING Li-qiu, LIU Dong-hong 2018, 15(2): 110-115.  Abstract ( 424 )   PDF (829KB) ( 291 )   Objective A data analysis of the adverse drug reactions (ADRs) induced by iohexol injection was conducted to understand the characteristics of The ADRs and provide technical support for the clinical safe use of the drug. Methods A total of 890 ADR reports collected by the Beijing Center for ADR Monitoring on iohexol injection inducing ADRs between 2003 and 2016 were sorted out and analyzed. Results ADRs, being on the increase year by year, mainly occur in people over the age of 40. Systems and organs affected by ADRs were mainly observed to be skin and appendages disorders, gastrointestinal disorders, and systematic disorders. A total of 60 cases of severe ADRs, including 7 cases of death, occurred, where anaphylactic shock, anaphylactic reaction, renal impairment, aphasia were the typical manifestations. Conclusion It is important that sufficient attention be paid to ADRs caused by iohexlo injection, with special focus on improving the ability to identify and treat severe ADRs. References | Related Articles | Metrics

Select

Literature Research and Risk Analysis of Nitrous Oxide Abuse LIU Zhi-jun, YUAN Xing-dong, ZHANG Wei, ZHOU Juan, XU Yu-ming 2018, 15(2): 116-120.  Abstract ( 358 )   PDF (348KB) ( 381 )   Objective To review the research status of nitrous oxide abuse, and provide reference for preventing the abuse of nitrous oxide and reducing its serious harm. Methods The domestic and foreign literature databases were retrieved, and the history of development and usage of nitrous oxide, pharmacological mechanism and clinical application, the harm of abuse and the situation at home and abroad were reviewed and summarized. Results The abuse of nitrous oxide could cause diseases relating to vitamin B12 deficiency, lead to mild paralysis and even threaten life. The abuse rate in Europe and United States was 15%~40% and 4%~8%, respectively, while surveillance data of abuse in China has not been retrieved. Conclusion The abuse situation of young people everywhere was very serious, and the supervision measures in China were not perfect. To avoid the abuse of nitrous oxide, the relevant departments should strengthen the management and monitoring of nitrous oxide. References | Related Articles | Metrics

Select

Typical Case Analysis of Children's Medication in Adverse Drug Reaction Information Bulletin of CFDA ZHAO Rui-ling, ZHANG Zhan-hui, ZHANG Guan-dong 2018, 15(2): 121-124.  Abstract ( 630 )   PDF (778KB) ( 364 )   Objective To analyze the information of children's safe medication in Adverse Drug Reactions Information Bulletin published by China Food and Drug Administration (CFDA) website, and promote the rational use of medicines in children. Methods Check the information of adverse drug reactions released by CFDA website from November 19, 2001, to January 5, 2017, and extract information about the children's safe medication. Results A total of 40 cases of adverse drug reactions/events in children were reported. Among them, there were 25 cases of adverse drug reactions/events, accounting for 62.50% (25/40), and 15 cases of serious adverse drug reactions/events, accounting for 37.50% (15/40). The number of anti-infective drugs was up to 19 cases, accounting for 47.50 % (19/40). In the 40 cases of adverse drug reactions/events, the unreasonable drug use was up to 75.00%. Conclusion It is necessary to call for the whole community to pay close attention to children's safe medication, to strengthen the children's rational drug use training and management for medical staff at all levels, and to solve the problem of children's medication from the policy and legal level. References | Related Articles | Metrics

Select

Comparative Analysis of Adverse Drug Reactions Caused by Iodixanol and Iohexol XU Zhi-xiang 2018, 15(2): 125-128.  Abstract ( 481 )   PDF (663KB) ( 399 )   Objective To investigate the characteristics of adverse drug reactions (ADRs) caused by iodixanol and iohexol in order to provide reference for safe drug use in clinical practice. Methods Reports of ADR caused by iodixanol and iohexol were selected from database of Hangzhou Drug and Medical Devices Adverse Reaction Monitoring Center from January 2013 to April 2017 and divided into two groups. Patients' information, major manifestations, proportion of serious ADR, proportion of delayed ADR and latent time of ADR were compared. Statistical methods such as statistical tables, statistical graphs, chi-square test, t-test, survival analysis and Breslow test were used to deal with the data. Results A total of 228 reports were entered, including 73 cases caused by iodixanol and 155 cases caused by iohexol. Mean age of iodixanol group was older than iohexol group (P<0.05). There was no statistically significant difference (P=0.69) in proportion of serious ADR between the two groups: 6.85% for iodixanol vs. 8.39% for iohexol. Proportion of delayed ADR of iodixanol group (69.86%) was higher than iohexol group (7.10%) (P<0.01). Average latent time of iodixanol group was longer than iohexol group (P<0.01). Conclusion Iodixanol and iohexol have some different clinical manifestations in ADR, iodixanol had higher proportion of delayed ADR and longer latent time, so maybe it's necessary to prolong medical observation time properly after administration of iodixanol. References | Related Articles | Metrics