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20 August 2017, Volume 14 Issue 8 Previous Issue    Next Issue

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Antagonistic Effect of Volatile Oil from Coconut Shell against Myocardial Injury Induced by Acute Myocardial Infarction YAO Rong-mei, ZHANG Guang-zeng, GAO Xiu-juan, GAO Jun, BAO Ju-tai 2017, 14(8): 449-452.  Abstract ( 413 )   PDF (1259KB) ( 179 )   Objective To investigate the antagonistic effect of volatile oil from coconut shell against myocardial injury induced by acute myocardial infarction (AMI). Methods 60 Wistar rats were divided into 6 groups: sham operation group, model group, positive control group (oral administration), high, medium and low group of volatile oil from coconut shell (atomization inhalation). Apart from sham operation group, the rest groups were established the model of AMI through coronary artery left anterior descending ligation. Administration began on the day of modeling, once a day and last for seven days. The cardiac function, the levels of CK-MB and cardiac troponin (cTnI, cTnT), pathological changes (HE staining), myocardial infarction area were evaluated on the eighth day. Results After the administration of volatile oil from coconut shell, the cardiac function was significantly improved (P <0.01). The levels of CK-MB, cTnI and cTnT were significantly improved (P <0.01) in the high and medium groups. The pathological damage and myocardial infarction area were significantly decreased (P <0.01). Conclusion The volatile oil from coconut shell could protect the myocardial injury induced by AMI through the improvement of the function of ischemic myocardium and seducement the damage of myocardial cells. References | Related Articles | Metrics

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13 Weeks Intravenous Repeated Dose Toxicity Study of Dexrabeprazole Sodium for Injection in Beagle Dogs LIU Cui-ling, DAI Xiao-li, MA Yu-kui, SUN Rong 2017, 14(8): 453-456.  Abstract ( 510 )   PDF (867KB) ( 229 )   Objective To reach the repeated dose toxicity of dexrabeprazole sodium for injection in Beagle dogs and compare the toxicity with rabeprazole sodium for injection. Methods Fifty normal Beagle dogs were divided into five groups： solvent control group, rabeprazole sodium for injection group (40 mg·kg-1) and dexrabeprazole sodium injection group (2.5, 10 and 40 mg·kg-1). The dogs were administered intravenously with corresponding drug for 13 weeks continuously. The body weights were detected every week and body temperature, ECG, ophthalmology, urine and stool were examined before and after administration period and recovery for 4 weeks. The serum and plasma of dogs were collected to detect hematology and blood biochemistry index, and dogs were autopsied to detect viscera index and histopathology at the end of administration and recovery for 4 weeks. Results The main toxicity symptoms of some dogs administered with dexrabeprazole sodium for injection (40mg·kg-1) are decreased voluntary activity, shortness of breath, salivation and prone. Abnormal reduction of the levels of RBC, HGB, HCT, TP, ALB and escalation of the levels of TC, TG, BUN and kidney index were found after administration for 13 wk. Pathological changes of thyroid was also found by histopathological examination. Conclusion Major toxic target organs of Beagle dogs after administration with dexrabeprazole sodium for injection (40mg·kg-1) for 13 wk are liver, kidney and thyroid. The toxicity level is similar in dexrabeprazole sodium for injection group and rabeprazole sodium for injection group with same dose. No observed adverse effect level (NOAEL) in Beagle dogs is 2.5 mg·kg-1. References | Related Articles | Metrics

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Clinical Observation on Etomidate Combined with Propofol in Painless Induced Abortion WANG Zhi-wei 2017, 14(8): 457-459.  Abstract ( 728 )   PDF (767KB) ( 178 )   Objective To observe the clinical efficacy and safety of etomidate combined with propofol in painless abortion anesthesia. Method 80 patients with painless induced abortion admitted from March, 2015 to March, 2016 were randomly divided into two groups. The patients in the control group were treated with propofol + sufentanil anesthesia. The patients in the experimental group were treated with etomidate + propofol and sufentanil. The correlation of clinical indexes, anesthesia related indexes, surgical events and adverse reactions were compared between the two groups. Result There were no significant differences in SpO2, MAP and HR between the two groups (P> 0.05). The recovery time and recovery time of the patients in the experimental group were significantly lower than those in the control group (P <0.01). The incidence of injection pain and overall adverse reaction in the experimental group was significantly lower than that in the control group (P <0.05). Conclusion The combination of etomidate and propofol has obvious clinical effect in painless induced abortion. It has the characteristics of quicker recovery and fewer adverse reactions. References | Related Articles | Metrics

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Clinical Observation of Thalidomide Combined Paclitaxel and Cisplatin in Treatment of Advanced Non-small Cell Lung Cancer ZHANG Jing-wei, DUAN Dong-mei, YUAN Xiao-sun, SUN Jun-zhong, REN Zhong-hai 2017, 14(8): 460-463.  Abstract ( 321 )   PDF (806KB) ( 257 )   Objective To discuss the clinical efficacy of thalidomide combined with paclitaxel plus cisplatin(TP) in treatment of advanced non-small cell lung cancer (NSCLC). Methods 84 elderly patients with advanced NSCLC which admission time is January 2013 to December 2014 were randomly divided into TP group and TP plus thalidomide respectively, Both groups contained 42 patients. The index of two groups to observe mainly contained clinical curative effect, tumor markers and side effects. Results The disease control rates of experimental group is high up to 85.71%, significantly higher than that in control group (χ2=5.143,P <0.05); the progress free survival and overall survival of experimental group were longer than that in control group (t=6.689, 2.754,P <0.05 ); The level of carcino-embryonic antigen (CEA), cancer antigen 125 (CA125) and cytokeratin-19-fragment (CYFRA21-1) of experimental group were 16.646, 15.125 and 16.428 (P <0.05). The incidence of nausea and vomiting of experimental group was 40.48%, obvious lower than that in control group which was 76.19%. Other adverse reactions such as lethargy, constipation and fatigue etc were significantly higher than control group. Both groups showed similar level of white blood cells, platelet and hemoglobin and the incidence of peripheral nerve toxicity(P >0.05). Conclusions Thalidomide combined with paclitaxel and cisplatin treatment helps to reduce the advanced non-small cell lung cancer serum tumor marker expression level, improve the clinical efficacy, but should prevent the side effects such as lethargy, constipation and fatigue etc. References | Related Articles | Metrics

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Review and Analysis of Active Post-marketing Surveillance Modes for Vaccine Safety CAI Ting, YANG Yu, WANG Ya-li, DONG Duo, ZHAN Si-yan 2017, 14(8): 464-469.  Abstract ( 613 )   PDF (774KB) ( 395 )   In the late 20 th century, active surveillance occurred as a novel method of post-marketing surveillance for vaccine safety, to recover the deficiency of traditional passive surveillance. Nowadays, active post-marketing surveillance is still in an initial stage of development, with various definitions and performance around the world. There have been active surveillance systems of vaccine safety established in developed countries and their achievements indicate the great advantages of active surveillance method. However, the primary surveillance mode of vaccine safety in China is currently in a passive way, as the most of developing countries. In view of the increasing amountof new vaccines and the enhanced public attention on vaccine safety, there is an insistent demand for conducting active surveillance for vaccine safety in Chinese population. This study will reviewthe development of active post-marketing surveillance for vaccine safety, analyze the different modes of active surveillance and explore the typical surveillance systems, with the aim to accelerate the foundation of active surveillance system for vaccine safety in China. References | Related Articles | Metrics

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Study on the Joint Review Mechanism of Multi-regional Clinical Trial WEI Fen-fang, SUN Yu-xin, ZHENG Yong-xia, YANG Yue 2017, 14(8): 470-476.  Abstract ( 755 )   PDF (955KB) ( 276 )   Objective To explore the establishment of Chinese multi-regional clinical trial (MRCT) joint ethical review mechanism. Methods The laws, regulations, operation and review mode of MRCT joint ethical review mechanism in the United States, Britain and Taiwan were analyzed. Results The ethical review mechanism of MRCT has not yet been established in China. The United States, the United Kingdom and Taiwan have adopted the independent review and joint review mechanism of the Center Ethics Committee and the Regional Ethics Committee to avoid duplication of ethical review. Conclusion The ethical review mechanism of MRCT is international trends, and China should be established the mechanism step by step. References | Related Articles | Metrics

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Survey on the Status of Adverse Drug Reaction Monitoring in Beijing Hospitals ZHOU Ying-qun, XING Li-qiu, LIU Dong-hong, 2017, 14(8): 477-480.  Abstract ( 618 )   PDF (873KB) ( 338 )   Objective To investigate the factors influencing adverse drug reaction monitoring work in Beijing hospitals. Methods Questionnaires including relative factors in recent three years were distributed to 106 Beijing hospitals. The differences of adverse drug reaction report number per ten thousand outpatients, adverse drug reaction report number per 100 sickbeds and adverse drug reaction report number per ten thousand discharged patients were compared among different types of hospitals. The major influence factors were disclosed. Results and Conclusion Different government departments should cooperate to increase the awareness of hospitals on adverse drug reaction monitoring by various measures, for example, the adverse drug reaction monitoring duty was put into performance appraisal on these institutions. The people in charge of the work should strengthen the communication with the hospital leader, keep the adverse drug reaction monitoring administrator team stable, and enhance the construction of safeguard measures. References | Related Articles | Metrics

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Analysis of 1110 Cases of Drug-induced Liver Injury in 79 Hospitals JIA Wang-ping, GUO Dai-hong, TIAN Xiao-yan, KOU Wei, WANG Xiao-yu, ZHAO Su-yu, HU Peng-zhou 2017, 14(8): 481-485.  Abstract ( 554 )   PDF (766KB) ( 511 )   Objective To investigate the condition and characteristics of drug-induced liver injury(DILI), and provide reliable basis for theprevention and treatment of DILI. Methods The cases of DLLI were collected from database of PLA ADR Monitoring Center from 2008 to 2016 and then patients' information, suspicious drugs, laboratory indexes and major manifestations, occurring time of DILI and administration route, treatment and outcomes were analyzed retrospectively. Results Among 1 110 DILI cases, the ratio of males and females was 1.51:1. Significant differences of age existed between males and females (χ2=25.136, P=0.01). The three predominant drug classifications were anti-infective agents, nervous system drugs, cardiovascular system drugs orderly. The predominant drugs were atorvastatin, rifampicin, moxifloxacin and levofloxacin orderly. Significant difference of outcomes existed between patients taking liver-protecting drugs and patients not taking liver-protecting drugs (χ2=25.136,P＜0.001).Conclusion Clinical medical staffs should learn more about drugs and use them reasonably, drug withdrawal and other symptomatic treatments should be given in time for patients with DILI. References | Related Articles | Metrics

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Retrospective Analysis on 365 Cases of Adverse Drug Reaction of Salcatonin Preparations LIU Zhi-jun, YUAN Xing-dong, ZHANG Wei, XU Yu-ming 2017, 14(8): 486-488.  Abstract ( 381 )   PDF (788KB) ( 289 )   Objective To analyze the characteristics of adverse drug reaction (ADR) of salcatonin preparations and provide scientific basis for rational drug use. Methods 365 cases of ADR reports of salcatonin preparations, from 2010 to 2016, were analyzed retrospectively. Demographic characteristics, primary diseases and allergies, method of treatment, distribution time of ADR, causality and outcome, systems or organs involved were summarized. Results ADR occurred in female accounted for 81.64%, and age over 60 years accounted for 69.59%; The highest ratio of daily use dose were 50 IU, accounted for 54.80% ; ADR occurred within 10 min after medication accounted for 34.79%. Systems or organs involved were up to 10, and the gastrointestinal system were damaged most. Conclusions To reduce the occurrence of ADR of salcatonin preparations, medication monitoring should be strengthened, while drug instructions ought to make supplement and complete by production enterprises. References | Related Articles | Metrics

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Detection Methods of Substandard/Spurious/Falsely Labelled/Falsified and Counterfeit Medical Products Based on Adverse Drug Reaction Surveillance System WANG Meng, GUO Xiao-jing, FENG Hong-yun, HOU Yong-fang, YE Xiao-fei, ZHANG Yuan, ZHANG Tian-yi, HE Jia 2017, 14(8): 489-492.  Abstract ( 375 )   PDF (684KB) ( 242 )   Objective Substandard/Spurious/Falsely labelled/Falsified and Counterfeit(SSFFC) medical products can not only guarantee the effectiveness of drugs, but bring about unexpected adverse reactions/events, which may threaten public health. Detecting drug quality defects currently depends on the identification and early-warning of safety signals on post-marketing drugs besides pharmaceutical analysis. Methods In this paper, we introduce four detection Methods by literature review, including Disproportional Filter, Temporal Change Detection Algorithm, Cluster Analysis and Early Warning System on Cluster Adverse Drug Events. Results To some extent, four Methods above-mentioned can find drug quality defects. Conclusion So far, there are no golden standards in detection Methods of SSFFC medical products. Take different Methods to analyze data may be more effective, which may provide references for adverse drug reactions surveillance. References | Related Articles | Metrics

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Investigation on Use of Antibacterial Drugs among College Students in the City of Chengdu WANG Qi, WANG Xin-yang, KANG Chuan-zhe 2017, 14(8): 493-497.  Abstract ( 428 )   PDF (899KB) ( 274 )   Objective To investigate the current situation of the use of antibacterial drugs in college students in Chengdu and analyze the relevant influencing factors, so as to provide reference for improving the rational use of antibacterial drugs in college students in Chengdu. Methods A questionnaire survey was conducted among 1 600 college students of 4 universities by stratified cluster random sampling. Results The incidence of not prescription use of antibacterial drugs in college students was 41.94% (648/1 545). The not prescription use of antibacterial drugs was significantly correlated with their professional and family location (P<0.05). Conclusion The incidence of not prescription use in colleges and universities in Chengdu is high, and the medication is frequent. It is necessary to carry out special education on the knowledge of antibacterial drugs in college students, and to further improve the rational use level of antibiotics in college students. References | Related Articles | Metrics