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20 November 2018, Volume 15 Issue 11 Previous Issue    Next Issue
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Establishment of Diabetic Gastroparesis Rat Model HUANG Jukai, CHENG Shuli, YANG Xiaohui 2018, 15(11): 641-643.  Abstract ( 415 )   PDF (721KB) ( 102 )   Objective To observe the gastric motility of diabetic rats and to explore a method of establishing a diabetic gastroparesis (DGP) rat model by feeding diabetic rats with high fat and high sugar diet combined with intraperitoneal injection of STZ. Methods To establish diabetic rat model, normal SD rats were fed with high fat and high sugar diet (45% fat content) for 2 weeks; then streptozocin (STZ) 50 mg·kg-1 was intraperitoneally injected after fasting and free drinking water for 12 hours. Ten normal SD rats were randomly selected for normal group, and 10 SD rats modeled successfully for model group. Stomachs of rats in the 2 groups were taken after 8 weeks of common feeding to measure gastric emptying and intestinal propulsion rate. Results Rats in the model group had thin physique, weight loss, and increased food intake. Compared with the normal group, the blood glucose level of the model group was significantly higher (P <0.05), the weight of the gastric residue was significantly increased (P<0.05), and the gastric emptying was significantly decreased. There was a negative correlation between the rate of intestinal propulsion in the model group (correlation coefficient r=-0.46, P =0.041). Conclusion Diabetic rat modeled by administrating high fat and high sugar diet feeding combined with STZ intraperitoneal injection and then administrating normal feeding for 8 weeks can establish a DGP rat model, which can be an economical, simple, and feasible modeling method for DGP animal experiments. References | Related Articles | Metrics

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Cardioprotective Mechanisms of Salvianolic Acid B Pretreatment against Myocardial Ischemia/Reperfusion Injury XIA Yang, ZHANG Huijun, LI Qiang 2018, 15(11): 644-647.  Abstract ( 359 )   PDF (771KB) ( 130 )   Objective To investigate the effects of salvianolic acid B (Sal B) on rats with myocardial ischemia/reperfusion injury (MI/RI) and its mechanisms involved. Methods MI/RI model in SD rats was prepared by 30 min of coronary artery ligation and subsequent 2 hours of reperfusion. Rats were randomized into 4 groups (n=20): sham, model, Sal B low dose (10 mg·kg-1) and Sal B high dose (20 mg·kg-1). Before the modeling operation, Sal B was injected intraperitoneally once daily for 7 days. After the reperfusion, myocardial infarction area (MIA) in rats was examined by staining method, myeloperoxidase (MPO) activity in myocardial tissue was detected by chromatometry, levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in myocardial tissue were determined by ELISA and expression of intercellular cell adhesion molecule-1 (ICAM-1) in myocardial tissue was examined by immunohistochemistry. Results Comparing with model group (42.60%), MIAs in Sal B groups (20 and 10 mg·kg-1) were reduced to 35.93% and 37.21%, respectively (P <0.05). Comparing with model group (337.84 U·g-1), myocardial MPO activities in Sal B groups (20 and 10 mg·kg-1) were 201.63 and 213.77 U·g-1, respectively (P <0.01). Comparing with model group (71.06%), positive area percentages of myocardial ICAM-1 expression in Sal B groups (20 and 10 mg·kg-1) were 36.37% and 36.94%, respectively (P <0.01). Comparing with model group (238.21 pg·mL-1), myocardial TNF-α levels in Sal B groups (20 and 10 mg·kg-1) were 162.18 and 181.57 pg·mL-1, respectively (P <0.01). Comparing with model group (607.41 pg·mL-1), myocardial IL-1β levels in Sal B groups (20 and 10 mg·kg-1) were 395.13 and 399.04 pg·mL-1, respectively (P <0.05 or P <0.01). Conclusion Sal B pretreatment could protect MI/RI, its mechanisms may be related with inhibition of intercellular cell adhesion molecule expression and neutrophil infiltration, downregulation of inflammatory cytokines and improvement of inflammation. References | Related Articles | Metrics

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Exploration on Direct Reporting System of Adverse Drug Reactions by Marketing Authorization Holders WANG Dan.DONG Duo 2018, 15(11): 648-651.  Abstract ( 885 )   PDF (1092KB) ( 401 )   In September 2018, the National Medical Products Administration issued a notice on the Direct Reporting of Adverse Drug Reactions(ADRs) by Marketing Authorization Holders(MAH). The Notice aims to enforce the legal responsibility of MAH for ADRs reporting and monitoring, and strengthen the whole life cycle management of drugs. This paper analyzed the background of the announcement, interpreted the core content of the notice, including the requirements of the ADRs monitoring system, the ADRs collection and reporting, analysis and evaluation, risk control and other provisions, and clarified the connotation and significance of establishing System of ADRs Direct Reporting. References | Related Articles | Metrics

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Research on Current Status and Countermeasures of Information Collection on Adverse Drug Reactions by Drug Manufacturers from Medical Institutions in China ZHAO Xia, LENG Meiling, WANG Peng, LI Xinling, CAO Lujuan, TIAN Chunhua, LIU Cuili 2018, 15(11): 652-657.  Abstract ( 576 )   PDF (924KB) ( 261 )   Objective To provide reference for improving adverse drug reactions(ADR) reporting capabilities of drug manufacturers by investigating the medical institutions' attitude towards establishing a direct reporting system based on drug manufacturers and the current status of information collection on ADR by drug manufacturers from medical institutions. Methods Six representative provinces/municipalities were selected nationwide, and one medical institution of each was selected from each of the three grades. Questionnaires and interviews on the collection of ADR information by enterprises were conducted with the medical staff, and the results were counted and analyzed. Results Medical institutions suffered mixed fortunes in the implementation of the direct reporting system, and enterprises would face many challenges. At present, the collection of ADR information by enterprises from medical institutions was not smooth, and the status was not optimistic. Conclusion In order to improve the ADR reporting capacity of drug manufacturers, it is necessary for medical institutions, enterprises and government departments to simultaneously exert efforts to jointly promote the smooth implementation of the direct reporting system. References | Related Articles | Metrics

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Current Status and Thinking of MAH on Post-marketing Adverse Drug Reaction Report of China CAO Lujuan, LI Xinling, TIAN Chunhua, LIU Cuili, ZHAO Xia 2018, 15(11): 658-662.  Abstract ( 524 )   PDF (759KB) ( 288 )   Objective To provide references for drug marketing authorization holder (MAH) of China to establish adverse drug reaction direct reporting system. Methods The related literatures were collected to summarize the current status of adverse drug reactions reporting, analyze the existing problems in depth, draw on the experience of foreign MAHs and put forward the corresponding countermeasures. Results & ConclusionThe monitoring and reporting of adverse drug reactions in China started relatively late, and the pilot work of MAH is also at the stage of accumulating experience. Few reports were actively collected and the main responsibility needs to be improved. In this regard, it is necessary for China to learn from the more mature experience of the European Union, the United States and other countries, and to raise the level of pharmacovigilance by strengthening the awareness of MAH's main responsibility, building professional gathering teams, and broadening the channels for information collection. References | Related Articles | Metrics

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Analysis of Crucial Elements in Published Case Reports of Drug-induced Liver Injury ZHU Lan, REN Jingtian, GUAN Wei, LIU Hongliang 2018, 15(11): 663-667.  Abstract ( 401 )   PDF (765KB) ( 172 )   Objective To assess the quality of published cases drug-induced liver injury (DILI) reports in China. Methods A list of 31 crucial elements necessary in evaluating causality of DILI was developed, then the reporting rate of the 31 crucial elements was investigated in 61 reports published from January 2015 to December 2017. Results Elements such as patients' age, sex, drug name and primary disease were widely reported, while some key elements in evaluating causality of DILI were under-reported. Conclusion Some reports of DILI lacked important or essential details. Creating guidelines of DILI reports submitted for publication is recommended to improve the quality of DILI reports in China, and it is important for the utility of these reports too, such as early detection of drug induced hepatotoxicity. References | Related Articles | Metrics

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Analysis of Related Factors of Hypophosphatemic Osteomalacia Induced by Adefovir Dipivoxil XIE Yanjun, WU Guizhi, XU Lili, CUI Xiaokang, LU Changfei, TIAN Yuejie 2018, 15(11): 668-673.  Abstract ( 484 )   PDF (844KB) ( 99 )   Objective To analyze the characteristics and related factors of hypophosphatemic osteomalacia induced by adefovir dipivoxil. Methods Cases treated by anti-hepatitis B drugs from 6 tertiary comprehensive hospitals were investigated retrospectively. The status of drug use, age, sex, medication, adverse drug reactions and treatment outcomes were analyzed descriptively. Results Anti-hepatitis B virus with adefovir dipivoxil may cause osteomalacia hypophosphatemia. The changes in renal function-related biochemical indicators, such as blood phosphorus, urinary phosphorus and creatinine, are the early indications. Hypophosphatemia usually occurs 3~5 years after treatment beginning, and the changes in renal function-related biochemical indicators mainly involved were blood phosphorus, urinary phosphorus, creatinine, etc. Patients with advanced age, poor nutritional status, and chronic liver and kidney diseases are easier to develop the adverse reaction. Conclusion For the patients treated by adefovir, clinicians should fully understand this adverse reaction, and should regularly monitor renal function and serum phosphorus. Patients with poor nutrition and with history of kidney disease should be monitored more strongly. References | Related Articles | Metrics

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Literature Analysis of 168 Adverse Drug Reactions Induced by Bailemian Capsule PENG Lili, FAN Yan, LIU Wei, GUO Xue, HU Jun 2018, 15(11): 674-676.  Abstract ( 463 )   PDF (714KB) ( 142 )   Objective To analyze the literatures on clinical application and adverse drug reactions (ADRs) induced by Bailemian capsule, so as to provide reference for its rational use in clinic. Methods The literatures on the clinical application and ADRs of Bailemian capsule were retrieved in CNKI, Wangfang data and VIP Chinese full-text database. The related literatures were screened out and analyzed. Results 29 available literatures were retrieved where 168 cases with adverse drug reactions were reported. Female patients were 1.54 times that of male patients, the most of patients were 32 to 65 years old, the ADRs were mainly gastrointestinal disorders, liver and biliary disorders, psychiatric and neurological disorders, skin and appendages disorders, including nausea, mouth dry, constipation, appetite decreased, sedation excessive, drug eruption etc, and there has been an individual case safety report about the hepatic function abnormal. Conclusion We should strengthen the safe application of Bailemian capsule, standardize and improve the drug labelling, promote the rational use of drug and guarantee the safety of patients. References | Related Articles | Metrics

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Clinical Characteristics of 106 Cases of Drug-Induced Liver Injury in Our Hospital YAN Huiyu,SHI Jiping,MAO Lichao,ZHANG Sixi 2018, 15(11): 677-681.  Abstract ( 384 )   PDF (781KB) ( 132 )   Objective To investigate the clinical characteristics and occurrence of drug-induced liver injury (DILI), so as to reduce the incidence of adverse drug reactions and promote the rational use of drugs. Methods A retrospective analysis was performed on 106 patients with drug-induced liver injury in our hospital from January 2015 to December 2017. The data were statistically analyzed by SPSS 22.0. The count data expressed as a percentage, measurement data with mean ± standard deviation (ヌ±s), multiple groups were compared using single factor analysis of variance. Results There were 40 males and 66 females with a mean age of (48.12±14.00) years involved. The drugs were orderly ranked traditional Chinese medicine, antineoplastic agents, NSAIDs and anti-infective drugs according to their constituent ratios. The time to onset was within 12 weeks with characteristics of yellow skin, darker urine, decreased appetite, nausea, vomiting and abdominal distension, while 18.4% of patients were asymptomatic. The types of injury were hepatocellular injury (41.51%), mixed type (28.30%) followed by cholestasis type (15.09%) and liver biochemical abnormality (15.09%). The pathological results of 50 patients tended to be drug-induced liver injury.Conclusion Clinical characteristics of drug-induced liver injury were not specific and easy to misdiagnose. However, most of the prognoses were good. Clinicians should strengthen their vigilance against DILI and carry out early identification, timely withdraw suspected drugs and apply appropriate hepatoprotective therapy based on etiology and clinical features. References | Related Articles | Metrics

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Literature Analysis of Tuberculosis Induced by Adalimumab CAI Jun, WEI Jing, JI Liwei 2018, 15(11): 682-685.  Abstract ( 834 )   PDF (740KB) ( 203 )   Objective To investigate the characteristics and patterns of tuberculosis induced by adalimumab, to find its risk factors and provide technical support for safe and rational use of drugs in clinic. Methods Literatures of tuberculosis induced by adalimumab published until July 2018 were retrieved from CNKI, Wanfang database, VIP Chinese full-text database and Pubmed. According to inclusion and exclusion criteria, the literatures were analyzed. Results A total of 39 papers, 39 cases were included. The proportion of tuberculosis occurring in men was almost the same as women. Patients aged over 40 years old had the highest percentage(79.49%), and the primary disease was rheumatoid arthritis (41.02%). The rate of tuberculosis screening before medication was 97.44%. The incidence of extrapulmonary tuberculosis was 53.85%. 94.87% patients suffered tuberculosis within 3 years after drug use. One patient (2.56%) died. Conclusion Attention of medical staff should be paid to the risk of tuberculosis induced by adalimumab, and the rational follow-up should be made to ensure the safe drug use in clinic. References | Related Articles | Metrics

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Analysis of 1 101 Cases of Adverse Drug Reactions Induced by Lappaconitine Hydrobromide LIU Songdong, QIU Jianmin, WANG Lanlan, DONG Fang 2018, 15(11): 686-689.  Abstract ( 330 )   PDF (741KB) ( 133 )   Objective To analyze adverse drug reactions (ADRs) of lappaconitine hydrobromide, and provide reference for clinical rational use. Methods The data of Shandong province from January 2004 to February 2018 on National Adverse Drug Reaction Monitoring System was retrieved and the data was analyzed. Results There are totally 1 101 cases of ADRs included in the analysis. The most common ADRs caused by lappaconitine hydrobromide were skin and appendages disorders(23.31%), gastrointestinal disorders(17.62%), neurological disorders(15.85%) and respiratory disorders(15.68%). 97 cases of severe ADRs were reported, mainly containing chest tightness, palpitations, dyspneas, rigors and hyperpyrexias. Besides, we found overdose and dissolvent mismatch in clinic. Conclusion The labelling of lappaconitine hydrobromide remains to be supplemented and perfected. Clinicians should strictly follow the instructions in terms of usage and dosage. When the lappaconitine hydrobromide was given by infusion, menstruum should be sufficient and away from light. References | Related Articles | Metrics

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Pharmaceutical Care of a Patient with Hydroxychloroquine Induced Long QT Syndrome ZHAO Rui, CUI Xiangli, LIU Lihong 2018, 15(11): 690-692.  Abstract ( 387 )   PDF (655KB) ( 225 )   Objective To analyze pharmaceutical care on one case of long QT syndrome(LQTS) induced by hydroxychloroquine (HCQ) sulfate tablets, so as to provide reference to the clinical safe medication. Methods By collecting the correlative papers and analyzing clinical drug use, we analyzed the correlation between the prescriptions and LQTS. Results HCQ has a significant correlation with LQTS, it induced prolongation of the QT interval and torsades de pointes(TdP). Conclusion HCQ is a drug with conditional TdP risk. We should pay attention to clinical medication and measures to prevent and deal with similar ADR. References | Related Articles | Metrics

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Analysis of Adverse Event Records in Quality Control of Drug Clinical Trial Institutions ZENG Ling, PAN Xiayun 2018, 15(11): 693-695.  Abstract ( 675 )   PDF (683KB) ( 406 )   Objective To explore and analyze the adverse event record problems in quality control of drug clinical trial institutions. Methods The records, treatment and reports of adverse events in the quality control reports of 19 clinical trial projects conducted in the institution from 2017 to 2018 were collected and analyzed. Results Problems include omission of adverse events, unclear determination of causality between adverse events and trial drugs, incomplete records of adverse events, and delayed SAE learning time. The reasons for the above problems include the researchers' weak awareness of GCP, insufficient understanding and attention to adverse events, and insufficient training and subject education. Conclusion The records of adverse events are easy to cause quality problems, researchers should attach great importance to them. All parties involved in clinical trials should strengthen the supervision of adverse events and jointly improve the quality and level of the project. References | Related Articles | Metrics

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One Case of Visual Disturbances Induced by Oxaliplatin for Injection FAN Baoxia, ZHANG Huajin, LI Na 2018, 15(11): 696-697.  Abstract ( 311 )   PDF (579KB) ( 124 )   References | Related Articles | Metrics

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One Case of Allergic Shock Induced by Atevacaine Epinephrine Injection ZHANG Zhaohui, DU Hui, QU Bin 2018, 15(11): 698-698.  Abstract ( 354 )   PDF (560KB) ( 112 )   References | Related Articles | Metrics

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One Case of Rapid Increase of γ-glutamyltransferase Induced by Biapenem for Injection YU Jin, WU Jingjing, BIAN Hailin 2018, 15(11): 699-700.  Abstract ( 309 )   PDF (580KB) ( 216 )   References | Related Articles | Metrics

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One Case of Anaphylactic Shock Induced by Hemocoagulase for Injection TAN Huiping 2018, 15(11): 701-701.  Abstract ( 292 )   PDF (556KB) ( 102 )   References | Related Articles | Metrics

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One Case of Skin Numbness of Limbs Induced by Misoprostol Tablets YANG Yan, YAO Haiyuan 2018, 15(11): 702-702.  Abstract ( 342 )   PDF (562KB) ( 109 )   References | Related Articles | Metrics

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One Case of Hypertriglyceridemia Induced by Bisoprolol Tablets HUANG Ailing, TANG Xurong, ZHAO Jue, ZHANG Hongcai, ZHANG Quan, NIE Qian 2018, 15(11): 703-703.  Abstract ( 361 )   PDF (622KB) ( 154 )   References | Related Articles | Metrics