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20 March 2018, Volume 15 Issue 3 Previous Issue    Next Issue

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Effects of Tangeretin on Proliferation and Apoptosis of Prolactinoma MMQ Cells and Its Mechanism in vitro ZHENG Shu-rong, GAO Hua, LI Dan, WANG Hong-yun, Gong Lei, LIU Qian 2018, 15(3): 129-131.  Abstract ( 397 )   PDF (823KB) ( 187 )   Objective To study the effects of tangeretin inhibiting the proliferation and inducing apoptosis of prolactinoma MMQ cells. Methods After treated with different concentration of tangeretin for 24, 48, 72 h, the proliferation of prolactinoma MMQ cells was determined by MTS. Simultaneously, the apoptosis ratio of MMQ by Annexin V-FITC/PI and the expression of bcl-2 and bax by Western blotting were detected. Results Tangeretin could effectively inhibit the proliferation of MMQ in a dose-dependent and time-dependent manner. At the same time, tangeretin induced apoptosis and down-regulated the level of bcl-2 and up-regulated the level of bax in MMQ cells. Conclusion Tangeretin maybe induced apoptosis and inhibited the proliferation of MMQ through bcl-2/bax signaling pathway. References | Related Articles | Metrics

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Intramuscular Repeated Dose Toxicity of Recombinant Hepatitis B Vaccine in Cynomolgus Monkeys LI Meng, DAI Xiao-li, DAI Xue-dong, MA Yu-kui 2018, 15(3): 132-135.  Abstract ( 383 )   PDF (757KB) ( 144 )   Objective To study the intramuscular repeated dose toxicity of recombinant hepatitis B vaccine in cynomolgus monkeys. Methods Thirty normal cynomolgus monkeys were divided into three groups：normal control group and recombinant hepatitis B vaccine groups (20, 40 μg, each animal). The cynomolgus monkeys were administered intramuscularly with corresponding dose of drug for four times and followed with four weeks withdrawal. The body weight, body temperature, ECG, ophthalmology, urine, hematology, blood biochemistry, immune indexes, viscera index and histopathology were examined to study the toxicity of recombinant hepatitis B vaccine in cynomolgus monkeys. Results The body weight gain of normal cynomolgus monkeys were slightly reduced after administration with recombinant hepatitis B vaccine (40 μg, each animal). Abnormal increase of the levels of NE%、EO% and slight muscle stimulation were also found after administration. High level of antibody was induced after administration with recombinant hepatitis B vaccine (20, 40 μg, each animal) for two times. Conclusion Recombinant hepatitis B vaccine intramuscularly taken showed significant immunogenicity(20, 40 μg, each animal) and there were slight toxicities on body weight, hematology and injection site after administration with recombinant hepatitis B vaccine (40 μg, each animal). References | Related Articles | Metrics

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Clinical Efficacy and Safety Evaluation of Advanced NSCLC Treated by Gemcitabine Combined Platin or Cisplatin XUE Yan-hong, WANG Lai-cheng, HU Li-li,*, YANG Bo 2018, 15(3): 136-139.  Abstract ( 396 )   PDF (661KB) ( 132 )   Objective To compare the two gemcitabine related chemotherapy regimens(gemcitabine (GEM) in combination with cisplatin (DDP) or nedaplatin(NDP)) on non-small cell lung cancer(NSCLC), analyze the differences of curative effect and adverse drug reactions (ADR), and provide reference to clinical individualized regimen. Methods The 58 cases diagnosed with NSCLC patients in Xuzhou Medical University Affiliated Hospital between January 2015 and April 2017 were divided into 2 groups, 30 cases of NDP combined with GEM (GN), 28 cases of DDP combined with GEM (GP), treatment cycles within 21 days. Recorded ADR of each cycle of chemotherapy regimens; evaluated curative effect using CT when the third cycle chemotherapy had been finished, then analyzed the adverse reactions and curative effect between the two regimens. Results GN regimen effective rate is 43.33%, GP is 42.86%, there is no significant difference (P>0.05). Gastrointestinal symptoms incidences of NP are lower than GP regimens (P<0.05), and there are no statistical significant differences in decreasing of NEUT, WBC, HGB and PLT, liver toxicity, kidney toxicity(P>0.05). Conclusion Curative effect of GN is similar to GP, and the gastrointestinal reaction of GN is slighter, good tolerance, without hydration treatment. From the effectiveness and safety considerations, GN scheme is comparable with GP for treatment options. References | Related Articles | Metrics

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Comparison of Sedative Effect and Safety of Midazolam and Dexmedetomidine on ICU Patients with Long-term Mechanical Ventilation YANG Bo, ZHAO YU-liang, ZHOU Wen-bo, WANG Xu-dong, JIANG Jun-hao, LIU Hai-sheng 2018, 15(3): 140-143.  Abstract ( 430 )   PDF (708KB) ( 119 )   Objective To compare the safety between midazolam and dexmedetomidine on ICU patients with long-term mechanical ventilation. Methods A total of 120 cases of ICU patients with long-term mechanical ventilation were randomly divided into the dexmedetomidine group (the observation group) and midazolam group (the control group). The patients in control group were given midazolam, while the patients in observation group received dexmedetomidine. Sedative effect, analgesic effect and incidence of adverse reactions of patients in two groups were compared. Results Duration of mechanical ventilation and the dosage of remifentanil of patients in observation group significantly lower than those of control group (P <0.05). Analgesic effect of patients in the observation group significantly higher than that in the control group (P <0.05). The time required to achieve the desired sedation and recovery time of patients in the observation group were significantly shorter than those in the control group (P <0.05). Incidence of adverse reactions of patients in the observation group significantly lower than those in the control group (P <0.05). Conclusion Compared with the traditional midazolam regimen, dexmedetomidine was associated with more analgesic effect, lower duration of mechanical ventilation and the dosage of remifentanil, shorter time required to achieve the desired sedation and recovery time, lower incidence of adverse reactions, hypotension and tachycardia in patients with long-term mechanical ventilation, which is worth clinical promotion. References | Related Articles | Metrics

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Developement of ICSR E2B Guideline HOU Yong-fang, DONG Duo, XIONG Wei-yi, LI Lan, LIU Hong-liang, LIU Rui, WAN Bang-xi 2018, 15(3): 144-146.  Abstract ( 784 )   PDF (600KB) ( 482 )   ICH E2B has now become the standard of ICSR electronic transmission, and is widely used by ICH countries and non-ICH countries' authorities and enterprises. This paper introduces background and value of ICH E2B standard and the progress of E2B standard; discusses the practical significance of implementing E2B standard in the context of China as a member of ICH and the current situation of national adverse drug reaction monitoring system in China. References | Related Articles | Metrics

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Investigation and Analysis of 40 Groups of Injection Drugs in Our Hospital WANGYan-li 2018, 15(3): 147-151.  Abstract ( 392 )   PDF (666KB) ( 232 )   Objective To compare the similarities and differences of the instruction contents among injections with same name from different manufacturers, and to propose reasonable suggestion in order to make the medicine specification a reasonable guide to the patient's medication. Methods Collected and analyzed 40 groups' injection instructions with the same ingredients from different manufacturers. Results 15 groups of instruction are basically similar, 5 groups are different in adverse reactions, 6 groups of instruction are different in contraindications, 4 groups of instruction are different in warnings and precautions, 5 groups of instruction are different in drug interactions, 5 groups of instruction are different in pregnant women and nursing mothers usage, 5 groups of instruction are different in children's usage, and 4 groups of instruction are different in the senior usage. Conclusion Injections with same components have different instruction from different manufactures. This should cause attention from drug administration departments, medical institutions and the medical staff, and improve administration. References | Related Articles | Metrics

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Research Progress of Target Related Toxicity of Anti-tumor Drugs LI Hong-ying, YANG Cui-ping,, JIN Hong-tao, 2018, 15(3): 152-157.  Abstract ( 456 )   PDF (620KB) ( 294 )   With the rapid development of medicinal chemistry, bioscience, molecular biology and molecular pharmacology, there are many anti-tumor drugs under research, coming into clinical trials or having been approved. With the discovery of disease-associated mutation sites and signaling pathways, therapeutic approaches to these mutations and signaling pathways have emerged, which is named targeted therapies. Targeted therapies are more accurate than conventional drugs with few side effects, good applicability, and high specificity. However, a series of toxicities associated with therapeutic targets have also emerged. According to the mechanism of action of drugs, this article has summarized the target related toxicity of anti-tumor drugs, and hopes to provide some ideas and suggestions for the safety evaluation of targeted therapy. References | Related Articles | Metrics

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Analysis on Composition Principles of Traditional Chinese Medicine Prescriptions for Prostate Cancer AN Wan-li, YANG Hong 2018, 15(3): 158-162.  Abstract ( 447 )   PDF (804KB) ( 198 )   Objective To analyze the composing principles of herbs in the prescriptions for prostate cancer by using Traditional Chinese Medicine Inheritance System, and make predictions of new formulations according to the composing principles. Methods By retrieving Chinese medicine prescriptions about treatments of prostate cancer in China National Knowledge Infrastructure(CNKI), VIP net-Warehouse online publishing platform and Wan-fang Data-Knowledge service platform, the papers on prescriptions for prostate cancer were collected, and then Traditional Chinese Medicine Inheritance System was used to set up a database so as to analyze the composing principles of herbs in the prescriptions and predict new prescriptions. Results The 289 prescriptions in the database were screened to achieve 40 commonly used Traditional Chinese medicines, 14 commonly used drug combination modes,6 core combinations of new prescriptions and 3 new prescriptions. Analysis showed that the effects of herbs are mainly Invigorating Qi and Reinforcing Liver and Kidney, partially Clearing Heat Anti-toxicant, Clearing Heat and Dissolving Dampness and Promoting Blood Circulation for Removing Blood Stasis. The effects of new prescriptions obtained by cluster analysis were speculated to be Benefiting Qi for Nourishing Yin, Activating Blood and Resolving Accumulation; Heat Anti-toxicant, Promoting Blood Circulation for Removing Blood Stasis and Reinforcing Liver and Kidney. Conclusion Composing principles of herbs in the prescriptions for prostate cancer that we studied based on Traditional Chinese Medicine Inheritance System provides a reference for clinical practice. The predicted new prescriptions are in line with the clinical treatment considerations and provide a preliminary basis for clinical treatment and drug development References | Related Articles | Metrics

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Literature Analysis of the Regularity and Adverse Reaction of Cinnamon and Its Prescription Preparations JI Yue, WANG Tuo-ran, ZHANG Ke-xin, ZHOU Zi-jun, LIU Yu-xuan 2018, 15(3): 163-168.  Abstract ( 355 )   PDF (745KB) ( 242 )   Objective To summarize the drug prescription of cinnamon and to analyze the related (Adverse drug reactions; ADR), and to provide reference for the rational use of drugs for diagnosis and treatment. Methods Cinnamon (oil) preparations were selected from the Chinese pharmacopoeia (2015 edition) and "Pharmacology of traditional Chinese medicine" ("Twelfth Five-Year", second edition) and retrieved from the 1962-2017 China Journal Full-Text Database (CNKI) and statistically relevant adverse drug reactions was calculated. Results A total of 50 cinnamon prescriptions, 1 single preparation, 285 proprietary Chinese medicines, and 30 adverse reactions were collected. Between 2000 and 2009 there were more distributions (40.7%); Most of the adverse reactions were type A, suggesting a predictable and dose-dependent characteristic. The incidence of reaction in the young and middle-aged patients was high (80%), mainly affecting the skin and its accessories and sensory system. The high frequency occurred within 60 minutes of drug use, 3 ~ 7 days of drug use, within 3 months of drug use and several months to six months of drug use. Conclusion The main causes of adverse reactions are related to compatibility, syndrome differentiation, abuse, misuse, and occupational diseases. Conclusion The reasons of ADR are mainly related to herb compatibility, wrong syndrome differentiation, misuse and occupational disease. References | Related Articles | Metrics

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Study on Risk Classification and Management of ADR Monitoring Varieties in Pharmaceutical Enterprises in Henan Province GONG Li-xiong, WANG Chang-zhi, CHEN Chao, YANG Yue, CHEN Jian-gang, GUO Hui, MA Xue-jiao, LIU Chao 2018, 15(3): 169-175.  Abstract ( 456 )   PDF (1145KB) ( 287 )   Objective To explore the relationship between drug quality risk and adverse drug reaction (ADR) and to provide valuable risk warning for regulators through ADR signal mining. Methods A adverse event cluster signals identification model was established and the results of the analysis were visualized. At the same time, retrospective analysis of calcium gluconate injection and citicoline sodium injection using the adverse reaction monitoring data provided by Henan Center was conducted to verify the model. Results The ADR data of Henan enterprises fed back by the National Center from March 1, 2015 to April 4, 2015 and the data collected by Henan Center from March 20, 2014 to April 9, 2014 were analyzed by the cluster signals identification model, respectively. Adverse reactions data were tested for one cycle for 7 days. Risk signals of lot number 14102421 of YSZY calcium gluconate injection were detected in the fourth cycle of the first period .The risk signals of AHLYYY's citicoline 130727 was detected in the second cycle of second period. Results of model analysis were in line with the situation of quality sampling. Conclusion The Methods of cluster signals detection and identification designed in this study are feasible and can be used for initial screening of specific batch risk of enterprise varieties. Taking into account only the use of ADR monitoring data in Henan province, as well as a small number of cases retrospective validation, the applicability of the model still needs further verification. In addition, this study uses visual processing to make the output of the model more intuitive, meets the actual needs of regulation and provides a reference for risk-based regulation, and we will continue to improve the system in the next step. References | Related Articles | Metrics

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Analysis of 491 Cases of Serious Adverse Drug Reaction Cause by Fat-soluble Vitamins XIE Yan-jun, WU Shi-fu, TIAN Yue-jie, WU Gui-zhi, XU Li-li, DONG Duo 2018, 15(3): 176-180.  Abstract ( 409 )   PDF (853KB) ( 219 )   Objective To explore the general characteristics and risk factors of serious adverse drug reaction (ADR) induced by fat-soluble vitamin for injection, so as to provide reference for rational and safe clinical drug use. Methods 491 serious ADR reports of fat-soluble vitamin for injection were collected based on Shandong adverse drug reaction database and the data were analyzed statistically. Results Serious adverse reactions of fat-soluble vitamins for injection could affect multiple systems. Allergic reactions were the main adverse reactions, and severe ones could lead to anaphylactic shock risk in clinic. Conclusion The manufacturer should carry out the safety monitoring of fat-soluble vitamin for injection, update the safety information contents of the drug instruction and warn drug risk in time. Drugs should be used reasonably following the indications, and dosage and administration to reduce the risk of ADRs. References | Related Articles | Metrics

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Literature Analysis of 109 Cases of Adverse Drug Reaction Induced by Aztreonam LUO Bin, ZHANG Zeng-zhu, CHEN Ji-zhi 2018, 15(3): 181-185.  Abstract ( 417 )   PDF (712KB) ( 182 )   Objective To explore the regularity and characteristics of ADRs induced by aztreonam, and to provide a reference for clinical rational use of drugs. Methods China journal full-text database (CNKI), wangfang database, VIP database were retrieved from 2000 to 2017, and 109 case reports of ADRs induced by aztreonam were analyzed and discussed. Results The most common clinical appearances of ADRs induced by aztreonam were anaphylactic reaction and secondly were digestive system and neuromuscular system reaction. The majority of ADRs occurred within 0.5 hour after injection(55.96%). Conclusion Doctors should pay more attention to the rules and characteristics of ADRs induced by aztreonam, and promote safety of drug use and strengthen the clinical care so as to decrease the occurrence of adverse reactions. References | Related Articles | Metrics

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Drug Utilization Evaluation of Voriconazole Injection Based on Weighted TOPSIS Methods LIANG Yin-wu, ZOU Jian 2018, 15(3): 186-189.  Abstract ( 460 )   PDF (732KB) ( 148 )   Objective To establish the evaluation standard for voriconazole injection based on weighted TOPSIS, and provide a reasonable basis for clinical application. Methods The reasonable application evaluation system of voriconazole injection was established based on weighted TOPSIS with reference to the dispensatory and application guide of voriconzole, and 100 voriconazole injection utilizing cases that happened in the first half of 2017 in our hospital were evaluated. Results Among the 100 patients, there were 25 cases whose relative approach degree were larger than 80％(accounting for 25％), 37 cases whose relative approach degree were between 60％~80％(accounting for 37％), and 38 cases whose relative approach degree were below 60％(accounting for 38％). Conclusion The reasonable application evaluation system of voriconazole injection based on weighted TOPSIS Methods can be used to evaluate the rationality of drug use and promote more rational evaluation behavior. The results showed that irrational administrations of voriconzole for injection are fairly common problems in our hospital, which means regulation should be strengthened. References | Related Articles | Metrics

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One Case of Severe Anaphylaxis Induced by Berberine Hydrochloride Tablets PAN Xing,WANG Hui-Ling 2018, 15(3): 190-190.  Abstract ( 491 )   PDF (574KB) ( 185 )   References | Related Articles | Metrics

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One Case of Hepatic Dysfunction Induced by Sodium Valproate for Injection MAO Jiao-jiao 2018, 15(3): 191-192.  Abstract ( 370 )   PDF (549KB) ( 218 )   References | Related Articles | Metrics