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20 April 2019, Volume 16 Issue 4 Previous Issue    Next Issue

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Evaluation of Toxicity of Acetaminophen on Human Hepatocyte Mitochondrial Aerobic Respiration by Cellular Energy Metabolism Analysis LI Mei, LIU Ning, ZHANG Fan, SUN Hua 2019, 16(4): 193-198.  Abstract ( 528 )   PDF (1165KB) ( 717 )   Objective This study aims to observe the effects of APAP on human hepatocyte mitochondrial aerobic respiration utilizing Seahorse XFe24 cell energy metabolism analysis system, thus to provide a methodological reference for the study of APAP toxicity prevention and mechanism in an energy metabolism way. Methods Human hepatocytes (HepG2) were treated with 1, 2, 4, 8, and 16 mM APAP for 24 h in vitro. Cell proliferation was detected by MTT assay and cell morphology was observed under an inverted microscope; cell protein was quantified by BCA assay. Experiment method in HepG2 cells was established by Seahorse XFe24 cell energy metabolism analysis system, effects and characteristics of different concentrations of APAP on human hepatocyte mitochondrial aerobic respiration were detected. Results The best conditions of Seahorse XFe24 cell energy metabolism analysis system for HepG2 were: 2×104 cells per well in 24 wells plate and the concentration of FCCP was 2 μM. APAP (4, 8, 16 mM) which could suppress cell proliferation in MTT results could interrupt mitochondrial aerobic respiration in human hepatocytes. APAP in 4 mM and 8 mM had a tendency to reduce basal respiration and ATP production in human hepatocytes, and 16 mM APAP can significantly inhibit basal respiration, maximal respiration and ATP synthesis. Conclusion High-dose APAP (16 mM) significantly inhibited cell energy metabolism in human hepatocytes live system and showed significant toxicity on live cell mitochondrial aerobic respiration. References | Related Articles | Metrics

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Effects of Ioversol, Iodixanol, Iopromide on Renal Function in Patients with Early Diabetic Nephropathy WANG Shengqi, WANG Aidan 2019, 16(4): 199-202.  Abstract ( 412 )   PDF (700KB) ( 137 )   Objective To observe the effects of ioversol, iodixanol and iopromide on renal function in patients with early diabetic nephropathy. Methods 163 cases of patients with early diabetic nephropathy(DN) that prepare for enhanced CT examination were randomly divided into group ioversol group, iodixanol group and iopromide group. The blood urea nitrogen(BUN), creatinine(Scr) and urinary albumin/creatinine ratio(mAlb·Cr-1) were checked before and 5 days, 10 days after the CT scan. The glomerular filtration rates(eGFR) were calculated. The renal function indexes, incidences of contrast nephropathy were compared. Results The levels of SCr, BUN and mAlb·Cr-1 after 5 days of enhanced CT examination were higher than that before the examination in the 3 groups (P <0.05). The eGFR was lower than that before the examination (P <0.05). The mAlb·Cr-1, eGFR of ioversol group and iopromide group after 10 days of enhanced CT examination did not recover the levels before the examination. The SCr and mAlb·Cr-1 of iodixanol group were significantly lower than that of ioversol group 5 days after CT examination (P <0.05). The eGRF was significantly higher than that of ioversol group (P <0.05). The SCr of iopromide group was significantly lower than that of ioversol group (P <0.05). The eGRF was significantly higher in ioversol group (P <0.05). The incidence of CIN was significantly higher in ioversol group than in iodixanol and iopromide group (P <0.05). The incidence of CIN was significantly higher in iopromide group than in iodixanol group (P <0.05). Conclusion Low-osmolality iodinated contrast media can reduce the incidence of CIN in patients with early DN. If the osmolality is similar, as the viscosity of the contrast media increases, the incidence of contrast nephropathy increases. References | Related Articles | Metrics

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Effects of Different Prophylactic Liver Protection Drug Regimens on Liver Injury after First Chemotherapy in Patients with Acute Myeloid Leukemia YANG Zhongyi, CAO Jiang 2019, 16(4): 203-207.  Abstract ( 394 )   PDF (788KB) ( 146 )   Objective To investigate the effect of different prophylactic liver protection drug regimens on liver injury after first chemotherapy in patients with acute myeloid leukemia. Methods 160 cases of patients with acute myeloid leukemia admitted between January 2015 and December 2017 were collected in our hospital for this prospective study. The patients were divided into control group (40 cases), glutathione (GSH) group (60 cases) and isoglycyrrhizinatel (ISO) group (60 cases). The control group was given chemotherapy only, the GSH group and the ISO group were additionally given GSH and ISO, respectively. The serum levels of aspartate aminotransferase (AST), alkaline phosphatase (ALP), alanine aminotransferase (ALT) and total bilirubin (TBil) pre- and post- chemotherapy were tested. The serum levels of interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) were measured by enzyme linked immunosorbent assay (ELISA). Meanwhile, the chemotherapy and the drug-induced liver injury of the three groups were analyzed. Results There was no significant difference in the efficacy of chemotherapy among the three groups (P>0.05). The pre-chemotherapy serum levels of AST, ALT, ALP, TBil, IL-6 and TNF-α were comparable (P>0.05) among the three groups. The post-chemotherapy serum level of AST, ALT, ALP and TBil and their changes from baseline of the ISO group were lower than control group and GSH group statistically (P <0.05). The post-chemotherapy serum level of IL-6 and TNF-α of the ISO group were lower than the control group and GSH group significantly (P <0.05); and their changes from baseline were higher than the latter two groups significantly (P<0.05). There were 13 cases (32.50%) and 15 cases (25.00%) of drug-induced liver injury in the control group and GSH group, respectively, without significant (P >0.05) difference between the two groups; while there were 7 cases (11.67%) in the ISO group, which was significantly (P <0.05) lower than the control group and GSH group. Conclusion ISO can improve the liver injury after first chemotherapy in patients with the acute myeloid leukemia, decrease the serum inflammatory factors, so it can play a role in protecting the liver. References | Related Articles | Metrics

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Challenges and Suggestions for Safety Monitoring of 50 New Drugs Accelerated Approval in 2018 WANG Yue, LI Ming 2019, 16(4): 208-211.  Abstract ( 496 )   PDF (728KB) ( 377 )   Objective To provide suggestions for safety monitoring of new drugs after marketing. Methods By consulting literature, databases and drug instructions, the indications, adverse reactions and safety risk factors of 50 new drugs in 2018 were analyzed. Results The accelerated approval of new drugs and insufficient exposure to potential risks posed severe challenges to post-marketing safety monitoring. Conclusion New drug Marketing Authorization Holders(MAH), medical institutions, monitoring agencies and regulatory authorities should fulfill the duty of notice on the Direct Reporting of Adverse Drug Reactions(ADRs) and actively carry out post-marketing risk monitoring of new drugs. References | Related Articles | Metrics

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Practice and Discussion on Active Surveillance by China Hospital Pharmacovigilance System HOU Yongfang, SONG Haibo, LIU Hongliang, LI Xilin 2019, 16(4): 212-214.  Abstract ( 770 )   PDF (805KB) ( 520 )   Objective To summarize China Hospital Pharmacovigilance System(CHPS), so to provide reference for active surveillance using real-world electronic medical data. Methods We have built CHPS by establishing China ADR Sentinel Surveillance Alliance to build cooperation mechanisms, and establishing Chinese Hospital Pharmacovigilance System to open data channels between data sources, and establishing risk analysis models to verify drug safety issues. Results & Conclusion CHPS, as an attempt to active surveillance, has been initially established, which can improve the efficiency and quality of adverse drug reaction reports, reduce missing cases of adverse reactions, and share drug safety information. It can play a role in verifying risk signals in the future. References | Related Articles | Metrics

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Problems and Thoughts on Reporting and Monitoring of Adverse Drug Reactions in Drug Manufacturers SANG Yuan, WU Shifu, LU Changfei, XIE Yanjun, CUI Xiaokang, XU Lili, LIU Wenwen, HUO Yanfei 2019, 16(4): 215-218.  Abstract ( 643 )   PDF (777KB) ( 427 )   Objective To discuss the main problems of the reporting and monitoring of adverse drug reactions in drug manufacturers, to provide suggestions for promoting drug manufacturers to fulfill the responsibility of drug safety through the analysis of the inspection findings on adverse drug reaction reporting and monitoring. Methods To classify and summarize the defect items for the non-compliance and recommendations of the 11 manufacturers which were inspected recently, and analyze the problems and causes on the adverse drug reaction reporting and monitoring of drug manufacturers. Results & Conclusion At present, drug manufacturers have improved adverse drug reaction monitoring work, but there are still varying degrees of problems as following in some companies: the awareness of the main responsibility for drug safety is not in place, the risk information collection capacity is not high, the understanding to carry out drug safety risk management concepts and methods is incomplete, the feedback data analysis and utilization capacity is not high and so on. It needs to intensify policy guidance from the regulatory level, enhance education and training, strengthen supervision and inspection, and promote drug manufacturers to fulfill the main responsibility for drug safety. References | Related Articles | Metrics

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Automatic Surveillance and Comparative Study of Omeprazole Related Abnormal Liver Function and Hepatic Impairment PANG Ning, GUO Daihong, KOU Wei, JIA Wangping, YANG Hongyi, WANG Xiaoyu 2019, 16(4): 219-222.  Abstract ( 432 )   PDF (862KB) ( 235 )   Objective To set the alarm conditions of the active surveillance and assessment system of adverse drug events(ADE-ASAS), so as to obtain the automatic surveillance results of omeprazole related abnormal liver function and hepatic impairment. Methods The ADE-ASAS was set with the criteria for abnormal liver function and hepatic impairment. The abnormal liver function and hepatic impairment of omeprazole were analyzed retrospectively, and the correlative factors were analyzed by nested case control study. Results Of the 5 352 patients included, under the two setting conditions, there were 1 256 cases and 385 cases of alarm cases. There were 175 (3.27%) cases of abnormal liver function, including ALT cases (126,2.35%), AST cases (92, 1.72%), ALP cases (25, 0.47%) and TB cases (45, 0.84%), and 64(1.20%) cases of hepatic impairment. Combined use of antimicrobials was a risk factor for abnormal liver function and hepatic impairment caused by omeprazole. Conclusion Hepatic impairment is more serious than abnormal liver function and should be paid more clinical attention, and setting the system with the standard of hepatic impairment can significantly reduce the cost of human screening. The tendency of abnormal liver function to hepatic impairment should be warned when combined with antibacterial agents. References | Related Articles | Metrics

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Analysis of Literature and Clinical Cases of Adverse Drug Reactions Induced by Zoledronic Acid Injection WANG Fangfang, CHEN Weihong, HE Zhiqiang, HU Xue 2019, 16(4): 223-227.  Abstract ( 411 )   PDF (775KB) ( 391 )   Objective To summarize and analyze the regularity and characteristics of adverse drug reactions (ADR) in clinical use of zoledronic acid injection, so as to provide reference for clinical safe medication. Methods Cases of ADR induced by the use of zoledronic acid injection and reported to the national adverse drug reaction monitoring center from October 2012 to November 2018 were included. At the same time articles in the CNKI database, Wanfang database and VIP Chinese full-text 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 the hospital and the literatures were analyzed together. Results The age of patients in both clinical cases and literature cases was mainly over 40 years old, accounting for 91.14% and 96.30% of all patients with medication respectively. All the patients suffered from malignant tumor with bone related diseases, and the primary tumor lesions were mainly lung cancer and breast cancer. In clinical cases, systemic response was the most involved organ/system of ADR(78.57%), while musculoskeletal system was the most reported (51.85%) in literature. A total of 28 severe cases were collected, except one from clinical cases, and the remaining 27 cases were all from literature. Among them, there were 13 severe cases of jaw necrosis and 1 death. Conclusion Most of ADR in the acute phase of this drug have achieved good results, and we should be alert to the possible delayed severe adverse reactions, especially the rare osteonecrosis of the jaw. It is suggested that ADR monitoring should be strengthened during the period of medication to promote the safety of clinical drug use. References | Related Articles | Metrics

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Pharmaceutical Care for One Case of Acute Leukemia Severe Infection with Torsade de Pointes ZHANG Junzhong, ZHANG Zhichao 2019, 16(4): 228-230.  Abstract ( 369 )   PDF (654KB) ( 285 )   Objective To analyze the drug treatment of severe infection with torsade de pointes(TdP), so as to investigate the method of pharmaceutical care. Methods Clinical pharmacists were active in the whole process of 1 case of secondary severe infection with TdP, assisted physicians to develop individualized therapeutic regimen and delivered special pharmaceutical care in main drug therapy. Results Clinical pharmacists can assist clinicians to adjust the therapeutic regimen, and take effective interventions to the adverse drug reaction, improve the level of clinical drug treatment. Conclusion The clinical pharmacists take advantage of the pharmaceutical knowledge as the entry point,offer pharmaceutical care for patients timely and rationally, which ensure medication safety and efficacy． References | Related Articles | Metrics

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Literature Analysis of Present Situation and Reporting Quality in TCM Safety Systematic Reviews Based on PRISMA Harms Checklist HU Ruixue, WEN Lingzi, YU Mingkun, REN Yiming, CAO Huijuan, GAO Jiaqi, LIU Kexin, ZHAO Luming, LI Yilin, LIN Ziyi, ZHANG Zixuan, MING Yang, WU Xuecen, LI Xun, LIU Jianping, FEI Yutong 2019, 16(4): 231-238.  Abstract ( 388 )   PDF (823KB) ( 111 )   Objective To understand the present situation and reporting quality of traditional Chinese medicine (TCM) safety systematic reviews, strengthen the safety awareness of TCM and improve reporting quality of TCM safety systematic reviews. Methods Three Chinese electronic databases, including CNKI, WanFang and VIP were searched from inception to October 2018. The TCM safety systematic reviews were identified and the PRISMA Harms checklist (including 27 items) was used to assess the reporting quality. Results 116 papers were finally included. The number of TCM safety systematic reviews published are little whose number ranging from 2000 to 2018 is gradually increasing annually. 69 studies (59.48%) use oral traditional Chinese medicine and 20 studies (17.24%) use TCM injection as intervention respectively. And 14 studies (12.07%) focus on cardiovascular and cerebrovascular diseases respectively. The literature type was mainly randomized controlled trials (63.79%). The quality assessment of literature mainly uses the Cochrane Collaboration's tool for assessing risk of bias (57.76%). The 27 reporting items of PRISMA Harms checklist only has two studies including more than 25 items. Conclusion The number of published TCM safety reviews is small, but the trend is increasing annually. Although most of the PRISMA Harms items were reported in the TCM safety systematic reviews we included, the overall reporting quality needs to be improved. Attention needs to be paid to the standard reporting of the contents of TCM safety systematic reviews, to enable readers to capture and understand the review results transparently. It is also recommended that the journals adopt PRISMA Harms when publishing papers to improve the reporting quality of reviews. References | Related Articles | Metrics

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Review of the Studies on the Knowledge, Attitude and Practice toward Adverse Drug Reactions Reporting among Different Reporting Entity at Home and Abroad XU Xiaodi 2019, 16(4): 239-243.  Abstract ( 456 )   PDF (670KB) ( 256 )   Though spontaneous reporting of adverse drug reactions (ADR) plays a critical role in pharmacovigilance, the under-reporting phenomenon is common around the world. This paper mainly reviewed the studies on the knowledge, attitude, and practice toward ADR reporting among different reporting entity such as pharmaceutical production enterprises, drug handling enterprises, medical institutions, and patients (publics) at home and abroad, in order to explore the main constraints in ADR spontaneous reporting and to provide references in improving the ADR spontaneous reporting work in our country. References | Related Articles | Metrics

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One Case of Exfoliative Dermatitis Induced by Lamotrigine Tablets WANG Xing 2019, 16(4): 244-245.  Abstract ( 319 )   PDF (586KB) ( 134 )   References | Related Articles | Metrics

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One Case of Cellulitis Induced by Pramipexole Hydrochloride Tablets LI Wenling, JIN Wei, CHEN Bohua, XU Beiming 2019, 16(4): 246-247.  Abstract ( 318 )   PDF (581KB) ( 166 )   References | Related Articles | Metrics

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One Case of Epileptic Seizure Induced by Increased Blood Concentration of Cyclosporine Injection ZHANG Jing, CHU Mingming, LI Letao, ZHANG Rong 2019, 16(4): 248-251.  Abstract ( 283 )   PDF (667KB) ( 141 )   References | Related Articles | Metrics

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One Case of Allergic Reaction Induced by Vinorelbine Tartrate Injection ZHUANG Ruichun, LI Guangcan, XIANG Anling 2019, 16(4): 252-252.  Abstract ( 292 )   PDF (565KB) ( 212 )   References | Related Articles | Metrics

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One Case of Hepatic Injury Induced by Cefoperazone Sodium/Sulbactam Sodium for Injection and Moxifloxacin Hydrochloride Sodium Chloride Injection WEN Zhiyong, LU Wenfen 2019, 16(4): 253-254.  Abstract ( 373 )   PDF (583KB) ( 190 )   References | Related Articles | Metrics

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One Case of Deafness Induced by Clindamycin Hydrochloride Injection LIU Wen 2019, 16(4): 255-256.  Abstract ( 547 )   PDF (580KB) ( 333 )   References | Related Articles | Metrics