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    20 May 2019, Volume 16 Issue 5 Previous Issue    Next Issue

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    Experimental Study on Acute Toxicity of Dendrobium Devonianum Extract in Mice
    DONG Shoutang, YANG Jiao, ZHANG Xuqiang, HU Yan, YANG Hongqin
    2019, 16(5): 257-259. 
    Abstract ( 403 )   PDF (703KB) ( 128 )  
    Objective To investigate the acute toxicity of Dendrobium devonianum extract in mice, and to evaluate the safety level. Methods There was no death in all mice after intragastrical administration of Dendrobium devonianum extract of the maximum concentration and maximum volume, and LD50 could not be detected, so the maximum tolerance dose was determined. Sixty mice were randomly divided into six groups (10 mice/group) by their sex and body weight, such as normal saline group, S1(2.8056 g·mL-1),S2(2.38476 g·mL-1),S3(2.0270 g·mL-1),S4(1.7230 g·mL-1),S5(1.4645 g·mL-1). After each mouse was given 0.5 mL materials by lavage within 1 day, the toxic reactions and body weight of mice were recorded daily for 7 days. The mice were sacrificed 7 days later, then the visceral changes were observed by naked eyes, and recorded liver, kidney weight. Results After the mice were given Dendrobium devonianum extract, there were no abnormal reactions and death or no significant changes of weight and liver, kidney index in mice during 7-day experimental period. And the maximum tolerance dose of Dendrobium devonianum extract in mice was 52.5590 g·kg-1. Conclusion Dendrobium devonianum extract has low toxicity, which is safe and reliable to eat.
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    Application of Bivaludine Combined with Tirofiban in Patients with STEMI without Reflow or Slow Blood Flow during Coronary Intervention
    GUO Xiaoli
    2019, 16(5): 260-264. 
    Abstract ( 339 )   PDF (735KB) ( 87 )  
    Objective To observe the effect of sequential intracoronary infusion of bivalirudin and tirofiban on no-reflow or slow blood flow in patients with acute ST-segment elevation myocardial infarction(STEMI) undergoing coronary artery intervention. Methods 108 STEMI patients undergoing no-reflow or slow blood flow during anticoagulation with bivalirudin, according to the different use of anticoagulants during operation, were divided into three groups including coronary artery group A (36 cases), coronary artery group B (38 cases) and coronary artery group C (34 cases). Coronary blood flow classification, ST-segment depression, left ventricular end diastolic diameter (LVEDD) and left ventricular ejection fraction (LVEF) were compared between the three groups after coronary angiography. The major adverse cardiovascular events (MACE) and the bleeding events during hospitalization and the incidence of thrombocytopenia were assessed. Results The proportions of TIMI 3 grade and ST-segment in the three groups were all highest in coronary artery group A, the lowest in coronary artery group C. The difference was statistically significant (P <0.05). At 3 months and 6 months after PCI, LVEDD gradually decreased and LVEF gradually increased. After 6 months, LVEDD was the shortest in coronary artery group A, and coronary artery group C was the longest. The LVEF coronary artery was the largest in coronary artery group A, and the smallest in coronary artery group C. The difference was statistically significant (P <0.05). The incidences of bleeding in coronary artery group A, B and C were 8.33%, 5.26% and 5.88%. The difference was not statistically significant(P>0.05). The incidences of MACE in coronary artery group A, B and C were 13.89%, 31.58% and 41.18%. Within 1 month after PCI, the incidence of MACE in coronary artery group A was significantly lower than that in coronary artery group B and coronary artery group C(P <0.05), but there was no significant difference between coronary artery group B and coronary artery group C (P >0.05). There was no significant difference in the thrombocytopenia among coronary artery group A, B and C (P >0.05). Conclusion Sequential intracoronary bivalirudin and tirofiban have significant efficacy in PCI with STEMI without increasing the risk of hemorrhage and thrombocytopenia, which can significantly improve the short-term clinical efficacy.
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    Analysis of Liver Injury Associated with Preparations Containing Tripterygium Wilfordii
    SONG Di, GE Feilin, ZHANG Le, WANG Jiabo, QIN Xuhua, GUO Yuming
    2019, 16(5): 265-269. 
    Abstract ( 445 )   PDF (1083KB) ( 187 )  
    Objective Through analyzing drug-induced liver injury (DILI) case reports associated with preparations containing Tripterygium Wilfordii (Lei Gong Teng, LGT), to investigate its characteristics of clinic and medication, and to provide reference for the rational drug use and safety evaluation on preparations containing LGT in clinical application. Methods To analyze and reevaluate characteristics of clinic and medication of preparations containing LGT reported between January 2012 and December 2016. Results A total of 251 DILI case reports associated with preparations containing LGT were collected during 5 years, whose age range was from 6 to 89 years old, with the concentrating distribution of age group from 41 to 60. Preparations containing LGT were mainly used for urinary system diseases, skin diseases, rheumatic diseases, etc, by analyzing the reasons for medication of 153 cases. The period of taking the preparations containing LGT until DILI occurring was from 0 to 1 793 days with the median of 12 days, and the range of daily dose was from 6 to 180 mg, with the median of 60 mg. From the analysis of rational drug use, we found that there were 25 cases with the prolonged treatment beyond prescribed course, 3 cases belonging to contraindication in people, and 9 cases with overdose respectively. Conclusion Preparations containing LGT were effective for urinary system and rheumatic immune diseases. However, under the premise of rational drug use, we should pay more attention to its duality of toxicity and effect and risk-benefit assessment while remind patients to detect their liver biochemical indexes regularly, which could guard against the risk of DILI, as well as improve the level of safe drug use in clinical application.
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    Analysis of Clinical Characteristics and Medication Rationality of Polygonum Multiflorum Thunb. and Its Preparation-related Liver Injury
    TU Can, GE Feilin, GUO Yuming, ZHANG Yaming, XIAO Xiaohe, WANG Jiabo
    2019, 16(5): 270-276. 
    Abstract ( 441 )   PDF (1261KB) ( 152 )  
    Objective To investigate the clinical characteristics of liver injury related to Polygonum multiflorum Thunb.(PM) and its common preparations, and analyze their risk factors, so as to provide reference for rational drug use in clinic. Methods Based on the cases of PM and preparation-related liver injury for the past 5 years (2012~2016), the clinical characteristics of PM-related liver injury, the rationality of drug use and possible risk factors were analyzed. Results The incidence age ranged from 8 to 93 years, and the median age of onset was 47 years (the median age of onset was 40.5 for men and 51 for women, respectively). The time span from administration to liver injury was 1~376 days, with a median of 31 days. The daily dose was 1~200 g, with a median of 10 g, suggesting that PM-induced liver injury had idiosyncratic properties. The results from further exploration of the risk factors showed that some unreasonable drug uses were important risk factors for liver injury of PM, such as individual self-medication (not under the guidance of a physician), mixed use of crude and processed PM, unconventional drug use (diet, alcohol, powder and tea) and irregular processing, etc. In addition, clinical repeated drug use, exceeding the drug instructions and inappropriate combination therapy were also important risk factors for liver injury caused by PM. Conclusion This article explores the safety risk factors of liver injury caused by PM and its preparations, suggesting that the clinical application of PM should be paid great attention to the risk of liver injury, avoid irrational use of drugs, and improve the level of safe drug use.
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    Analysis of Drug-induced Liver Injury Related to Psoriasis Treatment
    ZHU Jingxiao, Ge Feilin, LIU Yalei, ZHANG Yaming, WANG Jiabo, GUO Yuming, XIAO Xiaohe
    2019, 16(5): 277-280. 
    Abstract ( 423 )   PDF (769KB) ( 137 )  
    Objective To provide reference for rational medication of psoriasis by analyzing the demographic and drug characteristics of drug-induced liver injury for psoriasis treatment. Methods A retrospective study was performed in drug-induced liver injury cases associated with psoriasis between January 2012 and December 2016. Results A total of 155 DILI cases were collected, including 101 males and 54 females. The age range is 11 to 80 years and the age of 31~50 accounted for 48.38%. 120 cases(77.42%) of patients had clear history of medication, DILI caused by the traditional Chinese medicines(TCM) accounted for 32.5%, and DILI caused by western medicines accounted for 67.5%. The time span from taking drugs until liver injury occurred concentrated in 30 days. The median time of TCM (16 days) was longer than that of western medicines (10.5 days). Primary suspected western medicines were acitretin (38.27%) and methotrexate (34.57%). Suspected TCM mainly included tripterygium glycosides tablet(28.30%), Keyin pill(23.07%) and compound Qingdai capsule(15.38%). 35 cases (22.58%) of patients took two or more drugs, and the significant difference existed in the severity of adverse reactions caused by combined and single medication(P <0.05). The DILI reports about acitretin capsule and tripterygium glycosides tablet were with the largest number of people. Conclusion Drugs in treatment of psoriasis have a certain risk of liver injury, which should be paid close attention in clinical diagnosis and treatment. Latency period of liver injury caused by TCM is slightly longer than that of western medicines. After taking drugs related to psoriasis treatment, patients should monitor liver function timely and early, and be alert to the risk of liver injury caused by the combination of Chinese and western medicines.
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    Analysis and Consideration on Risks of Lysine Acetylsalicylate for Injection
    WANG Tao, LIU Songdong, WANG Dan
    2019, 16(5): 281-284. 
    Abstract ( 496 )   PDF (776KB) ( 410 )  
    Objective To analyze the risk of lysine acetylsalicylate for injection in china, in order to provide reference for clinical rational drug use. Methods The individual adverse drug reaction cases in WHO Vigilyze and China adverse drug reaction database, domestic literatures, and the domestic risk management measures were analyzed. Results The Data from WHO VigilyzeTM, China adverse drug reaction database and domestic literatures showed that the serious adverse drug reactions related to anaphylactic shock, severe cutaneous damage, and use of medicines in children were the major risks of lysine acetylsalicylate. Conclusion We should reinforce the safety monitoring of lysine acetylsalicylate for injection, timely update the drug labeling and promote the rational application of medicine.
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    Retrospective Analysis of Bortezomib-induced Intestinal Obstruction in Multiple Myeloma Patients
    MIAO Wenjuan, TIAN Jixin, LIAO Yingxi, YU Yaqing, WANG Xiaodan, YAN Haihong, ZHANG Ping
    2019, 16(5): 285-288. 
    Abstract ( 450 )   PDF (695KB) ( 245 )  
    Objective To investigate the clinical characteristics of intestinal obstruction induced by bortezomib in multiple myeloma patients, so as to provide reference for clinical safe drug use. Methods A retrospective method was used to collect and analyze the incidence of intestinal obstruction in 673 patients with multiple myeloma who received bortezomib from January 2014 to December 2018 in the Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences. Results A total of 42 multiple myeloma patients suffered from intestinal obstruction after treatment with bortezomib. There were no significant differences in gender and age between MM patients who used bortezomib with intestinal obstruction and without intestinal obstruction during the same period (P>0.05).All cases showed partial intestinal obstruction. The median occurrence chemotherapy course was the second (1~8) course of treatment with bortezomib. Among them, 21 patients (50%) used serotonin receptor antagonist antiemetics when using bortezomib. Twenty-nine patients (69.05%) complicated with infection before intestinal obstruction, and all of them were given broad-spectrum antibacterial drugs. In addition, 15 (35.71%) of them were combined with triazole antifungal drugs. After conservative medical treatment, most patients (35 cases, 83.33%) had remission of intestinal obstruction symptoms after one week. After remission of intestinal obstruction, 7 patients were adjusted to chemotherapy reducing the dose of bortezomib, and 5 patients were adjusted to chemotherapy without bortezomib. Conclusion Once intestinal obstruction occurred in the treatment with bortezomib in multiple myeloma patients, it often prevented the progress of chemotherapy remedy. Therefore, it is necessary to strengthen drug education and actively prevent the occurrence of intestinal obstruction, so as to improve the safety of medication.
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    Literature Analysis of 376 Cases of Adverse Drug Reactions Induced by Ceftriaxone Sodium for Injection
    WANG Fang, LI Yonghui, GUO Ruifeng, QIU Zhihong, LIU Xinxin
    2019, 16(5): 289-292. 
    Abstract ( 530 )   PDF (729KB) ( 240 )  
    Objective To understand the adverse reactions induced by ceftriaxone sodium for injection, and explore the regularity and characteristics of its occurrence, in order to provide a basis for safe and reasonable medication in clinic. Methods CNKI, WANFANG and VIP database were retrieved from January 2007 to June 2017, and 376 case reports of adverse drug reactions induced by ceftriaxone sodium were analyzed retrospectively. Results The incidence of ADR was related to solvent, combination, age, allergic history and alcohol-drinking history. Attention should be paid to the severe ADR that occured within 1 minute and delayed ADR. The risk warning of anaphylactic shock, gallstones and urinary calculi was insufficient in the drug instructions. Drug overdosage was a high risk factor for stones. Conclusion We should try to use sodium chloride as solvent, infuse alone, monitor children medication, be alert to the delayed ADR, pay attention to serious and new ADR, and take effective measures to prevent ADR.
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    Analysis of the Clinical Characteristics and Prognosis of 371 Cases of Drug-Induced Liver Injury in Our Hospital
    YANG Wen, WANG Qi
    2019, 16(5): 293-296. 
    Abstract ( 442 )   PDF (771KB) ( 169 )  
    Objective To investigate the clinical characteristics and the influence factors of prognosis of drug-induced liver injury. Methods To retrospectively analyze 371 patients' sex, age, underlying disease, drinking history, liver injury drugs, and laboratory inspection with drug-induced liver injury in our hospital in the past 4 years.Results From 2015 to 2018, the annual composition of patients with DILI in hospitalized patients with liver disease was gradually increasing in our hospital. The ratio of male to female was 1:1.25, and the age mainly concentrated on 40~69 years old (59.57%). Common medicines causing drug-induced liver injury were traditional Chinese medicines(33.25%), anti-tumor drugs (17.63%), and anti-microbial drugs (14.61%), of which single-agent cyclophosphamide (5.54%) was the most. 74.39% of patients had clinical symptoms, mainly including fatigue (56.33%), loss of appetite (55.53%), and jaundice(36.93%).The clinical type is mainly hepatocyte injury type(69.54%). Those patients with ALT, AST increased were prone to hepatocyte injury (P =0.000), the older and those with high ALP were prone to cholestasis (P =0.01, P =0.000), and those with a history of tumors and high albumin were prone to mixed type(P =0.01, P =0.000). 85.98% of patients with DILI had a good prognosis, but 14.01% had a poor prognosis. The risk factors of prognosis were age (OR=4.12, P =0.00), basic liver disease (OR=2.54, P =0.02), total bilirubin (OR=1.01, P =0.00) and cholestasis type (OR=4.04, P =0.01) so that the degree of risk was age> cholestasis>basic liver disease>total bilirubin. Albumin was the protective factor of prognosis(OR=0.21, P =0.00). Conclusion A number of drugs could cause drug-induced liver injury. The morbidity was gradually ascending. The clinical symptoms were not specific and clinical type was mainly hepatocyte injury type. Most patients had a good prognosis, but a minority of patients had a poor prognosis. Patients who are older, with basic liver disease, high TBIL, and clinical type of cholestasis had an increased risk of poor prognosis, while higher albumin was good for patients.
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    Medication Reconciliation and Pharmaceutical Care for One Case of Large Hemispheric Infarction
    DI Kun, WU Qiaona, ZHANG Yanan, LIU Suting, LIU Jinglei
    2019, 16(5): 297-300. 
    Abstract ( 358 )   PDF (646KB) ( 170 )  
    Objective To explore the feasibility and effectiveness of clinical pharmacists providing pharmaceutical care (PC) based on medication reconciliation (MR) in clinical therapy through clinical pharmacists participating in the treatment process of a patient with large hemispheric infarction (LHI). Methods The clinical pharmacists performed MR and checked prescription on patient, and then searched medication errors and provided advice on the medication therapy. In the end pharmacists discussed with the doctors to decide the medication regimens, conducted the whole-process pharmaceutical care for the hospitalized patient. Results Some preventable adverse drug events and medication errors were avoided, and the patient was discharged in good condition after systematic treatment. Conclusion Medication reconciliation-based pharmaceutical care can optimize medication regimens, ensure patients' medical safety, and achieve the accuracy and consistency of medication therapy.
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    Examples of Traditional Chinese Medicine Safety Systematic Review 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(5): 301-310. 
    Abstract ( 359 )   PDF (1249KB) ( 210 )  
    Objective To provide examples for TCM safety systematic reviews based on PRISMA Harms checklist. Methods Three Chinese electronic databases (CNKI, WanFang and VIP) were searched from inception to October 2018. TCM safety systematic reviews were identified and extracted. Based on predefined criteria, reviews with contents that best meet the requirement of PRISMA Harms items were selected and provided as examples. One to two examples were provided for each item. Results 116 reviews were included and examples were selected from 25 papers, which were relatively consistent with the requirements of PRISMA Harms checklist items. Supplemental explanations were given when the examples had significant limitations. Conclusion Our study provided examples for the reporting of TCM safety systematic reviews according to PRISMA Harms. Examples were selected from published TCM systematic reviews, and may have limitations. An updated reporting examples will be considered with the publication of better quality systematic reviews.
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    One Case of Pulmonary Embolism Induced by Ethinylestradiol and Cyproterone Acetate Tablets
    REN Jie, CUI Xiangli, GAO Ye, YUE Wenjing
    2019, 16(5): 311-312. 
    Abstract ( 346 )   PDF (561KB) ( 142 )  
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    Two Cases of Neonatal Hypocalcemia Induced by Sodium Phosphate for Injection
    CAO Jianying, QU Xiujun, QIN Ying, SHI Zhongge, ZHANG Anchao, LI Zhongliang
    2019, 16(5): 313-314. 
    Abstract ( 316 )   PDF (553KB) ( 134 )  
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    One Case of Rhabdomyolysis Induced by Levofloxacin-atorvastatin Drug-drug Interaction
    ZHOU Changkai, GAO Jing, XING Xiaomin, GUO Qie, CUI Xueyan, FENG Lifang, SHI Shiqiang, ZHANG Rui, CHENG Shaoyuan, CUI Mengna, SHANG Xiuling, CONG Yue, JING Fanbo
    2019, 16(5): 315-317. 
    Abstract ( 547 )   PDF (584KB) ( 250 )  
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    One Case of Anaphylactic Shock Induced by Pethidine Hydrochloride Injection
    QI Chendong, CHENG Jie, ZHU Yujun, FAN Guorong
    2019, 16(5): 318-318. 
    Abstract ( 355 )   PDF (538KB) ( 150 )  
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    One Case of Large Area Skin Rash Induced by Alanyl Glutamine Injection
    CHEN Qiaohui, CHEN Dezhi, XU Yanyu, CHEN Zhimin
    2019, 16(5): 319-320. 
    Abstract ( 347 )   PDF (558KB) ( 207 )  
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