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Design and Implementation of Bioequivalence Tests Based on Risk Management Strategies XUE Wei, QI Wenyuan, LIU Yue, CONG Duanduan, LIU Xiaohui, LI Hongyan, WANG Juan, LI Kexin, HU Xin 2020, 17(9): 549-552.  DOI: 10.19803/j.1672-8629.2020.09.01 Abstract ( 657 )   PDF (1079KB) ( 351 )   Objective To explain the considerations of investigators in the design and implementation of bioequivalence(BE) studies based on risk management strategies, so as to provide references for preventing potential security risks in large-scale BE studies in China. Methods Based on the general process of risk management and a dabigatran BE study, the research design and implementation were considered from the aspects of risk identification, risk assessment, risk decision-making, risk monitoring. Results The risk of bleeding was identified as an important risk in the study, and the risk level was evaluated according to the location and amount of bleeding. No bleeding and related adverse events occurred in the study, and all subjects were safely excluded from the study. Conclusion The risk management of this study has achieved the expected goals, which confirms the scientificity and effectiveness of the design and implementation based on risk management. References | Related Articles | Metrics

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Cardiotoxicity Evaluation of Moxifloxacin and Levofloxacin Used in Conjunction with Antiarrhythmic Drugs through HiPSC-CM WANG Qi, YAN Yujing, REN Lu, WEN Hairuo, GUO Jian 2020, 17(9): 553-558.  DOI: 10.19803/j.1672-8629.2020.09.02 Abstract ( 481 )   PDF (1355KB) ( 184 )   Objective To evaluate the cardiotoxicity of quinolone antibiotics used in combination with antiarrhythmic drugs using human induced pluripotent stem cell derived cardiac myocytes (hiPSC-CM) and the real-time cell analyzer (RTCA). Methods The hiPSC-CM was seeded onto the RTCA Cardio E-Plate 96 and treated with moxifloxacin, levofloxacin, quinidine, procainamide, and amiodarone of different concentrations, while the normalized cell index (NCI) and normalized beat rate (NBR) were used for the screening of toxic concentrations. After 24 hours of pretreatment with the highest non-toxic concentration and the lowest toxic concentration of moxifloxacin or levofloxacin, different concentrations of quinidine, procainamide, and amiodarone were used to treat the cells, and the difference in the NCI between the groups was compared. Results Moxifloxacin, levofloxacin, quinidine, procainamide, and amiodarone all decreased the NCI when used alone to treat the cells (P <0.05). Moxifloxacin combined with quinidine or procainamide reduced the NCI of cells (P <0.05), so did levofloxacin combined with amiodarone (P <0.05). Conclusion This study suggests that the combination of moxifloxacin and levofloxacin with antiarrhythmic drugs could increase the risk of cardiotoxicity, and that the in vitro evaluation model based on hiPSC-CM and RTCA is applicable to the prediction of risks of drug cardiotoxicity. References | Related Articles | Metrics

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Genotoxicity Evaluation of (R)-(+)-Rabeprazole Sodium for Injection GAO Mei, MA Hui, CHEN Kai, ZHANG Daizhou 2020, 17(9): 559-563.  DOI: 10.19803/j.1672-8629.2020.09.03 Abstract ( 424 )   PDF (1212KB) ( 159 )   Objective To evaluate the genotoxicity of (R)-(+)-rabeprazole sodium for injection in order to provide reference for clinical rational drug use. Methods The genotoxicity of (R)-(+)-rabeprazole sodium for injection was evaluated via three experiments, including bacterial reverse mutation test, Chinese hamster lung cell (CHL) chromosome aberration test in vitro and mouse erythrocyte micronucleus test. Results The results of the bacterial reverse mutation test showed that the number of bacterial colonies in each dose group of (R)-(+)-rabeprazole sodium for injection did not increase significantly compared with the solvent control group. In the In vitro chromosome aberration test of CHL cells, the chromosome aberration rate of each dose group was not statistically significant compared with the solvent control group. The In vivo micronucleus test of mice suggested that the micronucleus rate of each dose group was not statistically significant compared with the solvent control group. All the three tests were negative. Conclusion Under the same conditions as in this study, no genotoxicity is detected in (R)-(+)-rabeprazole sodium for injection. References | Related Articles | Metrics

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Risk Management of Pediatric Drug Clinical Trials PENG Shirong, CHEN Haiyan, WANG Qian, DING Qian, WANG Xiaoling 2020, 17(9): 564-566.  DOI: 10.19803/j.1672-8629.2020.09.04 Abstract ( 409 )   PDF (1068KB) ( 197 )   Objective To provide reference for pediatric drug clinical trial risk management. Methods Based on the theory of risk management, literature review and practical work experience, the risk factors and risk control measures of pediatric drug clinical trials were summarized. Results Risk identification and risk assessment are carried out from project assessment risk, such as Investigator's Brochure with results from young animals, data of adult and foreign children;Sponsors manage risk; Manage risks from professional teams, such as principal investigators with extensive pediatric clinical experience; the implementation risk of clinical trials, the management risk of Investigational Medical Product and biological sample,as well as the management system risk.Through risk aversion; Risk mitigation, such as enhanced quality control of clinical trials and enhanced management of clinical trial institutions; Risk transfer, such as the purchase of insurance, clear contract compensation and rights protection clauses and other measures to control the risk. Conclusion Through risk identification and assessment of risk factors in pediatric drug clinical trials, corresponding measures are adopted for risk management, so as to reduce and avoid the occurrence of clinical trial risks and protect the rights and interests of subjects and Investigators. References | Related Articles | Metrics

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Introduction to WHO Collaborating Centre for Pharmacovigilance WEI Fenfang, MAO Qiurong, CHENG Bin, ZHONG Ling 2020, 17(9): 567-571.  DOI: 10.19803/j.1672-8629.2020.09.05 Abstract ( 820 )   PDF (1110KB) ( 1142 )   Objective To find out more about the WHO Collaborating Center for Pharmacovigilance so as to provide reference for the establishment of pharmacovigilance-related international organizations in China. Methods Based on literature study and comparative analysis, the WHO Collaborating Center for Pharmacovigilance was introduced in terms of founding, development missions and ways of academic exchange. Results The WHO has issued a series of policies and regulations to support the official status of this center, while local governments have also actively provided financial assistance to it. The WHO has established multiple international pharmacovigilance collaborating centers using a variety of collaborating methods. These collaborating centers promote regional pharmacovigilance in various forms of exchange or training. Conclusion It is recommended that China learn from international practices and set up pharmacovigilance-related international collaborating organizations in developed coastal areas in order to make China more influential in the field of pharmacovigilance, fulfill international obligations, and play a leading role in Asia. References | Related Articles | Metrics

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Challenges to Pharmacovigilance by Medical Institutions under the New Drug Administration Law FENG Yanan, LIU Xinxin, LI Yonghui, WANG Fang, GUO Ruifeng 2020, 17(9): 572-573.  DOI: 10.19803/j.1672-8629.2020.09.06 Abstract ( 697 )   PDF (1079KB) ( 592 )   Objective To explore the challenges to pharmacovigilance by medical institutions under the new Drug Administration Law. Methods Literature analysis and comprehensive analysis were conducted for the discussion. Results Medical institutions lacked the ability to find and evaluate the potential risks to drug safety, showed poor initiative for pharmacovigilance, and were understaffed. Conclusion It is recommended that a complete hospital pharmacovigilance system be established, related training be improved, and social forces be given full play to in order to promote pharmacovigilance by medical institutions. References | Related Articles | Metrics

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Literature Analysis of 45 Cases of Drug-induced Hyperuricemia XU Wanyi, CUI Xiangli 2020, 17(9): 574-577.  DOI: 10.19803/j.1672-8629.2020.09.07 Abstract ( 544 )   PDF (1039KB) ( 263 )   Objective To investigate the types of drugs that cause hyperuricemia and the clinical features so as to provide reference for safe medication and treatment. Methods The CNKI and Wanfang database were searched to retrieve case reports of drug-induced hyperuricemia. The types of drugs responsible and high-risk factors were analyzed. Results A total of 39 case reports involving 45 patients were retrieved. A total of 7 categories (14 kinds) of drugs were involved, including 13 cases related to diuretics (28.89%) and 12 cases related to anti-tuberculosis drugs (26.67%). Hyperuricemia occurred in each age group, with those over 60 years old as the most vulnerable (19 cases, 42.22%). Gout occurred in 32 cases while asymptomatic hyperuricemia occurred in 13 cases. Conclusion Patients taking these drugs, especially the elderly with multiple chronic diseases who have to take long-term and combined multiple drugs, should be alert to drug-induced hyperuricemia, and the blood uric acid level should be monitored regularly to prevent the occurrence of hyperuricemia. References | Related Articles | Metrics

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Literature Analysis of 52 Cases of Adverse Drug Reactions Induced by Escitalopram LIU Hongming, WANG Jian 2020, 17(9): 578-582.  DOI: 10.19803/j.1672-8629.2020.09.08 Abstract ( 446 )   PDF (1071KB) ( 373 )   Objective To understand the occurrence and precautions of escitalopram adverse reactions(ADR). Methods The case reports of ADR in Wanfang database, VIP journal network, CNKI and PubMed were searched by computer. The gender, age, time of occurrence, clinical manifestation and involvement system-organs of ADR were analyzed. Results A total of 51 patients were enrolled in the literature, including 52 patients. The incidence of escitalopram ADR was mainly in female and middle-aged (41~65 years old). ADR occurred several hours to 6 months after administration, mainly involving the circulatory system. The nervous system, digestive system, endocrine system and others, among which most cases were hyponatremia. Conclusion Escitalopram should be used according to the recommended dosage of the instructions, and should not be added at will; medical staff should strengthen the attention, monitoring and reporting of ADR to promote clinical rational drug use. References | Related Articles | Metrics

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Analysis of 48 Cases of Drug Eruptions Induced by Amoxicillin ZHU Dongchun, SUN Xuqun, JIANG Haifeng, WANG Yushan, FANG Xianjun, XIA Quan 2020, 17(9): 583-588.  DOI: 10.19803/j.1672-8629.2020.09.09 Abstract ( 565 )   PDF (1153KB) ( 320 )   Objective To investigate the characteristics of amoxicillin-related drug eruptions and provide reference for the corresponding prevention and treatment of adverse drug reactions. Methods Analysis of inpatients admitted to a tertiary hospital between 2016 and 2018 for drug eruptions was conducted. Cases of amoxicillin-related drug eruptions were screened out, and patients' conditions and treatment outcomes were analyzed. The related data was obtained from the Hospital Information System (HIS). Results It was found that there were 48 cases of amoxicillin-related drug eruptions among the hospitalized patients, 41 of which involved amoxicillin and 7 involved amoxicillin/ clavulanate potassium. The mean age of the patients was 42.94 ± 20.78 years old. Among them, 14 patients had a previous history of allergy to amoxicillin or penicillin (29.2%). Respiratory tract infections and Helicobacter pylori infections were the main reason for medication. The incubation period of drug eruptions was within 1 day in 35.56% of the patients, and within 7 days in 86.67% of the patients after administration. The average length of hospital stay was 8.42±4.83 days, and cumulative dose of glucocorticoids (in terms of hydrocortisone) used during the hospital stay was 1 580.00(625.00, 2 470.00) mg. There was no statistically significant difference in the length of hospital stay(P =0.797)or the cumulative dose of glucocorticoids(P =0.977) between cases of drug eruptions related to amoxicillin and amoxicillin/ clavulanate potassium respectively. More patients were found to have abnormal levels of white blood cells (68.75%) and liver biochemical examination (29.17%). Conclusion The incubation period of amoxicillin-related drug eruptions is generally short, and it is within one week in most patients. There are no significant differences in severity and treatment outcomes of drug eruptions between amoxicillin and amoxicillin/clavulanate potassium. In case of drug eruptions, we need to be alert to blood system abnormalities and liver damage. Drug eruptions can have good prognosis after quick diagnosis and treatment. Attention must be paid to the patient's allergy history when such antibiotics as amoxicillin are prescribed. References | Related Articles | Metrics

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Clinical Analysis of 130 Cases of Drug-induced Liver Injury in Cancer Patients ZHANG Xialan, SHEN Xikun, Huang Yuyu 2020, 17(9): 589-593.  DOI: 10.19803/j.1672-8629.2020.09.10 Abstract ( 312 )   PDF (1132KB) ( 201 )   Objective To study the incidence of drug-induced liver injuries among inpatients at the Oncology Department of our hospital, summarize the clinical manifestations of liver damage, and evaluate the causality of drugs. Methods The medical history of drug-induced liver injuries that occurred in our hospital between January 2014 and December 2018 was retrospectively analyzed while the basic information of patients was recorded. The RUCAM score table was used to evaluate the causality of drug-induced liver injuries. Results A total of130 patients treated at the Department of Oncology of our hospital sustained drug-induced liver injuries, including 72 males and 58 females, with an average age of (64.4±10.71) years. The main clinical manifestations of liver injury were fatigue, yellowing of skin and mucous membrane, abdominal pain and anorexia. Sixty-four of these cases were of the cholestasis type, 20 cases of the hepatocyte damage type, and 46 cases were of the mixed type. Liver damage associated with chemotherapeutic agents was the most frequent with tegio, apatinib, capecitabine, oxaliplatin and cisplatin. Conclusion Drug-induced liver injury caused by chemotherapeutic drugs is one of the important causes of changes in the conditions of patients in the oncology department of internal medicine. Medical personnel should pay more attention to drug-induced liver injuries in the process of medical care. References | Related Articles | Metrics

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Influence of Community Pharmaceutical Care Service Led by Clinical Pharmacists on Construction and Evaluation of Service Systems for Medication of Elderly Patients with Statins LAN Xiaohong, ZHOU Yonggang, Zang Juxiang, WU Dongni, LI Xiang, XU Rui, CHEN Shudong, YU Hao ZHANG Ye 2020, 17(9): 594-599.  DOI: 10.19803/j.1672-8629.2020.09.11 Abstract ( 298 )   PDF (1202KB) ( 149 )   Objective To study the influence of clinical pharmacists' participation in community pharmaceutical care on the safety, effectiveness, expense, applicability, compliance and quality of life among elderly patients treated with statins and the influence of the community pharmaceutical service mode led by clinical pharmacists on the rationality of potential drug use among elderly patients in a community. Methods One hundred and sixty-one elderly patients with indications of statins were divided into the control group (n=81) and pharmacist-led group (n=80). The safety, effectiveness, expense and applicability of treatment with statins as well as compliance and quality of life of elderly patients were assessed from different perspectives and by related standards. Results In the safety indexes, the incidence of ADRs, repeated use, interactions, PIM and improper storage of drugs decreased from 28%, 4.2%, 4.9%, 15.3% and 45% to 13%, 2.0%, 1.3%, 2.1% and 26.3% respectively (P< 0.001). However, there was no significant change in the control group after the intervention. In the effectiveness indexes, the proportion of low compliance, lack of belief, poor knowledge and EQ-VAS decreased from 23.8%, 55%, 51.8%, 84.2±12.3 to 13.8 (P >0.05), 34.8 (P <0.05), 21.1 (P<0.05), 77.2±11.4 (P <0.05) respectively. In the past three months, the rate of hospital visits increased from 21.5% to 40.8% (P<0.001), but the mean value of EQ-5D did not change significantly (P >0.05). As for the economic indicators, the average number of medical insurance drugs, the average amount of drugs used and the average monthly drug cost decreased from 5.6%, 27.2 and 8.9% to 3.4%, 17.3% and 4.3% (P<0.05) respectively. In terms of the appropriateness indexes, there was no significant change in the usage of drugs with or without indications(P >0.05).The rate of insufficient dosage and improper treatment decreased from 27.2% and 8.9% to 17.3 and 4.3% (P <0.05) respectively. In EQ-5D indexes, the percentage of anxiety and depression decreased from 25.3% to 20.8% (P <0.05). Conclusion The community pharmaceutical care led by clinical pharmacists can significantly improve the safety, effectiveness, cost-effectiveness and validity of medication for elderly patients. Besides, this approach can enhance the social status and acceptance of clinical pharmacists while providing data for decision-makers to formulate laws and regulations. References | Related Articles | Metrics

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Seventy-three Cases of Suspected Unexpected Serious Adverse Reactions Reports with Chimeric Antigen Receptor T-cell Therapy Products LI Yanrong, YANG Ce, LIU Wendong, MA Runyi, YAO Zhuxing, HU Yangping, LIU Min, PEI Xiaojing, WANG Haixue 2020, 17(9): 600-606.  DOI: 10.19803/j.1672-8629.2020.09.12 Abstract ( 346 )   PDF (1367KB) ( 257 )   Objective To assess the suspected unexpected serious adverse reaction (SUSAR) reports of chimeric antigen receptor T (CAR-T) cells therapy products under clinical trials received by the Center for Drug Evaluation and National Medical Products Administration. Methods The SUSAR individual case safety reports of CAR-T therapy products received between May 1, 2018 and August 31, 2019 were retrieved from the pharmacovigilance database and analyzed retrospectively. Results A total of 73 SUSAR reports of CAR-T cells therapy products were received. An overall increase in the number of SUSAR reports was observed. The percentage of males and females was 54.1% and 45.9%, respectively. Most of the reported SUSARs involved subjects aged 60 to 69 (39.7%). The number of SUSAR reports from China was six (8.2%). The percentage of phase I/II clinical trials was the highest (43.8%). The percentage of grade 3 or above was 69.6%. Nervous system disorders, general disorders and administration site conditions were among the most commonly reported system organ class (SOC). The percentage of CRS and CRES was 39.6% and 23.3% respectively. Thirteen cases of death were identified in the pharmacovigilance database. Progression of cancer and severe infections were the main causes of death. Conclusion Sponsors should establish pharmacovigilance systems, submit reports of SUSARs as scheduled, and improve the quality of reports. In addition, regulators are expected to monitor and evaluate SUSARs to ensure the safety of subjects during clinical trials. References | Related Articles | Metrics

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Drug Abuse Monitoring Models in Medical Institutions in China HUANG Yuan, WANG Chenggang, WU Shifu, WANG Ling, TIAN Yuejie, WU Chen, WANG Xiaojun 2020, 17(9): 607-612.  DOI: 10.19803/j.1672-8629.2020.09.13 Abstract ( 286 )   PDF (1327KB) ( 168 )   Objective To explore an appropriate mode for drug abuse monitoring in medical institutions in China, and to provide decision-making support for drug abuse monitoring. Methods A random sampling method was used to investigate current methods of drug abuse monitoring and the needs of and suggestions about the establishment of drug abuse monitoring systems in medical institutions. The staffers of drug abuse monitoring agencies and medical institutions in 12 provinces in China were enrolled in this survey. Results A total of 37 staffers from 36 monitoring agencies and 358 staffers from 61 medical institutions were investigated. Sixteen monitoring agencies in 8 sampled provinces (8/12) carried out drug abuse monitoring in medical institutions. More than 83.8% of the respondents believed that drug abuse monitoring should be carried out in general hospitals and psychiatric hospitals. Over 50.0% believed that the departments of psychiatry, pain, pharmacy, emergency and psychiatry should be the focus of monitoring. More than 60% expressed the view that sentinel surveillance should be combined with routine monitoring, with sentinel surveillance as primary and routine monitoring in medical institutions as secondary. More than 70% of the respondents replied that the corresponding management system, information technology, and technical training were critical to monitoring. Conclusion Drug abuse monitoring in medical institutions in China involves improving the management system and administrative push at the national level, and using information technology. It should be steadily promoted on the basis of relevant technical training, personnel allocation, financial support and establishment of mechanisms for supervision, assessment and information feedback. References | Related Articles | Metrics

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Medication Adjustment of One Case of Crohn's Disease with Peritoneal Abscess by Clinical Pharmacists JIANG Li, BI Xiaoting, LI Bo 2020, 17(9): 613-616.  DOI: 10.19803/j.1672-8629.2020.09.14 Abstract ( 258 )   PDF (1075KB) ( 196 )   Objective To offer new ideas about the assessment, management and treatment of adverse drug reactions during clinical treatment by analyzing the medication adjustment of one case of Crohn's disease with peritoneal abscess. Methods The patient developed acute inflammatory demyelinating radiculopathy when taking thalidomide to combat Crohn's disease. When imipenem and cilastatin sodium for injection was used to treat abdominal abscess, urticaria appeared. Clinical pharmacists participated in the whole process of treatment and adjusted the dosage and frequency of thalidomide and antimicrobials. At the same time, the patient's conditions were monitored, including stool relief, temperature and abdominal abscess control, numbness of hands and feet, lisp aggravation and subsidence of urticaria. Results Physicians took the advice of clinical pharmacists, and monitored the patient's above conditions closely. The patient was basically recovered after 7 days in that his body temperature returned to normal, diarrhea became much less frequent, no pus outflowed from the fistula, and numbness of hands and feet as well as lisp stopped aggravating. Conclusion During clinical treatment, clinical pharmacists should actively collaborate with physicians in monitoring and treatment of adverse drug reactions, take effective interventions, and offer proper medication recommendations so as to work together to promote rational drug use and improve the therapeutic effect. References | Related Articles | Metrics

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140 Cases of Severe Adverse Drug Reactions/Events in a Hospital YOU Cuiyu, XU Xiaoli, LI Sha, XUE Siyu, CHEN Siying, WANG Maoyi 2020, 17(9): 617-621.  DOI: 10.19803/j.1672-8629.2020.09.15 Abstract ( 661 )   PDF (1194KB) ( 334 )   Objective To investigate the causes and characteristics of serious adverse drug reaction (ADR)/adverse event (AE) that occurred in the First Affiliated Hospital of Xi'an Jiaotong University along with literature research so as to provide reference for clinical rational, safe and effective drug use. Methods The clinical data on 140 cases of serious ADR/AE was collected between January 2016 and June 2019 in the hospital. The patients' age, gender, types of drugs, systems-organs involved, adverse manifestations and routes of administration were statistically analyzed. Results The ratio of male patients to female ones was 1.17:1 and the incidence of ADR/AE was the highest among patients over 50 years old (68.57%). The drugs involved were mainly anti-tumor (42.86%) and anti-infective (24.29%) drugs. There were 13 anti-tumor drugs and 2 antimicrobial drugs among the top 15 drugs, and voriconazole was responsible for more ADR cases than any of the other drugs. The main clinical manifestation was blood system damage. The incidence of ADR related to intravenous infusion was the highest, accounting for 59.28%. Conclusion Clinicians should be more cautious with the medication for middle-aged and elderly patients and with the usage of anti-tumor and antimicrobial drugs. Post-medication monitoring and guidance of clinical pharmacists should be put in place in order to reduce or prevent the occurrence of ADR/ AE and ensure the safety of patients' medication. References | Related Articles | Metrics

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Pharmaceutical Care of Listeria Meningitis in a Child with Normal Immunity YANG Xue, FANG Lingzhi, WEI Lina, JI Hongyan, DONG Lei 2020, 17(9): 622-624.  DOI: 10.19803/j.1672-8629.2020.09.16 Abstract ( 265 )   PDF (852KB) ( 155 )   Objective To explore the role of clinical pharmacists in the treatment of children with Listeria monocytogenes meningitis. Methods Clinical pharmacists participated in the medication of a child with Listeria monocytogenes meningitis. Pharmaceutical care involved the selection of antibiotics, drug dosage, adverse drug reactions, therapeutic effect and course of treatment. Results The patient got better and was discharged from the hospital Eventually. Conclusion Participation of clinical pharmacists in clinical treatment can provide individualized treatment for patients, which can help improve clinical treatment and promote rational drug use.Keywords: children; Listeria monocytogenes meningitis; pharmaceutical care References | Related Articles | Metrics

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Consistency of Case Evaluation of Adverse Event Adjudications in Various Clinical Studies DING Lijuan, YIN Lu, WANG Liping, SUN Yaya, HU Bo, LIU Xiaoyun, SUN Yi, LI Wei 2020, 17(9): 625-630.  DOI: 10.19803/j.1672-8629.2020.09.17 Abstract ( 515 )   PDF (710KB) ( 492 )   Objective To compare the difference in adjudications of adverse events between the Clinical Event Committee (CEC) and investigators, and evaluate the role of CEC in a wide range of clinical studies. Methods Data about adverse events was collected from the Prospective Urban and Rural Epidemiology study in China (PURE-China) and from two drug clinical trials. Inconsistency between CEC and investigators in various studies was compared and evaluated. Results A total of eleven CEC meetings for PURE-China study were conducted between February 2018 and June 2019, and 1 993 end-point events were evaluated. The number of inconsistent adjudications between CEC and investigators was seventy-six, accounting for 3.8%. In a phase Ⅰclinical trial, twenty adverse events were reported, five of which were inconsistent (25.0%). In another phase Ⅲ clinical trial, 197 adverse events were observed, 24.4% of which were inconsistent (48 adverse events). Conclusion The results of this study indicate that CEC meetings for adverse event adjudications can improve the quality and reliability of adverse event evaluation in multi-center clinical studies using unified criteria. References | Related Articles | Metrics

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Literature Analysis of Levofloxacin-induced Delirium YANG Lei, WANG Fengling, WU Jingwei, LI Jun 2020, 17(9): 631-635.  DOI: 10.19803/j.1672-8629.2020.09.18 Abstract ( 547 )   PDF (1200KB) ( 417 )   Objective To explore the clinical characteristics and related factors of levofloxacin-induced delirium so as to provide reference for rational and safe use of levofloxacin in clinic. Methods Such databases as CNKI, VIP, Wanfang, and PubMed were searched for related articles published since inception. With "levofloxacin", "delirium", "psychosis" or "disorder" as the key words, all the original literature on levofloxacin-induced delirium was selected and the data about the corresponding indicators was extracted and analyzed. Results A total of 712 articles were retrieved. According to the inclusion and exclusion criteria, 46 articles were accepted and 57 cases of delirium induced by levofloxacin were collected, 35 of whom (61.40%) were males and 22 (38.60%) were females. Among these cases of delirium induced by levofloxacin, 29 involved elders above 65 years old (50.88%). Conclusion Despite the low incidence of delirium induced by levofloxacin, the therapeutic effect and mental health of patients are affected, making it necessary to pay attention to the clinical use. When symptoms occur, correct regimens should be adopted without delay. References | Related Articles | Metrics

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Research Progress on Drug-loaded Albumin Nanoparticles LI Hui, WANG Dandan, YANG Han, ZHANG Xuenong 2020, 17(9): 636-642.  DOI: 10.19803/j.1672-8629.2020.09.19 Abstract ( 412 )   PDF (1082KB) ( 534 )   Albumin is widely used due to its good biocompatibility, nontoxicity and non-immunogenicity. Albumin nanoparticles have shown unique advantages in oncotherapy. This article summarizes the applications of albumin nanoparticles in tumor treatment and their preparation methods based on articles recently published at home and abroad. References | Related Articles | Metrics

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Research and Application Progress of Two-dimentional Liquid Chromatography on Quality Control for Traditional Chinese Herbal Medicines ZHU Xueyan 2020, 17(9): 643-646.  DOI: 10.19803/j.1672-8629.2020.09.20 Abstract ( 285 )   PDF (593KB) ( 124 )   Objective To summarize the development and the principal of applications of two-dimensional liquid chromatography. Methods The structures and application fields of two-dimensional liquid chromatography was introduced. The progress of its qualitative and quantitative study on Chinese Materia Medica was emphasized and described. Results and Conclusions Applications of two-dimensional liquid chromatography on quality control of traditional Chinese herbal medicines is prospected. References | Related Articles | Metrics