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Implications of Regulatory Science for the Construction of Medical Device Vigilance Systems MAO Zhenbin, LIU Shuyu 2021, 18(7): 601-605.  DOI: 10.19803/j.1672-8629.2021.07.01 Abstract ( 241 )   PDF (1427KB) ( 211 )   By reviewing the development of regulatory science in developed countries, and based on the research on the construction of medical device vigilance systems, the evolution and methods of regulatory science and vigilance systems of medical devices in China were explored while five strategies for innovation and optimization and seven disciplines of regulatory science of medical devices were proposed. The priorities for the establishment and innovation of the medical device vigilance system with Chinese characteristics were specified. References | Related Articles | Metrics

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Efficacy of Oral Dosage Forms of Clindamycin Palmitate Hydrochloride WANG Chen, XU Mingzhe 2021, 18(7): 606-610.  DOI: 10.19803/j.1672-8629.2021.07.02 Abstract ( 185 )   PDF (1510KB) ( 140 )   Objective To investigate strategies for efficacy evaluation of oral dosage forms of pro-drugs based on the findings related to oral dosage forms of clindamycin palmitate hydrochloride. Methods Beagles were used to determine the drug concentration in blood. A physiologically based pharmacokinetic (PBPK) model was established and validated with the data collected from animal experiments. The efficacy was compared between clindamycin palmitate hydrochloride dispersible tablets and suspension using inter-species extrapolation and population analog approaches. Results The results showed that the peak time of blood concentration (tmax) was 1.9 hours for both the testing sample and reference sample. The maximum concentration (cmax) was 1.215 and 1.150 μg/mL, respectively, and the 90% confidence interval of the ratio between average values was 95.6%~115.8%.The average value of the area under the curve (AUC0-t) was 5.462 and 5.331 μg·h/mL respectively,and the 90% confidence interval of the ratio between average values was 88.5%~116.4%. The testing sample and reference sample had similar pharmacodynamics parameters and it was predicted that testing sample was bioequivalent to the reference sample based on analysis of tmax, cmax and AUC0-t parameters. There was no significant difference between the testing and reference samples, for the gram-positive bacterium the antimicrobial inhibition time was 11.7 and 11.6 hours respectively, compared to 9.9 and 9.7 hours for the gram-negative bacterium. Conclusion The strategy developed in this research, which used data from only a few animal experiments, has considerable advantages over the in-vitro evaluating methods in terms of accuracy and reliability. It can be used as a low-cost and reliable pre-evaluation tool before conducting the conventional BE study. References | Related Articles | Metrics

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Determination of Silicon in Pantoprazole Sodium for Injection by ICP-MS DUAN Xiying, WANG Dongyun, XU Jia, QIU Yajing, XU Mingzhe 2021, 18(7): 611-613.  DOI: 10.19803/j.1672-8629.2021.07.03 Abstract ( 96 )   PDF (1067KB) ( 81 )   Objective To establish a method for the determination of silicon in pantoprazole sodium for injection. Methods Inductively coupled plasma mass spectrometry (ICP-MS) was used to determine the contents of silicon, while 45Sc was used as the internal standard of 28Si. Results The linear ranges of Si was 100-5 000 ng/mL. The r value was 0.999 9. The RSD of precision was 0.7%, compared to 1.0% for the repeatability test, and 1.1% for intermediate precision. The average recovery rate of low, medium and high concentrations was 102.3% (n=9). Conclusion This method is accurate and sensitive, which can be used for determination of Si in pantoprazole sodium for injection. References | Related Articles | Metrics

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Quality Consistency of Omeprazole Sodium for Intravenous Injection LIU Heying, LIU Xuping, ZHONG Zhenhua, PEI Kun, XIA Hongying, CHENG Qizhen, WANG Chen 2021, 18(7): 614-619.  DOI: 10.19803/j.1672-8629.2021.07.04 Abstract ( 185 )   PDF (1441KB) ( 259 )   Objective To study the quality consistency between generic drugs and reference drugs of omeprazole sodium for intravenous injection by comparing the data on the crystal form, impurity profiles and other standard tests. Methods Thirty-three batches of omeprazole sodium for intravenous injection (40 mg) produced by seven enterprises were tested. The crystal form was studied using the X-ray powder diffraction method. Related substances, alkalinity, clarity and color of solution, water content, weight uniformity, visible particles, insoluble particles and assay were determined according to the standards specified by Chinese Pharmacopoeia (2020 edition). Data was statistically processed using SPSS software. Results Generic drugs and reference drugs were both amorphous powders. The crystal form of omeprazole sodium from three enterprises was the same as that of reference drugs, but different from that of omeprazole. The generic drugs were not significantly different from reference drugs in impurity profiles, but significantly different from reference drugs in alkalinity (1 enterprise), color of solution (4 enterprises), water content (2 enterprises), average weight (4 enterprises) and content (1 enterprise). Only the generic drugs produced by one enterprise were not significantly different from reference drugs in the prescription, crystal form and test data. Conclusion Only the generic drugs produced by one enterprise are of the same quality as reference drugs, which suggests that enterprises should improve its product quality by improving its production process. References | Related Articles | Metrics

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Application Scope of Real-World Data in Post-Marketing Drug Safety Monitoring and Evaluation for Drug Safety QIAO Rui, LIU Yuqiang, ZHUO Lin, MENG Ruogu, SUN Feng, ZHAN Siyan 2021, 18(7): 620-623.  DOI: 10.19803/j.1672-8629.2021.07.05 Abstract ( 328 )   PDF (1180KB) ( 421 )   Objective To analyze and summarize the application status of real-world data (RWD) in post-marketing drug safety monitoring and evaluation. Methods The literature related to RWD and post-marketing drug safety were searched and statistical analyzed in PubMed, Embase, SinoMed, CNKI and other databases from the establishment to January 2, 2020. Results The scope of application of RWD in post-marketing drug safety monitoring and evaluation research is mainly reflected in 3 aspects, including research design, drug categories and clinical problems. Conclusion RWD has a wide range of applications in post-marketing drug safety monitoring and evaluation. The full and reasonable use of RWD to carry out real-world study (RWS) can open up a new way for the active monitoring and evaluation of drug safety after marketing. References | Related Articles | Metrics

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Application Values of Real-World Evidence in Post-Marketing Surveillances and Evaluation for Drug Safety MENG Ruogu, ZHUO Lin, QIAO Rui, LIU Yuqiang, SUN Feng, ZHAN Siyan 2021, 18(7): 624-627.  DOI: 10.19803/j.1672-8629.2021.07.06 Abstract ( 217 )   PDF (1046KB) ( 307 )   Objective To understand the application values of real-world evidence (RWE) in post-marketing surveillance and evaluation for drug safety. Methods Literatures related to RWE in post-marketing surveillance for drug safety were searched in PubMed, Embase, Web of Science, Scopus, SinoMed, CNKI, VIP, Wanfang Data from the establishment to January 2, 2020. Results and conclusion After research team and expert consultation, application values of RWE in post-marketing surveillance and evaluation for drug safety was summarized into four aspects, including supplementing drug safety evidence, auxiliary drug post-marketing management, supporting clinical decision-making and health policies, as well as technical methods development and optimization. And for each aspect reference cases were provided. References | Related Articles | Metrics

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Ethical Risks of Real-World Data in Post-Marketing Drug Safety Studies LIU Yuqiang, QIAO Rui, ZHUO Lin, MENG Ruogu, SUN Feng, ZHAN Siyan 2021, 18(7): 628-631.  DOI: 10.19803/j.1672-8629.2021.07.07 Abstract ( 211 )   PDF (1144KB) ( 310 )   Objective To provide a reference for making better use of real-world data (RWD) ethical requirements to carry out post-marketing drug safety monitoring and evaluation. Methods From the perspective of patient safety and data security, discuss the ethical requirements of RWD in the research protocol, the ethical requirements of research registration and publication, and the ethical considerations of data ownership and data usage permissions. Results and Conclusion It is recommended to legislate and formulate policies on ethical issues in real-world study (RWS), and at the same time strengthen research on related issues such as the innovation of RWD ethical review forms. References | Related Articles | Metrics

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Evaluation of Pharmacokinetics of Aconiti Lateralis Radix of Shenfu Prescription in Rats with Heart Failure XIE Guanghui, MA Zengchun, MEI Yu, ZHANG Xuemei, TAN Hongling, GAO Yue 2021, 18(7): 632-636.  DOI: 10.19803/j.1672-8629.2021.07.08 Abstract ( 68 )   PDF (1544KB) ( 71 )   Objective To study the pharmacokinetics of Aconiti Lateralis Radix of Shenfu prescription in rats with heart failure and provide data for toxicity reduction and enhanced efficacy of Ginseng and Aconiti Lateralis Radix. Methods An animal model with heart failure was established and evaluated in 40 SD rats (half male and half female). After surgery, SD rats were divided into three groups: normal, model and M+ginseng groups. Blood samples were collected at 0, 0.25, 0.5, 1, 2, 4, 8, 12, 24 and 48 h after oral administration of Fuzi extracts. UPLC-MS/MS was used for determination of blood drug concentrations while DAS software was used to analyze pharmacokinetic parameters. Results Evaluation of the model group showed that the heart failure markers in serum of rats were significantly higher. The coefficient of cardiac weight was increased. Meanwhile, mass death of myocardial cells was observed and the space between myocardial fibers was wider pathologically, suggesting that the establishment of the model was successful. The results of pharmacokinetic parameters showed that the AUC (0~48 h) became much smaller and t1/2z of AC and HA was significantly shortened in the model group compared with the normal group. In addition, compared to the model group, the AUC (0~48 h) and t1/2z of the M+ginseng group were increased. Conclusion The absorption of aconitum alkaloids in rats with heart failure is poor but the metabolic rate is faster, leading to a short retention time. Ginseng could improve the metabolic process of aconitum alkaloids in vivo significantly, which means better absorption and a longer action time. This may be the reason that the efficacy is enhanced. References | Related Articles | Metrics

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Study on Applicability of QAMS to Multi-component Content Determination of Citri Reticulatae Semen MA Zhaozhao, WANG Qian, GAO Le, ZHEN Yaqin, WANG Xinguo, NIU Liying, ZHANG Liyan 2021, 18(7): 637-640.  DOI: 10.19803/j.1672-8629.2021.07.09 Abstract ( 71 )   PDF (1200KB) ( 65 )   Objective To establish a quantitative analysis of multi-components by single mark (QAMS) for determining the contents of three compositions (limonin, nomilin, obacunone) from orange kernels, salt citri reticulatae semen and their granule, and verify the feasibility and applicability of this method in quality control. Methods Limonin was used as the internal reference substance. The HPLC analysis was performed on a Waters Symmetry C18 (4.6×250 mm, 5 μm) column with a mobile phase consisted of acetonitrile and water (45∶55) at a flow rate of 1 mL/min-1. The column temperature was maintained at 35 ℃, and the detection wavelength was set at 220 nm. Results The relative correction factors of Limonin, nomilin and obacunone were established, without significant difference between the calculated values by QAMS and measured valves. Conclusion The experimental QAMS method can accurately determine the contents of the three compositions in citri reticulatae semen, and can be used in the multi-index evaluation in orange kernels. References | Related Articles | Metrics

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Aripiprazole's Effect on Metabolism in Patients with Behavioral and Psychological Symptoms of Dementia and Correlations between Clinical Efficacy and Blood Concentration CHENG Xialong, ZHANG Xulai, WU Xiaoping, DAI Biao, WANG Anzhen, YAN Fanfan 2021, 18(7): 641-644.  DOI: 10.19803/j.1672-8629.2021.07.10 Abstract ( 102 )   PDF (1257KB) ( 425 )   Objective To observe the efficacy of aripiprazole in the treatment of behavioral and psychological symptoms of dementia (BPSD) and its effect on BMI, glucose and lipid metabolism, and explore the correlation between the blood concentration of aripiprazole and clinical efficacy. Methods Thirty patients with BPSD were treated with aripiprazole for 6 weeks. BEHAVE-AD and TESS were used for assessment of the efficacy while BMI, fasting blood glucose (FBS), cholesterol (TC), triglyceride (TG), and high-density lipoprotein (HDL) of the patients were determined. The blood concentration of aripiprazole was determined by HPLC. Results The patients’BEHAVE-AD score decreased significantly after 6 weeks of aripiprazole treatment (P<0.01). BMI, fasting blood glucose, cholesterol, triglyceride, and high-density lipoprotein did not change significantly after treatment. The blood concentrations of aripiprazole at the 4th and 6th weeks of treatment were significantly and positively correlated with the reduction rate of BEHAVE-AD. The blood concentration of the effective group was significantly higher than that of the ineffective group. Conclusion Aripiprazole is effective for BPSD, and has little effect on BMI、glucose or lipid metabolism. It is suitable for patients with cardiovascular and cerebrovascular diseases. There is some correlation between the blood concentration of aripiprazole in the treatment of BPSD and the clinical effect, suggesting that the use of blood concentration as an index can contribute to the efficacy and dose adjustment. References | Related Articles | Metrics

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Formulation and Research of Guidelines for Risk Assessment of Pesticide Residues in Traditional Chinese Medicine WANG Ying, ZHANG Lei, ZUO Tiantian, SHEN Mingrui, JIN Hongyu, MA Shuangcheng 2021, 18(7): 645-648.  DOI: 10.19803/j.1672-8629.2021.07.11 Abstract ( 168 )   PDF (1159KB) ( 139 )   Objective To provide route and reference for the research of pesticide risk assessment in TCM. Methods The risk assessment procedure of pesticide residues in TCM includes four steps: hazard identification, hazard characterization, exposure assessment and risk description. The common methods of pesticide risk assessment were summarized, and the research route and the selection of important parameters of pesticide risk assessment methods in TCM were discussed in this paper. Results The risk assessment system of pesticide residues in accordance with the use characteristics of TCM was gradually established, and the guiding principles of risk assessment were formed. Conclusion The risk assessment of pesticide residues in traditional Chinese medicine (TCM) is of great significance for the formulation of pesticide residue standards and safety supervision. References | Related Articles | Metrics

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Current Research on Quantitative Drug Benefit-Risk Assessment Methods and Its Englightenment GUO Zhijian, HU Fangyuan, ZHENG Yi, LIANG Jizhou, XU Jinfang, GUO Xiaojing, YE Xiaofei, HE Jia 2021, 18(7): 649-654.  DOI: 10.19803/j.1672-8629.2021.07.12 Abstract ( 268 )   PDF (1216KB) ( 321 )   Objective To introduce the basic principles and latest developments of current quantitative drug benefit-risk assessment methods. Methods Current guidelines for drug benefit-risk assessment were consulted while domestic and foreign literature on quantitative drug benefit-risk assessment methods was retrieved to conduct a literature review. Results Several well-grounded quantitative benefit-risk assessment methods were outlined. The current applications of quantitative benefit-risk assessment methods of drugs were analyzed and the developments of quantitative assessment methods were explored. Conclusion There is no specific consensus on the selection and use of quantitative drug benefit-risk assessment methods. The relatively novel methods have not been widely used and need to be verified and confirmed in the real drug benefit-risk assessment context. References | Related Articles | Metrics

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Early Warning of Aconitum Herbs in Breast Cancer Therapy by Bibliometric and Bioinformatics WANG Yu, LIN Zhijian, JIANG Zhuoxi, YANG Ting, WANG Xiao, ZHANG Bing 2021, 18(7): 655-662.  DOI: 10.19803/j.1672-8629.2021.07.13 Abstract ( 110 )   PDF (1803KB) ( 100 )   Objective To explore the rational application of traditional Chinese medicine in cancer therapies via the treatment of breast cancer with aconitum herbs. Methods Methods of bibliometric and bioinformatics were employed. The microarray data of GSE85871 was downloaded from GEO database and analyzed by means of Gene Ontology (GO) annotation, Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analysis and protein-protein interaction networks. Results The treatment of breast cancer with aconitum herbs might be accompanied by abnormalities of pathways of aldosterone synthesis and secretion, endocrine metabolism, neurochemical transduction and bone metabolism. Conclusion The circulatory system, nervous system, endocrine system and skeletal system deserve attention before and during medication with aconitum herbs. References | Related Articles | Metrics

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An Active Model for Monitoring and Early Warning of Cephalosporin Adverse Drug Reactions in Pediatrics Using Global Trigger Tools XIONG Daiqin, MA Xueying, TENG Liang, WANG Jie 2021, 18(7): 663-668.  DOI: 10.19803/j.1672-8629.2021.07.14 Abstract ( 124 )   PDF (1283KB) ( 111 )   Objective To establish an active monitoring model for adverse reactions of cephalosporins in hospitalized children using global trigger tools (GTT) in order to provide data for the prevention and treatment of related adverse reactions. Methods A total of 102 pediatric medical records of allergic reactions to cephalosporins in a hospital between 2017 and 2018 were collected as the test group, while another 269 patients who used the drug during the same period but without any allergic reactions were randomly selected as the control group. Single-factor analysis and multi-factor binary logistic regression analysis were conducted to establish an active monitoring model of adverse drug reactions (ADR). Then, the model's calibration was tested with the Hosmer-Lemeshow (HL) method, and the predictive value of the monitoring model was tested by the receiver operating characteristic (ROC) curve. Results There was no apparent difference in age and gender between the 102 cases with ADR after using cephalosporins. Skin rash and hypotension were the most common clinical manifestations in these cases. The independent variable factors with P≤0.2 in the results of the univariate analysis were selected to establish an active monitoring model of ADR of cephalosporins in pediatric patients: Logit(p)=In$\frac{p}{-p}$1.822=1.822 (neurological disease)-3.43 (white blood cell count<3×109/L)-4.162(with hormone drugs)-5.956 (excessive sedation/hypotension/drowsiness)-5.041 (skin rash). The goodness-of-fit test results showed that the model was highly accurate, specific and sensitive. Conclusion The active monitoring model of ADR induced by cephalosporins in pediatrics is of high predictive value. Active intervention in a child's primary disease, white blood cell count, drug use, blood pressure, consciousness, rash and other risk factors can help reduce the chance of adverse drug reactions. References | Related Articles | Metrics

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Analysis of 313 Instructions for Injectable Drugs ZHANG Yongheng, HAN Chen, YANG Xiao, HAN Xiuqi, YUAN Hongchang, DENG Zhijian 2021, 18(7): 669-673.  DOI: 10.19803/j.1672-8629.2021.07.15 Abstract ( 134 )   PDF (1150KB) ( 159 )   Objective To investigate the labeled information in the instructions of injectable drugs and provide reference for the improvement of instructions. Methods A total of 313 instructions for injectable drugs used in the First Affiliated Hospital of Xinxiang Medical University from January 2018 to November 2019 were collected before the items and contents in the instructions were statistically analyzed. The labeling rates were compared between imported drugs and home-made ones, and the difference in the specifications of the same type of injectable drug by different manufacturers was also studied. Results The labeling rate of drug interactions, drug overdose and toxicology in the instructions of imported drugs was higher than that of domestic drugs, with statistically significant differences (P<0.05). The difference rate in the specifications of the same type of drug produced by different enterprises was 42.86% (9/21). Conclusion The labeling rate of instructions of imported drugs is higher than that of home-made drugs. There are differences in the specifications of the same type of injectable drug produced by different enterprises. References | Related Articles | Metrics

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Literature Analysis of Anaphylactic Shock Induced by Reduced Glutathione for Injection XI Yuling, HUI Hongyan, GUO Xiaohe, DENG Zhijian 2021, 18(7): 674-677.  DOI: 10.19803/j.1672-8629.2021.07.16 Abstract ( 166 )   PDF (1270KB) ( 132 )   Objective To explore the clinical characteristics and regularity of anaphylactic shock by caused by reduced glutathione for injection in order to provide data for clinical rational drug use. Methods Related literature published between January 1979 and September 2019 was retrieved from CNKI, Wanfang databases, VIP and Pubmed. The age, gender, daily dose, time for medication of anaphylactic shock, combined medication, preexisting diseases, clinical manifestations as well as prognosis were analyzed. Results A total of 27 case reports related to anaphylactic shock and involving 30 patients were collected. Patients with immediate anaphylactic shock (within 30 minutes of medication ) accounted for 93.9% of the total. The initial symptoms of anaphylactic shock mainly involved the respiratory system (chest tightness, dyspnea and asthma) and the circulatory system (sudden drop of blood pressure, cyanosis of the mouth and lips). Conclusion Anaphylactic shock caused by reduced glutathione for injection in severe cases can lead to fatal events, especially within 30 minutes. The symptoms of patients should be closely monitored to prevent fatal events. References | Related Articles | Metrics

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Analysis of Safety Risks of Ginkgo Biloba Tablets and Other Oral Preparations YU Yi, HUANG Qianqian, XIAO Aili 2021, 18(7): 678-682.  DOI: 10.19803/j.1672-8629.2021.07.17 Abstract ( 164 )   PDF (1206KB) ( 159 )   Objective To analyze the risks of Ginkgo Biloba tablets and other oral preparations, and to provide reference for safe clinical use. Methods The adverse reactions/events reported by China adverse drug reaction monitoring systems and by domestic and foreign literature, as well as risk management measures taken by drug regulatory authorities were analyzed. Results Adverse reactions/events involving multiple systems / organs might occur in clinical use of Ginkgo Biloba tablets and other oral preparations. There was the risk of drug interactions in combination therapies, and there were also some risks to the control of free quercetin, kaempferol and isorhamnetin in the course of production. Conclusion In order to prevent and control the safety risks posed by Ginkgo Biloba tablets and other oral preparations in clinical use, hospitals should strive to ensure clinical rational drug use, marketing authorization holders should fulfill their main responsibility of pharmacovigilance, and institutions of monitoring and evaluation of adverse drug reactions should strengthen the monitoring of adverse reactions. References | Related Articles | Metrics

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Risks of Shuanghuanglian Oral Preparation YU Hongli, YU Dongmei, PANG Yu, SHAO Bo, SONG Haibo 2021, 18(7): 683-685.  DOI: 10.19803/j.1672-8629.2021.07.18 Abstract ( 188 )   PDF (1135KB) ( 159 )   Objective To analyze the risk of Shuanghuanglian oral preparation in order to provide reference for rational clinical use. Methods Cases of adverse reactions related to Shuanghuanglian oral preparation that were retrieved from China adverse drug reaction database and domestic literature were analyzed. Results The adverse drug reaction/adverse event (ADR/AE) reports from the national ADR monitoring system and literature showed that the ADR of Shuanghuanglian oral preparation involved multiple systems and organs, and that the clinical manifestations included rash, pruritus, nausea and vomiting, etc. Conclusion Shuanghuanglian oral preparation should be used with caution and related adverse reactions deserve attention. References | Related Articles | Metrics

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Bibliometric Analysis of Pharmacovigilance Research in China ZHENG Mingjie, ChENG Rong, SONG Haibo 2021, 18(7): 686-688.  DOI: 10.19803/j.1672-8629.2021.07.19 Abstract ( 283 )   PDF (1251KB) ( 272 )   Objective To analyze the current status and shortcomings of pharmacovigilance research in China and provide references for promoting pharmacovigilance research. Methods Literatures related to pharmacovigilance and Pharmacovigilance of PubMed and CNKI from the establishment of the database to 31 December 2020 were searched and analyzed. The trends of pharmacovigilance research at home and abroad were compared. The current status and deficiencies of relevant research in China were analyzed. Results The research on pharmacovigilance in China still focuses on traditional adverse drug reaction monitoring, mainly involving pharmacy, traditional Chinese medicine and preventive medicine., which may be due to the fact that China's pharmacovigilance system has just been implemented, domestic colleges and universities lack academic education in the field of pharmacovigilance, medical institutions and enterprises are not highly involved in pharmacovigilance research, and scientific research management departments have insufficient funding for pharmacovigilance research. Most academic journals do not regard pharmacovigilance related research as a key area of publication. Conclusion Effective measures should be taken to promote the research development and system implementation of pharmacovigilance in China. References | Related Articles | Metrics

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Pharmaceutical Care of a Patient with HBV Infection after Second Renal Transplantation SUN Shaowei, LIN Tingting, WEI Chuanmei, LYU Wenwen, SONG Zheng 2021, 18(7): 689-692.  DOI: 10.19803/j.1672-8629.2021.07.20 Abstract ( 88 )   PDF (1138KB) ( 53 )   Objective To explore pharmaceutical care methods for patients with hepatitis B virus (HBV) infection after second renal transplantation. Methods Clinical pharmacist provided individualized pharmaceutical care for a patient with HBV infection after second renal transplantation, analyzed the abnormal indexes during treatment, and offered recommendations about pharmacy. Results Urine protein and urine microalbumin disappeared, hepatitis B virus-related liver damage was improved, and the tacrolimus concentration was controlled to reach the standard. Conclusion Clinical pharmacists need to offer individualized pharmaceutical care for patients with hepatitis B virus infection after renal transplantation. References | Related Articles | Metrics

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Pharmaceutical Monitoring of Immunohepatitis Caused by PD-L1 Inhibitor: a Case Study WANG Xiaoxiao, CHEN Wanyi 2021, 18(7): 693-696.  DOI: 10.19803/j.1672-8629.2021.07.21 Abstract ( 156 )   PDF (1180KB) ( 154 )   Objective To explore the role of clinical pharmacists in the treatment of adverse drug reactions induced by PD-L1 inhibitors. Methods Related literature and guidelines were reviewed, while pharmaceutical recommendations and care were given by clinical pharmacists in response to adverse reactions induced after treatment of immune hepatitis with PD-L1 inhibitors (durvalumab). Results Adverse reactions were assessed by clinical pharmacists, who offered an effective and feasible treatment program so that the patient got better after treatment with hormones and immunosuppressive agents. Conclusion Clinical pharmacists should be alert to immune-related adverse reactions of PD-L1 inhibitors and help physicians to ensure the safety of clinical medication. References | Related Articles | Metrics

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Hypothyroidism Caused by Terepril and Literature Analysis ZHAO Shuang, MIAO Qiuli, SONG Yanqing, LI Yue 2021, 18(7): 697-699.  DOI: 10.19803/j.1672-8629.2021.07.22 Abstract ( 272 )   PDF (874KB) ( 1451 )   Objective To analyze the clinical characteristics, risk factors, diagnosis and therapeutic strategy of hypothyroidism caused by terepril monoclonal antibody based on the cases. Methods A case of hypothyroidism induced by rectal cancer treated with terepril monoclonal antibody was analyzed, and the related literature was summarized. Results In this case, a 44 year old male patient with multiple metastases of rectal cancer after two or three lines of chemotherapy was treated with terepril monoclonal antibody 240 mg intravenously. This patient presented with symptoms such as decreased levels of FT3 and FT4 and elevated levels of TSH . Left thyroxine sodium tablet was given 12.5 μg orally once a day. Blood routine showed that there was no significant abnormality in the three normal values of thyroid function. The patient did not stop the treatment of terepril monoclonal antibody. Conclusion During the treatment of terepril monoclonal antibody, we should pay attention to the clinical symptoms and imaging characteristics of the patients, identify the immune-related hypothyroidism that may be caused by terepril monoclonal antibody. The patients with immune-related adverse reactions should be given corresponding treatment according to their severity, and at the same time, we should be alert to the risk of recurrence after re administration. References | Related Articles | Metrics