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Chinese Journal of Pharmacovigilance
15 November 2022, Volume 19 Issue 11

15 November 2022, Volume 19 Issue 11 Previous Issue   
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Allergic test of azithromycin for injection in guinea pigs in non-clinical safety evaluation
LIU Chun, WANG Jucai, HUANG Yuchang, YE Xiaoqing, ZHAO Yingshu, ZHAN Meimei, WANG Chen
2022, 19(11): 1161-1164. 
DOI: 10.19803/j.1672-8629.20220377

Abstract ( 71 )   PDF (1227KB) ( 67 )  
Objective To evaluate the allergic test methods in non-clinical safety evaluation by investigating allergic reaction of guinea pigs induced by azithromycin for injection. Methods The active systemic anaphylaxis(ASA): Guinea pigs were randomly divided into negative control group, positive control group, low-dose group(2.5 mg·kg-1) and high-dose group(10 mg·kg-1) in experiment I.The intraperitoneal injections of azithromycin for injection were administrated to guinea pigs once every other day for three times. On the 14th and 21st days after the last sensitization, the symptom of allergic reaction was observed by intravenous administration of azithromycin for injection. The other methods were same as the experiment I, except the dose of high-dose group was set at 5 mg·kg-1 in experiment II.The doses of passive cutaneous anaphylaxis (PCA) were as same as the ASA. On the 11th day after the last sensitization, antiserums were prepared. Guinea pigs of each group were injected intradermally by diluted antiserum. The blue spot diameter in skin was measured after intravenous administration of the same doses after 24 hours. Results No systemic allergic reaction was observed on guinea pigs administrated of azithromycin on the 14th day after the last sensitization in experiment I of ASA. The symptom of nose-scratching or wheezing sound was observed in high-dose group after intravenous administration of azithromycin on the 21st day in experiment I of ASA. No systemic hypersensitive reaction was observed both on the 14th and 21st days in experiment II of ASA. The positive reaction was observed in positive control group, while no allergic reaction was observed in the azithromycin administration group of PCA. Conclusion The occurrence of allergic reactions may be related with the dose and the sensitization time. The method has its own limitations. More focus may be given to the allergic test in non-clinical safety evaluation, because even if it meets the guiding principles, allergic reactions may also be caused.
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Methodological research of abnormal toxicity and pyrogen on glycosaminoglycan from sea cucumber for injection
WANG Zongwei, XIAO Jiayin, WANG Chunyu, GAO Haishu, YAO Shangchen, XU Mingzhe
2022, 19(11): 1165-1169. 
DOI: 10.19803/j.1672-8629.20220397

Abstract ( 33 )   PDF (1331KB) ( 26 )  
Objective To establish abnormal toxicity test and pyrogen test of glycosaminoglycan from sea cucumber for injection. Methods The median ethal dose (LD50) and 95% confidence limit of glycosaminoglycan from sea cucumber for injection were obtained by referring to guiding Principles for Application of Injection Safety Test method in Pharmacopoeia of the people’s Republic of China, Volume IV, 2020 edition, and the limit of abnormal toxicity test was determined. A methodological study on pyrogen test of glycosaminoglycan from sea cucumber for injection was studied. Results The LD50 of this product was 189.4 mg·kg-1 for intravenous injection, and the 95% confidence limit was 239.0~139.8 mg·kg-1. 1/4 of the lower confidence limit (139.8 mg·kg-1) was taken as the limit of abnormal toxicity, that was, 35 mg·kg-1 was injected into the tail vein of mice. The product was prepared with sodium chloride injection into a solution with a concentration of 1.4 mg·mL-1, and examined according to the abnormal toxicity test method 1141, Pharmacopoeia of the People’s Republic of China, Volume IV, 2020 Edition. As the results, all the mice were in normal state after injection, and no death was observed in 48 hours. Glycosaminoglycan from sea cucumber for injection was prepared with sodium chloride injection in a solution of 1 mg·mL-1 at a dose of 2 mg·kg-1 of rabbits body weight (about 5 times of the clinical dosage), which had no interference on the increase of rabbits’ body temperature caused by bacterial endotoxin. Conclusion 35 mg·kg-1 dose can be used as the limit of abnormal toxicity; the pyrogen of this product can be controlled by rabbits method, and 2 mg·kg-1 dose is used as the limit for pyrogen examination.
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Evaluation of muscular irritation of parecoxib sodium injection
ZHAO Yingshu, LIU Chun, LI Liangcheng, WANG Chen
2022, 19(11): 1170-1173. 
DOI: 10.19803/j.1672-8629.20220390

Abstract ( 26 )   PDF (1735KB) ( 25 )  
Objective To evaluate the muscular irritation of Parecoxib Sodium injection in rabbits, and to provide a guideline for clinical safety. Methods The sample was injected intramuscularly in quadriceps of the rabbits, and reactions in the intra-individual left and right self-comparison method were compared in the same rabbit. The high and low concentrations of sample were 20 and 5 mg·mL-1 (in a volume of 0.5 mL) respectively. The general status, local visual observation of drug administration, anatomical observation and histopathological examination were used to synthesize the muscular irritation of the subject (or Parecoxib Sodium) in rabbits. Results The results showed a significant concentration-dependent irritation relationship after i.m. injection in rabbit quadriceps, namely 20 mg·mL-1 induced a moderate and irreversible irritation while 5 mg·mL-1 induced a minor and reversible irritation. Conclusion The common clinical concentration of Parecoxib Sodium for injection (20 mg·mL-1) has a high risk of muscle irritation, and under this test condition, 5 mg·mL-1 is the safe concentration for intramuscular injection.
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Feasibility study on grape seed proanthocyanidins as a new ophthalmic antibacterial agent
YIN Xiang, WANG Xi, SHI Chunhui, WANG Zongwei, WANG Lin, YAO Shangchen, XU Mingzhe
2022, 19(11): 1174-1180. 
DOI: 10.19803/j.1672-8629.20220398

Abstract ( 24 )   PDF (1505KB) ( 12 )  
Objective To investigate the bacteriostatic ability of grape seed proanthocyanidins in eye drops and provide experimental basis for the development of new antibacterial agents for eye drops. Methods The antibacterial ability and antibacterial efficacy of the original antibacterial agents and grape seed proanthocyanidins in eye drops were determined with reference to the general rule 1121 of the Ⅳ volume of the Chinese Pharmacopoeia, 2020 edition, and the ocular irritation of healthy rabbits was evaluated with reference to the compilation of guiding principles for preclinical research of new drugs (western medicines) issued by the national health and Family Planning Commission. In addition, in order to study the advantages of grape seed oligoprocyanidins as bacteriostatic agents, the cytotoxicity of grape seed procyanidins on HCEC cells and the inhibition of influenza A virus H1N1 were investigated by MTT colorimetry. Results With grape seed oligomeric proanthocyanidins as antibacterial agent, the reasonable addition was 0.10 mg·mL-1, and the antibacterial ability could reach grade 0.10 mg·mL-1 grape seed procyanidins aqueous solution had no irritation to rabbit eyes and had a certain inhibitory effect on influenza A (H1N1) virus. Conclusion Grape seed proanthocyanidin can be used as one of the antibacterial agents in eye drops.
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Discussion on the experimental scheme of microbial challenge method of sealing of packaging materials
SHI Chunhui, YIN Xiang, ZHANG Xiaoning, WANG Wei, YU Jiawei, YAO Shangchen, XU Mingzhe
2022, 19(11): 1181-1185. 
DOI: 10.19803/j.1672-8629.20220395

Abstract ( 65 )   PDF (1233KB) ( 57 )  
Objective To discuss the experimental scheme of microbial challenge method of sealing of packaging materials, so as to provide reference for ensuring the safety of sterile drugs in the whole life cycle. Methods The microbial suspension immersion method was adopted, and the key factors such as different packaging systems, different soaking strains and different soaking conditions were selected for corresponding experiments to explore the specific details of the microbial challenge method. Results This study determined the key parameters such as the preparation of positive samples, the selection of sample quantity, the selection of challenging microorganisms, the invasion concentration and the selection of microbial invasion conditions for the microbial invasion experiment, and selected the appropriate scheme to carry out the microbial challenge experiment on different packaging systems. The results met the corresponding requirements of various laws and regulations. The key pore size of microbial invasion is concentrated in 3-5μm,packaging systems with these apertures have the risk of contamination during daily storage and transportation. Conclusion Pharmaceutical enterprises should combine the actual situation,the physical method and the microbial challenge method should be effectively linked to ensure the sterility of the drug in the whole life cycle
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Content determination and health risk assessment of pyrrolizidine alkaloid N-oxides in Vignae Semen
ZAN Ke, ZHOU Ying, LI Yaolei, WANG Ying, JIN Hongyu, ZUO Tiantian, MA Shuangcheng
2022, 19(11): 1186-1190. 
DOI: 10.19803/j.1672-8629.20220317

Abstract ( 24 )   PDF (1333KB) ( 23 )  
Objective To determine the contents of pyrrolizidine alkaloid N-oxides in Vignae Semen, and to assess the risks. Methods A UPLC-MS/MS method was established to determine the contents of monocrotaline N-oxide, echinatine N-oxide,intermedine N-oxide and lycosamine N-oxide. An Acquity UPLC BEH C18 (50 mm× 2.1 mm, 1.7 μm) was used as the chromatographic column. The mobile phase was eluted with acetonitrile-0.1% formic acid solution (10:90) at a constant flow rate of 0.35 mL·min-1, and the injection volume was 2 μL. The electrospray spray ion source and positive ion multi-reaction monitoring mode were used. The contents were calculated using the standard curve method. Results The contents of monocrotaline N-oxide, echinatine N-oxide, intermedine N-oxide and lycosamine N-oxide in eight batches of Vignae Semen were 17.54-31.67 μg·kg-1. The risk assessment showed that the health risk of Vignae Semen was low. Conclusion This study provides data for quality control and safety evaluation of pyrrolizidine alkaloids in Vignae Semen.
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Comparative study on therapeutic effects of Qihuang Yiqi Shexue Formula prepared by different extraction processes on ITP model mice
LUO Yaqin, ZHANG Lanhong, HUANG Wei
2022, 19(11): 1191-1195. 
DOI: 10.19803/j.1672-8629.20210390

Abstract ( 20 )   PDF (1338KB) ( 15 )  
Objective To compare and screen the therapeutic effects of Qihuang Yiqi Shexue Formula prepared by different processes on immune thrombocytopenia (ITP) model mice. Methods The Qihuang Yiqi Shexue Formula was extracted by three different processes: water extraction, water extraction and alcohol precipitation, water extraction alcohol extraction, and the test samples prepared by process 1, process 2, and process 3 were obtained respectively; 70 BALB/c mice were randomly divided into 7 groups: normal group, model group, Qihuang Yiqi Shexue Formula process 1, process 2, process 3, Weixuening granules group and prednisone group, with 10 mice in each group. The intraperitoneal injection of guinea pig anti-mouse platelet serum (APS) was used to establish an ITP mouse model; on the 8th day after the injection of APS, each group was given intragastric administration for 14 consecutive days. To observe and compare the effects of each drug group on the general condition of ITP model mice, peripheral blood platelet count (PLT), spleen and thymus index, and bone marrow megakaryocyte count. Results Compared with the normal group, the PLT count and Hb concentration in the peripheral blood of the model group were significantly decreased (P<0.05 or P<0.01), the spleen and thymus index were significantly increased (P<0.01), and the number of megakaryocytes in the bone marrow plate was significantly reduced (P<0.01); compared with the model group, the Qihuang Yiqi Shexue Formula prepared by the three processes can significantly increase the PLT count of ITP model mice ( P<0.01), and the PLT of the process group 1 and group 3 increased significantly, among which the process 3 groups are close to the normal group; in terms of improving the Hb level, there was an increase in the process 1, 2, and 3 groups, but only the process 3 group had a significant difference (P<0.05); in terms of reducing the organ index, the spleen and thymus indexes of the process 1 and 3 groups all decreased significantly (P<0.05 or P<0.01), but there was no statistical difference in the degree of reduction in the process 2 group (P>0.05); in terms of improving the number of bone marrow megakaryocytes, the number of bone marrow-producing megakaryocytes in the process 1, 2, and 3 groups all increased significantly (P<0.01), and the increase was the most obvious in the process 3 group, but there was no statistical difference in other indicators (P>0.05). The positive drugs Weixuening granules and the prednisone group have different degrees of improvement on the above indicators, while the process 3 group was better than Weixuening granules and prednisone in increasing the PLT count, reducing the spleen coefficient, and increasing the number of bone marrow megakaryocytes. Conclusion The Qihuang Yiqi Shexue Formula prepared by 3 different processes has a certain therapeutic effect on ITP model mice, and the therapeutic effect is process 3>process 1 >process 2.
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Molecular mechanism of astragaloside IV in the treatment of ulcerative colitis and liver injury comorbidity based on network pharmacology
ZANG Kaihong, LIU Lili, WU Jianjun, GAO Tiantian, QIN Hongyan
2022, 19(11): 1196-1201. 
DOI: 10.19803/j.1672-8629.20210361

Abstract ( 20 )   PDF (1520KB) ( 18 )  
Objective To explore the pharmacological mechanism of Astragaloside IV in the treatment of ulcerative colitis and liver injury so as to provide evidence for clinical use of Astragaloside IV. Methods The action targets of Astragaloside IV for treating ulcerative colitis or liver injury were analyzed by searching PharmMapper and DRAR-CPI databases. GeneCards and OMIM databases were used to search for and screen the targets of ulcerative colitis and liver injury. The targets of Astragaloside IV were mapped to the disease targets of ulcerative colitis and liver injury respectively. STRING database was used to construct a “component-target-disease” network of Astragaloside IV for the treatment of ulcerative colitis and liver injury. The obtained results were further input into STRING database to analyze the protein-protein interactions in order to find the same targets related to ulcerative colitis and liver injury, and the DAVID database was used to conduct GO classification enrichment and KEGG signal pathway enrichment analysis. The key targets Astragaloside IV bounds to were validated using molecular docking techniques. Results A total of 322 targets related to Astragaloside IV were screened, including 202 anti-ulcerative colitis targets and 219 anti-liver injury targets, and 152 targets were involved in treating both ulcerative colitis and liver injury. Results from KEGG analysis showed that the shared mechanisms of Astragaloside IV against both ulcerative colitis and liver injury involved PI3K-Aktsignaling, FoxO signaling, JAK-STAT signaling, PPAR signaling and MAPK signaling pathways, which might have some effect on the processes of immune response, production of inflammatory cytokines, cells proliferation and differentiation. Conclusion The common therapeutic mechanism of Astragaloside IV against ulcerative colitis and liver injury involve PI3K-AKT signaling, FoxO signaling, JAK-STAT signaling, PPAR signaling and MAPK signaling pathways. Immune response, expressions of inflammatory factors, cell proliferation and differentiation regulation play an important role in the treatment of UC and liver injury comorbidity with Astragaloside IV.
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Effects of a single oral administration of finasteride tablets on bilirubin levels
LI Lingjun, TAO Lei, WEI Jun, LI Hongyang, CAI Baole, MA Pengcheng
2022, 19(11): 1202-1205. 
DOI: 10.19803/j.1672-8629.20210275

Abstract ( 28 )   PDF (1330KB) ( 19 )  
Objective To study the safety and adverse events of finasteride in healthy Chinese subjects and to provide reference for rational use of drugs. Methods A total of 103 healthy Chinese male volunteers were enrolled in fasting and fed states in two randomized, crossover, two-period, bioequivalence studies of the test preparation of single oral 5 mg finasteride. All laboratory parameters, vital signs, and adverse events were monitored and recorded throughout the study. Results In both trials, finasteride was well tolerated and no serious adverse events were reported. Among the adverse events that were observed, the elevation of bilirubin levels was the most frequent in each trial, and resolved within 10 days. Conclusion Finasteride is a potent and selective UGT1A4-competitive inhibitor that is critical to the metabolism of bilirubin. Finasteride may cause bilirubin elevation. It is recommended that clinicians pay attention to the risk of bilirubin elevation associated with finasteride in clinical use.
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Regularity of combined medication of elemene emulsion injection in the treatment of malignant tumors in the real world
WEI Ruili, ZHAO Xiaoxiao, XI Junyu, XIE Yanming
2022, 19(11): 1206-1212. 
DOI: 10.19803/j.1672-8629.20220045

Abstract ( 26 )   PDF (1448KB) ( 23 )  
Objective To explore the combined drug use law of Elemene emulsion injection in the treatment of malignant tumors in the real world based on data mining technology. Methods 3 671 malignant tumor patients who had used elemene injection at least once were included in hospital information system (HIS) from January 1, 2003 to July 31, 2019. The statistical analysis was completed by R software. This paper describes the clinical characteristics of malignant tumor population, uses Apriori algorithm to analyze the association of combined drug regimens for malignant tumor patients, and uses Louvain clustering method to mine the complex network of core treatment regimens of 1 233 excellent effect people. Results There were 146 cases of missing sex records in patients with malignant tumors treated with elemene emulsion injection. Male (2 244 cases, 61.13%) was higher than female (1 281 cases, 34.90%). The patients aged 46~65 years were the most (1 705 cases, 46.45%). The most common diseases are lung cancer(4 145 cases, 15.95%), with hypertension and diabetes. The frequency of combined use of Western medicines was significantly higher than that of Chinese patent medicines. The top three Western medicines were vitamins, dexamethasone and insulin for injection, and the top three Chinese patent medicines were compound Sophora flavescens injection, Kang’ ai injection and Shenqi Fuzheng injection. Compound Matrine injection is the most used Chinese patent medicine. Association rule analysis showed that elemene emulsion injection combined with lidocaine and heparin had the highest support (46.46%), and the support of combined Chinese patent medicine is generally lower than that of combined Western medicine. The results of complex network analysis of dominant population showed that elemene emulsion injection combined with heparin had the highest weight. The core anti-tumor drug regimen was elemene injection combined with heparin, lidocaine and dexamethasone. In addition, it was often combined with therapeutic drugs for cardiovascular system, respiratory system and digestive system. Conclusion Elemene injection combined with surgery, radiotherapy and chemotherapy in the treatment of a variety of malignant tumors. The combined drug characteristics suggest that we should pay attention to the management of patients’ basic diseases, especially cardiovascular disease and blood glucose. For the common complications of tumor (such as nausea, vomiting, venous thrombosis, constipation, etc.), based on the symptomatic treatment of Western medicine, various Chinese patent medicines are selected according to syndrome differentiation to improve the quality of life of patients.
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Risk difference between aristolochic acid and clinical use of traditional Chinese medicines in aristolochiaceae
ZHU Wenjing, ZHANG Lidan, ZHOU Yue, LEI Haimin
2022, 19(11): 1213-1217. 
DOI: 10.19803/j.1672-8629.20210325

Abstract ( 25 )   PDF (1330KB) ( 23 )  
Objective To study the difference between aristolochic acid toxicity and Aristolochiaceae in order to provide reference for rational use of toxic traditional Chinese medicines (TCM) and prevent confusion. Methods A series of problems with safe medication caused by aristolochic acid products was retrospectively analyzed through literature review. The risks of using Aristolochiaceae were summarized, and previous studies on aristolochic acid reduction were outlined. Results The problems caused by aristolochic acids were essentially different from those by Aristolochiaceae. Compliance with theories of TCM and rational use of Aristolochiaceae will not cause serious adverse reactions. Conclusion More rigorous supervision of toxic TCM are recommended. Irrational fears about the toxicity of TCM should be eliminated so as to boost the development of TCM industry.
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Comparative study on drug signal detection and evaluation at home and abroad
SUN Xuelin, QIAN Dongfang, TAN Siyuan, ZHANG Zixuan, HU Xin, ZHANG Yatong
2022, 19(11): 1218-1222. 
DOI: 10.19803/j.1672-8629.20220206

Abstract ( 155 )   PDF (1272KB) ( 210 )  
Objective To analyze the definitions, sources, detection methods and evaluation principles of drug signal management at home and abroad, and to provide reference for standardizing pharmacovigilance of drug marketing authorization holders. Methods The signal management systems of US, EU, Japan and WHO were analyzed, and the methods of signal detection and evaluation were summarized. Results All the countries concerned had clear definitions of drug signals, established relatively standard processes of signal detection and evaluation, and formulated corresponding guidelines according to the supervision intensity and characteristics of each country. Signal detection methods were based on the collection of more related information while signal verification not only highlighted the collection of more related information, but focused on properties of drugs, characteristics of patients and similar cases so as to make a more reliable judgment. In order to improve the efficiency of signal detection, prioritization was emphasized in the process of determining the nature of information in order to put more resources into the study on the potential risks that might affect the risk-benefit ratio. Conclusions ignal detection in pharmacovigilance in China has just started, so there is the pressing need to promote international exchange and cooperation, and steadily improve the competence of professionals of signal detection in China.
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Adverse reactions of benzodiazepines based on FAERS database
HUANG Liting, TANG Zaixiang, BAI Lu, SHI Guanhong, JIANG Yiguo
2022, 19(11): 1223-1227. 
DOI: 10.19803/j.1672-8629.20210738

Abstract ( 70 )   PDF (1353KB) ( 48 )  
Objective To analyze benzodiazepines-related signals based on the data (1Mar2004-30Sep2020) from the Food and Drug Administration Adverse Event Reporting System (FAERS), and to screen lorazepam a second time in order to contribute to rational use of the drug. Methods Using the frequency method, benzodiazepines-related signals were mined via the Chi-Squared test with Yates’ correction ( χ2Yates ), proportional reporting ratio (PRR) and the lower limit of the 95% confidence interval of the reporting odds ratio (ROR025). Results The number of signals related to alprazolam, clobazam, clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, oxazepam, quazepam, temazepam and triazolam was 1 345, 582, 1 532, 430, 1 430, 216, 312, 1 699, 618, 98, 1 027 and 330, respectively. Fifty-eight signals were obtained by the second analysis of lorazepam. Conclusion Most of the top 10 benzodiazepine-related signals have been described in drug labels, but most of the lorazepam-related signals mined in the second analysis have not been described in drug labels, so more attention should be paid to such signals in the subsequent use of lorazepam to reduce the side effects of the drug.
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Analysis of adverse reactions of ibrutinib with information component method
ZHENG Yi, GUO Xiaojing, XU Jinfang, GUO Zhijian, CHI Lijie, CHEN Chenxin, LIANG Jizhou, WEI Lianhui, CHEN Xiao, YE Xiaofei, HE Jia
2022, 19(11): 1228-1232. 
DOI: 10.19803/j.1672-8629.20210683

Abstract ( 45 )   PDF (1397KB) ( 40 )  
Objective To comprehensively and systematically explore the possible adverse drug reactions (ADR) of ibrutinib, and provide references for clinicians’ safe medication. Methods The ADR signals of ibrutinib were mined on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database using Information Component (IC) method. Results A total of 20 120 ADR reports of ibrutinib were included in FAERS database from the construction of the library to Jun 1, 2021, and 446 positive signals were detected, including two strong ADR signals with IC025>5, which were Richter syndrome (IC025 =5.67) and cerebral aspergillosis (IC025 =5.05). The top 3 ADR were atrial fibrillation (n=982, IC025=3.33, IC=3.44), fatigue (n=958, IC025=0.36, IC=0.47), diarrhea (n=931, IC025=0.64, IC=0.75), the reports of which also exceed 900. Conclusion Ibrutinib has more widespread ADR in multiple systems. Clinicians should pay full attention to its ADR, and take corresponding measures in time to ensure the safety of patients’ medication.
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Risk signal mining related to lenvatinib based on the US FDA adverse event reporting system
ZHAO Xiaohong, GUO Mingxing, WANG Xiaojian, LIN Jianrui, CUI Xiangli
2022, 19(11): 1233-1237. 
DOI: 10.19803/j.1672-8629.20210561

Abstract ( 70 )   PDF (1340KB) ( 64 )  
Objective To explore the risk signals of lenvatinib related adverse drug reactions (ADR) and provide reference for clinical safe applications. Methods The report odds ratio (ROR) and proportional reporting ratio (PRR) methods were used to mine the adverse reactions of the suspected drug-lenvatinib-from the FDA’s adverse event reporting system (FAERS) between the first quarter of 2015 and the fourth quarter of 2019. The detection threshold for these adverse reactions was that the number of reports was larger than 10, both ROR and PRR exceeded 2 and the 95% confidence interval (CI) lower limit of the ROR and PRR was above 1. Results During the given period of time, the FAERS database received 7 922 reports of adverse reactions with lenvatinib as the PS, and detected 191 risk signals, involving 18 SOC(systems on chips). There were 52 risk signals that were not mentioned in the manual, which were mainly concentrated in 8 signals of the gastrointestinal system, 7 signals of hepatobiliary diseases, 6 signals of benign, malignant and unspecified tumors (including cysts and polyps), 6 signals of abnormal laboratory examination, and 5 signals of infection and invasion. Among the top 50 adverse reaction signals of lenvatinib in terms of intensity, 12 adverse signals were not mentioned in the manual, mainly distributed in benign, malignant and unspecified tumors (4 signals), hepatobiliary diseases (3 signals). Conclusion The discovery of suspicious ADR signals of lenvastinib can provide reference for the safe use of this drug in treating hepatocellular carcinoma and renal cancer in China.
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Adverse drug reactions of hypokalemia caused by voriconazole in a hospital of Anhui Province
WANG Lechen, SHEN Aizong
2022, 19(11): 1238-1241. 
DOI: 10.19803/j.1672-8629.20210395

Abstract ( 60 )   PDF (1374KB) ( 48 )  
Objective To investigate the adverse reactions of hypokalemia induced by voriconazole and the influencing factors in order to provide reference for safe use in clinic. Methods Based on the Chinese Hospital Pharmacovigilance System (CHPS), 287 cases of adverse reactions of voriconazole reported in a hospital between Jan 1, 2018 and Dec 31, 2020 were selected for retrospective analysis so as to explore the incidence, clinical characteristics, risk factors and outcomes of adverse reactions of hypokalemia induced by voriconazole. Results Data showed that the incidence of hypokalemia caused by voriconazole was 41.2%(118 cases). There was no significant difference in the incidence of hypokalemia between primary diseases (P>0.05). Within one or two days of administration, the incidence of hypokalemia caused by injection formulations was significantly higher than that of oral formulations(P<0.05). The incidence of severe adverse reactions caused by injection formulations was significantly higher than that of oral formulations (P<0.05). Conclusion The proportion of hypokalemia caused by voriconazole injections is higher than that of oral preparations. These adverse reactions often occur soon after the use of voriconazole, which deserves more attention in clinic.
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Risk investigation of insulin storage and analysis and prevention of typical insulin-related medication errors
ZHANG Qingxia, JIANG Yongxian, DONG Yuexin, XIAN Ying, WANG Yuqin, YAN Suying
2022, 19(11): 1242-1245. 
DOI: 10.19803/j.1672-8629.20210548

Abstract ( 42 )   PDF (1218KB) ( 55 )  
Objective To find out about the amount of knowledge of insulin storage and the risks related to insulin storage via a questionnaire survey, and to recommend precautions. Methods The amount of knowledge of insulin storage among doctors and nurses from departments where the usage of insulin was the largest, pharmacists and patients who used insulin in Xuanwu Hospital of Capital Medical University was investigated via a questionnaire between July 18 and August 18, 2020. All the reports about insulin storage-related medication errors (MEs) from September 22, 2012 to September 30,2020 were collected from the National Monitoring Network for Clinical Safe Medication (referred to as Monitoring Network). The errors involved drugs, classification of errors, types of errors, sites of errors, people who were responsible, and causes of errors. Results A total of 93 questionnaires were collected, including 46 from health care providers and 47 from patients. All the respondents knew that insulin had to be stored at 2~ 8℃ before opening, but they did not know that insulin needed to stay away from the freezer coil. As for proper storage of insulin after opening, 20 patients (42.55%) were fully aware of the problems, and the proportion was higher than that of health care givers (34.78%). There were 16 cases of medication errors related to insulin storage in the Monitoring Network, which were mainly grade B in 11 cases (68.75%), grade C in 1 case (6.25%), grade D in 2 cases (12.50%) and grade E in 2 cases (12.50%). Among these 16 cases, 9 (56.25%) stored insulin at room temperature, 4 (25.00%) kept insulin near the freezer coil, 2 (6.25%) froze insulin when it was to be in cool storage and 2 cases (12.50%) kept insulin in cool storage when it had to be frozen. The main subjects involved in MEs were patients and their families (43.75%). Conclusion Health care providers and patients have a number of myths about insulin storage, and improper insulin storage affects blood glucose control. Therefore, attention should be paid to insulin storage to ensure the safe and effective use of insulin.
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153 linezolid-associated neurologic adverse reactions in patients with drug-resistant tuberculosis: a retrospective analysis
YANG Shaojie, XIA Yuchao, REN Pengfei, WANG Jie, CHEN Yu
2022, 19(11): 1246-1249. 
DOI: 10.19803/j.1672-8629.20210283

Abstract ( 38 )   PDF (1273KB) ( 26 )  
Objective To analyze the influencing factors and prognosis of linezolid (Lzd) associated neurologic adverse reactions in drug-resistant tuberculosis(DR-TB) patients. Methods The neurological adverse reactions caused by Lzd in DR-TB patients in the Sixth People’s Hospital of Zhengzhou between 2015 and 2020 were collected and analyzed. Results A total of 153 (27.18%) neurological adverse reactions occurred in 563 patients, 104 (67.93%) of which occurred within 3 to 9 months of use of LZD, mainly manifested as peripheral neuritis, optic neuritis, visual impairment, headache, insomnia and depression. Fifty-two cases (33.14%) were complicated with hypoproteinemia or malnutrition, and 28 (18.30%) with renal impairment. One hundred of these cases (65.36%) were discontinued with linezolid. Sixty-one cases (91.04%) of the central neurologic adverse reactions and optic neuritis were improved after symptomatic treatment or discontinuation of linezolid, but the prognosis of peripheral neuritis was poor. Conclusion Patients with long-term use of linezolid should be monitored for neurological adverse reactions. Early detection and prompt treatment have positive effects on prognosis.
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Risks and applications of parecoxib for injection based on drug instructions and judgment documents
ZHAO Jianbin, HUANG Yuling
2022, 19(11): 1250-1253. 
DOI: 10.19803/j.1672-8629.20210163

Abstract ( 36 )   PDF (1162KB) ( 42 )  
Objective To explore the risks of parecoxib for injection and improve the safety of medications with this drug. Methods Based on drug instructions of parecoxib and the ruling results of judicial cases, the potential risks of parecoxib were explored. Fifty cases of patients who had used this drug perioperatively were retrospectively evaluated. Results Risk assessment tables of parecoxib were formulated in line with drug instructions and judgment documents. The three main problems with the usage of parecoxib included contraindications, incompatibility and overuse. Conclusion Based on drug instructions and court verdicts, clinicians can have a better knowledge of risks of medications with parecoxib in order to ensure safe drug use.
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Pharmaceutical care of one case of hypoparathyroid cardiomyopathy
LI Youjia, XIE Jiao, YAO Hongyi, JI Cheng
2022, 19(11): 1254-1257. 
DOI: 10.19803/j.1672-8629.20210412

Abstract ( 32 )   PDF (1257KB) ( 28 )  
Objective To explore the treatment plan for one patient with hypoparathyroid cardiomyopathy, and to provide reference for clinical rational use of drugs. Methods The rationality of the medication was evaluated by combining the related literature with the pharmaceutical care of this patient. Results The increase of blood calcium levels was critical to the treatment of hypoparathyroid cardiomyopathy. Therefore, the dose of calcium supplements had to be increased once hypocalcemia was hard to improve. Hydrochlorothiazide, a thiazide diuretic with calcium-preserving effect, should be the candidate instead of furosemide. Meanwhile, improving hypomagnesemia contributed to the curative effect. Conclusion Pharmacists can help ensure the safety, effectiveness and rationality of drug use by participating in the treatment of patients with hypoparathyroid cardiomyopathy, assisting physicians in formulating and optimizing treatment plans, and implementing full-course pharmaceutical monitoring.
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Pharmaceutical care of a case of carbapenem resistant Klebsiella pneumoniae bloodstream infection treated with ceftazidime/verbatan
REN Zhao, LIU Jia, WANG Yumin, WANG Yue, XIE Qing
2022, 19(11): 1258-1261. 
DOI: 10.19803/j.1672-8629.20210178

Abstract ( 49 )   PDF (1243KB) ( 32 )  
Objective To investigate the role of clinical pharmacists in the treatment of bloodstream infection caused by carbapenem resistant Klebsiella pneumoniae. Methods Clinical pharmacists participated in the treatment of a patient with bloodstream infection caused by carbapenem resistant Klebsiella pneumoniae. Based on their expertise and the condition of the patient, the pharmacists recommended ceftazidime/avibactam monotherapy, and monitored the effectiveness and safety of medication. Results The clinicians took the advice of clinical pharmacists so that the patient’s temperature returned to normal, the inflammatory indexes were improved, and the blood culture showed no bacterial growth. Conclusion By participating in clinical practice, clinical pharmacists can quickly learn about the usage of new drugs, provide pharmaceutical services for clinicians, and ensure the rationality and safety of drug use.
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Research progress in safety and effectiveness of medication of iron deficiency anemia
CAI Lele, ZHANG Zhuolin, LI Xin, FANG Danjun, HAN Feng
2022, 19(11): 1262-1265. 
DOI: 10.19803/j.1672-8629.20210837

Abstract ( 45 )   PDF (1216KB) ( 39 )  
In recent years, there have been new types of iron preparations for the treatment of iron-deficiency anemia at home and abroad. Ferric citrate is used for iron-deficiency anemia in patients with chronic kidney disease while ferric maltol is used for iron-deficiency anemia in patients with inflammatory bowel disease and patients who do not respond to other oral iron preparations. New intravenous irons are mainly high-dose iron preparations, such as ferumoxytol, iron isomaltoside, ferric carboxymaltose, which can rapidly improve the symptoms of anemia, and show more advantages in patients with chronic kidney disease, heart failure, inflammatory bowel disease. This article outlines the effectiveness and safety of iron formulations and the mechanism of iron supplementation at home and abroad in order to provide evidence-based evidence for safe and effective use of iron-deficiency anemia.
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Research progress of treatment drugs for SARS-CoV-2
LI Tianyu, JIA Yijiang, WANG Yuji, WANG Jinhui, LI Ye
2022, 19(11): 1266-1271. 
DOI: 10.19803/j.1672-8629.20210509

Abstract ( 88 )   PDF (1201KB) ( 92 )  
Since the outbreak of the Corona Virus Disease 2019 (COVID-19) in 2019, its prevention and treatment have become one of the most popular fields at home and abroad. It is a respiratory infectious disease caused by the severe acute respiratory syndrome coronavirus 2(SARS-CoV-2), which seriously endangers human health and life safety, so the discovery and research of its related drugs is especially important. This paper analyzed and summarized the targets of SARS-CoV-2 therapeutic drugs, related chemical drugs, and the targeting effects of related Chinese herbal medicine monomers. Particularly, the research status of COVID-19 treatment drugs were reviewed in order to provide clue for follow-up studies.
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Research progress in Yi medicine Elephantopus scaber L. and predictive analysis of quality markers
GUO Jiahui, CAI Yuluo, ZHEN Yaqin, WANG Xinguo, NIU Liying, CHEN Zhong
2022, 19(11): 1272-1276. 
DOI: 10.19803/j.1672-8629.20210311

Abstract ( 12 )   PDF (1299KB) ( 17 )  
Elephantopus scaber L. is a traditional Chinese medicine which contains a variety of chemical components and has the functions of clearing heat, cooling blood, detoxification and diuresis. In recent years, studies have found that it has a wide range of pharmacological effects, such as anti-tumor, anti-inflammatory, anti-virus and liver-protecting properties. In this paper, flavonoids, steroids, triterpenoids and sesquiterpene lactones in Elephantopus scaber L. were described and analyzed, and the pharmacological effects were summarized. Based on the concept of quality markers (Q-markers) of traditional Chinese medicines, the Q-markers of Elephantopus scaber L. were predicted and analyzed in terms of pharmaphylogeny, component specificity and traditional efficacy. It was speculated that sesquiterpene lactones flavonoids and triterpenoids in Elephantopus scaber L. could be used as quality markers for quality evaluation.
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