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Pharmacological Effects of Reduning Inhalation Solution on Viral Pneumonia in Mice Infected by Influenza A/PR/8/H1N1 SUN Jing, ZHAO Ronghua, SHI Yujing, ZHANG Guangping, BAO Lei, GENG Zihan, SONG Ling, GAO Yunhang, LI Xiaolu, GUO Shanshan, CUI Xiaolan 2021, 18(12): 1101-1105.  DOI: 10.19803/j.1672-8629.2021.12.01 Abstract ( 207 )   PDF (1533KB) ( 126 )   Objective To explore the therapeutic effect of Reduning inhalation solution against the viral pneumonia model of mice infected with influenza A/PR/8/H1N1 so as to provide reference for clinical application.Methods Laboratory animals were randomly divided into eight groups according to their body weight: control group, model group, ribavirin group, Reduning injection group, and four Reduning aerosol inhalation groups including the 0.23 g crude drug/kg high-dose group (20 min), 0.12 g crude drug/kg middle-dose group (10 min) , 0.06 g crude drug/kg low-dose group (5 min) and 0.03 g crude drug/kg very-low-dose group (2.5 min) . A pneumonia model of mice was established via intranasal infection with influenza A/PR/8/H1N1. The effectiveness of Reduning inhalation solution was evaluated by detecting the lung index, lung index inhibition rate, pathological changes, viral load, as well as the production of IL-6 and TNF-α in lung tissue. Results All the four treatments with Reduning inhalation solution could reduce the lung index of mice, alleviate the pathological damage to lung tissue, and reduce the viral load and the content of IL-6 and TNF-α in lung tissue to different extents.Conclusion Aerosol inhalation of Reduning has a significant therapeutic effect against the pneumonia model infected with influenza A/PR/8/H1N1. References | Related Articles | Metrics

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Anti-inflammatory Mechanism of Gardenia Jasminoides Ellis Extract on Inhibition of Viral Pneumonia Induced by Influenza A Virus WANG Yaxin, BAO Lei, ZHAO Ronghua, GENG Zihan, BAO Yanyan, SUN Jing, SHI Yujing, ZHOU Lirun, CHEN Mengping, XU Yingli, PANG Bo, GUO Shanshan, CUI Xiaolan 2021, 18(12): 1106-1110.  DOI: 10.19803/j.1672-8629.2021.12.02 Abstract ( 142 )   PDF (2026KB) ( 89 )   Objective To explore the anti-inflammatory mechanism of Fructus Gardenia extract by which viral pneumonia caused by influenza A (H1N1) virus (FM1) is inhibited in mice.Methods In vitro experiments: the effect of Fructus Gardenia extract of different concentrations on the secretion of NO was studied with mouse macrophage RAW 267.4 induced by lipopolysaccharide (LPS). The RAW 267.4 cells were stimulated by LPS of two concentrations for 24 hours and then by Fructus Gardeniae extract of corresponding concentrations. The content of NO in the cell supernatant was detected after 24 hours. In vivo experiments: Except for the normal group, the ICR mouse pneumonia model infected with influenza A (H1N1) virus (FM1) was used in all the other groups. After four days of continuous administration, blood was collected from the eyeball by centrifugation for flow cytometry detection of serum inflammatory factors. After dissection, lung tissue was taken for pathological section and lung lesions were observed. Results In vitro experiments showed that the 5, 2.5 and 1.25 mg/mL dosage groups of Fructus Gardeniae extract could effectively reduce NO content, and there was significant difference compared with the LPS control group (P< 0.01). In vivo experiments indicated that the high, medium and low dose groups of Fructus Gardeniae extract could reduce the contents of inflammatory factors interleukin -6 (IL-6), tumor necrosis factor α (TNF-α) and monocyte chemoattractant protein -1 (MCP-1) to different extents compared with the model group. The pathological examination of mouse lung tissue showed that compared with the model group, lung lesions were significantly improved in high and medium dose groups of Fructus Gardeniae extract.Conclusion Fructus Gardenia extract not only has a good anti-inflammatory effect in vitro, but also effectively inhibits mouse viral pneumonia caused by influenza A (H1N1) virus (FM1). References | Related Articles | Metrics

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The Mechanism of Qingkailing Injection against Coronavirus Pneumonia GUO Shanshan, ZHAO Ronghua, GENG Zihan, BAO Lei, SUN Jing, SHI Yujing, BAO Yanyan, GAO Yingjie, CUI Xiaolan 2021, 18(12): 1111-1116.  DOI: 10.19803/j.1672-8629.2021.12.03 Abstract ( 366 )   PDF (1734KB) ( 121 )   Objective To investigate the mechanism of Qingkailing Injection in the treatment of coronavirus pneumonia based on mouse model combining disease and syndrome of human coronavirus pneumonia with heat-dampness pestilence attacking the lung.Methods BALB/c mice were randomly divided into eight groups, including normal group, HCoV-229E infection group, Heat-dampness group, model group, positive drug group（0.09g/(kg·d)）, Qingkailing Injection high-dose group（1.47mL/(kg·d)）, middle-dose group（0.73mL/(kg·d)）and low-dose group（0.37mL/(kg·d)）. The viral load in lung tissue was detected by RT-PCR, the febrile mediators, inflammatory factors and oxidative stress factors in hypothalamus and lung tissue were detected by ELISA, the percentage of immune cells in peripheral blood was detected by flow cytometry. Results Compared with the model, middle-dose and low-dose groups of Qingkailing Injection can reduce the lung index (P<0.05, P<0.01) and the viral load in lung tissue (P<0.01, P<0.05). Three dose groups of Qingkailing Injection reduce the contents of CD14 and IL-1β in lung tissue (P<0.01), the middle- and low-dose groups reduce the content of MDA (P<0.01, P<0.05), the high-dose and middle-dose groups increase the content of SOD (P<0.01), and the three dose groups of Qingkailing Injection could reduce the proportion of CD4+ T cells, CD8+ T cells and B cells in peripheral blood (P<0.01, P<0.05).Conclusion Qingkailing Injection can play a therapeutic role in this model by regulating immune function, inhibiting cytokine storm and reducing the accumulation of free radicals. References | Related Articles | Metrics

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The Mechanism of Cultured Bezoar against the Epidemic Model of Human Coronavirus Pneumonia ZHAO Ronghua, GUO Shanshan, SUN Jing, SHI Yujing, BAO Lei, GENG Zihan, BAO Yanyan, Zhou Guanru, GAO Yingjie, CUI Xiaolan, WANG Daohan 2021, 18(12): 1117-1122.  DOI: 10.19803/j.1672-8629.2021.12.04 Abstract ( 109 )   PDF (889KB) ( 66 )   Objective To observe the therapeutic effect of bezoar cultured in vitro on a mouse model of human coronavirus pneumonia caused by the lung-attacking damp-heat virus.Methods The therapeutic effect of bezoar cultured in vitro (0.128, 0.064, 0.032 g/kg) against a model was evaluated by comparing the effects of the drug on the lung index, inhibition rate of the lung index, viral load of lung tissue, contents of inflammatory factors IL-1 β, CD14, MDA and SOD in lung tissue, contents of cAMP and PGE-2 in the hypothalamus, and on percentages of CD4+ T lymphocytes, CD8+ T lymphocytes and B lymphocytes in peripheral blood. Results The weight of the model mice was reduced, food and water intakes decreased significantly, the reaction of the mice became slow, their skin went dry and less lustrous, the stool was sticky, the amount of urine became smaller and looked yellow. Bezoar cultured in vitro reduced the lung index of model mice, significantly inhibited the expression of viral nucleic acid in lung tissue, significantly reduced the content of inflammatory factors CD14 and MDA in lung tissue, but significantly increased the content of SOD, significantly reduced the content of cAMP in the hypothalamus of model mice, hardly changed the content of PGE2, but significantly increased the percentage of CD4+ T cells and CD8+ T cells in model mice.Conclusion Bezoar cultured in vitro has significant therapeutic effect against the mouse model of the syndrome of human coronavirus pneumonia with lung-attacking damp-heat virus by reducing the lung index, regulating the contents of cAMP and PGE2 in the hypothalamus, regulating the immune function and inhibiting the release of inflammatory factors. References | Related Articles | Metrics

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Effects of Chai Yin Granules on the Mouse Model of the Disease and Syndrome of Human Coronavirus Pneumonia Caused by Lung-attacking Damp-heat Epidemic Virus ZHAO Ronghua, GUO Shanshan, GENG Zihan, SUN Jing, SHI Yujing, BAO Lei, BAO Yanyan, GAO Yingjie, ZHANG Guimin, GUAN Yongxia, CUI Xiaolan, WANG Daohan 2021, 18(12): 1123-1128.  DOI: 10.19803/j.1672-8629.2021.12.05 Abstract ( 98 )   PDF (2497KB) ( 62 )   Objective To observe the therapeutic effects and mechanism of Chai Yin granules on a mouse model of the disease and syndrome of human coronavirus pneumonia caused by the lung-attacking damp-heat epidemic virus (LDEV).Methods Chai Yin granules (8.8, 4.4, 2.2 g/kg) were used to treat the model of the disease and syndrome of human coronavirus pneumonia caused by LDEV. The mechanism by which Chai Yin granules worked on the model was evaluated in terms of the manifestations of symptoms, lung inflammation, expressions of viral nucleic acid in lung tissue, contents of cAMP and PGE-2 in the hypothalamus, contents of inflammatory factors in lung tissue and the percentage of immune cells in peripheral blood. Results In the model control group, the body mass decreased, the intakes of food and drinking water decreased significantly, lying and inactivity increased until depression occurred in some cases, the hair was wet, the mice huddled in clusters, their reaction was slow, their appetite was poor, the stool was sticky in the first stage and dry in later stages. The above symptoms were significantly improved in high-, medium- and low-dose Chai Yin granule groups. Compared with the model control group, the lung index in high and medium dose groups decreased significantly, but the difference was not statistically significant (P>0.05). The inhibition rates of the lung index were 26.49% and 21.06%, respectively; The expression of viral nucleic acid in lung tissue of mice in the high dose group decreased significantly (P<0.05). The contents of PGE2 and CAMP in the three groups decreased significantly (P<0.05, P<0.01). The contents of IL-1β, CD14 and MDA in lung tissue of mice in the three groups decreased significantly, but the content of SOD increased (P< 0.05, P<0.01). The percentage of CD4 + T / CD8 + T in peripheral blood of mice in the low-dose group increased significantly (P<0.05).Conclusion Chai Yin granules have a significant therapeutic effect against the mouse model of the disease and syndrome of human coronavirus pneumonia caused by the lung-attacking damp-heat epidemic virus by reducing the lung index of model mice, decreasing the expression of virus nucleic acid in lung tissue, inhibiting the expressions of immune inflammatory factors, regulating the expressions of central factors of hypothalamic thermoregulation and the immune function of peripheral blood lymphocytes. References | Related Articles | Metrics

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Difference between CIA Rat Models of Different Ages and Intervention Effect and Safety of Modified Shaoganfuzi Decoction ZHANG Yuting, ZHU Yuelan, HOU Xiujuan 2021, 18(12): 1129-1133.  DOI: 10.19803/j.1672-8629.2021.12.06 Abstract ( 71 )   PDF (1259KB) ( 53 )   Objective To investigate the difference between collagen-induced arthritis (CIA) models of rats of different ages, and to study the effect of modified Shaoganfuzi decoction on the expression of inflammatory cytokines and its safety.Methods Forty young rats and forty old rats were randomly divided into four groups: the normal group, model group, control group and TCM group. Except the normal group, CIA models were established in all the other groups, and intragastric intervention was performed for 4 weeks after modeling. The conditions of the rats were observed, the drainage volume of the ankle was measured, the inflammation index (AI) was evaluated, the organ index after the last administration was calculated, and cytokines and safety indicators were detected. Results In the third week of modeling, the drainage volume of right feet in the elder model group was higher than that in the young model group (P<0.05). Two to four weeks into modeling, the AI scores of the elder model group were higher than those in the young group (P<0.05). The thymus indexes of the normal group, model group and control group were lower than those of the young group (P<0.01). Levels of γ-interferon(INF-γ), interleukin-2(IL-2), interleukin-6(IL-6), interleukin 17A(IL-17A) and tumor necrosis factor-α(TNF-α) in the elder TCM group were lower than in the model group (P<0.05). The level of IL-17A in the elder TCM group was lower than in the control group (P<0.05). The levels of TNF-α, IL-6, IL-17A and creatinine (CREA) in the young TCM group were lower than in the model group and the control group (P<0.05). Levels of alanine aminotransferase (ALT) in the elder and young TCM groups were lower than in the control group (P<0.05). Levels of creatine kinase isoenzyme (CK-MB) and troponin I (cTnI) in both the elder and young TCM groups were lower than in the model group and control group (P<0.05).Conclusion There are differences in the severity of joint inflammation between CIA rats of different ages. The modified Shaoganfuzi decoction is safe and effective. Thymus degeneration caused by ageing may account for the difference between EORA and YORA. References | Related Articles | Metrics

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Compatible Stability of Six Effective Components including Sodium Danshensu in Xiangdan Injection Mixed with Three Infusions ZAN Ke, ZHOU Ying, LI Wenting, TAN Chunmei, ZHU Qinglan, MA Shuangcheng, ZHENG Cheng 2021, 18(12): 1134-1137.  DOI: 10.19803/j.1672-8629.2021.12.07 Abstract ( 157 )   PDF (1200KB) ( 85 )   Objective To study the stability of six effective components in Xiangdan injection after being mixed with glucose injection, sodium chloride injection and glucose sodium chloride injection, respectively.Methods The contents of sodium danshensu, protocatechuic aldehyde, caffeic acid, lithospermic acid, salvianolic acid B and salvianolic acid A in Xiangdan injection were determined by HPLC after they were mixed with glucose injection, sodium chloride injection and glucose sodium chloride injection, respectively. Results After mixture with sodium chloride injection, the contents of lithospermic acid and salvianolic acid A decreased gradually while caffeic acid increased gradually. After mixture with glucose sodium chloride injection, the contents of salvianolic acid A decreased and caffeic acid content increased gradually. Only the content of salvianolic acid A decreased slightly after it was mixed with glucose injection.Conclusion It is recommended that Xiangdan injection be used in compatibility with glucose injection and be used as soon as possible. References | Related Articles | Metrics

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Antidepressant Effects and Mechanism of Dingzhixiaowan and Kaixinwan on CUMS Model Rats YANG Li, LIU Wanwan, ZHOU Xiaojiang, ZHANG Lan, DONG Xianzhe, LIU Ping 2021, 18(12): 1138-1143.  DOI: 10.19803/j.1672-8629.2021.12.08 Abstract ( 70 )   PDF (2199KB) ( 49 )   Objective To compare the effect of Dingzhixiaowan pills recorded in Essential Recipes for Emergent Use Worth One Thousand and Kaixinwan pills recored in Yimenfang on chronic unpredictable mild stress (CUMS) depression model rats and its possible mechanism.Methods A CUMS rat model was established. The rats were randomly divided into the normal group, model group, Dingzhixiaowan group, and Kaixinwan group. The rats in the last two groups were given their respective drug intragastrically for two weeks. The antidepressant effect of the two drugs was evaluated in terms of body weight, syrup partiality and open field test. The changes of glutamic acid (GLU), gama-aminobutyric acid (GABA) serum hypothalamic-pituitary-adrenal (HPA) axis transmitters, IL-1 and other cytokines in the hippocampus and cortex of rats in each group were determined. The difference in chemical composition between Dingzhixiaowan and Kaixinwan pills was analyzed. Results Dingzhixiaowan significantly increased the body weight, glycemic preference and open field scores of CUMS rats, reduced GLU content in the hippocampus and cortex of rats, increased GABA content, reduced HPA axis transmitters, and regulated serum cytokine levels. Kaixinwan increased GABA content in the hippocampus and cortex of model rats, but reduced serum cytokine levels.Conclusion Dingzhixiaowan pills have obvious antidepressant effect, but Kaixinwan pills do not in behavioral experiments. The antidepressant effect of Dingzhixiaowan may be related to the regulation of central neuron amino acid secretion, reversal of the hyperactivity of HPA axis, and reduction of the immune regulation of IL-1 and other cytokines. The antidepressant effect of the prescription may be closely related to the content of main chemical components such as ginsenosides. References | Related Articles | Metrics

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Applications of International Spontaneous Reporting System Databases CHI Lijie, CHEN Chenxin, ZHENG Yi, WEI Lianhui, CHEN Xiao, GUO Zhijian, GUO Xiaojing, HE Jia, YE Xiaofei 2021, 18(12): 1144-1147.  DOI: 10.19803/j.1672-8629.2021.12.09 Abstract ( 400 )   PDF (991KB) ( 356 )   Objective To outline the current applications of main international spontaneous reporting systems of ADR, including Vigibase, FAERS and EudraVigilance.Methods The websites of major foreign spontaneous reporting systems were searched and articles about the use of spontaneous reporting systems were retrieved. The data format of these databases, accessibility to them, data quality control and the applications of the databases were illustrated with examples. Results The databases of foreign spontaneous reporting systems can be downloaded publicly or obtained under certain conditions. A number of research programs have been conducted based on spontaneous reporting systems.Conclusion The spontaneous reporting system is of great value for post-marketing safety monitoring and China's spontaneous reporting system database can learn from foreign practices in data sharing. References | Related Articles | Metrics

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A Study on the American Cosmetics Adverse Reaction Monitoring System ZHU Ying, SHEN Lu, LI Lan, KONG Fanyao, WU Jianmin 2021, 18(12): 1148-1149.  DOI: 10.19803/j.1672-8629.2021.12.10 Abstract ( 174 )   PDF (949KB) ( 184 )   Objective To provide reference for the establishment and improvement of China's cosmetic adverse reaction monitoring system by studying the American cosmetic adverse reaction monitoring system.Methods The American cosmetics adverse reaction monitoring system was analyzed by consulting American laws and regulations and related literature. Results The monitoring level of cosmetic adverse reactions in the United States was improved and social co-governance was enhanced by diversifying reporting channels and promoting self-discipline and data disclosure in the industry.Conclusion The experience of American cosmetics adverse reaction monitoring is of positive significance for promoting the construction and improvement of China's cosmetics adverse reaction monitoring system. References | Related Articles | Metrics

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Influencing Factors of Abnormal Renal Function of Breviscapine for Injection Analyzed via Nested Case-control Study Combined with SMOTE Algorithm ZHANG Guanghui, SUN Linxi, WU Xianwen, XIE Yanming, GENG Hongjiao, YANG Xiaochen 2021, 18(12): 1150-1154.  DOI: 10.19803/j.1672-8629.2021.12.11 Abstract ( 96 )   PDF (1209KB) ( 65 )   Objective To analyze the influencing factors of renal dysfunction caused by breviscapine for injection in the real world, and to provide data for its clinical application.Methods The data on inpatients from 34 hospitals in China who had used breviscapine for injection at least once between January 1, 2002 and 31 December, 2015 was collected from the HIS, and the data on patients with abnormal renal function was retrieved. The design of nested case-control study was used to group cases at the ratio of 1∶4. Two groups were sampled using the SMOTE algorithm, and the data was analyzed with a binary logistic regression model. The selected frequency, regression coefficient and P value of all independent variables were calculated. Results Of the 43 962 inpatients included in the study, 17 patients had abnormal renal function, with an incidence of about 0.039%. It was found that the regression coefficient β was positive when the treatment with breviscapine for injection involved males, nephritis, type 2 diabetes, and combination with furosemide. The difference was statistically significant (P<0.05).Conclusion In clinical application of breviscapine for injection, renal function should be monitored when the patient is male, complicated with nephritis or type 2 diabetes and is using furosemide. References | Related Articles | Metrics

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Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature ZHU Lan, ZHU Yan, LIU Lihong, SHAO Bo, LIU Hongliang, XIONG weiyi 2021, 18(12): 1155-1158.  DOI: 10.19803/j.1672-8629.2021.12.12 Abstract ( 526 )   PDF (1092KB) ( 622 )   Objective To summarize problems with post-marketing adverse drug reaction (ADR) reports collected from literature in China and give related advice to marketing authorization holders (MAHs).Methods The common problems with ADR reports from related literature were listed and analyzed. Suggestions for improvement were offered based on the requirements of relevant guidelines and documents issued by the NMPA after 2018 and the requirement of ICH E2D guideline. Results and Conclusion The ADR reports collected from related literature are imperfect in terms of compliance, completeness and timeliness, and MAHs need to make more efforts to improve the quality of such reports. References | Related Articles | Metrics

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The Mechanism of Toxicity Reaction Induced by Protamine Sulfate Injection FAN Yan, WANG Dan, WANG Chunting 2021, 18(12): 1159-1161.  DOI: 10.19803/j.1672-8629.2021.12.13 Abstract ( 94 )   PDF (1089KB) ( 83 )   Objective To analyze the pathogenesis of and risk factors for toxic reactions induced by protamine sulfate injection so as to provide reference for clinical safe use.Methods The clinical classification and pathogenesis of toxic reactions induced by protamine sulfate injection were analyzed, while a wide range of risk factors leading to toxic reactions was discussed. Results Risk factors for toxic reactions in clinic included the speed of administration, routes of administration, insufficient knowledge, and special populations.Conclusion It is recommended that effective control measures be taken, including the monitoring of medication, selection of a proper speed and route of administration, use of ultrafiltration, control over special populations, and effective information intervention. References | Related Articles | Metrics

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Rationality of Prices of Antineoplastic Drugs Based on Price Comparison Analysis WANG Jingliu, LIU Pingyu, LI Xin, HAN Feng 2021, 18(12): 1162-1165.  DOI: 10.19803/j.1672-8629.2021.12.14 Abstract ( 95 )   PDF (1147KB) ( 92 )   Objective To compare current prices of antineoplastic drugs and conduct an empirical analysis of irrationality.Methods Comparative analysis of prices was used to compare the prices of original drugs, generic drugs, antineoplastic drugs, first-line antineoplastic drugs and targeting agents. Results The price range between original and generic drugs was 32.28, which was significant difference. The average range, average value, and standard deviation of various antineoplastic drugs prices were 194.7, 36.44, and 58.01, respectively. The prices of first-line drugs recommended by the anti-tumor treatment guidelines varied widely. For example, the range of paclitaxel was 5.33, and the range of domestic drugs with the same specifications was between 33.3 and 144.89.Conclusion There is a large price range and a large variety of antineoplastic drugs with different specifications in China. A series of measures needs to be taken to improve the mechanism of pricing, strike a balance between prices of antineoplastic drugs, and solve the contradiction between the development of the pharmaceutical industry and drug accessibility. References | Related Articles | Metrics

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Rational Use of Key Monitored Drugs Influenced by a Comprehensive Evaluation System for Clinical Medicine Based on Multidisciplinary Collaboration ZHANG Wen, PENG Jing, CHEN Ju, LIU Jun, YANG Chunyan, WANG Peipei, YANG Xiaojun, YANG Kui, LIU Xiaoyun, ZHANG Haoran, ZHONG Zhengling, ZHAO Jun, TANG Zenghui, LUAN Jiajie 2021, 18(12): 1166-1170.  DOI: 10.19803/j.1672-8629.2021.12.15 Abstract ( 127 )   PDF (1259KB) ( 112 )   Objective To explore the applicability of the evaluation standard system for clinical rational drug use based on multi-disciplinary collaboration in enhancing the management of key monitored drugs.Methods Based on the multi-disciplinary collaboration model, an evaluation standard system for clinical rational drug use was established before drugs in the catalogue of key monitored drugs were traced throughout the hospital. The data on eight drugs in the first batch of the national key monitored drug catalogue was collected, while the changes of the irrational drug use rate were statistically analyzed. The interrupted time series (ITS) model was used to analyze the changes of adverse reactions,dosage and amount of these eight drugs before and after monitoring. At the same time, the changes of dosage and amount of four types of drugs of the first batch of key monitored drugs in the national catalogue (but not in the catalogue of key monitored drugs for our hospital) before and after monitoring were also statistically analyzed. Results Since the key drugs were monitored in September 2018, the rate of irrational use of eight types of drugs included in the key monitored catalogue of our hospital trended down (P<0.01). Nine months into monitoring of key drugs, the rate of irrational use of drugs remained less than 10%. The incidence of irrational clinical use of the eight types of drugs, irrational drug use, improper usage and dosage and failure to comply with the instructions was significantly lower in June 2019 than in September 2018 (P<0.01 or P<0.05). The number of ADR reports and incidence of ADRs before and after the monitoring of key drugs were not significantly different. After monitoring of key drugs, the amount of these eight types of drugs used (β3=-3.79, P<0.01), and the amount of money (β3=-4.256, P<0.01) involved decreased significantly, unlike the four types of drugs not included in the catalogue of key monitored drugs in our hospital.Conclusion The evaluation standard system for clinical rational use of drugs based on the multi-disciplinary collaboration model can effectively promote the clinical rational use of key monitored drugs..It is an effective model that should be popularized. References | Related Articles | Metrics

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A Prospective Study on Adverse Reactions of Cefazolin Sodium Pentahydrate for Injection LI Jin, LANG Gang, WEI Li, QIN Zhengbi, SUN Yinxiang, LU Xiaoqin, CHEN Zhigao, LI Yunmei, LI Meijun, DENG Jianxiong 2021, 18(12): 1171-1175.  DOI: 10.19803/j.1672-8629.2021.12.16 Abstract ( 143 )   PDF (1196KB) ( 117 )   Objective To evaluate prospectively the adverse reactions of cefazolin sodium pentahydrate for injection and evaluate its safety by means of the Chinese Hospital Pharmacovigilance System (CHPS). Methods From March 1, 2018 to October 31, 2018, the data on 3 641 valid hospitalized patients was collected prospectively via the CHPS from six tertiary hospitals, and the post-marketing safety analysis of cefazolin sodium for injection was performed. Results The rate of adverse drug reactions (ADR) was 4.35‰. There were no serious ADR, and most of the ADR occurred within 24 hours of the administration. The drug was discontinued after the occurrence of ADR. Some patients received treatment after the discontinuation of this drug. All the patients were cured or improved after treatment. Conclusion The incidence of ADR (4.35‰) of cefazolin sodium pentahydrate for injection is significantly different from that of ADR (1.1%) in the instructions for amorphous cefazolin sodium. Probably due to the chelating structure of unstable cefazolin sodium pentahydrate, the sulfur-containing groups in the tunnel-shaped cavity protective molecules composed of cefazolin molecules will not easily fall off and can avoid contact with rubber plugs, thus improving stability, decreaseing catabolites and reducing adverse reactions. References | Related Articles | Metrics

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1160 Cases of Adverse Reactions Caused by Compound Liquorice Tablets and Risk Factors HUO Yanfei, XIE Yanjun, XU Lili, CHANG Hong, SUN Chunxiao, TIAN Yuejie 2021, 18(12): 1176-1180.  DOI: 10.19803/j.1672-8629.2021.12.17 Abstract ( 227 )   PDF (1202KB) ( 282 )   Objective To investigate the characteristics of and risk factors for adverse drug reactions (ADRs) caused by compound liquorice tablets in order to offer reference for clinical rational drug use.Methods A retrospective analysis was made of 1 160 ADR reports of compound liquorice tablets in Shandong ADR database (from January 1, 2004 to December 31, 2019). Results The adverse reactions related to compound liquorice tablets were mainly manifested as the damage to multiple systems and organs, such as the gastrointestinal tract, skin and its accessories. Nausea was the most common adverse reaction, and anaphylactic shock was the most severe one. Risks of hypokalemia, edema, hypotension and drug dependence were not mentioned in the instructions.Conclusion Manufacturers should carry out safety inspections of compound liquorice tablets and update the instructions in time. Health care providers and dealers of pharmaceuticals should become better informed of this drug. In particular, the risk of drug dependence caused by long-term medication should be minimized to ensure the safety of medications. References | Related Articles | Metrics

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Effects of Tigecycline on Coagulation Function of 74 Patients XU Shanshan, SONG Zhihui, HAN Furong, ZHANG Chao 2021, 18(12): 1181-1185.  DOI: 10.19803/j.1672-8629.2021.12.18 Abstract ( 203 )   PDF (1130KB) ( 89 )   Objective To study the effects of tigecycline on coagulation function of patients.Methods The clinical data on 74 inpatients who used tigecycline at Beijing Tongren Hospital between January 1, 2017 and December 31, 2019 was collected. The levels of fibrinogen (FIB), prothrombin time (PT), activated partial thromboplastin time (aPTT), thrombin time(TT), international normalized ratio(INR), and levels of D-dimer, platelets (PLT), alanine aminotransferase (ALT), total bilirubin(Tbil) and creatinine (CREA) before, during and after medication were recorded to assess the effect of tigecycline on coagulation function. Results The FIB level was significantly decreased while the median levels of aPTT, PT, TT and INR were all significantly increased (P<0.05). Spearman correlation coefficients revealed a strong positive association between the extent to which FIB declined and the baseline level of this parameter(R2=0.726,P<0.001). The FIB level returned to the pre-treatment level at day 6 after discontinuation, so did the levels of aPTT, PT, TT and INR at day 2 after discontinuation. There was no statistically significant difference in levels of ALT, Tbil, CREA and PLT before or after medication (P>0.05).Conclusion Tigecycline can prolong PT, aPTT, TT, INR and reduce the level of FIB. The decline of FIB is the key to abnormal coagulation function among patients who use tigecycline. The coagulation function should be closely monitored when the drug is used. References | Related Articles | Metrics

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Pharmaceutical Care of Adverse Reactions Caused by Rituximab in the Treatment of Graves Orbitopathy HE Xinyi, WANG Shaoke, XUE Xiaorong, HU Bin 2021, 18(12): 1186-1188.  DOI: 10.19803/j.1672-8629.2021.12.19 Abstract ( 150 )   PDF (557KB) ( 138 )   Objective To analyze the characteristics of adverse reactions caused by rituximab in the treatment of Graves orbitopathy and recommend ways of prevention and treatment so as to provide reference for clinical safe drug use and for pharmaceutical care.Methods The clinical data on a total of 48 patients who used rituximab 99 times between June 1, 2018 and December 31, 2019 was analyzed retrospectively. Results ADRoccurred in 10 of the 48 cases, including 8 females (80.00%) and 2 males (20.00%) aged 25 to 54. The organs/systems involved were the respiratory system, cardiovascular system, the skin and subcutaneous tissues. ADR mostly occurred the first time rituximab was administered, but the symptoms were mild.Conclusion Clinical pharmacists should strengthen pharmaceutical care when adopting treatment schemes involving new drugs that are not often used and lack safety study. Related physiological indicators and mental state of patients deserve more attention and priorities of pharmaceutical care should be specified. Contraindications should be eliminated in time to ensure medication safety and prove the worth of clinical pharmacists. References | Related Articles | Metrics

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Pharmaceutical Care of One Patient with Severe Acute Left Heart Failure Induced by Low-dose Epirubicin LI Li, ZHANG Dan, ZHOU Nan, ZHANG Peng, ZHU Yaning 2021, 18(12): 1189-1191.  DOI: 10.19803/j.1672-8629.2021.12.20 Abstract ( 121 )   PDF (436KB) ( 83 )   Objective To study the importance of clinical pharmacists monitoring adverse reactions among patients under chemotherapy by reviewing the process of treating one patient with severe acute left heart failure induced by low-dose epirubicin.Methods Clinical pharmacists participated in the adjustment of chemotherapy drugs, made correlation analysis, analyzed the risk factors for adverse reactions, and conducted comprehensive pharmaceutical monitoring for a patient with severe heart failure caused by epirubicin at a cumulative dose of only 51 mg/m2. Results Clinical pharmacists assisted physicians in making quick judgment and dealing with adverse reactions, analyzed potential risk factors, and removed obstacles to subsequent chemotherapy.Conclusion Anthracyclines have no absolute“safe dose”. Clinicians have to be alert to serious adverse reactions in elderly patients with liver dysfunction, hypoproteinemia, hypercalcemia, and low body weight. Clinical pharmacists can help physicians monitor patients under chemotherapy to prevent serious adverse reactions. References | Related Articles | Metrics

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One Case of Hyperkalemia Induced by Concomitant Use of Cyclosporine and Other Drugs YANG Xiaowen, WANG Xiaoxing 2021, 18(12): 1192-1195.  DOI: 10.19803/j.1672-8629.2021.12.21 Abstract ( 236 )   PDF (890KB) ( 108 )   Objective To explore the mechanism and clinical features of hyperkalemia induced by concomitant use of cyclosporine and other drugs.Methods The diagnosis and treatment of a patient with hyperkalemia caused by concomitant use of cyclosporine, voriconazole and sacurbatrovalsartan were analyzed. Based on literature review, the possible mechanism by which concomitant use of these drugs led to hyperkalemia was studied. Results After five days of combined administration of these drugs, the serum level of potassium began to exceed the upper limit. After withdrawal of cyclosporine and sulbactam, the serum level of potassium did not return to normal within five days until voriconazole was discontinued. There was no abnormal level of serum potassium when voriconazole was administered a second time. All this suggested that the combination of cyclosporine, voriconazole and sacurbatrovalsartan increased the risk of cyclosporine induced hyperkalemia.Conclusion When cyclosporine, voriconazole, and drugs acting on the renin-angiotensin-aldosterone system are administered in combination, hyperkalemia is likely to occur even if the blood concentration of cyclosporine is at a relatively low level. References | Related Articles | Metrics

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One Case of Palpitation and Muscle Tremor Induced by Tranexamicacid Acid Sodiwn Chloride Injection and Literature Analysis HONG Wenying 2021, 18(12): 1196-1197.  DOI: 10.19803/j.1672-8629.2021.12.22 Abstract ( 292 )   PDF (825KB) ( 121 )   Objective To explore the causes of palpitation and muscle tremor induced by tranexamic acid sodium chloride injection and the treatment measures.Methods The diagnosis and treatment of a case of palpitation and muscle tremor induced by tranexamic acid sodium chloride were analyzed. Combined with literature search, the mechanism and countermeasures of panic and tremor induced by tranexamic acid sodium chloride were explored. Results Sudden palpitation and muscle tremor in patients with tranexamic acid sodium chloride may be related to excessive infusion rate, pay attention to the dose, speed, concentration can reduce the occurrence of adverse drug reactions, may also be a precursor to tranexamic acid-induced epilepsy, early EEG monitoring is helpful for diagnosis, some general anesthesia drugs and benzodiazepines may be used for treatment; or may be tranexamic acid-induced typeⅠdrug allergy reaction, and anti-allergic treatment should be given in time.Conclusion In the course of clinical use of tranexamic acid, it is necessary to strengthen observation. In case of adverse reactions, the drug should be stopped immediately, and corresponding emergency measures should be taken according to different situations. References | Related Articles | Metrics

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One Case of Severe Adverse Drug Reactions Induced by rt-PA and Literature Analysis FU Hong, RONG Youhe 2021, 18(12): 1198-1200.  DOI: 10.19803/j.1672-8629.2021.12.23 Abstract ( 219 )   PDF (875KB) ( 146 )   Objective To discuss the mechanism and treatment of severe adverse drug reactions caused by rt-PA.Methods Based on the diagnosis and treatment of one case with severe allergic reactions caused by rt-PA, the possible mechanism and treatments were described in combination with literature analysis. Results After effective treatment, the patient improved significantly and tended to be stable.Conclusion The severe anaphylaxis caused by rt-PA is rare but life-threatening, so we need to pay more attention to the adverse reactions in our future work and deal with them properly. References | Related Articles | Metrics