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Clinical diagnosis of Chinese-herbal-induced liver injury YU Lecheng, HAO Kunyan, FAN Ye 2023, 20(5): 481-488.  DOI: 10.19803/j.1672-8629.20230021 Abstract ( 230 )   PDF (1421KB) ( 222 )   Objective To provide a roadmap based on modular evidence chains for the clinical diagnosis of herbal induced liver injury (HILI). Methods Four modules of information were investigated, including the temporal relationship between the application of Chinese herbal medicine and the occurrence of liver injury, the related liver toxicity information of the herbals itself, the possibility of drug combination as the cause of liver injury, and the potential non-drug factors of liver injury. All these information were incorporated to form an logistically structured chain of evidence for the diagnosis of HILI. Results and Conclusion The clinical diagnostic principle of HILI is similar to that of liver injury caused by modern drugs (including chemical drugs and biomedicine), but it has its own characteristics and difficulties. After analyzing the variability of temporal relationship between Chinese herbal medicine and liver injury, the following information were detailedly evaluated in multiple dimensions, including the liver toxicity information related to Chinese herbal medicine itself, the corresponding information of concomitant drugs, and the existent status of liver injury caused by other pathogens. Then a revised roadmap based on the evidence chain was proposed. Rousse Uclaf Causality Assessment Method (RUCAM) scale is advisable in the diagnosis of HILI, yet the diagnostic value of Revised Electronic Causality Assessment Method (RECAM) scale for HILI needs to be further investigated in real world clinic. If necessary, the diagnosis of HILI should be further confirmed with the Structured Expert Opinion Progress (SEOP). Some pathological features of liver biopsy may be helpful for the confirmation of HILI, and specific biomarkers of HILI need to be further explored. References | Related Articles | Metrics

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Component-effect/toxicity-target correlations of Tripterygium wilfordii in terms of lipid metabolism DING Zihe, ZHANG Yanqiong, LIN Na 2023, 20(5): 489-495.  DOI: 10.19803/j.1672-8629.20220734 Abstract ( 85 )   PDF (1695KB) ( 85 )   Objective To analyze the lipid metabolic pathways related to the efficacy and/or toxicity of Tripterygium wilfordii’s and to explore the component-effect/toxicity-target correlations. Methods Recent literature on the regulation of lipid metabolism by Tripterygium wilfordii preparations and its active components was collected and reviewed. An analytical model for component-effect/toxicity-target correlations was established based on theories of pharmacology, clinical use and experimental research. Results Tripterygium wilfordii preparations and its active components proved to exert therapeutic effects by regulating multiple key processes of lipid metabolism, including fatty acid metabolism, phospholipid metabolism and steroid metabolism while inducing various toxic effects due to lipid peroxidation, phospholipid metabolism disorders and bile acid accumulation. Conclusion The analysis of the component-effect/toxicity-target correlations from perspective of lipid metabolism pathways can help to better understand and evaluate its effectiveness and safety, which will facilitate rational medications in clinical practice. References | Related Articles | Metrics

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Overview of hepatotoxicity of Xianling Gubao capsules ZHU Chunwu, YU Xuejun, SUN Xin, LIU Chenghai 2023, 20(5): 496-499.  DOI: 10.19803/j.1672-8629.20230107 Abstract ( 147 )   PDF (1200KB) ( 186 )   Objective To analyze the hepatotoxicity of Xianling Gubao capsules and provide reference for its safe and reasonable use. Methods By referring to the relevant literature at home and abroad from January 1994 to August 2022, the research situation of liver toxicity of Xianling Gubao capsules from the aspects of liver toxicity, cause of liver injury, toxicity mechanism and attenuated countermeasures was summarized. Results The toxic components of Xianling Gubao capsules are mainly Psoraleae Fructus and Epimedii Folium, which are related to factors such as patient’s gender, age and dosage. Conclusion The monitoring of hepatotoxicity of Xianling Gubao capsules should be strengthened in clinical use to reduce the occurrence of liver injury. References | Related Articles | Metrics

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Chinese medical evidence and characteristics of combined medication in 635 cases of rheumatoid arthritis patients with liver injury caused by the application of Tripterygium wilfordii preparations LUO Qiong, LI Meng, LI Guangyao, HE Yanchun, ZHOU Zushan, SUN Xin, LIU Chenghai 2023, 20(5): 500-504.  DOI: 10.19803/j.1672-8629.20230108 Abstract ( 101 )   PDF (1370KB) ( 93 )   Objective To analyze the traditional Chinese medicine (TCM) syndromes and combined medication of liver injury caused by Tripterygium wilfordii preparation in patients with rheumatoid arthritis. Methods The clinical data of patients with rheumatoid arthritis treated with Tripterygium wilfordii preparation in Honghu Hospital of Traditional Chinese Medicine from December 22, 2014 to December 10, 2020 were retrospectively collected, and divided into observation group and control group according to the presence or absence of liver injury. The SNK-Q test or Nemenyi test was used for comparison between the two groups to explore the characteristics of TCM syndromes and combined medication. Results A total of 635 patients with rheumatoid arthritis who used Tripterygium wilfordii preparation were collected in the past six years; The majority of people aged 40 to 59 years old (56.69%); Adult females are more than males, the ratio of males to females is 1∶3.12; Among them, 349 patients with liver injury (observation group) and 286 patients without liver injury (control group) were matched with the same treatment at the same time. The proportion of patients with liver injury complicated by hypertension (P=0.003) was significantly higher than that of the control group. In the treatment of rheumatoid arthritis, Huangteng extract tablets were used in combination with other TCM based on syndrome differentiation, among which Qingre Tongbi tablets (damp-heat obstruction syndrome) accounted for the most proportion, and the proportion of patients with liver injury decreased (P=0.047). Most of the patients were also combined with other drugs, among which the proportion of liver injury was significantly higher in the patients combined with TCM decoction (P<0.001), TCM liquor (P=0.026), meloxicam (P=0.03), leflunomide (P<0.001) and/or non-steroidal anti-inflammatory drugs (P=0.012). In the observation group of liver injury, the level of serum alkaline phosphatase in patients with damp-heat obstruction syndrome (P=0.008) was significantly higher than that in patients with cold-dampness obstruction syndrome (P=0.029); The serum uric acid level in the damp-heat obstruction syndrome group was significantly higher than that in the qi and blood deficiency syndrome group (P=0.013). The degree of liver injury is mainly mild to moderate, and most patients have a good prognosis. Conclusion Tripterygium wilfordii single preparation (Huangteng extract tablet) combined with other TCM based on syndrome differentiation was the common clinical TCM treatment of rheumatoid arthritis. Reasonable combination of Qingre Tongbi tablet under the damp-heat obstruction syndrome could reduce the occurrence of liver injury to a certain extent. However, the combination of other TCM decoction, TCM liquor, meloxicam, leflunomide or non-steroidal anti-inflammatory drugs increased the incidence of liver injury. References | Related Articles | Metrics

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Clinical characteristics and risk factors of 113 cases of anti-neoplastic drug-induced liver injury LI Rongrong, LI Meng, GOU Yue, LUO Qiong, LYU Hua, SUN Xin, LIU Chenghai 2023, 20(5): 505-510.  DOI: 10.19803/j.1672-8629.20220718 Abstract ( 153 )   PDF (1352KB) ( 171 )   Objective To analyze the clinical characteristics of anti-neoplastic drug induced liver injury (DILI). Methods The clinical data of 113 patients with DILI during anti-neoplastic therapy in Shuguang Hospital Affiliated to Shanghai University of TCM from January 1, 2021 to June 30, 2022 was retrospectively analyzed, including gender, age, disease history, primary tumor sites, anti-neoplastic therapy regimens, blood routine, liver and kidney function and tumor indicators. Chi-square test, t test and nonparametric test were used for analysis. Results Among the 113 patients with antitumor DILI, the ratio of males to females was 1.13∶1, and most of them were over 55 years old. In terms of primary tumor sites, the incidence of DILI was higher in patients with colon cancer (25.7%), lung cancer (13.3%), and gastric cancer (12.4%). Among antitumor therapy regimens, chemotherapy and targeted combined chemotherapy were most likely to cause DILI. As for the clinical classification of DILI, the proportion of patients with cholestasis was the highest (107 cases, 94.7%), followed by the mixed type (6 cases, 5.3%). The degree of liver injury was mostly mild (107 cases, 94.7%). Logistic regression analysis showed that alcohol consumption (OR 4.336, P=0.042) was an independent risk factor for antitumor DILI. Conclusion DILI caused by anti-neoplastic drugs mostly occur in elderly patients, and chemotherapy and targeted combination chemotherapy are the most common. Cholestasis is the dominating type. The degree of liver injury is relatively mild, and a previous history of alcohol consumption increases the risk of anti-neoplastic DILI. References | Related Articles | Metrics

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One case of acute liver injury caused by tripterygium glycosides tablets LIU Baosheng, WANG Guanjie, WANG Zhenhua, LIU Lihong, ZHU Yan, ZHOU Xiuli 2023, 20(5): 511-513.  DOI: 10.19803/j.1672-8629.20220672 Abstract ( 163 )   PDF (1237KB) ( 206 )   Objective To investigate the clinical characteristics, high-risk factors and treatment options of acute liver injury caused by tripterygium glycosides tablets on a case-by-case basis. Methods The clinical data on one case of pharmacogenic liver injury caused by tripterygium glycosides tablets used for chronic glomerulonephritis was analyzed based on related literature. Results A 34-year-old female patient with chronic glomerulonephritis was treated with tripterygium glycosides tablets 20 mg orally three times daily. She developed elevated ALT, AST, ALP and GGT before being given reduced glutathione combined with magnesium isoglycyrrhizate after discontinuation of tripterygium glycosides tablets. Her liver function indexes returned to normal after symptomatic treatment. Conclusion The clinical symptoms and biochemical indexes of liver function of patients should be monitored during treatment with tripterygium glycosides tablets to identify the possible pharmacogenic liver injury caused by traditional Chinese medicine. Patients with adverse reactions of liver injury should be given quick and corresponding treatment according to their conditions. References | Related Articles | Metrics

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Radiation screening of Chaihu Shugan pills via photostimulated luminescence WANG Zhao, ZHAO Jianfeng, YU Xinlan, JIN Hongyu, MA Shuangcheng 2023, 20(5): 514-518.  DOI: 10.19803/j.1672-8629.20211101 Abstract ( 59 )   PDF (1324KB) ( 76 )   Objective To establish a photostimulated luminescence (PSL) method for radiation screening of Chaihu Shugan pills so as to provide reference for quality control and safe use of these pills. Methods Combined with the national drug evaluation sampling test and in line with the European Standard (EN) 13751:2009, a radiation screening method of Chaihu Shugan pills was established by using the SURRC PPSL irradiation food screening system after the samples were crushed or laminated. Results This method proved to be feasible after methodological investigation. The measured values could reflect whether the sample had been irradiated. The negative control was free of interference. A total of 102 batches of samples from 10 enterprises were tested for radiation. The results showed that 26 of these batches of samples by 6 enterprises were positive for radiation screening and had been treated by radiation sterilization, accounting for 25.5% of the total. Conclusion The established method can quickly screen the irradiation residues without complex pretreatment, which is simple, rapid and economical, and can provide reference for quality control and safe use of Chaihu Shugan pills. References | Related Articles | Metrics

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Effects of 60Co-γ ray irradiation sterilization on quality of Buthus martensii Karsch powder MA Yun, HAN Zhenming, ZHANG Wei, MA Jian, GUAN Yongxia, ZHANG Guimin 2023, 20(5): 519-523.  DOI: 10.19803/j.1672-8629.20220387 Abstract ( 81 )   PDF (1547KB) ( 82 )   Objective To study the effects of different doses of 60Co-γ ray radicidation on the composition and hygienic indexes of Buthus martensii Karsch powder, and to provide data for improvement of the sterilization process. Methods The Buthus martensii Karsch powder was irradiated with different doses of 60Co-γ rays, and pharmacopoeia-required test items, such as moisture, total ash, acid-insoluble ash, aflatoxin, acid-soluble leaches, heavy metals and harmful elements, were determined before and after sterilization of the samples. Such hygienic indicators as microbial contents were determined, and the contents of Buthus martensii Karsch powder sterilized by 4, 6, 8 and 10 kGy of 60Co-γ ray were analyzed. Results There was no significant difference in contents of moisture, total ash, acid-insoluble ash, aflatoxin, acid-soluble extract, heavy metals or harmful elements in the powder before and after irradiation with different doses of 60Co-γ. Before and after radicidation, the difference in hygiene indexes between the test groups was significant. The dynamic irradiation with 60Co-γ rays at the dose of 4 kGy or above could effectively kill microorganisms, and the sterilization effect of 6 kGy and above was good. There was no significant difference in the contents of five nucleoside components or seventeen amino acids before and after sterilization, as was determined by HPLC, and the quality was stable Conclusion 60Co-γ ray irradiation can effectively kill microorganisms in Buthus martensii Karsch powder. The doses of 6 to 10 kGy are the most effective. There is no obvious difference in the pharmacopoeia-required test items before and after radicidation. The quality of the powder after irradiation is better. References | Related Articles | Metrics

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Interpretations of reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statement NIE Xiaolu, TANG Shaowen, YU Jinyang, SONG Haibo, FU Zhu, SUN Feng 2023, 20(5): 524-529.  DOI: 10.19803/j.1672-8629.20220527 Abstract ( 374 )   PDF (1286KB) ( 457 )   Objective To help implementers and readers better understand and apply the reporting recommendations intended for pharmaceutical risk minimization evaluation studies(RIMES) statements by introducing the checklist of RIMES statements and interpreting them. Methods The characteristics and current research of RIMES were summarized. Meanwhile, the checklist of RIMES statements was translated based on the translation integrity procedure (TIP) through forward and backward translation. Results There were 43 items in the RIMES checklist in four dimensions, including key information, research design, implementation and evaluation. Conclusion With the increasing regulators of global pharmacovigilance, RIMES statements will provide an important framework for RIMES. References | Related Articles | Metrics

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Research in the construction of comprehensive evaluation systems of drugs in China YUE Xiaolin, LU Song, ZHANG Lan 2023, 20(5): 530-535.  DOI: 10.19803/j.1672-8629.20220171 Abstract ( 200 )   PDF (1283KB) ( 201 )   Objective To summarize the research progress of clinical evaluation system construction, discuss the clinical evaluation system suitable for Chinese conditions, and provide reference for the development of clinical evaluation of drugs. Methods Domestic and foreign literature on the construction of comprehensive evaluation system was searched and the latest progress of the construction process of comprehensive evaluation system was reviewed. Results Such as the UK and the US, drug evaluation was mainly aimed at the formulation and decision of drug list. The system construction had a certain foundation, and drug selection methods, evaluation indexes and proofreading methods were relatively standardized.In our country, the evaluation based on hospital drugs selection is gradually developed and improved, but the evaluation system is still in the exploratory stage. Conclusion The construction of comprehensive drug evaluation system can include several aspects, such as the construction of professional evaluation subject, standardized evaluation process, appropriate evaluation index system, scientific evaluation method, strict review system. References | Related Articles | Metrics

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Efficacy and safety of compound salvia miltiorrhiza spray/aerosol for angina pectoris due to coronary artery disease: a Meta analysis CHENG Fengjingming, LYU Jian, XIE Yanming 2023, 20(5): 536-543.  DOI: 10.19803/j.1672-8629.20211052 Abstract ( 93 )   PDF (2003KB) ( 85 )   Objective To evaluate the efficacy and safety of compound salvia spray/aerosol in the treatment of angina pectoris due to coronary artery disease. Methods Eight databases including CNKI, Wanfang Data, VIP, SinoMed, Cochrane Library, PubMed, Embase, and Web of Science were searched for related data that was published from inception to May 5, 2021. Randomized controlled trials of compound salvia spray/aerosol in the treatment of angina pectoris due to coronary artery disease were screened for meta-analysis. TSA software was used to predict the sample size of the outcome indicators. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to evaluate the quality of the included outcome indicators. Results A total of 9 studies were included, with a total sample size of 1 113 cases, 702 of which were in the trial group and 411 in the control group. The results of Meta-analysis showed that the therapeutic effect of compound salvia spray/aerosol alone was better than that of compound salvia tablets. Compared with nitrate drugs alone, the combination of nitrate drugs was not significantly different in terms of therapeutic effect against angina pectoris due to coronary artery disease, the effective rate of ECG or the incidence of adverse drug reactions. However, it was superior to nitrate drugs alone in the stabilization of plaques. The main adverse reaction was nasopharyngeal discomfort, which could resolve itself, and no serious adverse reactions occurred. Conclusion Compound salvia spray/aerosol is highly effective and safe in the treatment of angina pectoris due to coronary artery disease. References | Related Articles | Metrics

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Aerosol inhalation of Tanreqing injection in the treatment of chronic obstructive pulmonary disease: a Meta-analysis WANG Guohua, LI Xiaolei, LIU Xiping, DONG Yizhi, ZANG Chen, XU Hong, TIAN Jixiang, ZHAO Jing 2023, 20(5): 544-552.  DOI: 10.19803/j.1672-8629.20220616 Abstract ( 100 )   PDF (1623KB) ( 92 )   Objective To evaluate the efficacy and safety of atomization inhalation of Tanreqing injection (TRQ) in the treatment of chronic obstructive pulmonary disease (COPD). Methods The databases of CNKI, Wanfang data, VIP, SinoMed, PubMed, Cochrane Library and Web of Science were searched for literature on randomized controlled trials (RCT) of TRQ atomization inhalation in the treatment of COPD that was published between inception and May 22, 2022. The Cochrane Collaboration’s risk of bias evaluation tool was used to evaluate the methodological quality of the included studies. Revman 5.4.1 software was used for statistical analysis of the data, while TSA software developed by Copenhagen Clinical Trial Center was used for trial sequential analysis. Results Aerosol inhalation of TRQ combined with conventional treatments could not only improve the total effective rate of COPD treatment, but more significantly improve PaO2, than conventional treatments alone and budesonide or terbutaline atomized inhalation combined with conventional treatments. Aerosol inhalation of TRQ combined with conventional treatments could reduce inflammatory factor TNF-α more effectively than conventional treatments alone. Only a small number of studies have reported adverse events in the treatment of COPD with aerosol inhalation of TRQ. Conclusion Aerosol inhalation of TRQ is effective for the treatment of COPD to some extent, but the evidence available is not adequate enough to draw conclusions on the safety of this approach. Follow-up studies should be designed and registered in accordance with the internationally recognized SPIRIT Declaration, and standardized clinical trials with sufficient samples should be conducted. More comprehensive indicators should be selected in combination with the guidelines to provide high-quality evidence-based medical evidence for clinical practice. References | Related Articles | Metrics

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Content analysis and risk assessment of aristolochic acids in Chinese medicinal materials (decoction pieces) NIE Lixing, WANG Xinping, LI Jing, DAI Zhong, KANG Shuai, MA Shuangcheng 2023, 20(5): 553-559.  DOI: 10.19803/j.1672-8629.20220175 Abstract ( 128 )   PDF (951KB) ( 128 )   Objective To analyze the content of aristolochic acid analogues in Chinese medicinal materials (decoction pieces) and carry out preliminary risk assessment. Methods Based on related literature published over the past 10 years, the contents of aristolochic acid analogues in 478 samples of 12 types of Chinese medicinal materials (decoction pieces) were analyzed in terms of distribution, correlations and sample difference. Starting from hazard identification to hazard characterization, exposure assessment and risk characterization, the calculation formulas and specific parameters were defined, and the target hazard quotient (THQ) was used to evaluate the safety risk of aristolochic acid I in Asari Radix et Rhizoma. Results Twenty-five types of aristolochic acid analogues were detected in 478 samples of 12 types of Chinese medicinal materials (decoction pieces). In general, the content of aristolochic acid I was the highest and that of aristolochic acid F1 was the lowest. There were correlations between contents of some components. The contents of aristolochic acids in the fruits of medicinal plants were much higher than those in other parts, and the contents of aristolochic acids decreased significantly after processing. Based on the statistics of legal medicinal parts, there were significant differences in the contents of aristolochic acid I and aristolochic acid П between different varieties, with contents in Aristolochiae Cinnabaria Radix being the highest and contents in Houttuyniae Herba being the lowest. The results of risk assessment showed that the target hazard quotient (THQ) of aristolochic acid I in one of the 11 samples of Asari Radix et Rhizoma was above 1, indicating that there was a safety risk. Conclusion The current contents and risk assessment method of aristolochic acids in Chinese medicinal materials (decoction pieces) obtained in this study can provide reference for quality control and safe use of Chinese medicinal materials (decoction pieces) containing aristolochic acids. References | Related Articles | Metrics

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Research hotspots and trends of herb-induced liver injury based on CiteSpace knowledge maps XU Shuai, CHEN Xun, BIAN Haoyu, ZHAO Yuqing, ZHANG Liping 2023, 20(5): 560-567.  DOI: 10.19803/j.1672-8629.20230137 Abstract ( 74 )   PDF (2465KB) ( 100 )   Objective To explore the development status and trend of herb-induced liver injury, and predict the future research direction by analyze the literature through visual analysis. Methods The research literature on herb-induced liver injury published from database inception to February 28, 2023 was retrieved from CNKI and Web of Science. CiteSpace 6.1.R6 was used to visually analyze the annual number of papers, authors, institutions and keywords, so as to discuss the research hotspots, status and development trends in this field. Results A total of 2 393 Chinese articles and 488 English articles were included, and the number of publications increased year by year with a stable trend. There were 71 core authors, forming several research teams, while there was little cooperation among them. Institutional cooperation is closer in English literature than in Chinese literature, and there are some cross-regional cooperations. Recent research focuses on the chemical components, mechanism, the toxicity reduction of TCM processing and compatibility, clinical evaluation, prevention and control of herb-induced liver injury. Conclusion The research popularity in the field of herb-induced liver injury has increased year by year, and exploring the mechanism and clinical evaluation indexes based on multi-omics technology may be the future focus of research. References | Related Articles | Metrics

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Comparative study on data set of drug-induced liver injury YAO Keyu, ZHANG Shuqi, JIN Rui, LIU Lihong, ZHU Yan 2023, 20(5): 568-573.  DOI: 10.19803/j.1672-8629.20220447 Abstract ( 215 )   PDF (1505KB) ( 180 )   Objective To investigate and compare the data sources and methods for risk assessment and drug classification related to DILI so as to provide reference for the construction of DILI datasets and for clinical practice, research and regulation. Methods Five data sets (DILIrank, DICIst, Liver Tox, Suzuki, Greene) that involved more than 300 drugs and assessed the severity of human drug-induced liver injury were selected. The data sources, data volume, DILI risk assessment methods and drug classification were compared and analyzed. Results The data sources included drug labels, literature, network databases, clinical/registration center cases, regulators and other channels. LiverTox involved the largest number of drugs, DILIrank had the highest coincidence with other datasets, and the classification by DILIrank and LiverTox was more detailed. Risk assessment of DILI was classified according to the severity and odds of liver injury. DILI was determined by expert opinions or causal assessment. Conclusion A high-quality data set is related to the data source, data quantity, assessment methods and drug classification. Chinese drug-induced liver injury data sets, especially DILI data sets of Chinese medicines, need to be improved. References | Related Articles | Metrics

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Cefoperazone/sulbactam-related medication errors in the elderly and countermeasures ZHANG Qingxia, ZHOU Liujun, LI Xiaoling, WANG Yuqin 2023, 20(5): 574-578.  DOI: 10.19803/j.1672-8629.20220343 Abstract ( 138 )   PDF (1353KB) ( 159 )   Objective To investigate the incidence and causes of medication errors (ME) related to cefoperazone / sulbactam in the elderly (≥ 60 years old) so as to provide data for targeted precautions. Methods Reports about cefoperazone / sulbactam-related ME in the elderly were retrieved from the National Monitoring Network for Clinical Safe Drug Medication between September 22, 2012 and September 22, 2021. The severity of errors, content of errors, locations of errors, the person(s) responsible, and causes of errors were retrospectively analyzed. Results A total of 210 ME reports were retrieved, involving 143 males and 67 females, with a median age of 73 (60 to 97). In terms of severity of errors, errors of Class B (Minor ME) were dominating (139 cases, 66.19%). There were 10 cases of severe ME ( 4.76%): 4 patients with severe liver insufficiency were prescribed with cefoperazone / sulbactam, which aggravated their liver function, 2 patients at a high risk of bleeding had not had their blood coagulation indexes monitored, resulting in prolonged prothrombintime (PT), and one of them even suffered upper gastrointestinal tract bleeding, 2 patients with bleeding events did not discontinue medication immediately, which prolonged their PT, 1 patient presented with renal insufficiency after using cefoperazone / sulbactam, but did not stop medication immediately, resulting in severe renal insufficiency, and 1 patient with anaphylactic shock did not choose to use epinephrine first. Among these 213 ME, 140 (24.29%) were made by physicians. The top three types of errors were related to the dosage, frequency ( qd ) and variety. Most of these ME were due to a lack of knowledge or training and fatigue. ME made by pharmacists (51 cases, 24.29%) were mainly related to the variety (LASA drugs). One hundred and fifty-two (72.38%) of these errors were spotted by pharmacists. Conclusion The proportion of severe ME concerning cefoperazone/ sulbactam is higher than that of severe ME related to clinical drugs across the country. Errors associated with prescriptions and dispensing merit attention. Importance should be attached to the selection of the right drug variety, quick dose adjustment, monitoring of coagulation disorders and to prevention of combined use of drugs containing ethanol excipients in patients with hepatorenal insufficiency. It is recommended that information be made more accessible to reduce the ME related to prescriptions, drug selection be taken seriously, labels of LASA drugs be made more eye-catching to lower the risk of LASA errors. Clinicians ought to be better informed of rational drug use, and rescue processes for anaphylactic shock have to be formulated. References | Related Articles | Metrics

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Pharmaceutical care of a patient with Clostridium difficile infection and urinary tract infection during pregnancy FAN Xiucong, DONG Xiaohui, CHEN Danxia, BAO Siwei, MA Yabin 2023, 20(5): 579-582.  DOI: 10.19803/j.1672-8629.20220036 Abstract ( 91 )   PDF (1289KB) ( 109 )   Objective To analyze one case of pregnancy with Clostridium difficile infection and urinary tract infection, explore the rationality of the anti-infection treatment and provide reference for clinical rational drug use. Methods A clinical pharmacist participated in the treatment of a pregnant patient with Clostridium difficile infection and urinary tract infection. By retrieving related literature, strictly following the evidence-based medical practice and taking the patient’s conditions into consideration, the clinical pharmacist assisted the doctor in formulating the anti-infection treatment plan. Oral metronidazole and venous piperacillin tazobactam were used to treat Clostridium difficile infection and urinary tract infection, respectively. Results The clinical pharmacist helped doctors cure the infections and ensured the safety of the mother and fetus. Conclusion Clinical pharmacists should follow evidence-based methods and formulate a plan in combination with individual conditions. For the medication of concurrent infections, they should weigh the advantages and disadvantages and cure infections as long as the safety of the mother and fetus can be ensured, which can manifest the value of clinical pharmacists in obstetrics and gynecology. References | Related Articles | Metrics

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One case of muscle loss induced by ceftazidime-avibactam for injection combined with polymyxins B sulfate for injection after renal transplantation HUANG Shaolan, YANG Ge, LI Wei 2023, 20(5): 583-584.  DOI: 10.19803/j.1672-8629.20220446 Abstract ( 94 )   PDF (1197KB) ( 85 )   Objective To study the safety of ceftazidime-avibactam for injection combined with polymyxins B Sulfate for injection in patients after renal transplantation. Methods The clinical data of a 29-year-old female patient with Klebsiella pneumonia infection after renal transplantation was analyzed, who had been treated with intravenous infusion of polymyxin B sulfate for injection and ceftazidime-avibactam, but her kidney preservation solution was sensitive to colistin and ceftazidime-avibactam. She presented with weakness of muscle during infusion of the sixth dose of ceftazidime-avibactam for injection. The possible causes of adverse reactions were analyzed. Results Based on the Karch and Lasagna method and Naranjo scale, both polymyxin B sulfate and ceftazidime-avibactam were discontinued. These symptoms did not recur after the patient received intravenous infusion of ceftazidime-avibactam alone. Conclusion The combination of ceftazidime-avibactam for injection and polymyxin B sulfate for injection may increase the risk of weakness of muscle. References | Related Articles | Metrics

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Analysis of epileptic seizures induced by lenalidomide with high-grade B cell lymphoma PENG Miaoxin, WANG Yanqiong, XU Peipei, YANG Yonggong 2023, 20(5): 585-587.  DOI: 10.19803/j.1672-8629.20220352 Abstract ( 79 )   PDF (1134KB) ( 82 )   Objective To explore neuro-related adverse reactions of lenalidomide in elderly patients with advanced tumors. Methods One case of neuro-related adverse reactions that resembled epileptic-like seizures shortly after the administration of lenalidomide 10 mg in an elderly patient with advanced tumors was analyzed by referring to literature. Results After taking lenalidomide 10 mg, the patient presented with convulsion like transient seizures with urinary incontinence and unconsciousness, which were gradually alleviated on their own after one to two minutes, and no more CNS symptoms occurred after discontinuation of lenalidomide. More than twenty days later, the patient resumed 10 mg of lenalidomide and experienced transient loss of consciousness with convulsions a second time, but the symptoms were improved after withdrawal. Conclusion Lenalidomide is a new drug for the treatment of refractory recurrent lymphoma in recent years. Clinicians should be alert to the adverse reactions of the drug involving the central nervous system when prescribing it to elderly patients with advanced tumors. References | Related Articles | Metrics

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Suspected mental disorder in uremia hemodialysis induced by piperacillin sodium and sulbactam sodium for injection: a case report ZHANG Zhiwen, TANG Lihua 2023, 20(5): 588-590.  DOI: 10.19803/j.1672-8629.20220368 Abstract ( 105 )   PDF (1177KB) ( 118 )   Objective To provide reference for safe use of β-lactam in hemodialysis patients. Methods A case of mental abnormality caused by piperacillin sodium and sulbactam sodium for injection in a regular hemodialysis patient was retrospectively analyzed to find out about the possible causes of adverse drug reactions and the safety of medication. Results The adverse drug reactions might have involved piperacillin sodium and sulbactam sodium for injection. After drug withdrawal and symptomatic treatment, the patient developed no more mental abnormalities. Conclusion The dose or interval of piperacillin sodium and sulbactam sodium for injection should be adjusted according to the endogenous creatinine clearance(Ccr) to ensure the safety and efficacy of medications. Clinicians should be alert to serious adverse reactions related to the central nervous system. References | Related Articles | Metrics

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Applicability of bibliometric methods pharmacovigilance of traditioual Chinese medicine LIANG Shibing, YU Zeyu, KONG Lingyao, YAN Lijiao, HAN Mei, WU Jiarui, LIU Zhaolan, LIU Jianping 2023, 20(5): 591-594.  DOI: 10.19803/j.1672-8629.20220299 Abstract ( 144 )   PDF (1343KB) ( 172 )   Objective To summarize the applications of bibliometric methods in pharmacovigilance of Chinese medicine (PVCM). Methods CNKI, CQVIP, Wanfang, SinoMed and PubMed were searched for related literature that was published from their inception to August 24, 2021. Second research into the original literature in the field of PVCM carried out using bibliometric methods was included. The definition of bibliometric methods, applicability, selection of topics and implementation of bibliometric methods in the field of PVCM were outlined via examples. Results There were 50 articles on bibliometric research related to PVCM, and the range of topics involved in previous research was narrow ( limited to clinical adverse reactions of Chinese patent medicines). Application of bibliometric methods to in-depth analysis of related literature about PVCM could provide evidence-based evidence for researchers to keep themselves informed of the current research into PVCM, keep track of the frontiers of the discipline, identify hotspots of research, and predict the developments of the discipline at both micro and macro levels. Conclusion In the future, researchers are expected to carry out more high-quality bibliometric research on PVCM and choose a wider range of research topics so as to provide evidence-based support for sustainable development of PVCM. References | Related Articles | Metrics

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Risk factors and mechanisms for skin squamous cell carcinoma in lung transplant recipients induced by voriconazole LYU Peng, ZHANG Jingli, WANG Yunhong, MA Fenfen, ZHANG Yu, HUANG Yifei 2023, 20(5): 595-600.  DOI: 10.19803/j.1672-8629.20220441 Abstract ( 78 )   PDF (1323KB) ( 72 )   Voriconazole is an effective broad-spectrum antifungal agent characterized by high tolerance, safety and effectiveness that is often used as the first choice for the prevention and treatment of invasive aspergillosis after lung transplantation. With wider clinical application, case reports of voriconazole-related cutaneous squamous cell carcinoma, which is often aggressive and multifocal in nature, are ticking up, making this drug an independent risk factor for squamous cell carcinoma in lung transplant recipients. This article reviews the risk factors and potential mechanisms for the development of squamous cell carcinoma induced by voriconazole in order to provide reference for rational clinical application. References | Related Articles | Metrics