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15 January 2025, Volume 22 Issue 1 Previous Issue   

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Key Technologies for Quality Control of Oligonucleotide Drugs LIU Bo, YUAN Yanan, WANG Yue, CHENG Shuqian, LU Zhiguo, FAN Huihong, SUN Huimin 2025, 22(1): 1-9.  DOI: 10.19803/j.1672-8629.20240806 Abstract ( 14 )   PDF (2006KB) ( 42 )   Objective To review the basic data and quality control methods of oligonucleotide drugs in order to provide a reference for quality control of oligonucleotide drugs. Methods By searching related literature and databases at home and abroad, the methods of analysis of related substances, structural characterization, and quantification of oligonucleotides were summarized. Results There were three types of oligonucleotide drugs that had been listed: antisense oligonucleotide, small interfering RNA, and aptamer. Their domestic quality control guidelines mainly referred to foreign guidelines. Ion-pair reverse phase chromatography, ion exchange chromatography, and mass spectrometry were commonly used for quality control of oligonucleotide drugs. Other analysis techniques had their own advantages. Conclusion Significant progress has been made in quality control of oligonucleotide drugs. However, China lacks specific guidelines. Furthermore, there are several problems with the current oligonucleotide drug analysis techniques. To offer strong technical support for quality control of oligonucleotide drugs, research and the development of novel techniques are required. References | Related Articles | Metrics

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Methodology for Constructing Benchmark Database of Adverse Drug Reactions Based on Multi-Source Information NIE Xiaolu, SUN Feng, YAN Aixia, PENG Xiaoxia, ZHAN Siyan 2025, 22(1): 10-15.  DOI: 10.19803/j.1672-8629.20240911 Abstract ( 25 )   PDF (1541KB) ( 63 )   Objective To summarize the primary data sources used in constructing benchmark databases for adverse drug reactions (ADR) and to demonstrate a comprehensive, multi-source approach to building an ADR benchmark database using drug-induced thrombocytopenia (DITP) as an example so as to provide a reference for future computational modeling studies and to guide safer clinical drug use. Methods The advantages and limitations of the data sources used in existing ADR benchmark databases were compared and analyzed. A benchmark database for DITP was constructed by integrating data from multiple sources, and the consistency of these data sources was evaluated using the kappa statistic. The distribution and variability of DITP-risk drugs were analyzed based on the Anatomic Therapeutic Chemical (ATC) classification system. Results Using the FDA-recommended multi-source integration approach, a DITP benchmark database (DITPst) comprising 1 765 drugs was constructed. Analysis of the anatomical classification of drugs within the DITPst database revealed that antineoplastic and immunomodulating agents were the most frequently associated with DITP, with 77.17% (196/254) of these drugs identified as causing these ADR. Conclusion Constructing ADR benchmark databases using multi-source information provides a valuable data reference for computational modeling in drug development as well as for ensuring post-marketing drug safety and promoting rational drug use. References | Related Articles | Metrics

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Pediatric Drug-Induced Immune Thrombocytopenia Based on Real World Data and Quantitative Structure-Activity Relationship NIE Xiaolu, ZHAO Houyu, HUO Donghui, YAN Aixia, SUN Feng, PENG Xiaoxia, NI Xin, ZHAN Siyan 2025, 22(1): 16-22.  DOI: 10.19803/j.1672-8629.20240807 Abstract ( 8 )   PDF (1660KB) ( 45 )   Objective To conduct risk signal mining and toxicity evaluation related to drug-induced immune thrombocytopenia (DIIT) . Methods A real-world study was conducted using the electronic medical record data from Beijing Children's Hospital spanning from 2009 to 2020. Potential DIIT signals in children were mined using a modified laboratory extreme abnormal proportion imbalance method. Based on multi-source information, a DIIT benchmark database was constructed. Three machine learning algorithms-support vector machine (SVM), random forest (RF), and XGBoost-and drug molecular descriptors (ECFP4 and CORINA) were employed to establish quantitative structure-activity relationship (QSAR) models. Toxicity evaluation research on DIIT was conducted based on the physicochemical properties and molecular fingerprints of drugs. Results Eighteen positive signal drugs for pediatric drug-induced thrombocytopenia (DITP) were identified from the electronic medical record data. Among them, nystatin and latamoxef sodium emerged as two new positive DITP signals in both children and adults (DITP risks of OR: 1.75, 95%CI: 1.37 to 2.22 and OR: 1.61, 95%CI: 1.38 to 1.88, respectively). Additionally, six new positive signal drugs not previously reported in children were discovered: imipenem, teicoplanin, fusidic acid, cefotaxime sodium, ceftazidime, and cefepime. Among the nine different QSAR models constructed based on 1 319 compounds, the top three models with optimal performance were the SVM-ECFP4+CORINA model, the RF-ECFP4+CORINA model, and the XGBoost-ECFP4 model, with the area under the curve (AUC) values on the external validation set of 0.747, 0.732, and 0.712, respectively. A consensus model composed of these three optimal models accurately predicted the seven potential positive signals identified in the first step. Conclusion Combining real-world signal mining methods with QSAR models can enhance the methodological framework for post-marketing drug safety evaluation in China. References | Related Articles | Metrics

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Signal Mining and Analysis of ICIs-Associated Thrombocytopenia Adverse Events Based on FAERS Database SUN Ximu, ZHOU Han, LI Yanming, GUO Peng, NIE Xiaolu 2025, 22(1): 23-28.  DOI: 10.19803/j.1672-8629.20240875 Abstract ( 15 )   PDF (1695KB) ( 58 )   Objective To explore the immune checkpoint inhibitors (ICIs)-associated thrombocytopenia adverse events (AE) based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database in order to provide a reference for the safe use of ICIs in clinic. Methods AE reports on ICIs-related thrombocytopenia collected from the first quarter of 2011 to the second quarter of 2024 in the FAERS database were retrieved. Signals were mined using the reporting odds ratio (ROR) and information component (IC) methods. Results A total of 2 050 AE reports with ICIs as the primary suspected drug (PS) associated with thrombocytopenia were obtained, involving a higher percentage of males (52.29%) and elders (44.73%). The country that submitted the largest number of reports was Japan (19.95%). Indications were prevalent in the lungs (33.41%) and skin (13.41%). Except for cytotoxic T lymphocyte associated antigen-4 (CTLA-4) inhibitors, positive signals related to programmed death receptor 1 (PD-1) inhibitors and programmed death receptor ligand 1 (PD-L1) inhibitors were detected in both thrombocytopenia and immune thrombocytopenia. The positive signals of thrombocytopenia were classified as weak ones according to the information component (IC025) while those of immune thrombocytopenia were moderate except for cemiplimab (IC025=0.07) and avelumab (IC025=0.57), and the combination of PD-L1 inhibitor and CTLA-4 inhibitor had the highest ROR value [RR=26.15 (13.04~52.45)]. Conclusion Clinicians should be alert to the potential AE of thrombocytopenia caused by ICIs and promptly implement prevention or treatment strategies to improve the safety of ICIs in clinical application. References | Related Articles | Metrics

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Safety Surveillance for Vaccine-Induced Immune Thrombotic Thrombocytopenia: a Systematic Review SUN Yixin, WANG Chen, YU Yuelin, GUO Peng, NIE Xiaolu 2025, 22(1): 29-36.  DOI: 10.19803/j.1672-8629.20240968 Abstract ( 10 )   PDF (1360KB) ( 44 )   Objective To review the safety surveillance of vaccine-induced immune thrombotic thrombocytopenia (VITT). Methods The evidence-based medicine method was used in this research. PubMed (including Medline), Embase, Cochrane Library, CNKI, Wanfang, VIP and SinoMed were searched for eligible studies on the safety surveillance for VITT published between the inception of each database and September 30, 2024. Two researchers independently screened the literature and retrieved data. Qualitative methods of systematic review were used to summarize information from the literature, and the incidence rates (including reporting rates) and risks of VITT were analyzed. Results A total of 24 articles were included, which could be divided into two categories: 15 passive surveillance studies based on spontaneous reporting systems, and 9 active surveillance studies based on population or electronic healthcare databases. The results showed that VITT mostly occurred after the COVID-19 adenovirus-vectored vaccination (especially the first dose). The reporting rates ranged from 0.2/million doses to 19.9/million doses, and the incidence rates ranged from 2.11/100 000 person-years to 311/100 000 person-years. There were fewer reports on other types of COVID-19 vaccines, but some studies found that mRNA vaccines might also lead to an increased risk of VITT. Additionally, eight vaccines, including the measles-mumps-rubella vaccine, hepatitis B vaccine, rotavirus vaccine, encephalitis vaccine and hepatitis A vaccine, were also observed to be associated with VITT. In the included literature, nine studies reported the diagnostic criteria for VITT, involving five primary factors: recent vaccination history, thrombosis, concurrent thrombocytopenia, specific laboratory findings, and a comprehensive assessment by clinical experts. Conclusion VITT is a potential adverse event following immunization that requires extensive attention and can occur after multiple vaccine types. Its pathogenesis, clinical manifestations, and laboratory test characteristics have not yet been clarified and need to be understood and explored in depth by further studies. References | Related Articles | Metrics

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Developments and Prospects of Radiopharmaceuticals in China LI Wenlong, JIA Juanjuan, HUANG Haiwei, YAO Jing, ZHANG Chunqing, WANG Yan, ZHANG Hui 2025, 22(1): 37-42.  DOI: 10.19803/j.1672-8629.20240570 Abstract ( 13 )   PDF (1473KB) ( 41 )   Objective To find out about the overall development of radiopharmaceuticals in China and analyze the major obstacles to the production and use of radiopharmaceuticals. Methods In-depth studies were carried out where the radiopharmaceutical industry was concentrated in China, involving drug inspection organizations, manufacturers and medical institutions and based on field visits, literature review and a comparative study. Results and Conclusion It is recommended that the Measures for the Administration of Radiopharmaceuticals be revised as soon as possible, the approval and management of radiopharmaceuticals and medical devices be standardized, radiopharmaceutical testing institutions be upgraded, guidance on research and development of radiopharmaceuticals be increased, so as to promote the healthy,rapid and high-quality development of China's radiopharmaceutical industry. References | Related Articles | Metrics

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Assignment of Chemical Reference Substance of Aminopolyether -a Key Impurity in Fludeoxyglucose [18F] Injection SUN Deyang, SUN Jiabei, LI Wenlong, JIA Juanjuan, ZHANG Wenzai, LIU Yan, HUANG Haiwei, YAO Jing 2025, 22(1): 43-46.  DOI: 10.19803/j.1672-8629.20240582 Abstract ( 8 )   PDF (1470KB) ( 46 )   Objective To determine the content of aminopolyether using mass balance and quantitative nuclear magnetic resonance (qNMR) respectively. Methods The chromatographic purity of the aminopolyether reference substance was determined using HPLC-UV & HPLC-CAD methods. Moisture, ignition residues and residual solvents were determined with Karl-Fischer-Coulomb method, residue on ignition method and headspace gas chromatography, respectively. The purity of the aminopolyether reference substance was calculated using the mass balance method. Finally, the absolute purity of the aminopolyether reference substance was determined by qNMR. Results The chromatographic purity of the aminopolyether reference substance was 100% as detected with the HPLC-UV method and with the HPLC-CAD method. The result of the mass balance method was 99.75%, compared with 99.78% by qNMR. Conclusion The assignment results of mass balance and qNMR are consistent, so the two methods can guarantee the accuracy of assignment. The aminopolyether reference substance could be used for quality control of fludeoxyglucose [18F] injection and other F-18 substituted radiopharmaceuticals. References | Related Articles | Metrics

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Biological Distribution of 99mTc-DMSA Injection JIA Juanjuan, SUN Jiabei, ZHANG Wenzai, SUN Deyang, SHI Yaqin, HUANG Haiwei 2025, 22(1): 47-52.  DOI: 10.19803/j.1672-8629.20240648 Abstract ( 8 )   PDF (1443KB) ( 44 )   Objective To establish a biodistribution determination method for 99mTc-DMSA injection, and measure the biological distribution of 99mTc-DMSA injection in order to contribute to quality evaluation of this drug methodologically. Methods The measurement range and applicability of the instruments (dose calibrator and γ counter) required for biological distribution tests were examined. Using rats as experimental animals, 99mTc-DMSA injection was prepared using DMSA kits from 2 manufacturers to examine the impact of the injection dose on biological distribution. The uptake values of the same dose of 99mTc-DMSA injection from different manufacturers were compared in various organs of rats to study the differences in biological distribution between different manufacturers. Results The measurement range of the dose calibrator was≥1.6 μCi. The linear range of the γ counter measurement was 400 to 3 570 000 CPM, which corresponded to a maximum radioactivity of 2.6 μCi. There was no significant difference in biodistribution of samples injected with doses of 0.04 mCi to 1.7 mCi. Using the established biodistribution assay, the results showed differences in the biodistribution of the samples from 2 manufacturers in rats. The 99mTc-DMSA injection prepared using the kit from manufacturer A was metabolized faster compared with manufacturer B in rats. One hour after injection, 19.23% of preparation A and 10.29% of preparation B were excreted in urine. There was also a significant difference in the uptake values per gram of renal tissue, which were 17.00% and 26.95%, respectively. Conclusion A biological distribution method for 99mTc-DMSA injection has been established that offers data for quality evaluation of this drug and sparks ideas for quality evaluation of other 99mTc labeled drugs. References | Related Articles | Metrics

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Determination of Contents of 15 Elemental Impurities in Kits of Dimercaptosuccinate Acid and Stannous Chloride for Injection by ICP-MS YAO Jing, LIAN Xiaofang, ZUO Limin, GUO Xin, LIU Huiyi, GU Yongsheng, JIA Qingying, HUANG Haiwei 2025, 22(1): 53-57.  DOI: 10.19803/j.1672-8629.20240572 Abstract ( 7 )   PDF (1357KB) ( 43 )   Objective To establish an inductively coupled plasma mass spectrometric (ICP-MS) method for the determination of elemental impurities in kits of dimercaptosuccinate acid and stannous chloride for injection. Methods The elements in kits of dimercaptosuccinate acid and stannous chloride for injection were screened using ICP-MS in a semi-quantitative mode. The elemental impurities were determined before being examined and controlled as required by the ICH Q3D guidelines for elemental impurities. There were 15 elements: Li, Al, K, V, Fe, Co, Ni, Cu, Zn, As, Cd, In, Sb, Hg and Pb, which were chosen as the subjects. The kinetic energy discrimination (KED) mode was selected for ICP-MS while Sc, Ge, Y and Bi were used as the internal standards. The sampling was repeated three times to determine the average value. Results The contents of five elements-Al, K, Fe, Zn and In-were found to be relatively high in the kit of dimercaptosuccinate acid and stannous chloride for injection after elemental screening. The results of determination of elemental impurities of products by different enterprises revealed characteristics of distribution. Methodological validation indicated that the impurities of each element were within the linear range and correlated (r >0.991 7), and that the precision (RSD≤3.72%) and reproducibility (RSD≤3.53%) of the method met the requirements, with the average recoveries of these elements ranging from 93.45% to 105.38% (RSD≤4.28%, n=9), and the accuracy was good. Conclusion Metal salts may introduce impurities of elements other than those required by ICH Q3D guidelines. The method established in this study is simple, rapid and can meet the requirements for the detection and risk evaluation of elemental impurities in the kit of dimercaptosuccinate acid and stannous chloride for injection. References | Related Articles | Metrics

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Biodistribution of Therapeutic DNA Vaccines in Mice HOU Tiantian, WANG Xudong, YANG Ping, ZHOU Pengbo, QIN Chao, HUANG Ying, WANG Ailing, GENG Xingchao, ZHOU Xiaobing, LIU Defang 2025, 22(1): 58-66.  DOI: 10.19803/j.1672-8629.20240271 Abstract ( 6 )   PDF (3036KB) ( 36 )   Objective To evaluate the distribution and clearance of therapeutic DNA vaccines in mice Methods A total of 156 C57BL/6N mice were divided into the negative control group, mouse-derived DNA vaccine group and human-derived DNA vaccine group. Mice were given a single intramuscular injection. At 2 h, 24 h, 7 d, 14 d, 28 d and 56 d after administration, the mice were dissected and organs were collected. The distribution of the two DNA vaccines in different organs was detected using the real-time quantitative polymerase chain reaction (qPCR) method. Results After the administration of the mouse-derived DNA vaccine and human-derived DNA vaccine to C57BL/6N mice, the gene copy number peaked at 2 h and was widely distributed across tissues, among which the copy number at the injection site was the highest. Then, the gene copy number in various tissues and organs trended downward. At 14 d after administration, the gene copy number in various tissues and organs was low, with a decrease of approximately 99.9% compared to 24 h. The distribution was consistent between males and females. In blood, the gene copy number was high at 2 h, and by 24 h,the human-derived and mouse-derived DNA vaccine was basically cleared. Conclusion Two hours after intramuscular injection in C57BL/6N mice, the mouse-derived DNA vaccine and human-derived DNA vaccine are widely distributed in various tissues and organs, with the highest distribution at the injection site, and their survival time in the body does not exceed 56 d. References | Related Articles | Metrics

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Six Active Ingredients in Medicinal and Non-Medicinal Parts of Farfarae Flos: a Comparative Study ZAN Ke, CAI Xisheng, WU Yun, WANG Zhao, WANG Dandan, LI Hailiang, JIN Hongyu 2025, 22(1): 67-71.  DOI: 10.19803/j.1672-8629.20240569 Abstract ( 8 )   PDF (1335KB) ( 44 )   Objective To study the differences in contents of six active ingredients in medicinal and non-medicinal parts of Farfarae Flos. Methods A high-performance liquid chromatography method was established for simultaneous determination of six components, including chlorogenic acid, rutin, 3,4-O-dicaffeoylquinic acid, 3,5-O-dicaffeoylquinic acid, 4,5-O-dicaffeoylquinic acid, and tussilagone, in different parts of Farfarae Flos. The experiment was conducted using a ShimNex CS C18 (4.6 mm×250 mm, 5 μm) chromatographic column. The mobile phase was composed of acetonitrile-0.1% phosphoric acid aqueous solution under gradient elution. The detection wavelength was 220 nm at a flow rate of 1 mL·min-1 and the column temperature was 30℃. Results Rutin and tussilagone were not detected in the pedicels or roots of Farfarae Flos. The contents of other four caffeoylquinic acids were significantly lower than those in the buds. Conclusion The experiment has justified the use of buds of Farfarae Flos as the medicinal material. The mixture with non-medicinal parts will affect the quality of medicinal materials and should be avoided in the process of production. It is recommended that inspections of impurities be included in quality standards to ensure the quality of medicinal materials. References | Related Articles | Metrics

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Low Endotoxin Recovery and Mitigation Strategies PEI Yusheng, XU Lin, ZHAO Yuxin, CAI Tong, HUA Xiaodong 2025, 22(1): 72-75.  DOI: 10.19803/j.1672-8629.20240502 Abstract ( 10 )   PDF (1269KB) ( 36 )   Objective To investigate the mechanism of low endotoxin recovery (LER) in the process of manufacturing pharmaceuticals, reduce potential endotoxin contamination risks during product release, and prevent pyrogenic products from entering the market that may compromise patient safety. Methods The causes of LER were explored in terms of definitions, mechanisms, differences from other interferences, and mitigation strategies. Results and Conclusion By taking corrective measures for LER, the associated risks can be eliminated, quality control exercised throughout the manufacture, and drug quality supervision and medication safety ensured. References | Related Articles | Metrics

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Study on Catalpol Determination in Rehmanniae Radix DAI Mengru, LI Chun, ZHANG Yongxin, LU Yu, CHENG Boyu, FENG Weihong 2025, 22(1): 76-83.  DOI: 10.19803/j.1672-8629.20240568 Abstract ( 10 )   PDF (1605KB) ( 38 )   Objective To establish a method of UPLC for the determination of catalpol in Rehmanniae Radix so as to improve the quality standard of Rehmanniae Radix. Methods A Boltimate LP-C18 chromatographic column (4.6mm× 50 mm, 2.7μm) was used while pure water was used as the mobile phase and extraction solvent. The detection wavelength was set at 194 nm, the flow rate was 0.6 ml min-1, the column temperature was 35℃, and the sample volume was 1 μL. The contents of catalpol in 3 batches of fresh Rehmanniae Radix and 7 batches of raw Rehmanniae Radix were determined, and the result was compared with the one determined using the method specified in Chinese Pharmacopoeia. Results The RSDs of precision, repeatability, stability and spiked recovery tests of the new method were all below 0.5. Compared with the method specified in the current Chinese Pharmacopoeia, the sensitivity, reproducibility and accuracy of the new method were higher. The new method could complete the preparation of the test solution within 15 min, and accurately determine the content of catalpol in fresh/raw Rehmanniae radix within 10 min. Conclusion This method is simple, environmentally friendly, time-saving, and does not need any organic solvent. It can effectively prevent catalpol degradation in an acid environment, accurately determine catalpol contents, and provide a feasible method for quality control of Rehmanniae Radix. and its related preparations. References | Related Articles | Metrics

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Risks to Safety of Yinhuang Oral Preparation SHAO Bo, ZHONG Lumiao, CHENG Yuzhu, DENG Hua, ZHU Lan 2025, 22(1): 84-87.  DOI: 10.19803/j.1672-8629.20240613 Abstract ( 15 )   PDF (1238KB) ( 36 )   Objective To analyze the risk posed by Yinhuang oral preparation in order to provide a reference for proper clinical use. Methods Cases of adverse drug reactions (ADR) related to Yinhuang oral preparation retrieved from China's ADR monitoring database (collected between 2004 and 2023) and domestic databases (from inception to December 31, 2023) were sorted out and analyzed. Results Between January 1, 2004 and March 31, 2023, there were reports of a total of 8 700 cases of adverse drug reactions/adverse events (ADR/AE) related to Yinhuang oral preparation in the database, including 197 severe cases (2.26%). The ADR/AE reports from the national ADR monitoring system and literature showed that the ADR of Yinhuang oral preparation involved multiple systems and organs, and that the manifestations of adverse reactions varied, depending on dosage forms. The clinical manifestations included diarrhea, abdominal pain, abdominal discomfort, nausea, vomiting, rash, pruritus, and dizziness. There were also reports of individual cases of severe allergic reactions. The drug label of Yinhuang oral preparation was upgraded as required by the National Medical Products Administration (NMPA) on July 2, 2024. Conclusion Yinhuang oral preparation should be used with caution. Drug marketing authorization holders should strengthen pharmacovigilance and provide guidance to ensure safe medication. References | Related Articles | Metrics

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Adverse Reactions of Argatroban in the Treatment of Ischemic Stroke Leading to Gastrointestinal Bleeding ZHAO Qiuyue, WEI Hongtao, LI Dandan, YAN An, DI Xuan 2025, 22(1): 88-92.  DOI: 10.19803/j.1672-8629.20240435 Abstract ( 12 )   PDF (1271KB) ( 46 )   Objective To investigate the adverse reactions of argatroban in the treatment of acute ischemic stroke (AIS) leading to gastrointestinal bleeding and the results of pharmacist interventions. Methods Clinical pharmacists provided pharmaceutical care for patients with gastrointestinal bleeding who had used argatroban for AIS treatment between 2020 and 2023. The causes of bleeding, courses of treatment, and outcomes of adverse drug reaction (ADR) were analyzed. CNKI, Wanfang, VIP and PubMed were searched for related literature on treatment of AIS with argatroban before the safety of this drug was analyzed. Results There were a total of 196 patients with AIS and transient ischemic attack (TIA) who had used argatroban injections. Gastrointestinal bleeding caused by argatroban was observed in 15 cases (an incidence rate 7.65 %). Thirteen patients were only positive for occult blood, which had no significant effect on the primary disease, and two patients had active bleeding that prolonged hospitalization. After pharmacist interventions, such as drug withdrawal and the use of proton pump inhibitors (PPIs), the conditions were improved, and the progression of the primary disease was not obviously affected. Seven articles about the safety of argatroban therapy for AIS were retrieved, with a total of 1070 patients enrolled. Six articles showed that one patient had gastrointestinal bleeding in the argatroban group (an incidence rate 0.45%) while 3 had gastrointestinal bleeding in the control group (an incidence rate 1.36%). One article categorized gastrointestinal bleeding as other bleeding events, and the data showed no increase in the rate of other bleeding events. Conclusion The treatment of AIS with argatroban may cause gastrointestinal bleeding that is usually minimal, with a good prognosis, and has little effect on AIS treatment. Previous studies have also suggested that argatroban does not increase the risk of gastrointestinal bleeding in patients. References | Related Articles | Metrics

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Toxicity/Efficacy Relationship of Sargassum and Glycyrrhizae Radix et Rhizoma: a Visual Analysis CHEN Yingren, XUE Zeyu, HUANG Tianchi, LIANG Yihong, LIN Ziqi, XIU Linlin 2025, 22(1): 93-98.  DOI: 10.19803/j.1672-8629.20240380 Abstract ( 8 )   PDF (1467KB) ( 35 )   Objective To find out about the hot spots in research on applications of herbal pair-Sargassum (Haizao, HZ) and Glycyrrhizae Radix et Rhizoma (Gancao, GC)-and to explore the pharmacological and toxic mechanisms and the toxicity/efficacy relationship in order to facilitate safe and effective clinical use. Methods Bibliometrics and data mining were used for visual analysis of animal and clinical studies related to herbal pair HZ-GC. Results A total of 184 articles were included. The keywords were summarized and the related research was divided into two big categories: effectiveness and safety. The hot spots related to mechanisms included goiter, cell proliferation, hepatotoxicity and liver drug enzymes. A toxicity-effect correlation analysis conducted on animal experimental literature showed that the toxicity/efficacy relationship of this herbal pair was closely related to the proportion, dosage, administration methods and applications in the compound formula. Despite its role in correcting thyroid indexes, anti thyroid swelling and protecting the liver, the herbal pair caused such adverse reactions as inducing liver enzymes, affecting myocardial enzymes and reducing drug excretion. The adverse reactions increased along with the dosage of Sargassum. Conclusion The herbal pair HZ-GC has both therapeutic effects and adverse reactions that may coexist and transform into each other under certain conditions. Based on the holistic perspective and guidance of TCM and by focusing on the toxicity/efficacy relationship, the integration of theoretical studies, experimental research and clinical medications is of great significance for its clinical applications. References | Related Articles | Metrics

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808 Cases of Adverse Drug Reaction Caused by Antipsychotic Drugs DAI Biao, CAO Yin, SUN Yanhong, ZHANG Yuanyuan, XIA Qingrong 2025, 22(1): 99-103.  DOI: 10.19803/j.1672-8629.20240337 Abstract ( 23 )   PDF (1513KB) ( 49 )   Objective To analyze the characteristics, patterns, and influencing factors of adverse drug reactions (ADR) caused by antipsychotic drugs, and to provide data for clinical rational drug use. Methods A total of 808 reports about ADR caused by antipsychotic drugs reported by Anhui Mental Health Center Hospital to the National Adverse Drug Reaction Monitoring System between 2022 to and 2023 were collected. The Pareto chart was used to analyze the age of the patients, distribution of types of drugs, time of occurrence, and the major organs/systems involved. Results Among the 808 cases of ADR caused by antipsychotic drugs, the ratio of males to females was 1.3:1, and the incidence was high in groups ages 20-29, 30-39, and 10-19, accounting for 27.97%, 22.40%, and 17.20%, respectively. The reports of ADR involved a total of 15 antipsychotic drugs, with the top 5 drugs as risperidone (20.42%), olanzapine (20.17%), quetiapine (13.49%), aripiprazole (13.24%), and clozapine (13.24%). The main route of administration that caused ADR was oral administration (95.79%). ADR occurred most frequently within 2 to 10 days (37.62%). Neurological damage (46.78%) was the dominating ADR among the organs/systems affected. Among the 808 reports of ADR, there were 728 cases (90.10%) of mild ADR and 80 cases (9.90%) of severe ADR. Most adverse reactions had a good prognosis after symptomatic treatment. Conclusion According to Pareto chart analysis, the age of patients, onset time, and drug types should be considered in case of ADR caused by antipsychotic drugs. It is critical to promptly detect risk signals of drug use and take effective intervention measures to ensure patients' safety. References | Related Articles | Metrics

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Retrospective Analysis of 763 Cases of Drug Eruptions CHENG Weineng, PAN Qiuna, YANG Jing, FENG Qiang, TANG Xiaomeng, LIANG Yue 2025, 22(1): 104-108.  DOI: 10.19803/j.1672-8629.20240320 Abstract ( 30 )   PDF (1276KB) ( 52 )   Objective To analyze the incidence and clinical manifestations of drug eruptions and to provide a reference for safe clinical use of drugs. Methods The 763 cases of drug eruptions reported to the Adverse Drug Reaction Monitoring System by the hospital between 2019 and 2023 were analyzed in terms of the patients' gender, age, routes of administration, types of drugs, severity and treatments, respectively. Results There were 763 cases of drug eruptions, including 342 males (44.82%) and 421 females (55.18%). Suspected sensitizing medications involved antimicrobial agents in 310 cases, contrast agents in 160 cases, antitumor medications in 54 cases, Chinese patent medications in 47 cases, endocrine medications in 47 cases, and digestive system medications in 33 cases. The chief culprits among antibiotics were β-lactam antibiotics and quinolones. After the onset of drug eruptions, the suspected sensitizing medications were discontinued in 729 cases but continued in 34 cases. Among the 268 patients with drug eruptions who did not receive symptomatic treatment, the interval from occurrence to improvement for severe and mild drug eruptions was (1.93±1.22) days and (1.71±1.35) days, respectively. Four hundred and ninety-five cases received medications, involving antihistamines, glucocorticoids, calcium gluconate and glycerite lotion. Among them, loratadine was primarily used as the antihistamine, and dexamethasone was as the hormone drug. The time from occurrence to improvement of severe and mild drug eruptions was (2.40 ± 2.36) days and (1.80 ± 1.41) days, respectively. Among the symptomatically treated patients, 301 were treated with monotherapy alone, while 194 were treated with combination therapy. Conclusion There are differences in the incidence and severity of drug eruptions between different types of drugs. The decision to discontinue the drug and symptomatic management can be made according to the severity of drug eruptions. Monotherapy is the first option for the treatment of mild drug eruptions, and combination therapy can be determined based on changes in the patient's conditions. References | Related Articles | Metrics

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One Case of Adrenocortical Insufficiency Caused by Cadonilimab LIU Nannan, XI Yalin, CHEN Zhe 2025, 22(1): 109-112.  DOI: 10.19803/j.1672-8629.20240554 Abstract ( 9 )   PDF (1251KB) ( 39 )   Objective To analyze the clinical characteristics, risk factors, and treatment of adrenal insufficiency caused by cadonilimab and to explore the role of clinical pharmacists in the management of immune-related adverse events. Methods A case of 3rd grade adrenal insufficiency caused by cadonilimab was analyzed, and the related literature was summarized. Clinical pharmacists gave advice on management of adverse reactions, pharmaceutical care and medications. Results The fatigue, nausea, and hyponatremia experienced by the patient after receiving cadonilimab were likely attributed to immune-related adrenocortical insufficiency. After discontinuation of cadonilimab and start of oral steroid therapy, the patient had no more discomfort with good compliance. Conclusion During the treatment with cadonilimab, it is important to monitor the patient's clinical symptoms, such as fatigue, nausea, hyponatremia, which may indicate the chance of drug-related adrenal insufficiency. Quick countermeasures can be crucial to improving the patient's prognosis. References | Related Articles | Metrics

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One Case of Heart Failure Caused by Furmonertinib Mesilate Tablets ZHANG Wei, XU Dongjie, JIN Yu, ZOU Ying, ZHANG Ting, ZHOU Jiancheng 2025, 22(1): 113-115.  DOI: 10.19803/j.1672-8629.20240433 Abstract ( 12 )   PDF (1203KB) ( 39 )   Objective To investigate the clinical characteristics, mechanism and treatment strategies of heart failure caused by furmonertinib mesilate tablets. Methods A case of heart failure caused by the third generation of epidermal growth factor receptor-tyrosine kinase inhibitor (furmonertinib) in a female patient with advanced lung cancer was summarized. The potential mechanism and treatment strategies were studied based on a literature review. Results The patient developed heart failure 3 months after administration of furmonertinib. Considering that similar medication had been reported to induce heart failure, furmonertinib was believed to have induced heart failure in this patient after other potential risks were ruled out. Her cardiac function improved after reduction of the dosage of furmonertinib and anti-heart failure therapy. Conclusion The use of furmonertinib can cause heart failure, so echocardiography should be monitored for early identification and management in clinical practice. References | Related Articles | Metrics

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Research Progress in Applications of Strychnine Semen in Orthopedics and Traumatology YU Wenlu, ZHANG Hong 2025, 22(1): 116-120.  DOI: 10.19803/j.1672-8629.20240431 Abstract ( 14 )   PDF (1306KB) ( 40 )   Objective To investigate the safety and rational use of Strychnos Semen in orthopedic treatments in order to ensure therapeutic efficacy while reducing the risk of toxicity. Methods The applications of Strychnos Semen in treating such conditions as fracture healing, osteoarthritis, bone hyperplasia, spinal cord injuries, cervical spondylosis, and lumbar disc herniation were analyzed. The dosage control, medication monitoring, detoxification through processing, and contraindications with other medications were studied. Results Clinical applications demonstrated that Strychnos Semen had shown significant efficacy in treating fracture healing, osteoarthritis, bone hyperplasia, spinal cord injuries, cervical spondylosis, and lumbar disc herniation. However, the presence of toxic components in Strychnos Semen had cast doubt on its safe clinical application. Conclusion Strychnos Semen contains toxic components, so more research on its safe clinical applications is required. The safe and effective use of Strychnos Semen can be facilitated by appropriately controlling dosages, monitoring medication, processing for detoxification, and avoiding improper medication combinations. References | Related Articles | Metrics