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15 June 2025, Volume 22 Issue 6 Previous Issue   

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Effects and Challenges of Pharmacology and Toxicology of Aconitum Diterpenoid Alkaloids SUN Yinghao, ZANG Shuangyao, YU Wenhui, GUO Shuai, LI Tingting, ZHANG Yi, ZHANG Tingjian, MENG Fanhao 2025, 22(6): 601-607.  DOI: 10.19803/j.1672-8629.20250195 Abstract ( 41 )   PDF (1409KB) ( 55 )   Objective To summarize the pharmacological effects, toxicological mechanisms, and research progress related to Aconitum diterpenoid alkaloids so as to provide a reference for safe applications and development. Methods Based on a literature review and data integration, the molecular mechanisms, pharmacology, and toxicity of Aconitum diterpenoid alkaloids were analyzed. Results Aconitum diterpenoid alkaloids exhibited significant cardiovascular protective, neuroregulatory, anti-inflammatory, anticancer, and antimicrobial properties. The mechanisms involved the regulation of signaling pathways such as PI3K/Akt, MAPK, and NF-κB. However, their cardiotoxicity (through mitochondrial apoptosis pathways) and hepatotoxicity (mediated by PI3K/Akt/mTOR pathway-driven autophagy) deserved more attention. Conclusion There are relatively few research reports on the structure-activity relationship of Aconitum diterpenoid alkaloids. Most of the literature currently available is concerned with the pharmacological effects and toxic reactions studied through pharmacological experiments. Aconitum diterpenoid alkaloids promise good applications, but the toxicity remains an urgent issue. References | Related Articles | Metrics

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Effects of Sinomenine in Brassica rapa L. against Hypoxic Pulmonary Vascular Injury LIN Lin, YANG Tingyu, GAO Rong, MA Zengchun, SHEN Xin, GAO Yue 2025, 22(6): 608-613.  DOI: 10.19803/j.1672-8629.20241025 Abstract ( 22 )   PDF (2268KB) ( 45 )   Objective To observe the effects of interventions involving sinomenine in Brassica rapa L. on pulmonary vascular remodeling and pulmonary function in mice with hypoxic pulmonary vascular injury (HPVI). Methods Forty-eight mice were randomly divided into six groups: blank control group (Con), model group (Mod), sinomenine intervention low-, medium- and high-dose groups (L, M, H, at 50, 100, 150 mg·kg-1 respectively), and dexamethasone (Dex) administration group. When hypoxia was terminated, routine blood tests, bronchoalveolar lavage fluid (BALF) examination, small animal ultrasound, blood oxygen saturation (SaO2) measurement, blood biochemistry analysis, pulmonary tissue pathology examination, and immunohistochemistry were conducted. Western blot (WB) was used to detect the protein expressions of HIF-1α, VEGFA, Ang2, IL-1β, and NF-κB to find out about the mechanism of action. High-resolution mass spectrometry (HRMS) technology was employed for quantitative analysis of sinomenine in Brassica rapa L. Results The content of sinomenine in a 1 g·mL-1 aqueous extract sample of Brassica rapa L. was 3.558 mg·mL-1. Sinomenine reduced the numbers of such inflammatory cells as WBCs, NEUTs, and lymphocytes in the serum of HPVI mice. It could significantly lower the cell count in the alveolar lavage fluid and the levels of ALP and LDH. It enhanced the cardiopulmonary function and oxygen saturation of mice, but decreased the frequency of respiration. Furthermore, sinomenine mitigated pathological injury in lung tissues, and significantly reduced the percentage of the area and thickness of the vascular wall. Compared with the model group, sinomenine interventions significantly lowered the protein expression levels of HIF-1α, Ang2, VEGFA, and IL-1β, as well as NF-κB in lung tissues of HPVI mice. Conclusion Sinomenine interventions can effectively inhibit vascular remodeling in HPVI mice, especially in the medium dose group. Sinomenine can regulate vascular homeostasis, improve vascular permeability, enhance cardiopulmonary function, facilitate oxygen uptake and transport, and induce vascular normalization by reducing the expressions of angiogenic factors in lung tissues of mice. References | Related Articles | Metrics

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Optimization of a Determination Method for Aflatoxins in Polygalae Radix LU Yu, FENG Weihong, CHENG Boyu, DAI Mengru, LU Chenna, QIAO Lingzhi, ZHANG Yongxin, LIU Xiaoqian, LIANG Yaohua, LI Yanrong, SUN Xiaoli, LI Chun 2025, 22(6): 614-620.  DOI: 10.19803/j.1672-8629.20250078 Abstract ( 24 )   PDF (1487KB) ( 47 )   Objective To establish a high-performance liquid chromatography (HPLC) method for simultaneous determination of contents of four aflatoxins in Polygalae Radix medicinal materials. Methods An Ultimate XB-C18 column (4.6 mm×150 mm, 5 μm) was used as the stationary phase with methanol (A)-acetonitrile (B)-water (C) (22∶10∶68) as the mobile phase. The flow rate was 0.7 mL·min-1 and the column temperature 40°C. A fluorescence detector (λex=360 nm, λex=450 nm) was adopted, and the injection volume was 10 μL. The effects of extraction and purification were compared between different methods of extraction and between immunoaffinity columns of different brands. The pretreatment process was optimized, and the difference that matrix effects made in detection results was investigated. The aflatoxin levels of 28 batches of Polygalae Radix herbs and decoction pieces were tested. Results The results of the methodological investigation met the requirements of quality analysis of traditional Chinese medicine. AFG2 and AFB2 showed a good linear relationship within the range of 0.000 075 to 0.075 μg·mL-1, compared to 0.000 25 to 0.25 μg·mL-1 for AFG1 and AFB1.The correlation coefficients were 0.999 9. The matrix effect ranged from 94.49% to 103.51%, indicating that the Polygalae Radix matrix had no significant impact on the determination of aflatoxins. The average recovery of AFG2, AFG1, AFB2, and AFB1 at low, medium and high concentrations was 78.98% to 93.51%, 81.88% to 100.74%, and 82.19% to 116.12%, respectively, with RSDs ranging from 1.1% to 6.6%. For Polygalae Radix, a homogenizer was a better means to extract aflatoxins before enriching them with the immunoaffinity columns. Among the 28 batches of Polygalae Radix samples, 2 batches of crude drugs were found to be substandard. The highest total content of aflatoxins was 313.63 μg·kg-1 and the AFB1 content was as high as 143.27 μg·kg-1. Conclusion A simple and reliable new method for simultaneous determination of four aflatoxins in Polygalae Radix medicinal materials has been established, which can overcome the flaws of existing detection methods currently available and expose the risk of aflatoxin contamination in Polygalae Radix. References | Related Articles | Metrics

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Effects of Yangxue Antai Prescription on Placental Ferroptosis in Recurrent Spontaneous Abortion Mice HU Haipeng, YAO Weijie, FENG Xin 2025, 22(6): 621-626.  DOI: 10.19803/j.1672-8629.20240692 Abstract ( 19 )   PDF (1563KB) ( 45 )   Objective To investigate the regulatory effect of Yangxue Antai prescription on placental ferroptosis in recurrent spontaneous abortion (RSA) mice. Methods Cell experiment was divided into three groups. In Control group, 10% blank serum was added. In Erastin group, 25 μmol·L-1 Erastin was added to induce ferroptosis. In Erastin+Yangxue Antai group, 25 μmol·L-1 Erastin was added and intervened with 10% Yangxue Antai serum. The protein expressions of ferritin heavy chain 1 (FTH1) and ferroportin 1 (FPN1) in JEG-3 cells were measured by Western blot. Animal experiment was divided into four groups with four animals in each group. Normal pregnancy group and RSA group were intragastrically administered with distilled water. Yangxue Antai group and RSA+Yangxue Antai group were intragastrically administered with 28.08 g·kg-1 of Yangxue Antai prescription. The activity of superoxide dismutase (SOD), the contents of reduced glutathione (GSH), malondialdehyde (MDA) and ferrous ion (Fe2+) in mouse placenta were measured. The protein expression of glutathione peroxidase 4 (GPX4), solute carrier family 7, member 11 (SLC7A11), heme oxygenase 1 (HO-1), FTH1, FPN1, transferrin receptor protein 1 (TfR1) and divalent metal transporter 1 (DMT1) in mouse placenta were measured by Western blot. Results Compared with the control group, the protein expressions of FTH1 and FPN1 in JEG-3 cells in the Erastin group were significantly decreased. Compared with the Erastin group, the protein expressions of FTH1 and FPN1 in JEG-3 cells in the Erastin+Yangxue Antai group were significantly increased. Compared with the normal pregnancy group, the SOD activity, GSH and Fe2+ contents in placentas in the RSA group were significantly decreased, but the MDA content was significantly increased. The protein expressions of GPX4, SLC7A11, HO-1, FTH1 and FPN1 were significantly decreased in placentas, while those of TfR1 and DMT1 were significantly increased. Compared with the RSA group, the SOD activity, GSH and Fe2+ contents in placentas in the RSA+Yangxue Antai group were significantly increased, while that of MDA was significantly decreased. The protein expressions of GPX4, SLC7A11, HO-1, FTH1 and FPN1 were significantly increased in placentas while those of TfR1 and DMT1 were significantly decreased. Conclusion Yangxue Antai prescription can alleviate oxidative stress, reduce the intake of Fe2+, increase the storage and transfer of Fe2+, thus inhibiting the accumulation of Fe2+ and inhibiting the occurrence of ferroptosis. References | Related Articles | Metrics

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Efficacy of Tanreqing Aerosol Inhalation against Animals with Chronic Obstructive Pulmonary Disease and Mechanisms for Oxidative Stress and Mitochondrial Injury FU Rui, LUO Qian, PENG Bo, CHEN Weiya, WEI Xiaolu, CHEN Tengfei, SONG Ling, GAO Yunhang, ZHANG Guangping, HOU Hongping 2025, 22(6): 627-632.  DOI: 10.19803/j.1672-8629.20250215 Abstract ( 25 )   PDF (2027KB) ( 49 )   Objective To study the effects of aerosol inhalation of Tanreqing on animal models of chronic obstructive pulmonary disease (COPD) and explore the mechanisms for oxidative stress and mitochondrial damage. Methods SPF Wistar rats were randomly divided into the control group, model group, positive group and high-, medium- and low-dose medication groups（0.12、0.06、0.03 mL·kg-1）. COPD models were established in each group except the control group. The positive group inhaled budesonide suspension for 20 min while the medication groups inhaled Tanreqing for 20, 10 and 5 min, respectively. After one month, the lung function and histopathology of the animals were observed, and related indexes of oxidative stress and mitochondrial damage were detected. Results In the model group, autonomic activities decreased, so did lung compliance, the airway resistance, ROS and MDA increased, SOD and T-AOC decreased, so did mPTP and ATP levels, but Cytc release increased. However, the clinical symptoms of rats in the positive group and in the high-dose and medium-dose groups were relieved, the airway resistance decreased, but lung compliance improved. The levels of ROS and MDA decreased, while those of SOD and T-AOC increased significantly, P<0.01, so did the levels of mPTP and ATP, but the levels of Cytc decreased significantly, P<0.01 or P<0.001. Conclusion Aerosol inhalation of Tanreqing could relieve the symptoms of COPD by intervening in oxidative stress and mitochondrial damage, which provides a reference for treatment of COPD with traditional Chinese medicine. References | Related Articles | Metrics

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Precision Pharmacovigilance for Cell and Gene Therapy Products SHEN Lu, LIU Cuili, WANG Yi, HAO Mingqiang, WANG Yali, ZHU Huijuan, WU Chen, YANG Yang 2025, 22(6): 633-639.  DOI: 10.19803/j.1672-8629.20250205 Abstract ( 42 )   PDF (1419KB) ( 58 )   Objective To analyze the current monitoring practices at home and abroad,and to explore new approaches to pharmacovigilance for cell and gene therapy products. Methods By taking CAR-T cell therapy products, the domestic and overseas data on monitoring of these products, information about safety, and related technological guidelines were collected to assess the safety profile of the related drugs. The strengths, weaknesses and characteristics of passive monitoring and active monitoring, spontaneous reporting, and of intensive hospital monitoring were elaborated. Novel approaches to pharmacovigilance that targeted cell and gene therapy products were explored. Results Cell and gene therapy products had distinct features in terms of mechanisms of action, in vivo metabolism, therapeutic effects, and adverse reactions, which is why specific pharmacovigilance was required. Conclusion This study has explored a precision pharmacovigilance model that can not only combine passive monitoring with active monitoring and spontaneous reporting of adverse reactions with intensive hospital monitoring, but also identify risks of products. This study is expected to find a new means for pharmacovigilance for post-marketing monitoring of safety of cell and gene therapy products in China. References | Related Articles | Metrics

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Roles of National Arthroplasty Registries in Post-Market Surveillance of Medical Devices LI Dong, ZHAO Yan 2025, 22(6): 640-644.  DOI: 10.19803/j.1672-8629.20250142 Abstract ( 25 )   PDF (1280KB) ( 51 )   Objective To explore the role and significance of national arthroplasty registries in the post-market active surveillance of medical devices in order to provide a reference for establishing such a system in China. Methods By reviewing related literature, the developments, characteristics, and cases of applications of national arthroplasty registries worldwide were analyzed. Based on the need for regulation of medical devices in China, the applicability of these registries in surveillance of implant safety was evaluated. Results and Conclusion As an effective tool for post-market active surveillance of medical devices, national arthroplasty registries have been successfully implemented in many countries, which can facilitate early identification and control of implant-related risks. It is recommended that China quicken the establishment of a national arthroplasty registry, improve the system for regulation of whole lifecycle of medical devices and enhance the ability to monitor the safety of implants. References | Related Articles | Metrics

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983 Adverse Reaction Reports of Oxaliplatin ZHAO Yufang, SHI Wei, YANG Shengnan, LIU Zhien, LEI Wenpu, ZHANG Yanan, ZHAO Ke, GUO Hao 2025, 22(6): 645-648.  DOI: 10.19803/j.1672-8629.20240799 Abstract ( 67 )   PDF (646KB) ( 85 )   Objective To analyze the characteristics of adverse reactions caused by oxaliplatin in order to provide a reference for clinical safe drug use. Methods The ADR of oxaliplatin reported to the National Adverse Drug Reaction Monitoring System by a province between 2022 and 2023 were collected before signals were mined and analyzed using the reported odds ratio (ROR) method and the Medicines and Healthcare Products Regulatory Agency (MHRA) method. Results According to the 983 ADR reports of oxaliplatin, the age of the patients mostly ranged from 45 to 65, and most of the ADR occurred within 24 hours of medication. There were 275 cases (27.98%) serious ADR. The positive signals involved 9 systems-organs (SOC), and the top three preferred terms (PTs) were nausea, vomiting and bone marrow suppression. The top three PT signals were hyperhidrosis, dyspnea and itching. Conclusion Oxaliplatin has little chance of causing serious ADR or obvious ADR that affect preexisting diseases, but during or after infusion, hyperhidrosis, dyspnea and itching deserve special attention. There is the need to find out whether the ADR are allergies in order to offer quick interventions. References | Related Articles | Metrics

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Adverse Reactions Reports about Tislelizumab Injection in 447 Cases ZHU Lei, ZHANG Xian, WANG Ruiyan, LI Ying 2025, 22(6): 649-653.  DOI: 10.19803/j.1672-8629.20250098 Abstract ( 53 )   PDF (1246KB) ( 65 )   Objective To explore the incidence and characteristics of adverse drug reactions (ADR) related to tislelizumab injection. Methods ADR reports submitted by medical institutions to the national ADR monitoring system database in 2024 were collected, involving the basic information of patients, use of drugs, organs and systems involved, and manifestations. Charts were used to analyze the characteristics of ADR. Results In the 447 reports, 348 men (77.85%) and 99 women (22.15%) were involved. The mean age was (57.00±15.56) years. Most of the patients were above 50. The drug cycle of ADR ranged from 0 to 483 days. ADR were the most frequent in the first cycle (1 to 21 days) of treatment (89.71%). The ADR involved multiple systems-organs. There were 228 cases that involved the blood system (44.79%) and 2 cases of sequelae (0.45%). The clinical manifestations were all hypothyroidism. There were 270 cases (60.40%) of severe ADR of G3 and 4 cases of severe ADR of G4 (0.90%). All these ADR occurred after cycle 1 medication, but patients improved after treatment. Most of these ADR were mitigated (80.31%). Conclusion Tislelizumab injection is mostly used for treating a wide range of tumors. The related ADR involve multiple systems and organs, and some severe ADR are potentially life-threatening. Rational clinical use of this drug is recommended. Monitoring is required. Early detection and interventions are critical to management of ADR. References | Related Articles | Metrics

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133 Cases of Adverse Drug Reactions in Female Patients ZHENG Sili, ZHANG Xiaoqing 2025, 22(6): 654-658.  DOI: 10.19803/j.1672-8629.20240766 Abstract ( 105 )   PDF (1315KB) ( 95 )   Objective To analyze the characteristics of adverse drug reactions (ADR) from a Grade III Level A maternal and child health hospital in Shanghai, so as to provide reference for the safe and rational drug use in female patients. Methods A total of 133 cases of ADR reported to the National Adverse Drug Reaction Monitoring System from January 1, 2022 to June 30, 2024 by the hospital were collected. Retrospective analysis was conducted on patients’ gender, age,reasons for medication, classifications of suspected drugs, routes of administration, time of ADR, involved system-organs and clinical manifestations, and ADR prognosis. Results Among the 133 cases of ADR, most patients were woman over 18 years old. The most used drugs were for anti-gynecological tumors therapy and anti-infection therapy, with the ages of major patients being over 45 years old (66.67%) and 18 to 44 years old (74.57%), respectively. A total of 73 drugs and 183 times of administration were involved. The most used suspected drugs were anti-tumor drugs docetaxel injection and paclitaxel injection. The main administration route was intravenous infusion (81.97%). 70.68% of the ADR occurred within one day after medication.The skin and its appendages were most affected (32.35%). There were 16 serious ADR cases (12.03%), 13 of which involved tumor chemotherapy drugs. Most of the symptoms were relieved after drug withdrawal or treatment. Conclusion Women suffering from gynecological tumor diseases are prone to ADR when using chemotherapy drugs, therefore, ADR monitoring and prediction should be strengthened. As to medication for pregnant and parturient women, much attention should be paid to drugs with high incidence of ADR to promote safe and rational drug use in clinic. References | Supplementary Material | Related Articles | Metrics

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Immune-Related Adverse Events of Tislelizumab in 120 Patients with Hepatocellular Carcinoma LIANG Fanglin, CHEN Lingyuan, HU Danli, WEI Lingyun, WEI Tiemeng, ZHANG Faen, WEI Yana 2025, 22(6): 659-663.  DOI: 10.19803/j.1672-8629.20240987 Abstract ( 31 )   PDF (1328KB) ( 65 )   Objective To analyze the characteristics of immune-related adverse events (irAEs) of tislelizumab in patients with hepatocellular carcinoma and provide data for safe clinical use of the drug. Methods The irAEs caused by tislelizumab in the treatment of patients with liver cancer in Guangxi Zhuang Autonomous Region from February 2022 to June 2024 were collected. The data on gender of the patients, age distribution, indications for use, concomitant medications, clinical manifestations, toxicity grading, treatments, outcomes, and the characteristics of irAEs was statistically analyzed. Results A total of 120 cases of irAEs were collected. There were four times as many male patients as female ones, and most of the patients ranged from 45 to 64 in age. The systems and organs involved in irAEs were mostly the blood system, liver system and the skin system. There were 61 cases (50.83%) of irAEs ≥G3, but no death due to G5 irAEs occurred. Seventy-eight patients (65%) showed improvement or recovery after symptomatic treatment. Conclusion Although irAEs caused by tislelizumab involve multiple systems and organs, most patients have good outcomes if treated promptly. During clinical use of tislelizumab, irAEs should be detected as early as possible, and precautions have to be taken to ensure the safety and health of patients. References | Related Articles | Metrics

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Short-Term Efficacy and Safety of Thiotepia-based Conditioning Regimen Combined with Autologous Hematopoietic Stem Cell Transplantation in the Treatment of Primary Central Nervous System Lymphoma FU Weiran, ZOU Dongmei, NI Jing, SUN Wanling, GUO Yixian 2025, 22(6): 664-668.  DOI: 10.19803/j.1672-8629.20240864 Abstract ( 19 )   PDF (1312KB) ( 46 )   Objective To evaluate the short-term efficacy and safety of a conditioning regimen involving cetiapib in patients with primary central nervous system lymphoma (PCNSL) who meet the indications for autologous stem cell transplantation (auto-HSCT). Methods The clinical data of PCNSL patients was analyzed who underwent auto-HSCT with a thiotepia-based BCNU-TT conditioning regimen (carmustine 400 mg·m-2, administered via intravenous infusion 6 days before transplantation, thiotepia at 5 mg·kg-1, administered via intravenous infusion every 12 hours 4 and 5 days before transplantation) and a TBC conditioning regimen (thiotepia at 6.4 mg·kg-1, administered via intravenous infusion 1, 2 and 3 days before transplantation, busulfan at 30 mg·m-2, administered via intravenous infusion every 6 hours 3, 4 and 5 days before transplantation, cyclophosphamide at 60 mg·kg-1, administered via intravenous infusion 4 and 5 days before transplantation) between 2019 and 2023. The clinical characteristics of these cases were summarized before the outcomes and adverse reactions were compared. Results Among the eight PCNSL patients, one received the TBC regimen while the rest were treated with the BCNU-TT regimen. Three months after transplant, the CR rate was 100%. During a median follow-up of 466.5 days, regular assessments showed a CR rate of 100%. The primary adverse reactions and their severity ratings were febrile neutropenia (grade 3, 100%), nausea/vomiting (grade 1, 100%), diarrhea (grades 1-2, 75%), edema (grade 1, 37.5%), rash or lumps (grade 1, 50%), fatigue (grade 1, 62.5%), dizziness (grade 1, 37.5%), infections (grades 1-2, 50%), cough (grade 1, 37.5%), and liver function abnormalities (elevated transaminases grade 1 and grade 3, 37.5%). Conclusion The thiotepia-based conditioning regimen can effectively improve the short-term therapeutic efficacy and prognosis in auto-HSCT for PCNSL patients while demonstrating good tolerability in adverse reaction management. References | Related Articles | Metrics

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Risks of Pancreatic Adverse Events Associated with Tirzepatide: a Disproportionality Analysis Using Spontaneous Adverse Event Reporting System Data JING Tianshu, LU Guotao, WANG Shengfeng 2025, 22(6): 669-673.  DOI: 10.19803/j.1672-8629.20241041 Abstract ( 43 )   PDF (1471KB) ( 73 )   Objective To evaluate risks of pancreatic adverse events (AEs) caused by a newly marketed glucagon-like peptide-1 (GLP-1) receptor and glucose-dependent insulinotropic polypeptide (GIP) receptor dual target agonist, tirzepatide, and to compare the pancreatic safety of tirzepatide with other previously marketed GLP-1 drugs. Methods Data from the FDA Adverse Event Reporting System (FAERS) was used for signal mining of AEs from first quarter of 2004 to third quarter of 2024 while the Japanese Adverse Drug Event Report Database (JADER) was searched for validation of signals from 2009 to 2023. All the data used in this study was released as of the third quarter of 2024. Disproportionality analysis was used to detect AE signals of tirzepatide and compare tirzepatide with other GLP-1RA drugs. Sensitivity analyses were conducted of indications and time-to-onset (TTO) to eliminate potential confounding caused by association between AE and indications, and insufficient AE accumulation time of tirzepatide. Results Tirzepatide showed significant risk signals for pancreatitis (ROR=7.80, 95%CI: 7.07-8.61) and pancreatic necrosis (ROR=3.76, 95%CI: 2.06-6.85). After the association between indications and AEs through sensitivity analysis was controlled, tirzepatide showed positive signals for pancreatitis (ROR=2.74, 95%CI: 2.16-3.47). Higher risks of pancreatitis were associated with semaglutide (ROR=2.04, 95%CI: 1.82-2.30), liraglutide (ROR=4.76, 95%CI: 4.34-5.22) and dulaglutide (ROR=2.01, 95%CI: 1.82-2.21). Conclusion sThe analysis of spontaneous AE reports suggests that tirzepatide can increase the risk of pancreatitis, but the chances are smaller compared with other GLP-1 receptor agonists. When tirzepatide is used clinically or GLP-1RA medications are opted for, clinicians ought to be alert to pancreatic adverse events. References | Supplementary Material | Related Articles | Metrics

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Efficacy Semantic Mining and Safety Analysis of Chinese Patent Medicines for Headache LIU Yiyu, LI Yanwen, WANG Jiao, ZHOU Wenjing, PENG Yumeng, HE Wenbin, LI Zhiyong 2025, 22(6): 674-679.  DOI: 10.19803/j.1672-8629.20240297 Abstract ( 36 )   PDF (1426KB) ( 60 )   Objective To explore the efficacy semantics of Chinese patent medicines for headache currently on the market and to conduct a meta-analysis of safety of these medicines. Methods Based on the efficacy semantics of the above-mentioned Chinese patent medicines, an efficacy semantic network of Chinese patent medicines used for headache treatment was constructed. Meta-analysis was conducted to assess the adverse reactions of the above-mentioned Chinese patent medicines in clinic. Results The functional semantic features of Chinese patent medicines for headache focused on clearing heat, detoxification, relieving exterior syndrome, managing pain and dispelling wind. A total of 23 RCT studies were included. The results of Meta-analysis showed that Chinese patent medicines alone or combined with conventional Western medicine could reduce the incidence of adverse reactions [RR=0.46, 95 %CI (0.35,0.60), P<0.05].The incidence of adverse reactions was significantly different between patients taking Tianma Gouteng granules [RR=0.52, 95%CI (0.31,0.88), P<0.05] and those using Zaoren Anshen granules [RR=0.27, 95%CI (0.14,0.49), P<0.05]. Conclusion Chinese patent medicines for headache are different in efficacy aggregation when used to treat exogenous and internal headache, and are highly safe. References | Supplementary Material | Related Articles | Metrics

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Identification of Cremastrae Pseudobulbus/Pleione Pseudobulbus, Adulterants and Commonly-Used Products WU Kefei, ZHANG Heng, GUO Chenggang, XU Chunlian, WU Shasha 2025, 22(6): 680-685.  DOI: 10.19803/j.1672-8629.20240844 Abstract ( 22 )   PDF (1313KB) ( 45 )   Objective To unveil the difference between Cremastrae Pseudobulbus/Pleione Pseudobulbus, adulterants and commonly-used products so as to provide a reference for the selection of medicinal materials containing Cremastrae Pseudobulbus/Pleione Pseudobulbus. Methods The usage of authentic Cremastrae Pseudobulbus/Pleione Pseudobulbus and adulterants collected from markets and areas of production was studied. Dominating adulterants and commonly-used products were identified based on botanical characteristics and microstructures. Results The origins of authentic Cremastrae Pseudobulbus/Pleione Pseudobulbus included Cremastrae pseudobulbus (Cremastra appendiculata (D. Don) Makino) and Pleione bulbocodioides (Pleione bulbocodioides (Franch.) Rolfe and Pleione yunnanensis Rolfe). The adulterants of Cremastrae pseudobulbus included Oreorchis patens (Lindley) Lindley, Anthogonium gracile Lindl., Iphigenia indica while those of Pleione bulbocodioides included P. maculata (Lindl.) Lindl., P. saxicola Tang & F. T. Wang ex S. C. Chen, and P. praecox (J. E. Sm.) D. Don. Conclusion The identification of Cremastrae Pseudobulbus/Pleione Pseudobulbus mostly depends on the verification of origins and morphological identification. It is recommended that subsequent research and development take into account fingerprint spectra and content indicators to ensure the use of genuine products. References | Supplementary Material | Related Articles | Metrics

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One Case of Thrombocytopenia Caused by Cefoperazone Sulbactam Sodium for Injection WANG Hao, MA Jinfu, MA Rui, LI Xiaogang, ZHAO Qiang, ZHANG Xian 2025, 22(6): 686-688.  DOI: 10.19803/j.1672-8629.20250120 Abstract ( 50 )   PDF (1255KB) ( 64 )   Objective To study the characteristics of thrombocytopenia induced by cefoperazone sulbactam sodium, and to provide a reference for safe clinical use and management of adverse drug reactions. Methods One case of thrombocytopenia caused by cefoperazone sulbactam sodium for injection was studied. The adverse reactions and pathogenesis of thrombocytopenia caused by cefoperazone sulbactam sodium were analyzed via correlation evaluation and literature review before ways of prevention and treatment were recommended. Results After the drug instructions and literature were reviewed, and the time of administration was analyzed, other combination drugs were excluded. Cefoperazone sulbactam sodium was considered to have caused the adverse reactions. After drug withdrawal and supportive treatment, the patient’s platelets gradually returned to normal. Conclusion It is recommended that clinicians be alert to the risk of thrombocytopenia associated with antibiotics such as cefoperazone sulbactam, and monitor platelets during medication in high-risk groups such as the elderly, severe patients, those under a long course of medication, and those with hepatic and renal insufficiency so as to ensure the safety of patients. References | Related Articles | Metrics

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One Case of Drug Hypersensitivity Syndrome Caused by Hydroxychloroquine Sulfate Tablets SUN Zhonghui, LIU Yingchun, DONG Qi, ZHANG Qian, YANG Jing 2025, 22(6): 689-692.  DOI: 10.19803/j.1672-8629.20240903 Abstract ( 32 )   PDF (1231KB) ( 33 )   Objective To analyze the characteristics of hypersensitivity syndrome induced by hydroxychloroquine. Methods The diagnosis and treatment process of hypersensitivity syndrome caused by hydroxychloroquine sulfate tablets in a 41-year-old female patient was analyzed based on literature, who had been diagnosed with a connective tissue disease or Sjogren’s syndrome (likely) after two weeks of treatment with hydroxychloroquine. Results Based on such data as the patient’s history of both medication and allergy, the correlation between hydroxychloroquine and hypersensitivity syndrome was determined as “probable”. The patient improved after symptomatic treatment. Conclusion Hypersensitivity syndrome is a rare but serious adverse reaction of hydroxychloroquine. The results of blood tests may not be revealing. Human herpes virus screening can help identify drug hypersensitivity syndrome. This adverse reaction deserves more attention in clinical practice. References | Related Articles | Metrics

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One Case of Euglycemic Diabetic Ketoacidosis Caused by Metformin Hydrochloride and Empagliflozin Tablets(Ⅰ) ZHENG Guimei, XIE Zeyu, CHENG Xiaoling, LIU Jiang, ZHANG Yueyan, CAO Weiling 2025, 22(6): 693-695.  DOI: 10.19803/j.1672-8629.20240845 Abstract ( 35 )   PDF (1277KB) ( 66 )   Objective To explore the mechanisms of and risk factors for empagliflozin-induced euglycemic diabetic ketoacidosis (euDKA) so as to ensure the safety of medication. Methods One case of euDKA induced by metformin hydrochloride and empagliflozin tablets（Ⅰ）was retrospectively analyzed. Related literature was reviewed to find out more about the pathogenesis. Results The patient exhibited ketoacidosis with normal blood glucose levels, but his conditions were improved after discontinuation of the drug, fluid replacement, and insulin therapy. Literature suggested that euDKA was associated with insulin deficiency. Conclusion Empagliflozin may cause euDKA. The symptoms are usually insidious and prone to missed diagnosis. Clinically, high-risk patients deserve more attention. Pharmaceutical care should be enhanced to ensure the safety of patients. References | Related Articles | Metrics

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One Case of Black Hairy Tongue Caused by Doxycycline TAO Xingru, DUAN Yanyan, LIU Xiaoling, LIU Yuemei, ZHANG Shengnan 2025, 22(6): 696-698.  DOI: 10.19803/j.1672-8629.20240711 Abstract ( 33 )   PDF (1207KB) ( 62 )   Objective To investigate the characteristics of and contributing factors to doxycycline-induced black hairy tongue (BHT) and to provide references for safe clinical medication. Methods One case of BHT caused by doxycycline injection was analyzed based on literature review before recommendations about medication were given. Results A child with cystic fibrosis developed pigmentation on the mid-dorsal tongue after 18 days of doxycycline infusion. The symptoms were gradually improved after discontinuation of the drug. Causality analysis, combined with a review of related literature and case reports, indicated that this adverse reaction was likely associated with doxycycline. Conclusion Doxycycline, a widely used antimicrobial agent, carries the risk of inducing BHT. Clinicians should remain vigilant, particularly in patients with oral microbiome imbalances, underlying diseases, compromised immunity, or prolonged/high-dose antibiotic use. Enhanced oral care monitoring is recommended during treatment, and prompt assessment and regimen adjustment should be offered in case of pigmentation. References | Related Articles | Metrics

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One Case of Ischemic Colitis Caused by Compound Polyethylene Glycol Electrolyte Powder LU Jing, CAI Lei, TONG Fei, YU Changhui, FU Shunjun, PAN Mingxin 2025, 22(6): 699-701.  DOI: 10.19803/j.1672-8629.20240798 Abstract ( 38 )   PDF (1186KB) ( 59 )   Objective To study one case of ischemic colitis (IC) caused by compound polyethylene glycol electrolyte powder so as to provide a reference for safe medication. Methods The process of diagnosis and treatment of one case of IC that occurred after compound polyethylene glycol electrolyte powder was used for bowel preparation was analyzed. Based on related literature, drugs that might have induced IC in this patient were identified before the possible mechanisms and treatments were explored. Results The adverse reaction of the patient was diagnosed as IC. After such factors as the patient’s underlying diseases, concomitant medications, and colonoscopy were excluded, the correlations between compound polyethylene glycol electrolyte powder and IC were considered “probable”. After symptomatic treatment, the patient gradually improved. Conclusion IC is a rare adverse reaction caused by polyethylene glycol electrolyte solution. When early symptoms of IC are found in patients, the chances of IC induced by polyethylene glycol electrolyte solution should be considered and therapeutic interventions implemented quickly. References | Related Articles | Metrics

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Developmental Toxicity and Mechanisms of Acetaminophen Exposure during Pregnancy MEI Haonan, ZHANG Ziyi, WANG Yuxi, WANG Hui, GUO Yu 2025, 22(6): 702-707.  DOI: 10.19803/j.1672-8629.20240815 Abstract ( 42 )   PDF (1504KB) ( 62 )   Objective To investigate the developmental toxicity of prenatal acetaminophen (APAP) exposure and the potential mechanisms in order to provide references for safe clinical medication. Methods The associations between the use of APAP during pregnancy and such developmental outcomes as intrauterine growth restriction, developmental malformations and functional impairments in offspring, and between APAP and postnatal and adult-onset diseases involving the nervous system, urogenital system, respiratory system and immune system were discussed based on the latest literature. Results Medications with APAP during pregnancy might cause intrauterine fetal growth retardation, developmental malformations, organ dysfunctions, and increased susceptibility to neurological, genitourinary, and respiratory diseases in adult offspring. The potential mechanisms underlying developmental toxicity included cyclooxygenase inhibition, oxidative damage, endocrine disruption, and epigenetic dysregulation. Conclusion The rational use of APAP during pregnancy is crucial to maternal and fetal health. References | Related Articles | Metrics

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Research Progress on Intestinal Safety of Anthraquinone Laxatives ZHENG Kaifan, LENG Hongxu, XU Kaixuan, CAI Wenlu, ZHANG Ying, ZHAO Pengfei, TAN Shengjie, XIN Guizhong 2025, 22(6): 708-713.  DOI: 10.19803/j.1672-8629.20240882 Abstract ( 43 )   PDF (1326KB) ( 61 )   Objective To investigate the intestinal toxicity and mechanisms of action of anthraquinone laxatives, so as to provide a reference for the rational use of anthraquinone laxatives. Methods A comprehensive review and analysis were conducted through literature and database searches on the mechanisms of intestinal toxicity of an-thraquinone compounds and the presence of these compounds in clinical drugs. Results Long-term use of anthraquinone-containing laxatives can damage the enteric nervous system and gastrointestinal pacemaker cells (interstitial cells of Cajal), leading to cathartic colon. Additionally, these compounds can cause damage and apoptosis of intestinal epithelial cells, resulting in melanosis coli. Correlative studies indicate a significant association between melanosis coli and the detection rates of colonic polyps and adenomas, though its link to colorectal cancer remains controversial. Conclusion Future development of laxative drugs and foods should prioritize balancing efficacy with intestinal toxicity. Systematic evaluation of the long-term effects of anthraquinone laxatives on interstitial cells of Cajal is necessary, along with the establishment of daily limits and usage duration guidelines. Restoring intestinal function is essential for addressing functional constipation. Hence, there is an urgent need to focus research on developing drugs or foods that can be used long-term and aid in the recovery of intestinal function. References | Supplementary Material | Related Articles | Metrics

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Research Progress in Drugs for Brain Metastases from Advanced Breast Cancer YE Ling, LIU Xiaoying, DANG Xuefei, LI Xuelian, LI Gang 2025, 22(6): 714-720.  DOI: 10.19803/j.1672-8629.20250055 Abstract ( 28 )   PDF (1456KB) ( 44 )   Objective To analyze the current drug therapies for brain metastases from breast cancer (BCBM) and to explore innovative therapeutic strategies for overcoming the blood-brain barrier (BBB) and blood-tumor barrier (BTB) so as to enhance the clinical efficacy of treatments for patients with advanced BCBM. Methods Based on subtypes of breast cancer, novel antitumor drugs were classified and their respective clinical efficacy in BCBM was summarized. Results With the incessant development and marketing of novel anti-tumor drugs, small-molecule kinase inhibitors, such as antibody-drug conjugates and novel nanomedicines, demonstrated their potential applications in the treatment of BCBM. Conclusion The pathogenesis of BCBM requires more in-depth studies in the future, and more effective therapeutic agents need to be developed to improve life quality of patients. References | Related Articles | Metrics