1.Construction and Application Evaluation of an Integrated Traditional Chinese and Western Medicine Risk Prediction Model for Readmission in Patients with Stable Angina of Coronary Heart Disease:A Prospective Study Based on Real-World Clinical Data
Wenjie HAN ; Mingjun ZHU ; Xinlu WANG ; Rui YU ; Guangcao PENG ; Qifei ZHAO ; Jianru WANG ; Shanshan NIE ; Yongxia WANG ; Jingjing WEI
Journal of Traditional Chinese Medicine 2025;66(6):604-611
ObjectiveBy exploring the influencing factors of readmission in patients with stable angina of coronary heart disease (CHD) based on real-world clinical data, to establish a risk prediction model of integrated traditional Chinese and western medicine, in order to provide a basis for early identification of high-risk populations and reducing readmission rates. MethodsA prospective clinical study was conducted involving patients with stable angina pectoris of CHD, who were divided into a training set and a validation set at a 7∶3 ratio. General information, traditional Chinese medicine (TCM)-related data, and laboratory test results were uniformly collected. After a one-year follow-up, patients were classified into a readmission group and a non-readmission group based on whether they were readmitted. Univariate and multivariate logistic regression analyses were performed to identify independent risk factors for readmission. A risk prediction model of integrated traditional Chinese and western medicine was constructed and visualized using a nomogram. The model was validated and evaluated in terms of discrimination, calibration, and clinical decision curve analysis. ResultsA total of 682 patients were included, with 477 in the training set and 205 in the validation set, among whom 89 patients were readmitted. Multivariate logistic regression analysis identified heart failure history [OR = 6.93, 95% CI (1.58, 30.45)], wiry pulse [OR = 2.58, 95% CI (1.42, 4.72)], weak pulse [OR = 3.97, 95% CI (2.06, 7.67)], teeth-marked tongue [OR = 4.38, 95% CI (2.32, 8.27)], blood stasis constitution [OR = 2.17, 95% CI (1.06, 4.44)], phlegm-stasis mutual syndrome [OR = 3.64, 95% CI (1.87, 7.09)], and elevated non-high-density lipoprotein cholesterol [OR = 1.30, 95% CI (1.01, 1.69)] as influencing factors of readmission. These factors were used as predictors to construct a nomogram-based risk prediction model for readmission in patients with stable angina. The model demonstrated moderate predictive capability, with an area under the receiver operating characteristic curve (AUC) of 0.818 [95% CI (0.781, 0.852)] in the training set and 0.816 [95% CI (0.779, 0.850)] in the validation set. The Hosmer-Lemeshow test showed good calibration (χ² = 4.55, P = 0.80), and the model's predictive ability was stable. When the threshold probability exceeded 5%, the clinical net benefit of using the model to predict readmission risk was significantly higher than intervening in all patients. ConclusionHistory of heart failure, teeth-marked tongue, weak pulse, wiry pulse, phlegm-stasis mutual syndrome, blood stasis constitution, and non-high-density lipoprotein cholesterol are influencing factors for readmission in patients with stable angina of CHD. A clinical prediction model was developed based on these factors, which showed good discrimination, calibration, and clinical utility, providing a scientific basis for predicting readmission events in patients with stable angina.
2.Quality evaluation of diagnosis and treatment guidelines and expert consensus for children with immune thrombocytopenic purpura
Yaping XING ; Ying DING ; Shanshan HAN ; Wenchao XING ; Lu JIA ; Min TONG ; Xiaodan REN
China Pharmacy 2025;36(13):1671-1676
OBJECTIVE To evaluate the quality of diagnosis and treatment guidelines and expert consensuses on childhood immune thrombocytopenic purpura (ITP) published domestically and internationally, in order to provide reference for clinical practice and future guideline/expert consensus development and improvement. METHODS A systematic search was conducted across multiple databases, including PubMed, Cochrane Library, Embase, CNKI, Wanfang data, VIP, CBM; additionally, supplementary searches were carried out on websites such as Medlive, the Chinese Medical Association’s official website, and National Institute for Health and Clinical Excellence in the UK. The retrieval time ranged from the inception to September 2, 2024. Researchers who had undergone systematic training independently evaluated the methodology and report quality included in the guideline/consensus using the Appraisal of Guidelines Research and Evaluation Ⅱ (AGREE Ⅱ) and the Reporting Items for Practice Guidelines in Healthcare (RIGHT). RESULTS A total of 11 guidelines/consensuses were included. The average scores for the six domains of AGREE Ⅱ tool respectively were “range and purpose” ([ 66.67±17.98)% ], “participants” [58.33% (13.89%,73.61%)], “rigor” ([ 41.81±23.85)% ], “clarity”([ 69.57±19.35)%], “applicability” ([ 35.98±17.83)%], and “independence” [27.08% (0,75.00%)]; out of 11 articles, 9 had a recommendation level of B, 2 had a recommendation level of C, and there were no A-level articles. The average reporting rates of the 7 areas in the RIGHT tool were “basic information” ([ 72.35±12.95)% ], “background” ([ 54.55±15.40)%],“ evidence” ([ 36.36±24.81)%],“ recommended opinions” ([ 53.25±19.20)%],“ review and quality assurance” [0 (0, 25.00%)], “funding and conflict of interest statement and management” [12.50%(0,25.00%)], and other aspects [8.33%(0, 50.00%)]. In addition, there was no statistically significant difference in the AGREE Ⅱ and RIGHT scores between the guidelines and consensuses (P>0.05). CONCLUSIONS The overall quality of the guidelines and consensuses included in this study is not high, with a recommended level of B or C. It is recommended that clinical decision-making prioritize referring to the relatively high-quality guideline/consensus among them. The quality of evidence in the existing traditional Chinese medicine guidelines for children with ITP needs to be improved, and there is no integrated guideline/consensus for traditional Chinese and Western medicine. It is recommended to revise or write relevant guideline/consensus according to the requirements of AGREE Ⅱ and RIGHT in various fields to guide clinical practice.
3.Therapeutic Effect of Cranial Painkiller Pills' Extract Powder in Treatment of Trigeminal Neuralgia Induced by Injection of Talci Pulvis into Infraorbital Foramen of Model Rats Based on OTULIN-regulated Neuroinflammation
Shuran LI ; Xinwei WANG ; Jing SUN ; Dan XIE ; Ronghua ZHAO ; Lei BAO ; Zihan GENG ; Qiyue SUN ; Jingsheng ZHANG ; Yaxin WANG ; Xihe CUI ; Xinying LI ; Bing HAN ; Tianjiao LU ; Xiaolan CUI ; Liying LIU ; Shanshan GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):21-28
ObjectiveThis paper aims to verify the therapeutic effect of Cranial Painkiller pills' extract powder prepared by the new process on the rat's trigeminal neuralgia model caused by infraorbital injection of Talci Pulvis, evaluate its potential clinical application value, and compare the therapeutic effect with that of Cranial Painkiller granules, so as to provide data support for the application of the Cranial Painkiller pills' extract powder and precise treatment. MethodsThe rat's trigeminal neuralgia model was constructed by infraorbital injection of Talci Pulvis, and the rats were randomly divided into the normal group, model group, carbamazepine group (60 mg·kg-1), Cranial Painkiller granules group (2.70 g·kg-1), and low, medium, and high dosage groups of Cranial Painkiller pills' extract powder (1.35, 2.70, 5.40 g·kg-1) according to the basal mechanical pain thresholds, and there were 10 rats in each group. The drug was administered by gavage to each group 2 h after modeling, and distilled water was given by gavage to the normal and model groups under the same conditions once a day for 10 d. Von Frey brushes were used to measure mechanical pain thresholds in rats. Hematoxylin-eosin (HE) staining was used to detect pathological changes in the trigeminal ganglion, and enzyme-linked immunosorbent assay (ELISA) was used to detect the inflammatory factors interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-α (TNF-α) levels in rat serum, as well as neuropeptide substance P (SP) and β-endorphin (β-EP) levels in rat brain tissue. Western blot technique was used to detect the levels of NLRP3, ASC, Caspase-1, and OTULIN proteins in rat brain tissue. ResultsCompared with the normal group, the pain threshold of rats in the model group showed a continuous significant decrease (P<0.01). The pathological damage of brain tissue was significant (P<0.01), and the inflammatory levels of IL-1, IL-6, IL-8, and TNF-α in serum were significantly elevated (P<0.01). The level of the SP in the brain tissue was significantly elevated (P<0.01), and the level of β-EP was significantly reduced (P<0.01), while the level of OTULIN was significantly reduced, and NLRP3, ASC, and Caspase-1 protein levels were significantly elevated (P<0.01). After administration of the drug, compared with the model group, the pain threshold of each dose group of the Cranial Painkiller pills' extract powder and the Cranial Painkiller granules group significantly increased (P<0.01). The inflammatory levels of IL-1, IL-6, IL-8, and TNF-α and SP levels significantly decreased (P<0.01), and the β-EP levels were significantly elevated (P<0.01), while the levels of OTULIN protein were significantly elevated (P<0.05, P<0.01), and the levels of NLRP3, ASC proteins were decreased (P<0.01)in high dose Cranial Painkiller pills' extract powder. Meanwhile, compared with those in the model group, the trigeminal ganglion lesions of rats in the Cranial Painkiller pills' extract powder and Cranial Painkiller granules groups showed different degrees of improvement (P<0.05, P<0.01). ConclusionThe Cranial Painkiller pills' extract powder has significant therapeutic effects on the rat model of trigeminal neuralgia induced by infraorbital injection of Talci Pulvis, and its mechanism is related to the improvement of OTULIN-regulated neuroinflammation.
4.Therapeutic Effect of Cranial Painkiller Pills' Extract Powder in Treatment of Trigeminal Neuralgia Induced by Injection of Talci Pulvis into Infraorbital Foramen of Model Rats Based on OTULIN-regulated Neuroinflammation
Shuran LI ; Xinwei WANG ; Jing SUN ; Dan XIE ; Ronghua ZHAO ; Lei BAO ; Zihan GENG ; Qiyue SUN ; Jingsheng ZHANG ; Yaxin WANG ; Xihe CUI ; Xinying LI ; Bing HAN ; Tianjiao LU ; Xiaolan CUI ; Liying LIU ; Shanshan GUO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):21-28
ObjectiveThis paper aims to verify the therapeutic effect of Cranial Painkiller pills' extract powder prepared by the new process on the rat's trigeminal neuralgia model caused by infraorbital injection of Talci Pulvis, evaluate its potential clinical application value, and compare the therapeutic effect with that of Cranial Painkiller granules, so as to provide data support for the application of the Cranial Painkiller pills' extract powder and precise treatment. MethodsThe rat's trigeminal neuralgia model was constructed by infraorbital injection of Talci Pulvis, and the rats were randomly divided into the normal group, model group, carbamazepine group (60 mg·kg-1), Cranial Painkiller granules group (2.70 g·kg-1), and low, medium, and high dosage groups of Cranial Painkiller pills' extract powder (1.35, 2.70, 5.40 g·kg-1) according to the basal mechanical pain thresholds, and there were 10 rats in each group. The drug was administered by gavage to each group 2 h after modeling, and distilled water was given by gavage to the normal and model groups under the same conditions once a day for 10 d. Von Frey brushes were used to measure mechanical pain thresholds in rats. Hematoxylin-eosin (HE) staining was used to detect pathological changes in the trigeminal ganglion, and enzyme-linked immunosorbent assay (ELISA) was used to detect the inflammatory factors interleukin-1 (IL-1), interleukin-6 (IL-6), interleukin-8 (IL-8), and tumor necrosis factor-α (TNF-α) levels in rat serum, as well as neuropeptide substance P (SP) and β-endorphin (β-EP) levels in rat brain tissue. Western blot technique was used to detect the levels of NLRP3, ASC, Caspase-1, and OTULIN proteins in rat brain tissue. ResultsCompared with the normal group, the pain threshold of rats in the model group showed a continuous significant decrease (P<0.01). The pathological damage of brain tissue was significant (P<0.01), and the inflammatory levels of IL-1, IL-6, IL-8, and TNF-α in serum were significantly elevated (P<0.01). The level of the SP in the brain tissue was significantly elevated (P<0.01), and the level of β-EP was significantly reduced (P<0.01), while the level of OTULIN was significantly reduced, and NLRP3, ASC, and Caspase-1 protein levels were significantly elevated (P<0.01). After administration of the drug, compared with the model group, the pain threshold of each dose group of the Cranial Painkiller pills' extract powder and the Cranial Painkiller granules group significantly increased (P<0.01). The inflammatory levels of IL-1, IL-6, IL-8, and TNF-α and SP levels significantly decreased (P<0.01), and the β-EP levels were significantly elevated (P<0.01), while the levels of OTULIN protein were significantly elevated (P<0.05, P<0.01), and the levels of NLRP3, ASC proteins were decreased (P<0.01)in high dose Cranial Painkiller pills' extract powder. Meanwhile, compared with those in the model group, the trigeminal ganglion lesions of rats in the Cranial Painkiller pills' extract powder and Cranial Painkiller granules groups showed different degrees of improvement (P<0.05, P<0.01). ConclusionThe Cranial Painkiller pills' extract powder has significant therapeutic effects on the rat model of trigeminal neuralgia induced by infraorbital injection of Talci Pulvis, and its mechanism is related to the improvement of OTULIN-regulated neuroinflammation.
5.Equivalence of SYN008 versus omalizumab in patients with refractory chronic spontaneous urticaria: A multicenter, randomized, double-blind, parallel-group, active-controlled phase III study.
Jingyi LI ; Yunsheng LIANG ; Wenli FENG ; Liehua DENG ; Hong FANG ; Chao JI ; Youkun LIN ; Furen ZHANG ; Rushan XIA ; Chunlei ZHANG ; Shuping GUO ; Mao LIN ; Yanling LI ; Shoumin ZHANG ; Xiaojing KANG ; Liuqing CHEN ; Zhiqiang SONG ; Xu YAO ; Chengxin LI ; Xiuping HAN ; Guoxiang GUO ; Qing GUO ; Xinsuo DUAN ; Jie LI ; Juan SU ; Shanshan LI ; Qing SUN ; Juan TAO ; Yangfeng DING ; Danqi DENG ; Fuqiu LI ; Haiyun SUO ; Shunquan WU ; Jingbo QIU ; Hongmei LUO ; Linfeng LI ; Ruoyu LI
Chinese Medical Journal 2025;138(16):2040-2042
6.Food-derived bioactive peptides: health benefits, structure‒activity relationships, and translational prospects.
Hongda CHEN ; Jiabei SUN ; Haolie FANG ; Yuanyuan LIN ; Han WU ; Dongqiang LIN ; Zhijian YANG ; Quan ZHOU ; Bingxiang ZHAO ; Tianhua ZHOU ; Jianping WU ; Shanshan LI ; Xiangrui LIU
Journal of Zhejiang University. Science. B 2025;26(11):1037-1058
Food-derived bioactive peptides (FBPs), particularly those with ten or fewer amino acid residues and a molecular weight below 1300 Da, have gained increasing attention for their safe, diverse structures and specific biological activities. The development of FBP-based functional foods and potential medications depends on understanding their structure‒activity relationships (SARs), stability, and bioavailability properties. In this review, we provide an in-depth overview of the roles of FBPs in treating various diseases, including Alzheimer's disease, hypertension, type 2 diabetes mellitus, liver diseases, and inflammatory bowel diseases, based on the literature from July 2017 to Mar. 2023. Subsequently, attention is directed toward elucidating the associations between the bioactivities and structural characteristics (e.g., molecular weight and the presence of specific amino acids within sequences and compositions) of FBPs. We also discuss in silico approaches for FBP screening and their limitations. Finally, we summarize recent advancements in formulation techniques to improve the bioavailability of FBPs in the food industry, thereby contributing to healthcare applications.
Humans
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Peptides/therapeutic use*
;
Structure-Activity Relationship
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Functional Food
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Diabetes Mellitus, Type 2/drug therapy*
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Biological Availability
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Alzheimer Disease/drug therapy*
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Inflammatory Bowel Diseases/drug therapy*
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Hypertension/drug therapy*
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Liver Diseases/drug therapy*
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Bioactive Peptides, Dietary
7.Fabrication and evaluation of dexmedetomidine hydrochloride microneedles based on 3D printing.
Yuanke YANG ; Xiaolu HAN ; Xianfu LI ; Xiaoxuan HONG ; Shanshan YANG ; Chunyan LIU ; Zengming WANG ; Aiping ZHENG
Chinese Journal of Biotechnology 2025;41(8):3214-3227
Compared with conventional transdermal drug delivery systems, dissolving microneedles significantly enhance drug bioavailability by penetrating the stratum corneum barrier and achieving intradermal drug delivery. In order to improve the transdermal bioavailability of dexmedetomidine hydrochloride, in this study, a novel microneedle delivery system was developed for dexmedetomidine hydrochloride based on 3D printing combined with micro-molding. By systematically optimizing the microneedle geometrical parameters, array arrangement, and preparation process parameters, we determined the optimal ratio of drug-carrying matrix as 15% PVP (polyvinyl pyrrolidone) K90. The microneedles exhibited significant drug loading gradients, with mean content of (209.99±27.56) μg/patch, (405.31±30.31) μg/patch, and (621.61±34.43) μg/patch. They showed a regular pyramidal structure under SEM and handheld electron microscopy, and their mechanical strength allowed effective penetration into the stratum corneum. The surface contact angles were all < 90°, indicating excellent hydrophilicity. The microneedles dissolved completely within 10 min after skin insertion, achieving a cumulative release rate of 90% (Higuchi model, r=0.996) during 2 hours of in vitro transdermal permeation. The cytotoxicity test and hemolysis test verified good biocompatibility. Pharmacodynamic evaluation showed that the microneedle group demonstrated pain-relieving effect within 15 min, with the pain threshold at the time point of 60 min being 3 times that in the transdermal cream group. The microneedle system developed in this study not only offers an efficient drug delivery option for patients but also establishes an innovative platform for rapid percutaneous delivery of hydrophilic drugs, demonstrating significant potential in perioperative pain management.
Dexmedetomidine/pharmacokinetics*
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Printing, Three-Dimensional
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Needles
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Drug Delivery Systems/methods*
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Administration, Cutaneous
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Animals
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Microinjections/instrumentation*
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Skin Absorption
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Skin/metabolism*
8.Research progress on the mechanism of traditional Chinese medicine in regulating autophagy to intervene in ovulatory disorders
Yaxue QU ; Ying DING ; Shanshan HAN ; Zhaoheng SUN ; Wenchao XING
China Pharmacy 2025;36(24):3132-3136
Ovulatory disorders are mainly characterized by abnormal follicular maturation or ovulation, with complex etiologies and a lack of effective prevention and treatment methods. Autophagy dysfunction is closely related to the generation and progression of ovulatory disorders. This article systematically elucidates the mechanisms of TCM on follicular development and ovulatory disorders from the perspective of autophagy. It also reviews relevant studies on how TCM regulates autophagy to influence follicular development and improve ovulatory disorders. The findings reveal that TCM monomers/active ingredients (leonurine, total flavonoids from Eucommia ulmoides, alpinetin, icariin, etc.) and compound formulas (including Cangfu daotan decoction, Guishen yugong decoction, Zhuluan decoction, Yishen yangluan formula, Guishen pill, etc.) improve the follicular microenvironment, regulate sex hormone levels, and reduce follicular atresia by regulating autophagy-related genes and signaling pathways such as phosphoinositide 3-kinase/protein kinase B/mammalian target of rapamycin and AMP-activated protein kinase. These actions thereby promote normal follicular development and ovulation, and delay ovarian aging. Most research in this field is based on cellular and animal experiments, often focusing on a single signaling pathway or factor. Some studies fail to fully reflect the individualized treatment characteristics of TCM that emphasize “syndrome differentiation and treatment”, highlighting the urgent need for further investigation.
9.Clinical Experience of Acupuncture in Treating Oculomotor Nerve Palsy
Shanshan LI ; Lulu BIN ; Yongming YE ; Weina PENG ; Jinna YU ; Biying HAN ; He LI
Journal of Traditional Chinese Medicine 2024;65(20):2159-2162
It is believed that the pathogenesis of oculomotor nerve palsy is insufficient marrow sea (髓海), withered yang qi, poor contraction of eyelids and periocular meridians, and inability to open and close the eyes. The eye system is connected to the marrow sea, as well as the the foot taiyang (太阳) channel, foot yangming (阳明) channel, foot jueyin (厥阴) channel, yinqiao mai (阴跷脉) and yangqiao mai (阳跷脉), and is nourished by the liver, spleen and kidney. Treatment should take into account both the branch and the root cause. It is suggested to treat the root by regulating the marrow sea, and treat the branch by unblocking the meridians and dredging the collaterals, thereby balancing the mild and the urgency of the yinqiao mai and yangqiao mai. Using the "Gen (根)-Liu(溜)-Zhu (注)-Ru (入)"acupoints to bypass the various meridians and taking the gallbladder meridian according to twelve major meridians that run on both sides of the body, both of which can provide ideas for improving symptoms such as ptosis and limited eye movement caused by oculomotor nerve palsy.
10.Analysis of Clinical Application on Prescriptions of Toxic Traditional Chinese Medicine Decoction Pieces in Oncology Outpatient Department
Shanshan QIAN ; Xiaoming GAO ; Mingchen HAN ; Manqin YANG
Chinese Journal of Modern Applied Pharmacy 2024;41(8):1099-1105
OBJECTIVE
To analyze the use and distribution characteristics of toxic traditional Chinese medicine decoction pieces in oncology outpatient department, and to provide data reference for the safe and rational use of toxic traditional Chinese medicine decoction pieces in clinical applications.
METHODS
The 838 prescriptions data of toxic traditional Chinese medicine from the Oncology Outpatient Department of The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine in 2022 were collected and made retrospective statistical analysis of patient gender, age, clinical diagnosis, variety of toxic traditional Chinese medicine, frequency of use, frequency of overdose, and combination use of toxic traditional Chinese medicine.
RESULTS
Among the 838 prescriptions of toxic Chinese herbal medicines, 22 toxic Chinese herbal medicines were involved, accounting for 81.48% of the hospital's toxic Chinese herbal medicines. The majority of prescriptions (217 cases, accounting for 25.89%) aged 50 to 60 years old. Most of the single prescriptions were concentrated in 11 to 15, and the toxic Chinese herbal decoction pieces were mainly used in various tumor diseases, digestive system diseases and gynecological diseases, etc. In addition to golden larch bank, ginkgo and centipede, the other toxic traditional Chinese medicines all had the overdose problem. 231 prescriptions of toxic traditional Chinese medicine were used in combination with≥2 , with 190 prescriptions of 2 ingredients being the most commonly used (accounting for 22.67%). There were 78 incompatibilities, most of which were the combination of Aconiti Lateralis Radix Praeparata and Pinelliae Rhizoma. It was used to treat chronic Atrophic gastritis, insomnia and depression.
CONCLUSION
Toxic traditional Chinese medicine decoction pieces are widely used in oncology department. However, the overdose phenomenon is serious, it is necessary to be aware of the potential risks of overdose and combination of toxic traditional Chinese medicine. Therefore, it is necessary to further strengthen drug management, promote rational application, and ensure patient medication safety.


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