Chinese Journal of Pharmacovigilance

Classification and influencing factors of toxicity of Chinese medicine based on ancient books of materia medica

FU Lu, JIN Yan, PENG Huasheng, YUAN Yuan

2022, 19(4): 349-352.
DOI: 10.19803/j.1672-8629.2022.04.01

Abstract ( 227 )

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Objective To propose ways of improving the current methods of toxicity classification of traditional Chinese medicine (TCM) based on the review of ancient records of toxicity of Chinese herbal medicines. Methods The literature research method was used to search for literature related to the toxicity of TCM in ancient Chinese herbal books and to clarify concepts of TCM toxicity, the evolution of toxicity classification of TCM, and the main determinants of the toxicity of TCM. Results The classification of the toxicity of TCM has undergone three-level classification, four-level classification, and five-level classification. The difference in genes, preparations, medications, and physique of patents will affect the toxicity of TCM. Conclusion A multi-level and multi-factor toxicity evaluation system for TCM should be established, involving the source of the medicine, methods of preparation, the time and dosage of the medicine used, and the condition of the patient.

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Toxicity differences analysis of toxic medicinal materials

BAI Zhenfang, WANG Ning, WU Fei, XIAO Yao, JIANG Dan, REN Guangxi, LIU Chunsheng

2022, 19(4): 353-356.
DOI: 10.19803/j.1672-8629.2022.04.02

Abstract ( 182 )

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Objective To summarize the toxicity of 206 kinds of toxic medicinal materials, so as to provide scientific basis for rational utilization and in-depth development of them. Methods The list of toxic medicinal materials, search the literature on from the establishment to september 20, 2021 toxic medicinal materials reported by CNKI, VIP, Wanfang data, Chinese biomedical literature data and PubMed from the establishment to September 20, 2021 was analyzed and summarized. Results Among 206 kinds of toxic medicinal materials, the toxicity about 109 kinds were researched, including renal toxicity, hepatotoxicity and cardiovascular toxicity. Conclusion The toxic components and toxic mechanism of most toxic medicinal materials are still unknown, and more research to do for their safe and effective clinical use.

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Micromorphology and ultrastructure of poisonous medicinal materials of seeds

WANG Lili, LIU Mengqi, WANG Haichun, SONG Xiaoyu, CHEN Suiqing

2022, 19(4): 357-360.
DOI: 10.19803/j.1672-8629.2022.04.03

Abstract ( 99 )

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Objective To observe the micromorphology and ultrastructure of poisonous seed herbs using the stereomicroscope and scanning electron microscope (SEM). Methods After seed herbs were collected, the surface micromorphology of the herbs was observed under a stereomicroscope and SEM, and their surface and transverse characteristics were recorded. Results The micromorphology of these herbs was described in terms of the shape, size, surface and section characteristics. The identification of properties of these herbs was improved; The ultrastructure of crushed materials was summarized to facilitate the identification of crushed poisonous seed herbs. Conclusion Due to the large differences in size, shape and surface characteristics, microscopic studies can quickly detect seed medicinal materials; for medicinal materials that are already powdery, ultrastructural observation can easily identify their characteristics, thereby preventing misuse and mixed use.

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Ultramicrostructure of leaves of five toxic Chinese herbs including Alangium chinense(Lour.)Harms

XU Lu, YANG Jingfan, SHEN Zhirui, LU Sangyu, CHEN Suiqing

2022, 19(4): 361-368.
DOI: 10.19803/j.1672-8629.2022.04.04

Abstract ( 148 )

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Objective To observe the ultrastructure of poisonous herbal medicines, such as Alangium chinense(Lour.)Harms. Chelidonium majus L. Geisemium elegans (Gardn.et Champ.) Benth. Solanum nigrum L. and Solanum lyratum Thunb. in order to provide reference for safe medication. Methods Scanning electron microscopy (SEM) was used to identify the ultramicrostructure of these herbs. Results There were three types of stomata in the leaves of Alangium chinense(Lour.)Harms: anomocytic, paracytic, and actinocytic. There was non-glandular and rod-shaped hair and two collateral vascular bundles in the midrib. There were two types of stomata in the leaves of Chelidonium majus L: anomocytic and actinocytic. There was single stalk glandular hair and multicellular non-glandular hair in the lower epidermis and one collateral vascular bundle in the midrib. There was calcium oxalate crystal on the leaf surface of Geisemium elegans(Gardn.et Champ.) Benth. with three types of stomata: anomocytic, paracytic and actinocytic. One amphicribral vascular bundle was found in the midrib. The leaves of Solanum nigrum L. also had three types of stomata: anomocytic, anisocytic, and actinocytic. There was also multicellular non-glandular, with one bicollateral vascular bundle and sand crystals in the midrib. There was a small amount of single-stalk glandular hair and a large amount of branching multicellular non-glandular hair in the leaves of Solanum lyratum Thunb. There were two types of stomata in the lower epidermis: anomocytic and actinocytic. Sand crystals were scattered on the surface. Conclusion The leaves of 5 types of toxic Chinese herbal medicines have distinct microscopic characteristics, which can facilitate the identification and quality evaluation of toxic Chinese herbal medicines.

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Herbal textual research on toxicity of Zanthoxylum bungeanum

FU Lu, PENG Huasheng, YUAN Yuan, JIN Yan

2022, 19(4): 369-371.
DOI: 10.19803/j.1672-8629.2022.04.05

Abstract ( 150 )

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Objective To study the toxicity of Zanthoxylum Bungeanum based on herbal literature and analyze the influence of origin, places of production, medicinal properties, and processing methods on the toxicity of Zanthoxylum bungeanum so as to contribute to the clinical application of Zanthoxylum bungeanum. Methods The herbal textual research method was used to sort out the ancient records of toxicity of Zanthoxylum bungeanum, and the related influencing factors were analyzed. Results Zanthoxylum bungeanum documented in ancient books could be divided into two categories: medicinal and edible. The varieties of Zanthoxylum bungeanum used as medicines were more toxic than those used as foods. Zanthoxylum bungeanum had hot medicinal properties and a pungent smell. Excessive use could cause such adverse reactions as asthma, toothache and clouded vision. The toxicity of Zanthoxylum bungeanum could be reduced by heating, cleaning, and preparing it with other herbs. Conclusion The toxicity of Zanthoxylum bungeanum is related to its origin, place of production, processing methods, ways of administration and patients' condition. Therefore, the clinical use of Zanthoxylum bungeanum involves using different methods and distinguishing the syndrome of patients.

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Textual research of the toxic herb Kansui Radix

YANG Jingfan, XU Lu, CHEN Suiqing

2022, 19(4): 372-375.
DOI: 10.19803/j.1672-8629.2022.04.06

Abstract ( 124 )

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Objective To investigate the origin, concoction and toxicity of the toxic herb Kansui Radix, and to provide reference for research application. Methods This study made a systematic textual research on the historical evolution and changes of the name, origin, producing areas, harvesting time, processing methods and toxicity of Kansui Radix, compared them, and explored them in depth with modern literature. Results The name, origin and efficacy of Kansui Radix had not changed significantly during its historical development. Kansui Radix was a toxic herb, in order to reduce the toxicity and ensure the safety of the medicine, a variety of processing methods had been recorded in the various ancient documents. Kansui Radix was the "holy medicine of draining water", it was toxic and should not be used on the weak. It should not be taken excessively, and it should be stopped when it was sick. Conclusion By examining the Chinese herbal medicine Kansui Radix, we can identify the history of its use, avoid poisoning in clinical use, and lay the foundation for regulating the market circulation and unifying its use.

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Textual research on origin and molecular identification of Tripterygii Radix

YANG Jingfan, CUI Zhao, YANG Hao, CHEN Suiqing

2022, 19(4): 376-379.
DOI: 10.19803/j.1672-8629.2022.04.07

Abstract ( 92 )

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Objective To ensure the safety and efficacy of Tripterygii Radix for clinical use, we conducted a literature review on the origin of Tripterygii Radix and established a specific rapid PCR molecular identification method. Methods The origin of Tripterygii Radix were validated by reviewing literature reports; the DNA barcodes of Tripterygii Radix and the forgeries were compared. The specific identification sites with stable differences were screened, the identification primers were designed and the specific rapid PCR amplification conditions were optimized. Results The literature review revealed that Tripterygium wilfordii and Tripterygium hypoglaucum hutch had a large number of intermediate types and blurred interspecific boundaries in terms of plant morphological characteristics, secondary metabolite characteristics of medicinal parts and genetic information system differentiation. A specific rapid PCR method was developed to identify the authenticity of Tripterygii radix. All authentic Tripterygii Radix were able to amplify the target gene bands between 300 and 400 bp, while no corresponding bands were found for the forgeries. Conclusion It is suggested that Tripterygium wilfordii and Tripterygium hypoglaucum hutch should be combined as a source of Tripterygii Radix, and a rapid, accurate and stable specific rapid PCR method should be established for Tripterygii Radix and its hybrid for authenticity identification.

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TLC identification and content determination of Cinnamomi Ramulus

OUYANG Luodan, XIAO Suping, ZHOU Jianxin, CHEN Meng, DENG Zhe, ZHOU Haiyan, DU Jie, WANG Jiyong

2022, 19(4): 380-383.
DOI: 10.19803/j.1672-8629.2022.04.08

Abstract ( 280 )

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Objective To improve the method for thin-layer identification and content determination of Cinnamomi Ramulus (Chinese Pharmacopoeia 2020 edition). Methods Cinnamaldehyde, Cinnamic acid and control medicinal materials of Cinnamomi Ramulus were used as reference materials to study the TLC identification of Cinnamomi Ramulus. The crude medicine of Cinnamomi Ramulus from different areas of production was identified by thin layer and content determination. Results TLC manifested clear spots, good separation, easy detection and good reproducibility. This content determination method had a high efficiency of separation and good repeatability. Conclusion The established method for thin-layer identification and content determination is simple and specific, which can simultaneously detect cinnamaldehyde and cinnamic acid in Cinnamomi Ramulus, and provide reference for the revision of the pharmacopoeia.

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Inhibitory effect of total saponins from Kangke capsules on apoptosis induced by Coxsackie virus B

ZHANG Zhibin, YAO Rongmei, MA Huixia, BAO Jutai, GUO Shanshan, CUI Xiaolan

2022, 19(4): 384-389.
DOI: 10.19803/j.1672-8629.2022.04.09

Abstract ( 65 )

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Objective To observe the inhibitory effects of saponins from Kangke capsules on apoptosis caused by Coxsackievirus B (CVB), and to explore the mechanism. Methods CVB was inoculated into cardiomyocytes to establish an infection model in vitro. The cytopathic effect method (CPE) was adopted to determine the 50% inhibitory concentration (IC₅₀) and therapeutic index (TI) of saponins from Kangke capsules on CVB₃, CVB₄ and CVB₅. CCK-8 kit was used to detect cell viability. TdT-mediated dUTP notch end labeling technique (TUNEL) was used to determine the apoptosis rate of cardiomyocytes. Western-blot was used to study the expressions of Bcl-2 and Bax protein in primary rat cardiomyocytes. Results Saponins from Kangke capsules could significantly alleviate cytopathy induced by CVB. The IC₅₀ for CVB₃, CVB₄, and CVB₅ was 223.34, 315.48 and 306.53 μg·mL^-1 respectively, while the therapeutic index was 4.68, 3.24 and 3.24 respectively. The doses of 390.63, 195.32, and 97.66 μg·mL^-1 could increase the survival rate of cardiomyocytes after viral infection. Saponins from Kangke capsules could significantly inhibit viral replication and cell apoptosis after infection while increasing the expression of Bcl-2, decreasing the expression of Bax, and elevating the Bcl-2/Bax ratio. Conclusion Saponins from Kangke capsules can improve cytopathy caused by CVB infection, improve cell survival rate, and inhibit apoptosis. The mechanism is related to the regulation of apoptosis-related protein expressions in cardiomyocytes.

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Clustering analysis of natural products derived from Polygonum multiflorum Thunb. based on spectral clustering algorithm

HU Xiaowen, YANG Jianbo, WEI Feng, MA Shuangcheng

2022, 19(4): 390-394.
DOI: 10.19803/j.1672-8629.2022.04.10

Abstract ( 83 )

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Objective To establish a proper method for clustering natural products by using the spectral clustering algorithm and compounds derived from Polygonum multiflorum Thunb. Methods Major categories of compounds including stilbenes and anthraquinones that originated from Polygonum multiflorum Thunb. were collected from the literature and converted into the simplified molecular input line entry specification (SMILES). Extended-Connectivity Fingerprints and physicochemical properties were extracted and filtered by variance before the spectral clustering algorithm was used for clustering. The Calinski Harabaz (CH) score was employed for the parameter optimization of the spectral cluster. The optimal method was applied to the natural products and the features of each class were analyzed. Principal component analysis of the three main categories was carried out to visualize the spatial distribution. Finally, the topological polar surface area (TPSA) and lipid-water partition coefficient (LogP) of the main compounds were calculated, and the feature distribution of the properties was analyzed. Results A total of 123 natural products of thirteen categories were collected from the literature. After feature calculation and removal of features with near-zero variance, 207 valid features were obtained. The spectral clustering algorithm achieved the highest CH score when the number of clusters was set at 10 and γ set at 0.004. Principal component analysis showed that three major classes were clustered individually in 3-dimentional space. Besides, and that the distribution of TPSA and LogP tended to be centralized. Conclusion The spectral clustering algorithm can not only distinguish the compounds with unique structures, but also have a better performance for complex compounds in Polygonum multiflorum. These results provide novel ideas for screening of natural products.

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Network Pharmacology of Astragalus-Rhizoma Saposhnikovia divaricata drug pair in the treatment of COVID-19

WU Zuomin, YANG Juan, WANG Longlong, WANG Rui

2022, 19(4): 395-399.
DOI: 10.19803/j.1672-8629.2022.04.11

Abstract ( 123 )

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Objective To investigate the pharmacological mechanism of Astragalus-Rhizoma Saposhnikovia divaricata against Covid-19. Methods The effective components and related target protein of Astragalus-Rhizoma and Saposhnikovia divaricata were screened via the Traditional Chinese Medicine Systems Pharmacology (TCMSP) analysis platform. An effective compound- target protein visual network was established using Cytoscape software, and topology analysis was performed. The targets related to COVID-19 were found via the GeneCards online analysis platform. The core targets were selected by the Venny platform, and a protein-protein interaction (PPI) network of the core targets was constructed and analyzed by STRING database. GO (Gene Ontology) enrichment and KEGG (Kyoto Encyclopedia of Genes and Genomes) pathway enrichment of target protein coding genes were performed using DAVID database. Results A total of thirty-six types of effective compounds which included quercetin, kaempferol and wogonin, 215 targets and 59 core targets which included VEGFA, IL-6, TNF, TP53 and MAPK8 were selected. GO functional enrichment analysis obtained 286 GO items (P<0.05), while KEGG pathway enrichment analysis obtained 97 pathways related to COVID-19 P<0.05), involving cancer signaling pathways, HIF-1 and Toll like signaling pathways. Conclusion The active compounds in Astragalus-Rhizoma Saposhnikovia divaricata drug pair can exert a preventive or therapeutic effect on COVID-19 by means of multiple components, multiple targets and multiple pathways.

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Contraindications in package inserts of Chinese patent medicine

XIAO Wangzhong, LIN Cong, HUANG Li, DAI Bing, GAO Yuanfeng

2022, 19(4): 400-403.
DOI: 10.19803/j.1672-8629.2022.04.12

Abstract ( 288 )

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Objective To provide reference for the standardization of specifications in package inserts of Chinese patent medicine (CPM). Methods The package inserts of two hundred and three types of CPM which were prescribed in the First Affiliated Hospital of Hunan University of Traditional Chinese Medicine between January 1, and June 30, in 2020 were collected. The problems with labeling of those package inserts were compared and analyzed according to the People's Republic of China (2020 edition)（ChP). Results Among the two hundred and three specifications of CPM, only one mentioned the incompatibility of drugs and seven presented antagonistic ingredients. The package inserts of twenty-three specifications mentioned syndrome type contraindications, five of which were inconsistent with the ChP. Fifty-seven specifications contained pregnancy contraindication labels, which were inconsistent with the ChP in five cases. In addition, there were twenty-two specifications that contained diet taboos, thirteen of which differed from those of the ChP. Conclusion Some package inserts of CPM have substandard labels of contraindications that show poor consistency with the ChP. Drug regulatory departments should continue to strengthen supervision and management. Meanwhile, it is necessary to enhance the quality of prescriptions and to improve the contents of the (ChP).

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113 reports of adverse drug reactions induced by fluoroquinolones in patients with tuberculosis

ZHU Na, KAN Xiaohong, WU Xinli, DING Haihua, XUE Shuya, ZHANG Yunling

2022, 19(4): 404-407.
DOI: 10.19803/j.1672-8629.2022.04.13

Abstract ( 274 )

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Objective To analyse the adverse drug reactions (ADR) reports induced by fluoroquinolones in patients with tuberculosis, so as to provide reference for rational drug use. Methods The cases of ADR induced by fluoroquinolones in patients with tuberculosis from January 1, 2013 to June 30, 2020 in our hospital were retrospectively investigated and analyzed. Results A total of 113 cases of ADR of fluoroquinolones were reported in tuberculosis patients, of which serious ADR accounted for 10.62%. Three kinds of fluoroquinolones were involved, levofloxacin, enoxacin, and moxifloxacin in turn. Clinical manifestations involved skin and appendages disorders, systemic reaction, gastrointestinal system. ADR induced by intravenous administration was more than oral administration. 7.08 % of the patients had irrational drug use, which manifested as unsuitable selection of drugs. Conclusion The monitoring of ADR of fluoroquinolones in tuberculosis patients should be attached great importance in clinical treatment, and effective measures should be taken timely to improve the safety of drug use.

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Current applications and rationality of ribavirin in pediatrics in seven cities in China

YANG Miao, YANG Li, ZHAO Zhigang

2022, 19(4): 408-412.
DOI: 10.19803/j.1672-8629.2022.04.14

Abstract ( 155 )

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Objective To evaluate the rationality of ribavirin in pediatric use and to provide the basic data for rational use of ribavirin. Methods Sample prescriptions from 107 health institutions in 7 cities in China were included after searching "The Hospital Prescriptions Cooperation Project" by Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association from January 1, 2013 to December 31, 2017 to assess the rationality of related prescriptions based on domestic and foreign prescriptions of ribavirin and related guidelines. Results Ribavirin accounted for a large proportion of antiviral drugs(49.4%). Ribavirin was mainly used in pediatrics in China for respiratory tract infections, hand-foot-and-mouth disease, bronchitis, pneumonia and herpangina. The children who used ribavirin were mostly aged 1 to 2 and 3 to 5. The most commonly used dosage form of ribavirin was injection(40.43%). Conclusion There is some off-label or beyond-the-age-limit use of ribavirin in China, so a prescription rating system for ribavirin should be established to regulate the applications in pediatrics in China.

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Applications of antiviral drugs in 456 patients with COVID-19

YANG Fan, MA Haiping, YOU Mengru, LIAO Sha, LIU Lan, ZHU Jun

2022, 19(4): 413-416.
DOI: 10.19803/j.1672-8629.2022.04.15

Abstract ( 198 )

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Objective To evaluate the clinical characteristics of COVID-19 patients and current usage of antiviral drugs in our hospital to provide data for rational use drugs in cliuic. Methods The clinical data on COVID-19 patients diagnosed in Xiantao First People's Hospital from February 1 to February 29, 2020, their characteristics, as well as the usage, dosage and combined use of antiviral drugs and adverse drug reactions (ADR) were analyzed retrospectively. Results A total of 456 patients were collected. Patients aged 30 to 65 accounted for 71.71%. The usage and dosage of antiviral drugs basically conformed to the national diagnosis and treatment plans. Monotherapy was the main treatment, combined use of antiviral drugs accounted for 8.78%, and arbidol was the most frequently used. ADR occurred in 29 patients, and the main symptoms were nausea, vomiting and poor appetite. Conclusion The use of antiviral drugs in patients with COVID-19 was generally appropriate, but a few patients were treated with three or more types of antiviral drugs.

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257 cases of adverse drug reactions induced by lidocaine hydrochloride injection used in dentistry

MAO Shumin, QIU Jianmin, ZHAO Xifeng, LYU Xinhua

2022, 19(4): 417-420.
DOI: 10.19803/j.1672-8629.2022.04.16

Abstract ( 203 )

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Objective To analyze the features of adverse drug reaction(ADR) induced by lidocaine hydrochloride injection used in dentistry in order to provide data for rational use of drugs in clinic. Methods Two hundred and fifty-seven cases of ADR caused by lidocaine hydrochloride injection used in dentistry that were collected from January 1, 2009 to December 31, 2019 in the Shandong provincial ADR monitoring system were analyzed. Results ADR induced by lidocaine hydrochloride injection usually occurred within ten minutes of medication. Multiple systems were affected, including the central system, peripheral nervous system and the cardiovascular system. Conclusion Health care providers should be alert to ADR induced by lidocaine hydrochloride injection used in dentistry. Drug manufacturers should revise and improve the safety information in drug instructions promptly.

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Association between ABCB1 C3435T polymorphisms and methotrexate-induced toxicity in childhood acute lymphoblastic leukemia: Meta analysis

LI Yu, FAN Huihui, FENG Xiaojun, ZHANG Yonghuang, CHEN Qin, WANG Yunhong, CHEN Chuantao, ZHANG Lei, SHI Tianlu

2022, 19(4): 421-425.
DOI: 10.19803/j.1672-8629.2022.04.17

Abstract ( 93 )

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Objective To study the correlations between ABCB1 C3435T genetic polymorphisms and the safety of MTX in pediatric ALL. Methods PubMed, Science direct, CNKI, and Wanfang database were searched for the most eligible studies published from the inception to March 2020. Meta analysis was performed using RevMan 5.3 software. Results A total of 13 studies were included involving 1951 patients. Meta-analysis results showed that CT/TT genetype increased the chance of hepatotoxicity in pediatric ALL compared with CC genetype[OR=2.36, 95% CI (1.38~4.06), I²=0%, P=0.002]. There was no association between ABCB1 C3435T genetic polymorphisms and mucositis[OR=1.44, 95% CI (0.94~2.19), I²=25%, P=0.09], gastrointestinal reaction[OR=0.91, 95% CI (0.54~1.54), I²=0%, P=0.74], myelosuppression [OR=1.24, 95%CI (0.42~3.67), I²=74%, P=0.69], renal insufficiency[OR=0.51, 95% CI (0.13~1.93), I²=0%, P=0.32], excretion delay [OR=1.05, 95% CI (0.38~2.90), I²=0%, P=0.92] , 24 h[SMD=0.49, 95% CI (-0.59~1.57), I²=83%, P=0.37] and 42h [SMD=0.03, 95% CI(-0.40~0.47), I²=0%, P=0.88] MTX concentrations in children with ALL. Conclusion ABCB1 C3435T genetic mutations can increases the incidence of hepatotoxicity in pediatric ALL. The genetic polymorphism of ABCB1 C3435T has no effect on mucositis, gastrointestinal reactions, myelosuppression, renal insufficiency, excretion delay or plasma levels of MTX .

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Leflunomide-induced hepatotoxicity: data analysis based on the FDA adverse event reporting system

CUI Xiangli, ZHANG Zhiqi, SUN Liying, GUO Mingxing, ZENG Zhigui, XU Wanyi

2022, 19(4): 426-431.
DOI: 10.19803/j.1672-8629.2022.04.18

Abstract ( 214 )

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Objective To explore the characteristics of adverse drug reactions induced by leflunomide, such as hepatotoxicity, by using the FDA adverse event reporting system (FAERS) data in the United States, and to recommend that liver function should be closely monitored during clinical medication to prevent the hepatotoxicity of leflunomide. Methods The recommendations in the instructions and guidelines for the use of leflunomide among patients with liver damage in different countries were compared. The adverse event reports in FAERS data from January 1, 1999 to December 31, 2019 in the United States were mined by using the report ratio (ROR) method and the proportion report ratio (PRR) method. The signals of liver injury caused by leflunomide were mined, and the demographic characteristics, primary diseases, concomitant medications, clinical outcomes and other information were analyzed. Results Contraindications of leflunomide in Chinese instructions included severe liver damage, which was too broad compared with instructions or guidelines recommended by other countries. The US instructions deliberately added a black box to warn reports of severe liver damage and fatal liver failure to prevent this drug from being used by patients with a previous liver disease history or ALT>2 times the normal value. A total number of 28 186 adverse events of flunomide were retrieved, 4 319 (17.9%) of which were hepatotoxic adverse events. The ROR and PRR of hepatotoxicity of leflunomide and other drugs were 51.6 and 43.9 respectively. There were 3.5 times as many female patients with liver damage as male ones. The percentage of patients aged 46 to 60 was the highest (35.1%). Rheumatoid arthritis was the dominating primary disease, accounting for 77.5%. In terms of combined medication, 2 288 patients were treated with flunomide alone, accounting for 52.98%, while those treated with one to five types of drugs made up 29.22%. The combined use of adalimumab, glucocorticoid, non-steroidal anti-inflammatory drugs and methotrexate was the most common. The risk of death was mainly related to age and gender, and had no obvious correlations with the types of combined drugs, but tended to increase in male and elder patients. Conclusion Clinicians should be alert to the hepatotoxicity of leflunomide in China, and the liver function of patients should be monitored at an intervals of 2~4 weeks. Patients with a history of liver desease should avoid using this drug.

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Adverse reactions of solriamfetol after listing based on real world data

CHEN Tianyu, CHEN Qiying, ZHANG Yuezhen

2022, 19(4): 432-435.
DOI: 10.19803/j.1672-8629.2022.04.19

Abstract ( 225 )

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Objective To analyze ADR induced by solriamfetol after listing via the FAERS (the US Food and Drug Administration Adverse Event Reporting System) so as to provide reference for clinical rational drug use. Methods The data on adverse reaction reports of solriamfetol submitted to the FAERS between January 1, 2019 and March 31, 2020 was retrieved and analyzed by MYSQL software. Results There were 122 ADR reports with solriamfetol as the primary suspected drug, 14 of which involved severe ADR. The main symptoms were psychiatric disorders, nervous system disorders, cardiac disorders, respiratory disorders, thoracic and mediastinal disorders. The top ten types of adverse reactions were anxiety, insomnia, paraesthesia, chest pain, sinus tachycardia, suicidal ideation, disturbance in attention, dizziness, headache and fatigue. Most of the people who reported discomfort were consumers, and the most of the patients with adverse reactions were female, with an average age of (31.95 ±15.26) years. Narcolepsy was the main manifestation, and the dose of 150 mg·d^-1 was the most common. 83.33% of the patients developed adverse reactions after less than one month of medication. Conclusion The analysis of the incidence of adverse reactions after the listing of solriamfetol by means suggests that we should pay more attention to this drug in the process of clinical application, keep in mind the indications of drug use and try every means available to ensure the safety of this drug.

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Literature review of 58 cases of adverse drug reactions induced by flurbiprofen

HUANG Li, WEI Long, LI Hemei, YI Dan

2022, 19(4): 436-440.
DOI: 10.19803/j.1672-8629.2022.04.20

Abstract ( 173 )

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Objective To analyze the characteristics of adverse reactions induced by flurbiprofen and provide reference for safe medication. Methods Using "flurbiprofen" "adverse reaction" "case" as key words, the related articles in the CNKI, Wanfang Database, VIP and Pubmed from established to December 31, 2019 were searched for and retrieved. Results The adverse reactions were mostly skin and accessory damage, and damage to the central nervous system, which occurred within one hour of medication. The highest incidence of adverse reactions was due to intravenous injection. Conclusion It is important for clinicians to be alert to the adverse reactions of flurbiprofen, enhance the monitoring and guidance of drug use, and ensure the safety of medication.

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Pharmaceutical care of three types of Qingrejiedu traditional Chinese medicine injections

ZHOU Peng, YANG Jingjing

2022, 19(4): 441-445.
DOI: 10.19803/j.1672-8629.2022.04.21

Abstract ( 155 )

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Objective To provide evidence-based data for the rational use of three types of antipyretic and antidotal injections: Xiyanping, Tanreqing and Reduning. Methods The problems with clinical use of Xiyanping, Tanreqing and Reduning were summarized and analyzed. Results The instructions about Xiyanping, Tanreqing and Reduning failed to give a detailed account of the diseases and syndromes diagnosed by TCM. There were problems with clinical use of these drugs, such as inaccurate syndrome differentiation, improper solvent selection and use of these drugs beyond indications specified by western medicine. Conclusion Clinical pharmacists can strengthen the pharmaceutical care of the three drugs in terms of medication indications, usage and dosage, incompatibility and adverse reactions so as to ensure safe, effective and rational medication.

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Pharmacy practice during the treatment of primary central nervous system lymphoma with high dose methotrexate

CHEN Fangfang, ZHANG Hongxu

2022, 19(4): 446-449.
DOI: 10.19803/j.1672-8629.2022.04.22

Abstract ( 169 )

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Objective To study the clinical pharmaceutical practice in the process of treating primary central nervous system lymphoma (PCNSL) with high dose methotrexate (HD-MTX). Methods One patient with PCNSL was treated with HD-MTX. The clinical pharmacist took active part in the clinical treatment of this patient using pharmaceutical knowledge, assisted doctors in formulating chemotherapy and rescue plans, gave pharmaceutical care to this patient, and provided individualized pharmaceutical service to ensure the safety and effectiveness of medication. Results Drug treatment of this case of PCNSL was safe, effective and smooth. Conclusion Clinical pharmacists can play a role in the process of clinical drug treatment, improve the level of clinical drug treatment, and ensure the safety and effectiveness of drug use.

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Pharmaceutical care of a patient with lung abscess with drug fever and rhabdomyolysis induced by piperacillin-tazobactam

DU Jing, LI Yonghui, YAN Naxin, GUO Lijie, LIU Yang

2022, 19(4): 450-452.
DOI: 10.19803/j.1672-8629.2022.04.23

Abstract ( 229 )

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Objective To explore the causes of drug fever and rhabdomyolysis among patients with lung abscess during anti-infective treatment so as to provide reference for clinical rational use of drugs. Methods The process of monitoring one patient with lung abscess by a clinical pharmacist was retrospectively analyzed, related literature was retrieved, and the causes of adverse reactions of piperacillin-tazobactam and moxifloxacin as well as ways of safe clinical application with reference to the patient's condition were discussed. Results When antibiotics were used, especially β -lactams such as piperacillin and tazobactam, the likelihood of drug fever should be considered if the body temperature rose suddenly. Rhabdomyolysis caused by moxifloxacin might have been related to its chemical structure, so infusion speed had to be controlled and the drug withdrawn in time in case of adverse reactions. Conclusion Clinicians should be alert to the adverse drug reactions that may occur during anti-infective treatment. Clinical pharmacists are expected to consult literature to find evidence for the safety and effectiveness of clinical medication.

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One case of acute kidney injury induced by rifampicin

REN Quanxia, WU Bin, HUANG Mingxia

2022, 19(4): 453-455.
DOI: 10.19803/j.1672-8629.2022.04.24

Abstract ( 251 )

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Objective To explore ways in which acute kidney injury induced by rifampicin can be treated. Methods The process of treating one case of rifampicin-induced acute kidney injury was analyzed. The possible pathogenesis and treatments of rifampicin-induced acute kidney injury were discussed based on literature review. Results The serum creatinine was 477.2 mol·L^-1 after the second oral rifampicin. Rifampicin was immediately withdrawn and hemodialysis was performed ten times. The serum level of creatinine decreased from 579.2 mol·L^-1 to 80.6 mol·L^-1. Conclusion Rifampicin should be withdrawn immediately after acute kidney injury, and corresponding treatments should be provided according to the severity of acute kidney injury.

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Research advances in pharmacological and toxicological activities of dioscin

FANG Cheng, XU Xiaomin, LIU Shumin

2022, 19(4): 456-459.
DOI: 10.19803/j.1672-8629.2022.04.25

Abstract ( 127 )

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Dioscin is the principal active ingredient of a variety of herbs, natural drugs and listed traditional Chinese medicine preparations. It is used to treat cardiovascular diseases, arthritis and other diseases. In recent years, the anti-cancer activity of dioscin has been widely explored as a hotspot. This paper reviews the recent advances in pharmacological and toxicological studies on dioscin in order to facilitate research and development of dioscin.

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Advances in clinical and experimental research on treatments of immune thrombocytopenia with traditional Chinese medicine

LUO Yaqin, HUANG Wei

2022, 19(4): 460-464.
DOI: 10.19803/j.1672-8629.2022.04.26

Abstract ( 175 )

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Immune thrombocytopenia (ITP) is a common clinical bleeding disorder characterized by a decrease in the number of peripheral blood platelets. Mild cases have no obvious bleeding symptoms. In severe cases, skin and mucous membrane bleeding, menorrhagia, and even internal organ bleeding and intracranial bleeding may occur, which is life-threatening. The pathogenesis of ITP is currently unclear, and it is believed to be related to autoimmunity. ITP has never been cured once for all. Western medicine uses glucocorticoids as the first choice for treatment. However, with the withdrawal of hormones, many patients become hormone-dependent and prone to relapse, along with poor long-lasting effects and high costs. In recent years, clinical applications of traditional Chinese medicine or integrated traditional Chinese and western medicine have made great progress in the treatment of ITP. This paper summarizes the advances in the treatment of ITP with TCM in the past five years from theoretical, clinical and experimental perspectives, hoping to provide reference for the in-depth study of the mechanism by which Chinese medicine helps prevent and treat ITP so as to contribute to the prevention and treatment of the disease.

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