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Chinese Journal of Pharmacovigilance
15 May 2022, Volume 19 Issue 5

15 May 2022, Volume 19 Issue 5 Previous Issue   
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Contents
2022, 19(5): 468-468. 
Abstract ( 23 )   PDF (485KB) ( 19 )  
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Risk assessment and pre-warning of injection within Bufonis Venenum in the treatment of liver cancer
ZHANG Xiaomeng, LYU Jintao, ZHANG Bing, LIN Zhijian, LIU Rongxue
2022, 19(5): 469-474. 
DOI: 10.19803/j.1672-8629.2022.05.01

Abstract ( 34 )   PDF (1701KB) ( 14 )  
Objective To explore the risk assessment and pre-warning model of injection within Venenum Bufonis (VBI) in the treatment of liver cancer, so as to demonstration research for clinical practice. Methods The randomized controlled trials (RCTs) of VBI in the treatment of liver cancer were collected by searching comprehensively and systematically in journal literature databases such as CNKI, Wanfang Database, SinoMed, PubMed since the establishment of the database until January 31, 2022. By using the multi-criteria decision analysis model, the benefit-risk assessment (BRA) of VBI in the treatment of liver cancer under different kinds of medication conditions was taken. Then based on BRA values, the VBI risk pre-warning level could be predicted by the entropy weight and matter-element extension model. Results 64 RCTs of VBI in the treatment of liver cancer were included. The BRA value of the treatment method without transarterial chemoembolization was 81.55% higher than that of combined use; the BRA value of Cinobufasu injection was 100% higher than the Chansu injection or Delisheng injection; the conventional dose group was better than the off-label dose group; and the difference between 28 days and long course of treatment was 19 [95%CI(9.42, 28.88)]. Based on the BRA results, the course of treatment need to be first-level pre-warning response. Conclusion Multi-criteria decision-making and entropy weight matter-element extension model can be used as risk assessment and pre-warning model for herbs, which provide basis for traditional Chinese medicine pharmacovigilance.
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Research on the application of clinical drug-oriented risk assessment method for harmful components of traditional Chinese medicine
LI Yaolei, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian, ZAN Ke, JIN Hongyu, MA Shuangcheng
2022, 19(5): 475-480. 
DOI: 10.19803/j.1672-8629.2022.05.02

Abstract ( 30 )   PDF (2243KB) ( 12 )  
Objective To explore the practicability of risk assessment methods for harmful components of traditional Chinese medicine (TCM) based on clinical medication. Methods The samples were processed by microwave digestion, and lead (Pb), cadmium (Cd), arsenic (As), mercury (Hg), copper (Cu) in Farfarae Flos, Patchouli, Sennae Folium and Arnebiae Radix by inductively coupled plasma mass spectrometry (ICP-MS) were determined. Based on clinical drug use factors such as drug frequency, use time limit, and decoction transfer rate, the health risk assessment of the carcinogenicity of harmful components in TCM was carried out. Furthermore, it also given weight to the security factor. Results The content levels of five heavy metals and harmful elements in Farfarae Flos, Patchouli, Sennae Folium and Arnebiae Radix were different. According to the risk assessment method with the characteristics of clinical use of TCM, the overall non-carcinogenic risk of Pb, Cd, As, Hg, and Cu was low, and the hazard coefficient (THQ) was less than 1. In addition, the carcinogenic risk (CR) of the three elements Pb, As, and Cd were all less than 1×10-6, and the overall carcinogenic risk was low. Conclusion The clinical drug-oriented risk assessment method for harmful components of TCM has strong overall practicability. It can reflect the risk of drug use of TCM and guide clinical rational drug use.
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Risk ranking and pharmacovigilance thinking of renal injury induced by traditional Chinese medicine with acrid, hot and toxic properties
WU Huanzhang, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian, ZHANG Zhiqi1, ZHANG Yongqiang
2022, 19(5): 481-485. 
DOI: 10.19803/j.1672-8629.2022.05.03

Abstract ( 21 )   PDF (1368KB) ( 8 )  
Objective Taking the renal target organs as the entry point, to establish a graded model of renal injury risk with the example of traditional Chinese medicine with acrid, hot and toxic properties. And corresponding pharmacovigilance was carried out according to this model. Methods A semi-qualitative and quantitative three-dimensional matrix risk ranking model for renal injury was established by collecting case reports of adverse drug reactions (ADR) induced by traditional Chinese medicine with acrid, hot and toxic properties from CNKI, VIP and WanFang database from construction to December 31, 2021, and using a spatial distance model from the three-dimensional perspective of drugs, patients and clinical medication. Results Based on the case reports of traditional Chinese medicine with acrid, hot and toxic properties Caowu (Aconiti Kusnezoffii Radix), Banmao (Mylabris), Xionghuang (Realgar), Wugong (Scolopendra) and Cangerzi (Xanthii Fructus) included in this paper, a three-dimensional evaluation of the toxicity of drug toxicity, the patient's original kidney-related disease and the patient's clinical use of the drug preparation, dose, medication compliance, drug combination and route of administration was conducted to assign a risk rating to different cases, and cautionary measures of contraindication and prohibition could be applied respectively according to the risk evaluation level. Conclusion The risk ranking system of kidney injury induced by toxic Chinese medicine realizes the assessment and rank, which can provide reference for clinical drug evaluation, and realize targeted pharmacovigilance measures.
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Mechanism analysis and pharmacovigilance considerations of traditional Chinese medicine with "potency-toxicity" bi-directional effect of heart
YIN Yuling, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian, HAN Yu
2022, 19(5): 486-492. 
DOI: 10.19803/j.1672-8629.2022.05.04

Abstract ( 22 )   PDF (1888KB) ( 10 )  
Objective To investigate the mechanism and provide suggestions for the pharmacovigilance and rational use of traditional Chinese medicine with cardiac therapeutic effect and possible cardiac injury. Methods Traditional Chinese medicines with "potency-toxicity: bi-directional effect of the heart was Systematically search and excavatd from Chinese periodical literature databases such as CNKI, Weipu, Wanfang Data Knowledage Service Platform. The retrieval time was from inception to November 30, 2021. Analyze the components, mechanisms, transformation factors of "potency-toxicity" effect of these medicines by combining bibliometric and bioinformatics tools. Results 10 Chinese herbs, such as Shandougen (Sophorae Tonkinensis Radix Et Rhizoma), Wuzhuyu (Euodiae Fructus), Maidong (Ophiopogonis Radix), Liangmianzhen (Zanthoxyli Radix) and Xiangjiapi (Periplocae Cortex), had cardiac "potency-toxicity” bi-directional effect. The types of bi-directional components include alkaloids, cardiac glycosides, saponins, etc. The mechanism of bi-directional effects is mainly related to the AKT/AMPK/mTOR pathway and myocardial Ca2+-Na+-K+ channels. The potency-toxicity effect conversion is related to the patient's pre-existing heart disease, physical differences, drug dosage, administration and combination, as well as potency-toxicity components and other factors. Conclusion The administration of cardiac potency-toxicity bi-directional effect traditional Chinese medicines requires multiple measures of pharmacovigilance to prevent the conversion of such medicines from potency to toxicity, especially to enhance the attention to the medication monitoring of patients with pre-existing cardiac diseases.
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Toxicity of Jingfang granule extract on embryo-fetal developmental of rats
ZHENG Chengcheng, WANG Huiping, XU Baihui, XU Jiaoyan, LI Beibei, ZHANG Xiaohong, ZHANG Wei, SUN Ying, WANG Enli
2022, 19(5): 493-497. 
DOI: 10.19803/j.1672-8629.2022.05.05

Abstract ( 22 )   PDF (885KB) ( 5 )  
Objective To explore the developmental toxicities of Jingfang granule extract on embryo-fetal of rats, so as to provide reference for the further development of its medicinal value. Methods Totally 112 fertilized rats were divided randomly into control group, Jingfang granule extract 1, 3, and 10 g·kg-1·d-1 groups, 28 in each group. Animals were intragastrical administered with Jingfang granule extract from day 6 of pregnancy (GD6) once daily;; Rats were treated until GD15 and sacrificed on GD20. The clinical manifestation of animals was observed every day during test period, feed take and bodyweight were detected regularly. Corpora lutea number, implantation number, and living fetus number were counted. Lengths of fetus Crown-Rump and tail were measured and the appearance, skeleton, and viscera of fetus were detected. Results With the exception, no apparent toxic reaction in pregnant animals was shown in all groups. Compared with control group, rats treated with Jingfang granule extract had no abnormal change on maternal pregnancy rate, average corpora lutea number, average implantation loss rate, and average living fetus rate, and likewise, average lengths of fetus Crown-Rump and tail were normal. Moreover, rats treated with Jingfang granule extract had no malformation in fetus appearance, skeleton, and viscera compared with vehicle control. Conclusion Jingfang granule extract has no potential developmental toxicities on embryo-fetal of rats. Under the experimental conditions, the no observed adverse effect level (NOAEL) of Jingfang granule extract on developmental toxicity of rats is 10 g·kg-1·d-1.
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Toxicity of Jingfang granule extract on perinatal rats
ZHENG Chengcheng, XU Baihui, XU Jiaoyan, WANG Huiping, LI Beibei, ZHANG Xiaohong, SUN Ying, YAO Jingchun, WANG Enli
2022, 19(5): 498-504. 
DOI: 10.19803/j.1672-8629.2022.05.06

Abstract ( 20 )   PDF (1001KB) ( 10 )  
Objective To investigate the effect of Jingfang granule extract giving from embryo to cub on pregnant and lactating female rats as well as F1 and F2 rats. Methods A total of 96 rats were divided into solvent control group, Jingfang granule extract low dose group (1 g·kg-1·d-1) , medium dose group (3 g·kg-1·d-1) , and high dose group (10 g·kg-1·d-1). Jingfang granule extract were given from the day 6 of gestation through weaning. F0 pregnant rats were observed for body weight, food intake, childbirth and lactation. The appearance, body weight, growth and development index, nerve reflex index and behavioral index of the newborn rats were observed in F1 and F2 rats. Results Jingfang granule extract had no toxic effects on F1 generation and F2 generation offspring rats. Compared with solvent control group, Jingfang granule extract groups had no significant effects on body weight, feeding, growth, nerve reflex, learning and memory ability in F1 and F2 generation rats (P>; 0.05). In addition, no effect on the development of the organs or reproductive function of the F1 generation rats was observed. Conclusion Under the experimental conditions, Jingfang granule extract has no toxicities on perinatal of rats, and the no observed adverse effect levels (NOAEL) is 10 g·kg-1·d-1.
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Toxicity of the reproductive and early embraonic development of Jingfang granule extract in rats
ZHENG Chengcheng, WANG Enli, XU Baihui, XU Jiaoyan, LI Beibei, ZHANG Xiaohong, ZHOU Zongyi, WANG Yonggang, YAO Jingchun
2022, 19(5): 505-509. 
DOI: 10.19803/j.1672-8629.2022.05.07

Abstract ( 19 )   PDF (842KB) ( 5 )  
Objective To observe the effects of Jingfang granule extract on fertility and early embryonic development of SD rats, so as to provide reference for the further development of its medicinal value. Methods Totally 168 rats were divided randomly into control group and Jingfang Granule Extract 1, 3, 10 g·kg-1·d-1 groups, 42 in each group; half male and half female. Prior to mating, male rats were treated for 4 weeks and female rats were treated for 2 weeks respectively by intragastric administration with volume 15 mL·kg-1 once a day. With each treatment group, the male and female rats were co-housed (1∶1). The clinical manifestation of animals was observed every day during test period, feed taking and bodyweight were detected regularly. Sperm motility, quantity and morphology of male rats, pregnancy of pregnant female rats, corpora lutea number, implantation number, and living fetus number, absorbed fetus number, dead fetus number, main reproductive organs were detected. Results Compared with the control group, there were no significant changes in the pre-mating weight of female and male rats, pregnant weight and weight gain of female rats, pre-mating food intake of female and male rats and pregnant food intake of female rats of all the Jingfang Granule Extract treatment groups. There were no abnormal changes on animal precoital interval, mating index, gestation index, sperm quality of male rats and pregnancy outcome of female rats. During test period, no abnormal signs were found in the control and Jingfang granule extract 1, 3 and 10 g·kg-1·d-1groups. Conclusion Under the experimental conditions, Jingfang granule extract has no potential developmental toxicities on embryo-fetal of rats, and the no observed adverse effect levels (NOAEL) is 10 g·kg-1·d-1.
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Toxicity of Jingfang granule extractum by 90 days repeated ingastric administration in rats
XU Baihui, WANG Enli, ZHENG Chengcheng, XU Jiaoyan, LI Beibei, ZHANG Xiaohong, ZHOU Zhongyi, WANG Yonggang, YAO Jingchun
2022, 19(5): 510-514. 
DOI: 10.19803/j.1672-8629.2022.05.08

Abstract ( 17 )   PDF (1723KB) ( 6 )  
Objective To observe the repeat-dose toxicity of Jingfang granule extractum in rats, to as to guide the safe and rational use of Jingfang granules in clinic. Methods Totally 144 SPF rats were randomly divided into 4 groups, namely blank control group (0 g·kg-1·d-1 of water for injection), Jing Fang granule extractum 1, 3, 10 g·kg-1·d-1, with 36 rats in each group and half male and half female. All rats were administered intragastrically once a day for 90 days with 30 days recovery phase. Test indicators included general clinical observation, feeding, weight, ophthalmology and urine examination, hematology, biochemical examination, major organ weighing and organ coefficient, and histopathological examination. Results After 90 days of repeated intragastric administration of Jingfang granule extractum at doses of 1, 3 and 10 g·kg-1·d-1, there were no abnormal changes in general state, food intake, body weight, hematology, blood biochemistry and histopathology. At the dose of 10 g·kg-1·d-1, male rats had lower food intake and slower body weight gain, and histopathological examination showed an increased incidence of early chronic progressive kidney disease, all of which returned to normal after the recovery phase. Conclusion The non-toxic dose (NOAEL) of Jingfang granule extractum is 3 g·kg-1·d-1 and the toxic dose was 10 g·kg-1·d-1. Under this dose, Jingfang granule extractum can cause anorexia and increase the incidence of chronic progressive nephritis (CPN) in animals. Considering that there is no disease corresponding to CPN in human, It is prudent to conclude that at the most severe dose, there is a potential for minor kidney injury. The above effects are recovered after the end of the recovery phase, which indicating that the adverse reactions caused by Jingfang granule extractum are reversible.
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Toxicity of Jingfang granule extract by repeated gavage for 28 days in young rats
XU Jiaoyan, WANG Enli, YU Limei, ZHANG Wei, SUN Ying, ZHANG Guimin
2022, 19(5): 515-521. 
DOI: 10.19803/j.1672-8629.2022.05.09

Abstract ( 16 )   PDF (1599KB) ( 5 )  
Objective To investigate the toxicity of Jingfang granule extract on newly weaned SD rats after repeated intragastric administration for 28 days, so as to provide reference for the application of Jingfang granule extract in children. Methods A total of 144 newly weaned SD rats were selected and randomly divided into three dose groups of Jingfang granule extract 1, 3, 10 g·kg-1·d-1 and control group (water for injection 0 g·kg-1·d-1), 36 animals in each group, half male and half female. Animals were gavaged with Jingfang granule extract and water for injection at the corresponding concentration at an administration volume of 15 mL·kg-1, once a day, for 28 d, and the drug was withdrawn and recovered for 28 d. During the experiment, the general state of the animals was observed daily, the body weight and food intake of the animals were detected twice a week, the time of foreskin separation, testicular sperm count, and serum testosterone was examined in male mice, and the time of vaginal opening, estrous cycle and serum estrogen were examined in female mice. At the end of the administration period and the end of the recovery period, the animal bone development, nervous system function, learning and memory, growth hormone level, immunoglobulin level, ophthalmology, hematology, blood biochemistry, urology and histopathology were examined respectively. Results There were no abnormal signs related to the test substance in Jingfang granule extract 1, 3 and 10 g·kg-1·d-1 groups, and there was no significant change in body weight and food intake. The hematological indexes WBC, NEUT, LYMPH, MONO and blood biochemical indexes TP, TG, TC, HDL-C, LDL-C and ALB in 10 g·kg-1·d-1 group changed slightly;; and the spleen observed under the microscope can see the "starry sky" phenomenon. Conclusion The administration of Jingfang granule extract to young rats for 28 days does't cause abnormal changes in general signs, body weight, food intake, sexual development, sex hormone level, growth and development and other indexes of animals. Hematological and biochemical indexes change slightly with histopathology, but not considered to be related to the toxic effects of the test substance.
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Determination of anthraquinones in Polygoni Multiflori Radix from different origins and processed differently by HPLC
GAO Huiyu, YANG Jianbo, SUN Hua, SONG Yunfei, CHENG Xianlong, WANG Xueting, WEI Feng1, WANG Qi, WANG Ying, JIN Hongtao, MA Shuangcheng
2022, 19(5): 522-526. 
DOI: 10.19803/j.1672-8629.2022.05.10

Abstract ( 19 )   PDF (1592KB) ( 9 )  
Objective To simultaneously determine the contents of emodin-8-O-β-D glucoside, emodin, physcion, free anthraquinone and bound anthraquinone in Polygoni Multiflori Radix from different origins and processed with different methods. Methods The contents of emodin-8-O-β-D glucoside, emodin and physcion were determined on an Agilent 5 TC-C18 (2) (250 mm×4.6 mm, 5 μm) column with a mobile phase composed of methanol and 0.1% formic acid solution with gradient elution at 1.0 mL?min-1. The detection wavelength was 254 nm, the column temperature 30℃, and the injection volume was 10 μL. The contents of free anthraquinone and bound anthraquinone were determined using the method for Polygonum multiflorum specified in Chinese Pharmacopoeia (2020 Edition). Results Emodin-8-O-β-D glucoside, emodin, physcion had good linear relationships in the ranges of 0.674 5~21.584 5, 0.426 7~13.655 0 and 0.200 3- 6.968 5 μg?mL-1, respectively (R2≥0.9991). The recovery was 98.42%, 100.08% and 96.60% respectively. The contents of emodin-8-O-β-D glucoside, emodin, physcion, free anthraquinone and bound anthraquinone in Polygoni Multiflori Radix from different origins were 0.13~2.62, 0.08~0.13, 0.05~0.72, 0.1~1.7 and 1.0~8.7 mg?g-1, respectively. Conclusion This method is simple, accurate and reproducible, which can be used for the determination of anthraquinones in Polygonum multiflorum.
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Analysis of impurity profile of levofloxacin lactate and sodium chloride injection
XIAO Qinqin, CHEN Xi, DUAN Hexiang, ZHANG Yinhua, LIU Xuping, WANG Chen
2022, 19(5): 527-531. 
DOI: 10.19803/j.1672-8629.2022.05.11

Abstract ( 22 )   PDF (1942KB) ( 10 )  
Objective To establish the impurity profile of levofloxacin lactate and sodium chloride injection, and predict the toxicity of the identified impurities. Methods The impurity profile of levofloxacin lactate and sodium chloride injection was studied according to the inspection method of levofloxacin related substances in ChP 2015 edition. Together with the prescription and process, the source and attribution of impurity were analyzed and the influence of metal complexing agent in the prescription on the impurities of the product was studied. At the same time, ADME/T property prediction software was used to predict the toxicological properties of the known impurities. Results Eight main impurities were found in levofloxacin lactate and sodium chloride injection, four degradation impurities B, E, F, G and four unknown process impurities, the impurities in preparations mainly come from raw materials, and key impurity E was key factor in raw materials producing control, impurities G, the light degradation impurity, was the key factor for quality control. All impurities were toxic with different levels. Conclusion The establishment of impurity profile of levofloxacin lactate can provide a data reference for consistency evaluation of levofloxacin lactate and sodium chloride injection.
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Reports and influencing factors of drug-induced hypokalemia induced by diammonium glycyrrhizinate
WANG Chunting, WEN Wen
2022, 19(5): 532-536. 
DOI: 10.19803/j.1672-8629.2022.05.12

Abstract ( 22 )   PDF (1354KB) ( 13 )  
Objective To analyze reports and influencing factors of drug-induced hypokalemia in diammonium oxalate adverse reactions. Methods the ADR reports from January 1, 2004 to June 30, 2020 of diammonium glycyrrhizinate collected by the national adverse drug reaction monitoring system from January 1, 2004 to June 30, 2020 were retrospectively analyzed. A total of 12 816 adverse reaction/event reports of diammonium glycyrrhizinate were included in the analysis, including 110 reports of hypokalemia. The reporting rate of hypokalemia was analyzed according to age, gender, dosage form, medication time and underlying diseases (diabetes and hypertension). The chi-square test was conducted to compare the difference in the reports rate of hypokalemia among different groups. Logistic regression analysis was conducted to further explore the influencing factors of hypokalemia. Results Among the adverse reactions of diammonium glycyrrhizinate, the reporting rate of hypokalemia was 1.72% in the oral preparation group, and 0.56% in the injection preparation group (the difference was statistically significant) and the reporting rate of hypokalemia increased significantly with age as well as duration of medication. Logistic regression analysis showed that the corrected OR value of the oral preparation was 2.171 compared with the injection preparation. The corrected OR values of middle-aged and elderly groups were 2.534 and 3.394 compared with the young group. The corrected OR values of 2~3, 4~6, 7~14, 15~30 and >; 30 days were 6.761, 28.253, 28.762, 48.071 and 134.501 compared with the 1 day group. The corrected OR value of diabetic patients was 3.223 compared with non-diabetic patients. Conclusion Elderly, oral preparations, long time medication and diabetes mellitus are risk factors for drug-induced hypokalemia among the adverse reaction of diammonium glycyrrhizinate.
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Adverse drug reactions of cefoperazone sodium and sulbactam sodium in children
LI Yan, SUN Chong, LYU Meng, ZHOU Yuxue, MA Shuli
2022, 19(5): 537-540. 
DOI: 10.19803/j.1672-8629.2022.05.13

Abstract ( 35 )   PDF (1138KB) ( 17 )  
Objective To analyze the characteristics of adverse drug reactions (ADR) of cefoperazone sodium and sulbactam sodium in children, and to provide data for clinical decision-making. Methods ADR reports of cefoperazone sodium and sulbactam sodium in children in Henan Pediatric Medical Alliance between 2014 and 2018 were collected. The gender, age distribution, types of ADR and involved systems and organs were analyzed. Results A total of 877 reports were collected, 536 of which involved males and 341 involved females. There were 50 reports related to the neonatal group (5.70%), 126 the 1-12-month-old group (14.37%), 319 the 1-3-year-old group (36.37%), 208 the pre-school age group (23.72%), 95 the school-age group (10.83%), and 79 related to the adolescent group (9.01%). The peak of ADR occurred between the day of administration and the third day. There were 83 reports (0.95%) on serious cases, and the proportion of severe ADR in the pre-school age group was the highest (3.42%). The clinical manifestations of ADR in children were mainly skin lesions (65.90%) and digestive system lesions (20.07%), and hematological system lesions were rarely reported (0.98%). Severe ADR included severe skin rash, convulsions and epilepsy. Conclusion There is something unique about ADR of cefoperazone sodium and sulbactam sodium in children, which is worthy of attention in clinic.
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400 reports on adverse drug reactions associated with antineoplastic drugs
TAI Xinjuan, MA Hongfeng, LI Jun, MA Weixing, YAN Yawei
2022, 19(5): 541-544. 
DOI: 10.19803/j.1672-8629.2022.05.14

Abstract ( 43 )   PDF (1256KB) ( 46 )  
Objective To analyze the characteristics and regularities of adverse drug reactions (ADR) induced by antineoplastic drugs and provide reference for clinical rational use of antineoplastic drugs. Methods Totally 400 reports about ADR caused by antineoplastic drugs between January 1, 2017 and August 31, 2019 were collected and retrospectively analyzed based on patients' gender, age, routes of administration, reaction grading, drug types and organs/systems involved in the ADR caused by antineoplastic drugs. Results Amon the 400 reports of ADR, 159 involved males (39.75%) and 241 involved females (60.25%). The percentage of patients aged 61 to 70 was the highest (30.25%). Breast cancer was the primary disease in 151 of these cases (37.75%). Most of the ADR occurred during intravenous dripping (336, 84.00%). New and severe ADR occurred in 28 cases (7.00%) and severe ADR in 88 cases (22.00%). The highest composition ratio was with cisplatin in 123 cases (23.16%), and the digestive system was most likely to be involved in ADR, with a total of 313 cases (43.78%). A total of 377 cases (94.25%) of ADR were cured and improved. Conclusion To monitor ADR in clinical use of antitumor drugs, clinicians should focus on special populations, key drugs and typical symptoms while treating ADR promptly and properly to ensure the safety of drug use.
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Effects of pharmacists' intervention on anticoagulant management of patients treated with warfarin after heart valve replacement
XIANG Yunxia, PU Wen, LI Dongfeng, WANG Jie
2022, 19(5): 545-549. 
DOI: 10.19803/j.1672-8629.2022.05.15

Abstract ( 23 )   PDF (1299KB) ( 8 )  
Objective To evaluate the effects of pharmaceutical care on patients chronically taking warfarin and highlight the importance of clinical pharmacists. Methods A total of 226 patients who had undergone heart valve replacement and took warfarin as an anticoagulation treatment between May 2018 and December 2019 were enrolled according to the inclusion criteria. These patients were followed up according to the pharmaceutical service process. Their knowledge of the anticoagulation treatment with warfarin and medication compliance after pharmacist interventions were compared, and the improvement of time in therapeutic range (TTR) was analyzed. Results After interventions by pharmacists, the patients' knowledge of the use of warfarin and medication compliance were improved significantly. The number of patients with good medication compliance increased from 19 (8.41%) to 121 (53.54%), and the TTR increased from 30.25% to 63.65% (P<; 0.05). Conclusion Pharmacists' intervention in patients under long-term anticoagulation treatment with warfarin can improve the efficacy and safety of this therapy.
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215 cases of adverse drug reactions related to small molecule kinase inhibitors
FAN Qianqian, ZHANG Bo, ZHAO Bin, LI Qiuyue, LIU Fang, MA Jie
2022, 19(5): 550-553. 
DOI: 10.19803/j.1672-8629.2022.05.16

Abstract ( 25 )   PDF (1146KB) ( 10 )  
Objective To investigate the characteristics of adverse drug reaction (ADR) related to small molecule kinase inhibitors (SMKIs), and provide reference for safe and rational use of drugs. Methods The medical records of inpatients in our hospital who had developed ADR after SMKI treatments between October 1st 2012 and April 30th 2019 were collected and reviewed. The demographics of patients, suspected drug use and clinical characteristics of ADR were analyzed. Results A total of 215 patients developed ADR secondary to SMKI treatments. The ratio of males to females was 1.29∶1 and the average age was 58.91±13.75 years. Seventeen types of SMKIs were involved, and the top five were erlotinib (20.47%), gifitinib (16.74%), sunitinib (14.42%), imatinib (12.56%) and sorafenib (12.09%) according to the proportions of ADR. Multiple systems-organs were implicated in ADR related to SMKIs, and impairments in the skin and its accessories (35.62%) and in the digestive system (31.05%) weres prevalent. Most of these cases were common ADR, but there were severe ones that led to drug discontinuation. Conclusion SMKI-related ADR can possibly involve multiple systems/organs. Close monitoring, early detection and intervention are required to improve patients' compliance and clinical efficacy of targeted therapies.
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92 cases of adverse drug reactions induced by risperidone tablets
JIANG Yanqiong, LIU Hongjian, LIU Xiaoxia
2022, 19(5): 554-556. 
DOI: 10.19803/j.1672-8629.2022.05.17

Abstract ( 23 )   PDF (1135KB) ( 14 )  
Objective To analyze the characteristics of adverse drug reactions (ADR) of risperidone tablets so as to provide reference for rational drug use. Methods Ninety-two cases of ADR caused by risperidone tablets that were collected by Xinjiang Production and Construction Corps Center for ADR Monitoring were from January 1, 2015 to December 31, 2019 analyzed. Results There were 2.29 times as many female patients as male ones. Most of the patients ranged from 18 to 44 years old (68.48%). ADR included central and peripheral nervous system diseases (51.02%), heart diseases(16.33%), gastrointestinal diseases (9.18%). Clinical manifestations included extrapyramidal disorders, tachycardia, sinus bradycardia, menstrual disorders, and abnormal liver function. Conclusion Clinicians should be alert to ADR caused by risperidone tablets in clinical practice, care for medication safety of female patients, and strengthen the training of reporting personnel so as to improve the quality of reports.
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Echocardiographic monitoring during medication with trastuzumab following treatment of breast cancer patients with anthracyclines
DONG Baihui, JANG Hong, XIAO Xiang, FU Dongliang, LI Chunyan
2022, 19(5): 557-560. 
DOI: 10.19803/j.1672-8629.2022.05.18

Abstract ( 21 )   PDF (1157KB) ( 11 )  
Objective To investigate the results of echocardiographic detection and the incidence of left ventricular systolic dysfunction during medication with trastuzumab following treatment with anthracyclines in patients with human epidermal growth factor receptor 2 (HER-2) positive early-stage breast cancer, and to provide reference for rational drug use. Methods The results of echocardiographic detection of patients with early-stage breast cancer treated with trastuzumab following anthracyclines in a big hospital between July 1, 2016 and December 31, 2019 were collected. At baseline (T1), before administration of anthracycline (T2), during trastuzumab administration (T3) and when trastuzumab therapy was finished (T4), the detection rate of echocardiography, the number of times of echocardiographic detection at T3 and the changes of left ventricular ejection fraction (LVEF) were analyzed. Results Among the 60 patients with breast cancer who met the inclusion and exclusion criteria, 15.00%, 58.33%, 51.67% and 11.67% underwent echocardiographic detection at T1, T2, T3 and T4. At T3, the composition ratio of the number of times of echocardiography detection was 41.94% (once), 25.81% (twice), 29.03% (three times) and 3.23% (four times) respectively. There was no significant decrease in LVEF (P<0.05) after treatment, However, LVEF decreased when trastuzumab was used (P>0.05), but by less than 10%. Its damage to the heart was below the diagnostic criteria of cardiotoxicity. Conclusion Failure to effectively monitor the left ventricular systolic function during medication with trastuzumab following the anthracyclines therapy may pose a risk to the safety of patients.
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Thirty-six cases of adverse drug reactions/events caused by Xinhuang tablets
ZHANG Ruili, SU Shuang, JIANG Jiming, ZHANG Jing
2022, 19(5): 561-563. 
DOI: 10.19803/j.1672-8629.2022.05.19

Abstract ( 25 )   PDF (1125KB) ( 10 )  
Objective To retrospectively analyze ADR induced by Xinhuang tablets in order to provide reference for rational use of this drug in clinic.Methods?With?"Xinhuang tablets",?"adverse reaction" or "cause" as the key words, related articles were retrieved from the CNKI, Wanfang database and VIP Chinese full-text database that had been published from the inception to April 30, 2020. Literature related to ADR induced by Xinhuang tablets was screened and analyzed.?Results?Twenty-four articles were included, involving 36 cases of adverse drug reactions. The dominating adverse reactions were manifested as neurological damage, gastrointestinal damage and systemic damage. Common symptoms included nausea, vomiting, dizziness, headache and chest distress. Anaphylactic shock, which was life threatening, was also reported in severe cases. Conclusion It is important that clinicians and patients become aware of ADR induced by Xinhuang tablets. Precaution should be taken to ensure the safe use of this drug.
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Automatic dispensing system on influence of work efficiency of outpatient pharmacy and the safety of prevention and control of COVID-19
ZHAO Xuan, GUO Jing, MEI Long, ZHANG Wei
2022, 19(5): 564-567. 
DOI: 10.19803/j.1672-8629.2022.05.20

Abstract ( 22 )   PDF (1259KB) ( 12 )  
Objective To analyse the impact of the automatic dispensing system on the work efficiency of outpatient pharmacies and the safety of COVID-19 prevention. Methods The hospital information system (HIS) data of the outpatient pharmacy with or without the automatic dispensing system and the related data of the automatic dispensing system were adjusted in two adjacent hospitals with similar department settings, layouts, and patient types. And pharmacists and patients were surveyed. The data and questionnaire results were compared and analyzed. Results and Conclusion The pharmacists in the hospital with the automatic dispensing system are more accurate and quicker. The dispensing process is more reasonable and efficient. The internal staff of the pharmacy is less. The regional division is more reasonable. The prevention and control level is clearer and the working environment is safer. The waiting time is more reasonable and the time for drug taking is shorter. Reduce aggregation and reduce the risk of cross-contamination.
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One case of acute renal injury caused by postoperative chemotherapy for rectal cancer
LI Yatan, MA Liangying
2022, 19(5): 568-571. 
DOI: 10.19803/j.1672-8629.2022.05.21

Abstract ( 19 )   PDF (1078KB) ( 9 )  
Objective To retrospectively analyze the whole process of treating acute kidney injury after postoperative chemotherapy in a patient with rectal cancer so as to explore the role of clinical pharmacists. Methods Taking into consideration the adverse reactions of a rectal cancer patient after chemotherapy and his renal injury, the clinical pharmacist provided pharmaceutical care for the patient before chemotherapy, during treatment and after chemotherapy. Results Through individualized adjustment of the patient's chemotherapy regimen and symptomatic treatment of renal function injury, the clinical pharmacist was a great success in his effort to give clinical pharmaceutical care to the patient. Conclusion In the course of medication for a tumor patient, clinical pharmacists can use their knowledge and expertise to assist clinicians in providing technical support for individualized drug treatment, which can not only facilitate clinical practice, but also ensure rational medication.
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Pharmaceutical care for a patient with urinary tract infection and drug fever
YANG Baochun, SUN Xin, YANG Xin, WU Lin, WANG Liping
2022, 19(5): 572-573. 
DOI: 10.19803/j.1672-8629.2022.05.22

Abstract ( 20 )   PDF (1024KB) ( 10 )  
Objective To explore the effect of monitoring of drug use by clinical pharmacists for a patient with urinary tract infection and to advance physicians' and pharmacists' understanding of drug fever. Methods A clinical pharmacist participated in the analysis and intervention of a suspected cefdiazine-induced fever patient. Results Based on the mechanism, clinical characteristics of drug fever, clinical symptoms, laboratory test results and drug use of the patient, the clinical pharmacist suspected that the fever might have been caused by cefdiazine and suggested that cefdiazine be discontinued. The clinician took the advice so that the patient's temperature gradually returned to normal. Conclusion Active participation in drug monitoring by clinical pharmacists will help to detect adverse drug reactions as soon as possible so as to prevent irrational use of drugs.
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An overview of medicinal research on Citron
SHI Yan, WEI Feng, MA Shuangcheng
2022, 19(5): 574-578. 
DOI: 10.19803/j.1672-8629.2022.05.23

Abstract ( 18 )   PDF (1136KB) ( 14 )  
Citron, as an important traditional Chinese medicine, has a wide range of clinical applications, which has also played an important role in the life and culture in western countries since it was introduced into the Mediterranean area as a result of the East-West exchanges. In this paper, the historical records, appearance, chemical composition and pharmacological activities of Citron are summarized so as to provide reference for the study of citron and other Citrus herbs.
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Research progress on hesperetin and its derivatives against fibrosis
WAN Wei, CHANG Jun, ZHU Du, CHEN Wen
2022, 19(5): 579-584. 
DOI: 10.19803/j.1672-8629.2022.05.24

Abstract ( 17 )   PDF (1911KB) ( 4 )  
Hesperetin is a dihydro flavonoid compound derived from young fruits of the Citrus in Rutaceae family,which has a significant inhibitory effect on the fibrosis process of lung, liver, kidney and heart. However, due to the complex mechanism of hesperetin inhibiting fibrosis, it is still in the experimental research stage and needs further study. This article explores the mechanism of hesperetin on pulmonary fibrosis, hepatic fibrosis, renal fibrosis, heart fibrosis and other diseases from the aspects of anti-inflammatory, anti-oxidative stress, promoting cell apoptosis, inhibiting cell activation and proliferation, and inhibiting cell epithelial-mesenchymal transition, and expounds that hesperetin and its derivatives inhibit fibrosis Research progress. It will provide some reference and help for the future development of hesperetin as a targeted fibrosis drug and how to improve the utilization of hesperetin.
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