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Chinese medicine pharmacovigilance and pharmaceutical care for progestational, pregnant and post-partum women based on ancient literature LYU Jintao, ZHANG Xiaomeng, ZHANG Bing, JIANG Hao, LIN Zhijian 2022, 19(6): 585-590.  DOI: 10.19803/j.1672-8629.2022.06.01 Abstract ( 623 )   PDF (1392KB) ( 294 )   Objective To explore ancient theories about pharmacovigilance for progestational, pregnant and post-partum women in Chinese medicine, and provide reference for clinical pharmaceutical care and safe use of Chinese medicine. Methods Statements about pharmacovigilance were collected from 20 books on gynaecology and obstetrics published from the Tang Dynasty to the Qing Dynasty. Such information as phases, diseases, drugs, contraindications and precautions was retrieved. Notions of pharmacovigilance in Chinese medicine were ultimately collected via comparisons and summaries. Results In such phases as pregnancy preparation, pregnancy, perinatal and post-partum periods, pharmacovigilance measures for Chinese medicine included contraindications based on syndromes/ symptoms/ diseases, those based on people and time, control of dosage and courses of treatment, and dietary incompatibility. Such factors as drugs, patients and medications should be taken into consideration in pharmaceutical care according to the characteristics of different phases. Conclusion Pharmacovigilance measures for progestational, pregnant and post-partum women vary. Pharmaceutical care and guidance for rational use of Chinese medicine should be delivered based on physiological and pathological characteristics. References | Related Articles | Metrics

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Pharmacovigilance and pharmaceutical care of traditional Chinese medicine based on ancient pediatric literature WANG Xiaofang, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian, WEI Changce 2022, 19(6): 591-594.  DOI: 10.19803/j.1672-8629.2022.06.02 Abstract ( 239 )   PDF (1304KB) ( 226 )   Objective To provide a basis for medication vigilance and pharmacy services for special pediatric populations by mining pediatric ancient literature for awareness of safe medication use in children. Methods By the methods of philology and based on the early stage of the research of "practice of cognition, application, prevention and rescue of drug toxicity" of pharmacovigilance of Chinese medicine, extract related alert expression of the Tang dynasty Luxin Jing, Song dynasty Key to Therapeutics of Children's Diseases and A New Book of Pediatrics, Yuan dynasty Huo You Xin Shu, Ming dynasty You Ke Fa Hui and Qing dynasty Collection of Words on Pediatrics, You Ke Shi Mi seven representative pediatric monographs. Results The ancient books of pediatrics paid attention to the safety of pediatric medicine, and the understanding of pharmacovigilance was more systematic and comprehensive, and the use of medicine was aimed at calmness and harmony, mostly from the spleen and stomach theory of treatment, from the dosage form, dose, course of treatment, preparation, combination and other aspects to enhanced the efficacy and prevented adverse reactions. Conclusion In the face of the phenomenon of irrational use of drugs in clinical practice, the traditional ancient books of pediatrics provide a basis for modern pediatrics to carry out pharmacovigilance, guide the safe and rational use of drugs in clinical practice, and provide direction for the development of pharmacy services. References | Related Articles | Metrics

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Consideration of rational use of traditional Chinese medicine and pharmaceutical services for the elderly based on literature analysis MA Bingbing, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian, LYU Jintao 2022, 19(6): 595-599.  DOI: 10.19803/j.1672-8629.2022.06.03 Abstract ( 219 )   PDF (1372KB) ( 198 )   Objective The factors of adverse drug reactions/events(ADR/ADE) caused by the use of proprietary Chinese medicines in the elderly and the rational drug use basis and pharmaceutical service suggestions. Methods Taking 268 varieties of Chinese patent medicines contained in the national catalogue of essential drugs (2018 Edition) as the search object, the case reports of ADR/ADE caused by Chinese patent medicines to the elderly published in Chinese journal databases such as CNKI, Wanfang Data and VIP database were systematically searched. The time is up to January 1, 2021. After judging the causal relationship, the neural network method was used to mine the influencing factors of ADR/ADE in the elderly. Excavate the relevant expressions about rational drug use of the elderly in traditional ancient books, and form the thinking of rational drug use and pharmaceutical services. Results A total of 373 cases of ADR/ADE using Chinese patent medicines in the elderly were collected, involving 88 kinds of Chinese patent medicines, involving systemic damage, skin and adnexal system damage. There was a strong correlation between the severity of ADR/ADE and the duration of medication, mode of administration, and combination medication. A total of 20 459 pieces of warning information about the elderly in ancient books were sorted out, involving drug contraindications, treatment principles, drug dosage, and drug administration methods. Conclusion Clinical attention should be paid to the elderly's self-medication, combined medication, overdose and ultra-course of treatment, etc., strengthen pharmaceutical services, and improve the level of rational drug use. References | Related Articles | Metrics

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Risk factors of liver injury in traditional Chinese medicine and TCM pharmacovigilance for medications against hepatic insufficiency ZHANG Zhiqi, ZHANG Xiaomeng, ZHANG Bing, LYU Jingtao 2022, 19(6): 600-604.  DOI: 10.19803/j.1672-8629.2022.06.04 Abstract ( 210 )   PDF (1760KB) ( 221 )   Objective To identify the risk factors for liver injury caused by traditional Chinese medicine, and to recommend measures of pharmacovigilance for medications against liver insufficiency of different degrees. Methods Adverse drug reactions of liver injury caused by traditional Chinese medicine as of the end of 2021 were collected from different databases, while possible influencing factors and their correlations with the severity of liver injury were analyzed using Apriori and the Bayesian network. Results A total of 88 cases of liver injury caused by traditional Chinese medicine with exact causality were included, involving 24 types of Chinese herbal medicines. The percentage of patients ages 46 to 64 was the highest. Of the 69 cases whose severity of liver injury could be determined, the majority were mild and severe ones, and the main symptoms ranged from jaundice, nausea, vomiting through aversion to oil, loss of appetite to impaired consciousness. The occurrence of liver injury was associated with drugs, the physique of patients, and medications, and liver injury became severe along with the duration of treatment. Conclusion Targeted measures should be taken among patients with hepatic insufficiency, such as the selection of herbal medicines and medication monitoring according to the degrees of severity, which can effectively reduce the risk of liver injury during the application of traditional Chinese medicine. References | Related Articles | Metrics

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Research progress on the mechanism of hepatotoxicity associated with Polygonum multiflorum Thunb LI Yanyi, ZHANG Yujie, WANG Qi, MA Shuangcheng 2022, 19(6): 605-609.  DOI: 10.19803/j.1672-8629.2022.06.05 Abstract ( 152 )   PDF (1248KB) ( 143 )   Objective To analyze the mechanism of hepatotoxicity and hepatotoxic substances of Polygonum multiflorum Thunb. Methods Reports on the mechanism of hepatotoxicity and controversial components of Polygonum multiflorum Thunb. were categorized, analyzed and summarized by consulting the literature. Results The hepatotoxicity of Polygonum multiflorum was specifically manifested in the functions and expressions of liver metabolic enzymes, the obstruction of bile metabolic circulation and functions of transporters, as well as immune stress and mitochondrial dysfunction. It was reported by literature that the possible toxic components were fat-soluble anthraquinones, characteristic distyrene glycosides, tannins and bianthrone compounds. It was speculated that the individual or synergistic effect of the above substances on the body might be related to the occurrence of hepatotoxicity. Conclusion It is possible that the hepatotoxicity of Polygonum multiflorum works via varied mechanisms. Related studies are expected to facilitate the research, development and safe applications of Polygonum multiflorum. References | Related Articles | Metrics

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Research progress on material basis of liver toxicity of Polygonum multiflorum Thunb. YANG Jianbo, GAO Bowen, SUN Hua, JIN Hongtao, GAO Huiyu, NIU Hui, CHENG Xianlong, WANG Xueting, SONG Yunfei, WEI Feng, WANG Qi, WANG Ying, HU Xiaowen, MA Shuangcheng 2022, 19(6): 610-614.  DOI: 10.19803/j.1672-8629.2022.06.06 Abstract ( 113 )   PDF (1279KB) ( 104 )   Objective To analyze the material basis of liver toxicity of Polygonum multiflorum Thunb. based on related reports about the risk of liver injury caused by P. multiflorum. Methods Such databases as CNKI, Wangfang, VIP, PubMed and Web of Science were searched for literature related to the potentially hepatotoxic components of P. multiflorum reported over the past 25 years. Results Anthraquinones, stilbenes, naphthalene, mycotoxins from P. multiflorum might be the major hepatotoxic components that resulted in the "inherent hepatotoxicity" "idiosyncracy hepatotoxicity" "synergistic hepatotoxicity" and "liver toxicity caused by exogenous contaminants". Conclusion The material basis of liver injury caused by P. multiflorum is so complicated that the acute toxicity and mechanism of liver injury of these components need to be further studied in order to provide reference for the research on the hepatotoxicity of P. multiflorum and for rational use of P. multiflorum in clinic. References | Related Articles | Metrics

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Difference analysis of chemical composition of Polygoni Multiflori Radix and Polygoni Multiflori Radix Preparata based on plant metabonomics YANG Jianbo, Wang Qi, WANG Xueting, CHENG Xianlong, WANG Ying, GAO Huiyu, SONG Yunfei, WEI Feng, MA Shuangcheng 2022, 19(6): 615-619.  DOI: 10.19803/j.1672-8629.2022.06.07 Abstract ( 78 )   PDF (1945KB) ( 82 )   Objective To explore the chemical differences between Polygoni Multiflori Radix (PMR) and Polygoni Multiflori Radix Preparata (PMRP) with the help of plant metabonomics in order to clarify the regularity of chemical composition change before and after processing and the toxicity-attenuating material basis. Methods An ultra-performance liquid chromatography-quadrupole/time-of-flight mass spectrometry (UPLC-Q-TOF-MS/MS) based metabolomics method was selected to analysis the composition of PMR and PMRP. Principal component analysis (PCA) method was used to observe the overall distribution trend of samples. Statistical analysis techniques were used to screen the differential compounds in the volcano plot. By comparing Agilent Natural Product Personal Compound Database and Library (PCDL), the chemical compositions were preliminarily identified. Results There were significant differences between PMR and PMRP. 45 differential compounds were tentatively identified and their contents were significantly decreased after processing. Conclusion There were significantly difference compounds between PMR and PMRP, especially for anthraquinone (mono and binuclear anthraquinone) and stilbene glycosides, which might be the main material basis for attenuating toxicity of Polygoni multiflorum Thunb. References | Related Articles | Metrics

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Study on the components of Polygonum multiflorum aqueous extract in rats after long-term administration WANG Qi, WEN Hairuo, YANG Jianbo, WANG Ying, LI Yanyi, MA Shuangcheng, ZHANG Yujie 2022, 19(6): 620-625.  DOI: 10.19803/j.1672-8629.2022.06.08 Abstract ( 81 )   PDF (1856KB) ( 78 )   Objective To investigate the accumulation characteristics of the components in the liver, kidney, plasma and bile of rats after gavage of the aqueous extract of Polygonum multiflorum for 42 consecutive days, so as to provide data support for the study on the hepatotoxicity of Polygonum multiflorum. Methods UPLC-LTQ-Orbitrap MS technology was applied to qualitatively identify and speculate the prototype components and metabolites of Polygonum multiflorum in different tissues of rats by comparing with the reference substance and analyzing using the scitific library module. Results After a long-term induction with the aqueous extract of Polygonum multiflorum by oral gavage in the rat, tweenty-four related compounds of Polygonum multiflorum could be identified and detected in vivo, of which 7 were prototype components, 5 were phase Ⅰ metabolites, and 12 were phase Ⅱ metabolites. Among which, the main components included stilbene glycosides and anthraquinone prototypes and their metabolites. Various components had a selective accumulation pattern, and the most of them accumulated in the kidney, the contents in the liver and bile were equivalent, and the least was found in the plasma. Stilbene glycosides were mainly subjected to sulfation and glucuronidation reactions, while emodin mostly undergoes oxidation reactions and glucuronidation reactions. Conclusion The prototype components emodin, aloe-emodin, emodin-8-O-glucoside, stilbene glycosides, rhein, and gallic acid are likely to be highly related to the adverse reactions caused by Polygonum multiflorum, which should attract attention. Acid and stilbene glycoside-glucuronide-sulfate are only detected in bile, gallic acid and protocatechuic acid and a large number of emodin phase II metabolites are only detected in kidney, while other potential toxicity risks should be further investigated. References | Related Articles | Metrics

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Effects of Polygonum multiflorum extract on rat kidneys based on transporters WANG Qi, YANG Jianbo, WANG Ying, MA Shuangcheng, WEN Hairuo 2022, 19(6): 626-629.  DOI: 10.19803/j.1672-8629.2022.06.09 Abstract ( 61 )   PDF (1944KB) ( 74 )   Objective To explore the effects of long-term administrations of Polygonum multiflorum ethanol extract (PME) and water extract (PMW) on kidneys of rats. Methods PME and PMW were administered to rats via oral gavage for 42 days, and the biochemical indexes as well as renal pathological changes were examined. The expression levels of major kidney transporters (Oat1, Oat2, Oct2, Mrp2, P-gp) after administration were detected, and the mechanism of Polygonum multiflorum-induced renal injury was analyzed in terms of transporters. Results After the administration of PME and PME, the biochemical indexes of serum in the PME group, including blood urea nitrogen (BUN), creatinine (CRE), total protein (TP) and albumin (ALB), were significantly increased (P<0.01). In the PMW group, BUN, CRE and TP were significantly increased (P<0.01), but the increase in ALB was not statistically significant (P>0.05). Renal histopathologic results suggested renal pigmentation in both PME and PMW groups, but renal tubular degeneration was seen in the PME group only. Data on gene expression detection showed that Oat1, Oct2, P-gp and Mrp2 were significantly down-regulated (P<0.01), while Oat2 was significantly up-regulated (P<0.01) in the PME group. In the PMW group, Oat1, Oct2 and Mrp2 were significantly down-regulated (P<0.01), but Oat2 was significantly up-regulated (P<0.01), and the change in P-gp was not statistically significant (P>0.05). Conclusion After a long-term medication, both PME and PMW can lead to kidney injury in rats and the effect of PME is more prominent. The mechanism of action is associated with the effect of both extracts on renal transporters. The potential nephrotoxic components may be stilbene glycosides and emodin. References | Related Articles | Metrics

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Screening of hepatotoxic components in Polygonum multiflorum by taking FXR nuclear receptors as targets WANG Qi, WEN Hairuo, MA Shuangcheng 2022, 19(6): 630-634.  DOI: 10.19803/j.1672-8629.2022.06.10 Abstract ( 80 )   PDF (2139KB) ( 75 )   Objective To establish a rapid method for screening hepatotoxic components in Polygonum multiflorum (P.M.) by taking the farnesoid X receptor (FXR) as the target. Methods First of all, computer molecular docking technology was adopted, Discovery Studio 2.5 software was used to molecularly dock the target compounds with the FXR, and the target compounds were screened virtually with FXR inhibitors as the reference objects. Next, the cell counting kit (CCK-8) method was used to investigate the toxicity of the target compounds on HepaRG after 24 h of treatment, while real-time PCR was used to determine the effects of the target compounds on the relative expression level of FXR genes in HepaRG cells. Results The molecular docking results showed that nine components in Polygonum multiflorum, including aloe-emodin-8-O-β-D-glucoside and emodin-8-O-β-D-glucoside, were potential inhibitors of FXR. In vitro cytotoxicity test further confirmed that both aloe-emodin-8-O-β-D-glucoside and emodin-8-O-β-D-glucoside had hepatotoxicity that could significantly inhibit the expression level of FXR genes. Conclusion This study effectively predicts the potential hepatotoxic components of Polygonum multiflorum, and a rapid and efficient high-throughput hepatoxicity screening method is established, which is expected to provide new ideas for safety evaluation of traditional Chinese medicine. References | Related Articles | Metrics

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In vivo genotoxic risk assessment of emodin WEN Hairuo, WANG Yanan, JIANG Hua, WANG Xue, WANG Qi, MA Shuangcheng 2022, 19(6): 635-640.  DOI: 10.19803/j.1672-8629.2022.06.11 Abstract ( 75 )   PDF (1717KB) ( 91 )   Objective To evaluate the in vivo genotoxic risk of emodin administered by oral gavage to mice for 28 consecutive days. Methods KM mice were repeatedly administered with emodin for 28 consecutive days by oral gavage, followed by a recovery period of 28 days. Peripheral blood was collected before administration, 14, 28, 42 and 56 days after the first administration to detect the mutation rate of reticulocytes and total red blood cells as well as the percentage of reticulocytes in total red blood cells. Liver, kidney and peripheral blood was collected after the last administration to carry out the comet test. The percentage of tail DNA of at least 100 cells in each animal was analyzed. Samples of bone marrow cells were prepared after the last administration, and polychromatic erythrocytes as well as the incidence of micronuclei in polychromatic erythrocytes were calculated. Results Compared with the vehicle control group (0.5% carboxymethylcellulose sodium), the Pig-a gene mutation rate in groups dosed with emodin was not increased after 28 consecutive days of administration of 300 mg·kg-1 or under. Compared with the vehicle control group (0.5% carboxymethylcellulose sodium), the percentage of tail DNA of kidney cells in groups dosed with emodin was significantly increased with a dose-response pattern (P<0.01, P<0.001）. Data on bone marrow micronucleus test showed no increase in the rate of micronuclei within the current dose range. Conclusion After 28 consecutive days of oral administration of emodin to mice, the main action site of emodin in mice is found to be the kidney. Under current conditions, emodin does not increase in the rate of Pig-a gene mutation or in the incidence of bone marrow micronuclei in mice, but it could lead to DNA damage to kidney cells. References | Related Articles | Metrics

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Analysis of national monitoring data of adverse drug reactions related to zoledronic acid-related osteonecrosis of the jaw XIONG Weiyi, REN Jingtian 2022, 19(6): 641-644.  DOI: 10.19803/j.1672-8629.2022.06.12 Abstract ( 228 )   PDF (1429KB) ( 151 )   Objective To describe the characteristics of zoledronic acid related osteonecrosis of the jaw (ONJ) in China, explore the risk factors, and to give tips about risk control. Methods Zoledronic acid related ONJ reports received by the National Adverse Drug Reaction Monitoring System between January 1, 2004 and June 30, 2021 were analyzed to identify the characteristics of ONJ reports. Results A total of 73 zoledronic acid related ONJ reports were retrieved, 90.41% of which were serious reports. The information about 2 cases was missing. Among the 71 cases reported, 94.37% (67/71) were related to anti-tumor drugs and 5.63% (4/71) anti-osteoporosis drugs. Cancer-related reports mainly involved middle-aged and elderly women. 44.78% of primary tumors were breast cancer, 59.70% of the patients had received concomitant therapies, 41.79% had undergone dental surgery, and 52.24% had fully recovered or were recovering. The four reports about osteoporosis patients were all elderly women with a dental surgery history. Conclusion Zoledronic acid related ONJ is rarely reported in China, most of the reports involve serious cases. There have been more reports from patients with cancer than from patients with osteoporosis. A dental surgery history is an important risk factor for ONJ, and the concomitant therapy might have some effect on the onset of ONJ. The risk of ONJ induced by zoledronic acid deserves more attention and effective measures should be taken to ensure drug safety. References | Related Articles | Metrics

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Analysis of 1028 statins-related medication errors and prevention strategies SHAO Chen, ZHANG Qingxia, YAN Suying, WANG Yuqin 2022, 19(6): 645-648.  DOI: 10.19803/j.1672-8629.2022.06.13 Abstract ( 184 )   PDF (1204KB) ( 178 )   Objective To investigate the incidence and causes of medication errors (ME) related to statins in China in order to formulate targeted preventive measures and ensure the safety of drug use in patients. Methods ME reports were collected from the National Monitoring Network for Clinical Safe Drug Use from January 1, 2016 to December 31, 2020, and analyzed in terms of the origin, classification, drugs involved, types of errors, personnel responsible, discovers of errors and causes of errors. Results A total of 1 028 ME reports were collected from 132 hospitals in 23 provinces and cities. Most of these reports involved grade B errors (848 cases, 82.49%), and there were 5 cases of severe ME (0.49%). Many of these errors were related to the variety, involving 300 cases (29.10%, LASA drugs). The five serious ME errors involved drugs interactions (2 cases), contraindications (1 case), dosage (1 case), and repeated administration (1 case). Those most responsible for ME were doctors, involving 515 cases (50.10%, and the main cause of errors was repeated administration). 849 cases of errors (79.72%) were found by pharmacists. Most of these ME were due to human factors, involving 590 cases (52.73%, mainly because of fatigue and lack of knowledge). Conclusion Statins-related ME are mostly of grade B and caused by LASA. It is recommended that clinicians be better informed of rational drug use, and that the stress of health care providers be reduced so as to lower the risk of LASA errors and ensure the drug safety of patients. References | Related Articles | Metrics

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Efficacy and safety of rabeprazole in the treatment of reflux esophagitis: a Meta-analysis LU Song, YANG Li, DONG Xianzhe, ZHANG Lan 2022, 19(6): 649-653.  DOI: 10.19803/j.1672-8629.2022.06.14 Abstract ( 148 )   PDF (2077KB) ( 125 )   Objective To systematically evaluate the efficacy and safety of rabeprazole versus omeprazole in the treatment of reflux esophagitis (RE) and to provide reference for clinical rational drug use. Methods The databases of CNKI, Wanfang Data, CQVIP、PubMed, Cochrane Library, Web of Science and Embase were searched for related articles published from inception to December 3, 2020. Randomized controlled trials (RCT) with rabeprazole versus omeprazole in the treatment of RE were included, and the data needed was retrieved and analyzed using RevMan5.3. Results Fifteen RCTs were included in the study, involving a total of 1 607 patients. Meta-analysis results showed that the total effective rate of rabeprazole in the treatment of RE was higher than that of omeprazole[OR=4.46, 95%CI (3.01~6.59), P<0.001]. Subgroup analysis showed that the total effective rate after 4 weeks and 8 weeks of treatment was higher in the experimental group than in the control group [OR=3.10, 95%CI (1.63~5.90), P<0.001; [OR=5.41, 95%CI (3.29~8.91), P<0.001]. Endoscopy suggested that rabeprazole was more effective than omeprazole, and the difference was statistically significant [OR=0.36, 95%CI (0.22~0.59), P<0.001]. In addition, the incidence of adverse reactions in the rabeprazole group was lower than that of the omeprazole group [OR=0.32,95%CI (0.18,0.56), P<0.001]. Conclusion Rabeprazole is more effective in the treatment of RE than omeprazole, and the incidence of adverse reactions is lower, but omeprazole is cheaper. Clinicians can select appropriate drugs for patients on the basis of safety, effectiveness and cost of drugs. References | Related Articles | Metrics

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Safety of terlipressin for injection based on electronic medical records LI Xiaofei, CHENG Rong, WU Xuemei, LIU Zhi 2022, 19(6): 654-656.  DOI: 10.19803/j.1672-8629.2022.06.15 Abstract ( 114 )   PDF (1262KB) ( 89 )   Objective To investigate the incidence of adverse drug reactions (ADR) and clinical symptoms related to terlipressin. Methods The electronic medical records and ADR reports of patients using terlipressin in the Affiliated Hospital of Guizhou Medical University between 2016 to 2019 were collected. Statistical analysis was conducted according to patients' gender, age, clinical manifestations and outcomes. Results A total of 1 816 medical records and 56 ADR reports of patients using terlipressin were collected. The incidence of ADR was 3.08%, and higher among females than among males. Males over 45 years old were the most vulnerable. Adverse reactions mainly involved the digestive system and cardiovascular system, manifested as diarrhea, abdominal pain and palpitations. Conclusion The clinical manifestations of terlipressin-induced adverse drug reactions vary. To prevent serious ADR and ensure drug safety, clinicians should be vigilant and drug monitoring needs to be strengthened. References | Related Articles | Metrics

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Signal detection and analysis of adverse reaction of hydroxychloroquine sulfate induced visual impairment WANG Tiezhu 2022, 19(6): 657-660.  DOI: 10.19803/j.1672-8629.2022.06.16 Abstract ( 198 )   PDF (1316KB) ( 164 )   Objective To evaluate the post marketing safety signals of hydroxychloroquine sulfate recommended by the expert consensus on comprehensive treatment of coronavirus diseases in Shanghai in 2019 in order to provide evidence for safe clinical use of this drug. Methods ADR related to the suspected drug commonly known as "hydroxychloroquine sulfate" that were collected by Anhui ADR monitoring system between Jan 1, 2004 and Dec 31, 2020 were selected. The report odds ratio (ROR) method was used for signal detection, focusing on the extraction, analysis, evaluation and data mining of cases of such adverse reactions as visual impairment. Results Among the 292 case reports, ADR mostly involved the skin and its appendages, central and peripheral nervous systems and the gastrointestinal system, and were manifested as visual impairment, hearing and vestibular dysfunction. According to signal detection, 30 cases involved visual impairment, accounting for 10.3% of the total cases of ADR. The top ten signal values were related to photophobia, blurred vision, visual abnormalities, adverse reactions of eyes and other visual impairment. The incidence of visual impairment was the highest among patients whose primary disease was systemic lupus erythematosus. The time interval of ADR was wide among patients with visual impairment. Conclusion Signal detection of ADR based on the real world can help assess the safety of hydroxychloroquine sulfate, which is expected to provide reference for the rational use of drugs for COVID-19 and for clinical utilization of conventional drugs. References | Related Articles | Metrics

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Characteristics of Montelukast-induced adverse drug reactions in the nervous system CHEN Ruijia, SA Kejia, ZENG Xiaofang 2022, 19(6): 661-664.  DOI: 10.19803/j.1672-8629.2022.06.17 Abstract ( 224 )   PDF (1311KB) ( 200 )   Objective To investigate the clinical characteristics and causes of neurological and mental adverse drug reaction (ADR) induced by montelukast. Methods Such databases as CNKI, Wanfang, VIP and PubMed were searched for related articles published from the inception of databases to February 29, 2020. Case reports and clinical studies on neurological adverse drug reactions (ADR) caused by montelukast were included. Such information as the gender and age of patients, dosage, the time adverse drug reactions in the nervous system occurred and clinical manifestations was classified and summarized. Results A total of 112 patients aged 1 to 86 were collected. ADR mostly occurred in children under 14 years old. The time of intervals ranged from 30 minutes after medication to 2.5 years, and most of them occurred within one week of medication. The main symptoms of ADR were nightmares, sleep disorders, aggressiveness and anxiety. Conclusion Neurologic and mental ADR caused by montelukast are more common in children, and physicians should weigh the potential risks and benefits based on the patient’s condition while remaining alert to the possible risk of suicide. References | Related Articles | Metrics

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Influencing factors and treatment of drug-induced liver injury WEI Xianni, XU Huiyi, HUANG Yuhong, XIE Genying 2022, 19(6): 665-669.  DOI: 10.19803/j.1672-8629.2022.06.18 Abstract ( 225 )   PDF (1285KB) ( 206 )   Objective To study the influencing factors and treatments of drug-induced liver injury(DILI) in our hospital in recent years and to provide data for clinical drug selection and treatment. Methods The data on patients with DILI between January 1, 2013 and 2020 January 1, was collected and analyzed. Results The main types of drugs that induced DILI were anti-infective drugs, traditional Chinese medicine, anti-lipidemic drugs, anti-tumor drugs, antipyretic and analgesic drugs. DILI was most likely to occur within 4 weeks of medication (72 cases). The incidence of DILI was slightly higher in male patients (51.00%) than in female ones (49.00%), and the average age was (51.0±17.7). The incidence of DILI was the highest among patients aged 41 to 60 (38.00%). In terms of complications, 82 cases had preexisting diseases. There was no significant difference in the incidence of DILI between different genders, age groups or between people with or without preexisting diseases (P>0.05). After drug-induced liver injury, 72 cases stopped taking drugs, 23 cases continued to take drugs, and 3 cases decreased the dosage. Among the 91 cases treated with hepatoprotective drugs, cases 23 were cured, 45 cases improved, 14 cases not cured and 9 cases unknown. Conclusion The dominating drugs that cause DILI are anti-infective drugs, followed by traditional Chinese medicine. The prognosis of DILI is generally good, and the incidence is relatively high among middle-aged and elder people. In order to prevent and reduce the occurrence of DILI, clinicians should strengthen monitoring and take immediate measures. References | Related Articles | Metrics

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Bradycardia induced by bortezomib-based combined chemotherapy WANG Guoxiang, ZHAO Hong, HUI Wuhan, SU Li, SUN Wanling 2022, 19(6): 670-673.  DOI: 10.19803/j.1672-8629.2022.06.19 Abstract ( 122 )   PDF (1176KB) ( 93 )   Objective To analyze the clinical characteristics and prognosis of bradycardia caused by bortezomib-based combined chemotherapy during clinical applications, and provide reference for clinical safe medication. Methods The clinical data of four patients with plasma cell diseases who suffered from bradycardia after bortezomib-based combined chemotherapy in the Department of Hematology of Xuanwu Hospital was analyzed retrospectively while related literature was reviewed to explore the risk factors and countermeasures for bradycardia caused by bortezomib. Results Four patients developed bradycardia or exacerbation of bradycardia when the cumulative dose of bortezomib ranged from 1.3 to 31.2 mg·m-2, two of whom had underlying heart diseases. Prolonging the medication interval failed to bring bradycardia under control. However, the four patients had their bradycardia relieved on its own 5 to 21 months after the withdrawal of bortezomib. Conclusion Patients with plasma cell diseases may develop bradycardia after bortezomib-based combined chemotherapy, which may be related to the cumulative dose of bortezomib, the age of patients and underlying heart diseases. During medication, changes of patients' heart rate should be closely monitored, and a reduced dosage or discontinuation should be considered in case of bradycardia. References | Related Articles | Metrics

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Evaluation of drug use during applications of clinical pathways in patients with STEMI based on DUR and DUE YU Ji, RAN Shuo 2022, 19(6): 674-679.  DOI: 10.19803/j.1672-8629.2022.06.20 Abstract ( 125 )   PDF (1323KB) ( 87 )   Objective To evaluate the drug use and its rationality among patients with acute ST segment elevation myocardial infarction treated with clinical pathways (CP). Methods The clinical data on STEMI patients who had implemented CP in our hospital between January 1, 2018 and December 31, 2019 was collected. The drug utilization index (DUI), evaluation index, diagnosis, effect of therapeutic drug monitoring and that of clinical diagnosis and treatment were analyzed using methods for drug use review and drug use evaluation. Results There were thirty-eight main types of drugs used by seventy-six patients. The DUI for five of these types was above 1, less than 1 for twenty types, and was 1 for thirteen types. Aspirin enteric coated tablets, clopidogrel bisulfate tablets, atorvastatin calcium tablets, ticagrelor tablets, pantoprazole enteric coated tablets, isosorbide mononitrate tablets and trimetazidine hydrochloride tablets were high in drug use intensity. All 76 patients were monitored for the first time after admission for myocardial injury, liver function, renal function, blood routine examination and blood lipid level; During the treatment, 100.00%, 40.78%, 22.36%, 9.21% and 3.94% of them received the monitoring of myocardial injury markers, liver function, renal function, blood routine and blood lipid levels and abnormal re monitoring respectively. There were nine cases of adverse drug reaction ADR. After treatment, the clinical symptoms of the seventy-six cases (100.00%) improved significantly. Conclusion The combination of DUR and DUE can comprehensively evaluate the drug use of STEMI patients treated with CP. Irrational drug use should be detected in time and rational use of clinical drugs promoted. References | Related Articles | Metrics

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One case of pharmaceutical care during sulfanilamide desensitization treatment of sjogren's syndrome with pneumocystis carinii pneumonia LIU Lei, ZHANG Huijuan, QIAN Xiaosen, SUN Ruifang 2022, 19(6): 680-683.  DOI: 10.19803/j.1672-8629.2022.06.21 Abstract ( 109 )   PDF (1182KB) ( 87 )   Objective To explore the role of clinical pharmacists in pharmaceutical care of a patient with Sjogren's syndrome complicated with pneumocystis carinii pneumonia. Methods Clinical pharmacists participated in the treatment of a patient with Sjogren's syndrome complicated with Pneumocystis carinii pneumonia. Due to the patient's history of sulfanilamide allergy, the lack of alternative drugs and high cost, the pharmacists suggested trying the sulfanilamide desensitization test. According to the usage recommended by the guidelines, the feasible steps of the sulfanilamide desensitization test were designed, and the desensitization program was carried out with the attending physician. At the same time, individualized pharmaceutical care was provided to ensure the efficacy and to prevent adverse reactions. Results Physicians took the advice of clinical pharmacists and the sulfanilamide desensitization test was a success. After 21 days of treatment, the lung abnormal lesion was absorbed basically and infection was brought under control. Conclusion Clinical pharmacists can optimize the therapy plan of patients through pharmaceutical care to promote rational drug use in clinic, improve the effectiveness and safety of clinical treatment, and reduce the health care cost for patients. References | Related Articles | Metrics

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Data mining of adverse drug events of alirocumab from openFDA ZHANG Chi 2022, 19(6): 684-691.  DOI: 10.19803/j.1672-8629.2022.06.22 Abstract ( 174 )   PDF (1381KB) ( 139 )   Objective s To analyze the signals of adverse drug events (ADE) induced by alirocumab in the real world based on openFDA in order to provide reference for clinical rational use of the drug. Methods All the data on ADE was retrieved from the openFDA database collected between January 1, 2004 and May 7, 2020. ADE signals were detected by ROR and MHRA. Results Totally, 15 511 cases and 56 912 combinations of alirocumab were reported. Most of the reporters were consumers or non-health care providers, accounting for 71.10%. Reports from the United States accounted for 95.82%. After screening, 163 positive signals of alirocumab were obtained. ADE were mainly manifested as systemic disorders, responses at the sites of administration, musculoskeletal and connective tissue disorders, injury, poisoning, complications, and respiratory, thoracic and mediastinal disorders. Common ADE occurred in the nasopharynx and at the sites of injection. Conclusion The ADE signals of alirocumab involve 20 SOCs. Special attention should be paid to female or elderly patients or those with underlying heart diseases. References | Related Articles | Metrics

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Research progress in quality control of nucleoside antiviral drugs HUANG Lu, LIU Bo, WANG Yan, FAN Huihong, ZHANG Qingsheng 2022, 19(6): 692-696.  DOI: 10.19803/j.1672-8629.2022.06.23 Abstract ( 168 )   PDF (1221KB) ( 106 )   In recent years, nucleoside antiviral drugs have been increasingly developed, and the related quality control standards have also been improved. Based on 2020 edition of Pharmacopeia of people's Republic of China (ChP2020), 43 edition of the United States Pharmacopeia (USP43), 10.0 edition of European Pharmacopeia (EP10.0), 17 edition of Japanese Pharmacopeia (JP17) and relevant domestic and foreign guidelines, the inclusion of nucleoside antiviral drugs in these pharmacopoeias was summarized, while the critical elements of quality control, such as identification, assay and genotoxic impurities, were analyzed in general and related substances in particular so as to provide reference for the research and development of more accurate quality control methods for nucleoside antiviral drugs. References | Related Articles | Metrics

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Review of drugs on uterine leiomyomas YU Ya, PENG Changsheng, CUI Tao 2022, 19(6): 465-468.  DOI: 10.19803/j.1672-8629.2022.06.24 Abstract ( 107 )   PDF (1128KB) ( 115 )   Uterine leiomyomas (fibroids) is one of the most common gynecological tumors. At present, the most effective cure method for uterine fibroids is surgery. Surgical approach includes hysteromyomectomy, total hysterectomy and subtotal hysterectomy. Surgery inevitably reduces fertility and increases the obstetrical risks. In addition, because some uterine fibroids may shrink and become smaller after menopause, which makes some patients with childbearing aspiration choosing non-surgical treatments. This article summarizes the currently commonly used drugs in clinical practice and treatments that may be promising in clinical application. References | Related Articles | Metrics