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International Cooperation on Cosmetics Regulation Promotes Regulatory Science Internationalization of Cosmetic HUANG Xiankai, DONG Yinmao, MENG Hong, ZUO Min, HE Yifan, MENG Yuxi, JIA Yan 2021, 18(5): 401-405.  DOI: 10.19803/j.1672-8629.2021.05.01 Abstract ( 321 )   PDF (1369KB) ( 226 )   The release of the Regulation on the Supervision and Administration of Cosmetics in 2020 marks a new era of cosmetics supervision in China. How to better promote cosmetics supervision, industry upgrading, enhance cosmetics supervision and governance capabilities, and build a cosmetics supervision and governance system, while basing on China's national conditions, learning from foreign advanced concepts and practical experience. International Cooperation on Cosmetics Regulation(ICCR), as an international cosmetics regulatory organization, has important guiding significance for the internationalization of China's cosmetics supervision. This article explains the basic structure, main research directions and the scientific concept of cosmetic supervision of ICCR in order to put forward beneficial suggestions for cosmetic supervision in China, propel the modernization of cosmetic management ability and management system in China, and continuously enhance China's international voice in global cosmetics industry. References | Related Articles | Metrics

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Comparison of International Pharmacovigilance of Traditional Chinese Medicine and Natural Medicines WU Hao, ZHANG Bing, LIN Zhijian, ZHANG Xiaomeng 2021, 18(5): 406-410.  DOI: 10.19803/j.1672-8629.2021.05.02 Abstract ( 307 )   PDF (1214KB) ( 277 )   Objective To provide reference for the construction of pharmacovigilance systems of traditional Chinese medicine(TCM) and natural medicines by analyzing the development of pharmacovigilance of TCM and natural medicines. Methods Domestic and foreign literature was searched. Laws, regulations and guidelines related to TCM and natural medicines in some countries and regions were retrieved, the official websites of drug regulatory agencies were browsed, and pharmacovigilance regulatory agencies, related responsibilities, and regulatory content of TCM and natural medicines in various countries and regions were analyzed. Results Pharmacovigilance of TCM and natural medicines was specified in the pharmacovigilance system in many countries and regions. The European Union, India and other countries had established related regulatory agencies and worked out specific regulatory documents for TCM and natural medicines, but related pharmacovigilance systems were still under construction. Conclusion The pharmacovigilance of TCM and natural medicines has become an important part of pharmacovigilance in various countries and regions. The pharmacovigilance system of TCM and natural medicines in China is relatively complete compared with other countries and regions. China should keep up with the development of pharmacovigilance in various countries to motivate sustained research on pharmacovigilance of TCM and natural medicines and boost the development of global pharmacovigilance systems of TCM and natural medicines. References | Related Articles | Metrics

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Traditional Chinese Medicine Property-Based Understanding of Toxicity, Efficacy and Pharmaco-vigilance ZHANG Bing, LYU Jintao, ZHANG Xiaomeng, LIN Zhijian 2021, 18(5): 411-415.  DOI: 10.19803/j.1672-8629.2021.05.03 Abstract ( 248 )   PDF (1334KB) ( 232 )   Objective To explore toxicity, efficacy and pharmacovigilance of traditional Chinese medicine (TCM) based on the property of TCM so as to provide reference for research on and implementation of Chinese medicine pharmacovigilance. Methods Based on related theories, actual clinical medication and experimental research, the factors that influenced the effectiveness and safety of TCM were analyzed, and the relationship between the property, toxicity and efficacy was studied. Meanwhile, a TCM property-based pharmacovigilance model was established. Results Efficacy and toxicity were positive and negative expressions of TCM property, and one could be transformed into the other. Pharmacovigilance of TCM was supposed to start with the property of TCM, which involved advancing our understanding of properties of TCM, facilitating "toxicity to efficacy" transformation, preventing "efficacy to toxicity" transformation and detoxification. Factors including drugs, patients and medication had to be taken into consideration in the whole process of pharmacovigilance by means of quality control, terminal signal monitoring and process warning. Conclusion The medicinal property is the clinical feature of TCM. Pharmacovigilance of TCM calls for keen insights into the property of TCM while giving weight to toxicity and efficacy so as to establish a model of pharmacovigilance that could provide new ideas and guide rational use of TCM. References | Related Articles | Metrics

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Construction and Application of Four-Dimensional and Chained Research Platform for Pharmacovigilance of Traditional Chinese Medicine ZHANG Dan, LYU Jintao, ZHANG Bing, LIN Zhijian, WU Huanzhang, ZHANG Xiaomeng 2021, 18(5): 416-421.  DOI: 10.19803/j.1672-8629.2021.05.04 Abstract ( 183 )   PDF (1292KB) ( 170 )   Objective To construct a four-dimensional and chained research platform for pharmacovigilance of TCM given the complexity of safe clinical use of traditional Chinese medicine (TCM) in order to provide reference and guidance for research on the safety of TCM. Methods By exploring the critical elements of pharmacovigilance of TCM, the core models of risk signal discovery, risk evidence enhancement, risk-benefit assessment and drug risk communication were utilized by the platform, which could comprehensively, systematically, quantitatively and accurately discover, determine, assess and prevent problems with safety of clinical medication of TCM. Results This research platform was not only able to integrate the models of risk signal mining, risk evidence enhancement, risk benefit evaluation and drug risk communication, but used for pharmacovigilance research of TCM. Conclusion The four-dimensional and chained research platform of TCM pharmacovigilance can be used to comprehensively and Objectively account for the complex problems with the safety of TCM, properly and systematically clarify the essence of traditional ideas about safe application of TCM, and promote the implementation and development of TCM pharmacovigilance. References | Related Articles | Metrics

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Pharmacovigilance of Traditional Chinese Medicine in Pharmaceutical Care in Medical Institutions SA Rina, ZHANG Bing, LIN Zhijian, WANG Xiaofang, ZHANG Xiaomeng 2021, 18(5): 422-426.  DOI: 10.19803/j.1672-8629.2021.05.05 Abstract ( 204 )   PDF (1275KB) ( 227 )   Objective To explore medical institutions carry out traditional Chinese medicine(TCM) pharmacovigilance practice combined with pharmaceutical service. Methods Through literature review and preliminary clinical research results, the current situation of pharmaceutical care and the problems of pharmacovigilance of TCM in medical institutions were mastered. Based on the results of pharmacovigilance of TCM in our research group, the risk of pharmacovigilance of TCM in pharmaceutical care posts was refined and practiced. Results Medical institutions were the basic units to implement pharmacovigilance in China, and their pharmaceutical care level is an important guarantee for the implementation of pharmacovigilance. Conclusion Attention should be paid to the role of pharmacovigilance of TCM in pharmaceutical care in medical institutions and strengthen the pharmacovigilance of Chinese medicine. A practical model should be established with clinical pharmacists in medical institutions as the main body and pharmacovigilance as the breakthrough point to carry out the whole-process pharmaceutical care. References | Related Articles | Metrics

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Experimental Study on Acute Toxicity of Qing 'e Pills and Their Separated Prescriptions Aqueous Extract in Normal Mice Guo Xin, Cai Taotao, HUANG Nana, Sun Rong 2021, 18(5): 427-432.  DOI: 10.19803/j.1672-8629.2021.05.06 Abstract ( 122 )   PDF (2384KB) ( 88 )   Objective To compare the acute toxicity of Qing'e pills and their separated prescriptions aqueous extract in mice and to explore the mechanism of prescription compatibility so as to provide data for safe and rational drug use in clinic. Methods According to the classical principle of "monarch, minister, assistant and guide" and the seven-emotion compatibility of Chinese medicine, as well as the theory of nature, taste and indications, Qing'e pills were divided into five groups: combination 1 (salt Eucommia ulmoides Oliver+salt Psoralea corylifolia L+fried Juglans regia L.), combination 2 (salt Eucommia ulmoides Oliver+salt Psoralea corylifolia L), combination 3 (salt Psoralea corylifolia L + Alliumsativum L.), combination 4 (salt Psoralea corylifolia L+fried Juglans regia L. + Alliumsativum L.), and combination 5 (Qing'e pills). The aqueous extract of Qing'e pills was prepared, and the contents of psoralen and isopsoralen in each drug group were detected by HPLC. The classical experimental method for acute toxicity was used to compare the difference in acute toxicity between Qing'e pills and their separated prescriptions aqueous extract. Results The contents of psoralen in the water extracts of combination 1, combination 2, combination 3, combination 4 and combination 5 were 0.156 3%, 0.172 6%, 0.104 8%, 0.050 3% and 0.083 8% respectively, compared with 0.160 6%, 0.158 9%, 0.096 0%, 0.036 6% and 0.062 3% respectively for isopsoralen. The maximum tolerated dose (MTD) value of each group was 165.32, 156.52, 156.00, 118.78 and 129.84 g/(kg·d),respectively, which were equivalent to 779.77, 892.94, 1779.6, 956.8 and 538.59 times the daily dosage per kilogram of body weight of 70 kg people. The main toxic symptoms of mice were depression, inactivity, ataxia, stiffness, and proneness to clonic convulsion. The mice in each group had different degrees of redness and swelling in ears, tails and eyes. Conclusion The acute toxicity of combinations mentioned above is not so severe as that of salt Psoralea corylifolia L, suggesting that the prescriptions of Qing 'e pills combined according to the prescription structure of traditional Chinese medicine can reduce the acute toxicity of Psoralea corylifolia L. The compatibility of traditional Chinese medicine can ensure effective safety control. The mechanism of detoxification needs to be further studied. References | Related Articles | Metrics

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Chronic Toxicity of Xuezhining Pill on Normal Rats Guo Xin, HUANG Nana, Sun Rong 2021, 18(5): 433-437.  DOI: 10.19803/j.1672-8629.2021.05.07 Abstract ( 141 )   PDF (1647KB) ( 69 )   Objective To observe the toxicity of Xuezhining pill to normal rats, the main manifestations, involved organs and the recovery after drug withdrawal, so as to provide a toxicological basis for clinical safety administration. Methods With reference to Technical Guidelines for the Study of Chronic Toxicity of Traditional Chinese Medicine and Natural Medicine, general conditions such as weight, daily diet and daily water intake of rats were observed after 90 days of continuous administration and 45 days after drug withdrawal. 24 hours after the last administration, 10 rats were randomly selected from each group to take blood samples for routine blood test and blood biochemical test. After taking blood, the rats were killed and dissected, and the organs such as heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary, brain, stomach, small intestine, thymus, epididymis, colon and rectum were weighed. The ratio of viscera to brain was calculated except intestine, and the organs were examined by histopathology. Results During the experiment, no rats in each group died. After continuous administration for 90 days, compared with the normal group, the weight of rats in each group increased slowly (P>0.05). MCV, RET, HCT, PT and MCH in high dose group were significantly decreased (P<0.01). MCH increased significantly (P<0.01) and RET decreased significantly (P<0.01) in middle dose group. RET in low dose group decreased significantly (P<0.01). In high dose group, ALT and ALP increased significantly (P<0.001), TG decreased significantly (P<0.001), AST, BUN, Cr and ALB increased significantly (P<0.01), T-CHO decreased significantly (P<0.01) and Cl- decreased significantly (P<0.05). The ALP in low dose group increased significantly (P<0.01). There was no statistical difference between other biochemical indexes and normal group (P>0.05), and the pathological examination of each organ had no obvious abnormality. After stopping the drug, all indexes could return to normal. Conclusion After 90 days of continuous administration of 7.5~15.0 g/kg (equivalent to 35~70 times of clinical daily dosage of 70 kg), Xuezhining pill can increase the indexes of liver and renal function in rats, which can return to normal after 45 days of drug withdrawal. References | Related Articles | Metrics

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Chronic Toxicity of Salt Psoralea Corylifolia L. Aqueous Extract in Male and Female Rats ZHAO Xiao, CAI Taotao, GUO Xin, HUANG Nana, SUN Rong 2021, 18(5): 438-443.  DOI: 10.19803/j.1672-8629.2021.05.08 Abstract ( 132 )   PDF (2006KB) ( 94 )   Objective To study the long-term toxicity of salt Psoralea corylifolia L. aqueous extract in male and female Wistar rats. Methods Eighty normal rats were randomly divided into the normal group, low dose (L) group (0.56 g/kg)、medium dose (M) group (1.12 g/kg)、and high dose (H) group (5.6 g/kg). The 90 days of continuous administration were followed by the recovery period of 45 days. The degree of toxic reactions, toxic target organs, action characteristics and rate of recovery were observed. Results After continuous administration of 90 days, there was no significant difference in daily food intake or water intake between each administration group and the normal group (P>0.05). The changes of blood routine indexes, blood biochemical indexes and liver related indexes in rats were more significant, and other indexes increased or decreased to varying degrees, but almost returned to normal at the end of recovery, which was of no toxicological significance. The thymus / brain ratio of female and male rats in salt Psoralea corylifolia L. H group was significantly decreased (P<0.01), so was the ovary / brain ratio of female rats in salt Psoralea corylifolia L. H group and the epididymis / brain ratio of male rats in salt Psoralea corylifolia L. H group (P<0.01), but these ratios returned to normal recovery. The liver / brain ratio of male and female rats in salt Psoralea corylifolia L.H and M group increased 45 days after drug withdrawal (P<0.05). Conclusion Ninety days of continuous administration of 5.6 g/kg (equivalent to 40 times clinical 70 kg daily dosage) of Psoralea corylifolia water extract to rats can cause liver injury. References | Related Articles | Metrics

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Chronic Toxicity of Qing 'e Pills in Normal Rats LI Jianchao, CAI Taotao, Guo Xin, HUANG Nana, Sun Rong 2021, 18(5): 444-449.  DOI: 10.19803/j.1672-8629.2021.05.09 Abstract ( 76 )   PDF (2428KB) ( 63 )   Objective To investigate the chronic toxicity of Qing'e pills in Wistar rats and observe the severity of toxic reactions, involved organs, action characteristics and recovery of experimental animals so as to provide toxicological data for clinical safe drug use. Methods In line with the Technical Guidelines for Long-term Toxicity Studies of Traditional Chinese Medicine and Natural Medicines, 80 normal rats were randomly divided into the normal group, and Qing'e pill L、M、H groups (the doses were 4.82, 11.25 and 22.50 g/kg respectively),with 20 rats in each group. After 90 days of continuous administration, the condition of rats in each group was observed. The body weight, daily diet and daily water intake of rats were recorded every 9 days. After the last administration, 10 rats were randomly chosen from each group for blood routine test and blood biochemical index test. Such viscera as the heart, liver, spleen, lung, kidney, adrenal gland, thymus, uterus, ovary, brain, stomach, thymus and epididymis were weighed to calculate the visceral brain coefficient. Histopathological examination was performed. The rest of the rats entered the recovery period, and the same detection was conducted as in the administration period. Results After 90 days of consecutive administration, there was no significant difference in body weight, daily diet and daily water intake between the administration groups and the normal group (P<0.05). The blood biochemical indexes of rats in each group increased or decreased to different extents. Liver cells in Qing'e pill H group showed punctate necrosis. Conclusion The 90 days of continuous administration of Qing'e pills to rats 22.50g/kg (equivalent to 70 times the clinical daily dosage of 70 kg) can cause liver injury in rats, so Qing'e pills should be administered according to the doctor’s instructions, and those with liver and kidney dysfunction should use these pills with caution. References | Related Articles | Metrics

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Safety Evaluation of Heavy Metals and Harmful Elements in Earthworms ZUO Tiantian, JIN Hongyu, WANG Zhao, YU Kunzi, KANG Shuai, PANG Yu, SUN Lei, MA Shuangcheng 2021, 18(5): 450-453.  DOI: 10.19803/j.1672-8629.2021.05.10 Abstract ( 177 )   PDF (1270KB) ( 120 )   Objective To analyze the contents of heavy metals and harmful elements in earthworms, and to study the association of heavy metals and harmful elements in traditional Chinese medicines with the origins of Chinese medicinal materials. Methods After microwave digestion, the contents of lead, cadmium, arsenic, mercury and copper in earthworms were determined by inductively coupled plasma mass spectrometry (ICP-MS). The safety of samples was evaluated by single factor pollution index method and Nemerow comprehensive pollution index method. Results The average contents of lead, cadmium, arsenic, mercury and copper of 17. batches from 9 places of origins were 8.58, 1.50, 9.86, 0.57 and 27.71 mg/kg, respectively. The results of safety evaluation showed that all batches of earthworms from Shanghai, Jiangsu, Guangxi and Henan were heavily polluted. Earthworms from Guangdong and Zhejiang were moderately polluted, those from Shandong were lightly polluted, those from Anhui were within the safety line, and those from Hainan were safe. The safety evaluation results obtained by single factor pollution index method and Nemerow comprehensive pollution index methods were associated with the origins. Conclusion The study has provided not only reliable data on the relationship between the origin distribution of Chinese medicinal materials and heavy metals and harmful elements, but also reference for safety evaluation, quality control and exploitation of resources of animal medicines. References | Related Articles | Metrics

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Determination of 7 N-nitrosoamines in Metformin Hydrochloride Sustained Release Tablets by LC-HRMS LIU Bo, ZHANG Tong, HUANG Lu, ZHANG Qingsheng, FAN Huihong 2021, 18(5): 454-458.  DOI: 10.19803/j.1672-8629.2021.05.11 Abstract ( 266 )   PDF (1555KB) ( 155 )   Objective To establish an LC-HRMS method for determination of 7 N-nitrosoamines(7 NAs) genotoxic impurities in metformin hydrochloride sustained release tablets. Methods The separation was carried out on a C18 column (100 mm×4.6 mm, 3μm) by linear gradient elution using 0.1% formic acid as mobile phase A and 0.1% formic acid methanol as mobile phase B. The HRMS determination of NDMA was conducted by means of positive electrospray ionization parallel reactions monitoring. Results Linear calibrations were established for 7NAs in the range of 1 to 100 ng/mL. The limits of quantification ranged from 0.5 to 1 ng/mL while the average recovery ranged from 82.6% to 111.4%. Conclusion The established LC-HRMS method has proved to be suitable for the simultaneous quantitative determination of 7 NAs genotoxic impurities in metformin hydrochloride sustained release tablets. References | Related Articles | Metrics

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Introduction and Application of Standardization of case Reports on Drug Safety ZHANG Xiaowen, LIU Jianping 2021, 18(5): 459-463.  DOI: 10.19803/j.1672-8629.2021.05.12 Abstract ( 356 )   PDF (1262KB) ( 411 )   Objective To evaluate the standardization of Case Report(CARE) on drug safety, improve the accuracy and transparency of case reports, and provide sufficient information for identification of adverse drug reactions and the causality between drugs and events. Methods Based on CARE Checklist and Chinese Journal of Pharmacovigilance, the quality of case reports published in this journal over the past ten years was assessed. Results Between 2010 and 2019, 508 case reports were published in Chinese Journal of Pharmacovigilance on drug safety. Each report had an average of 5.85 items that met the 14 items requirements of CARE Checklist. Follow-up and results were fully reported, adverse reactions and adverse drug events were described in detail; but the description of the patients' condition was based on results of detection currently available, and the limitations of cases were not fully reported. Conclusion We recommend reporting the past history of a patient in detail, presenting the diagnostic process, and mentioning the perspective and experience of patients, which can improve the accuracy and transparency of case reports and provide more information for identification of adverse drug reactions and the causality between drugs and events. References | Related Articles | Metrics

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Analysis of Monitoring Reports on Suspected Adverse Events Following Immunization in Pingshan District Shenzhen City during 2015~2018 Chen Aihong, Yin Qiangbing, Li Huadan, Wu Nengjian 2021, 18(5): 464-468.  DOI: 10.19803/j.1672-8629.2021.05.13 Abstract ( 137 )   PDF (1321KB) ( 108 )   Objective To analyze the characteristics of adverse events following immunization(AEFI) between 2015 and 2018 in Pingshan District, Shenzhen, and to evaluate the operation of the AEFI surveillance system and epidemiology of AEFI. Methods Cases of AEFI in Pingshan District, Shenzhen were collected between 2015 and 2018 via the National Immunization Program Information Management System as well as the actual vaccination data were analyzed by descriptive epidemiological methods. Results The annual coverage rate of clinical vaccination was 100.0%. A total of 318 cases of AEFI were reported between 2015 and 2018, and the cumulative report rate was 20.35/100,000 doses. Among the 318 cases of AEFI, 69.5% were vaccinated with the first class vaccines, and 30.5% with the second class vaccines. The rate of AEFI was the highest with DaTP(20.4%), and the most frequently reported vaccine was PPV23 with 162.14/100,000 doses. 90.3% of AEFI occurred within 24 hours of vaccination. Common reactions were dominating (71.1%), followed by adverse reactions (27.4%). All these cases were cured or improved. Conclusion The AEFI surveillance system in Pingshan is operating smoothly and the sensitivity is gradually improved. However, it is still necessary to improve the mechanism of vaccination, the quality of data on AEFI monitoring and emergency response to severe AEFI. References | Related Articles | Metrics

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Adverse Drug Reactions of Anti-thyroid Drugs and Effects of 131I Replacement Therapy in Patients with Hyperthyroidism MA Yini, ZHANG Lixiang, ZHANG Zhetao, WANG Xiaoyu, SHI Tianlu 2021, 18(5): 469-472.  DOI: 10.19803/j.1672-8629.2021.05.14 Abstract ( 160 )   PDF (1169KB) ( 796 )   Objective To investigate the clinical manifestations, latency, ADR monitoring,and treatment of adverse reactions related to anti-thyroid drugs（ATD）and the clinical effect of 131 I replacement therapy so as to provide individualized treatment for patients with hyperthyroidism and reference for safer ATD treatment. Methods The clinical data on 119 patients with hyperthyroidism hospitalized due to ADT-induced ADR between June 1, 2017 to May 31, 2019 was retrospectively analyzed. Patients' age, gender, involved organs and systems, types and clinical manifestations of ADR, incubation of ADR, treatments and treatment outcomes were statistically analyzed. The clinical efficacy of 131I in these patients was also evaluated. Results 79% of the patients developed ADR within one month of medication. ADR occurred as shortly as one day after medication manifested by rashes and myalgia and as late as two years after medication, with leucopenia as the symptom. The highest incidence of ADRs was attributed to the hepatobiliary system damage (MMI 52.78%, PTU 66.67%), blood system damage (MMI 30.56%, PTU 41.67%), and skin and accessory system damage (MMI 19.44%,PTU 8.33%). After 131I was applied to these patients, the difference in indicators of serum TSH, T3 and T4 was statistically significant (P<0.05).The effective rate of treatment was as high as 93.2%, and there was some chance of long-term hypothyroidism. Conclusion Drugs should be rationally selected according to the characteristics of different ATD treatments. Blood routine indexes, liver function, thyroid function and other indicators should be checked regularly during the treatment to prevent ADRs and ensure the safe use of drugs for patients. 131I treatment has significant efficacy and is quite safe in patients with hyperthyroidism who develop adverse reactions to ATD treatment. References | Related Articles | Metrics

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Analysis of Adverse Drug Reactions in 182 Neonates LI Jing, PENG Cuiying, LUO Fangmei, ZHANG Haixia 2021, 18(5): 473-477.  DOI: 10.19803/j.1672-8629.2021.05.15 Abstract ( 290 )   PDF (1188KB) ( 287 )   Objective To explore the causes, characteristics and influencing factors of adverse drug reactions (ADR) in neonates in order to reduce neonatal ADR and promote rational clinical use of drugs in neonates. Methods The 182 cases of ADR in neonates reported by our hospital between October 1, 2006 and December 31, 2019 were statistically analyzed. The ADR severity index (SIADR)of various drugs was calculated. Results The ratio of boys and girls was 2.57∶1. The main drugs that caused ADR in newborns were antibacterial drugs, nervous system drugs, and traditional Chinese medicine preparations. However, the three drugs with the highest SIADR were sedative and hypnotic drugs, blood system drugs and electrolytes, acid-base balance and nutritional drugs. The most common ADR were injuries to the skin and its appendants. Off-label drug use and irrational drug use were found during clinical medication of neonates. Conclusion ADR among neonates are closely related to gender, neonatal pharmacokinetics, off-label drug use and irrational drug use. Drugs with a high severity index deserve attention in clinical use. The following measures are recommended to reduce the incidence of neonatal ADR and promote the rational use of drugs: investing more in the study on neonatal pharmacokinetics, boosting R&D of special drugs for newborns; and to promote rational antibacterial drugs use. References | Related Articles | Metrics

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Analysis of Adverse Drug Reactions Induced by SGLT-2 Inhibitors ZHANG Houjing, JI Liwei 2021, 18(5): 478-482.  DOI: 10.19803/j.1672-8629.2021.05.16 Abstract ( 343 )   PDF (1124KB) ( 149 )   Objective To explore the characteristics and regularity of adverse drug reactions(ADR) induced by SGLT-2 inhibitors, so as to improve the safety of clinical medication. Methods CNKI, WanFang, VIP, PubMed, Embase and Medline database were retrieved from database building to November 28, 2019 and ADR induced by SGLT-2 inhibitors were analyzed retrospectively. Results A total of 40 cases of ADR induced by SGLT-2 inhibitors was enrolled in this study. Among them, 13 ADR were involved, and the top 3 types of ADR induced by SGLT-2 inhibitors were diabetic ketoacidosis (55.0%), acute pancreatitis (10.0%), fanconi syndrome (7.5%). Conclusion ADR induced by SGLT-2 inhibitors were varied, in which more attentions should be paid to new ADR such as fanconi syndrome, sweet syndrome and so on. During application of SGLT-2 inhibitors, the indications should be strict and close monitoring was necessary. References | Related Articles | Metrics

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Signal Mining and Analysis of Adverse Reactions Induced by Tacrolimus and Voriconazole CAO Xin, SUN Yuquan, HUANG Guimin, RAN Zhongyang, CUI Xiangli 2021, 18(5): 483-488.  DOI: 10.19803/j.1672-8629.2021.05.17 Abstract ( 330 )   PDF (1234KB) ( 201 )   Objective To mine and analyze signals of adverse reactions due to the combined use of immunosuppressive agents tacrolimus and voriconazole by using the FDA ( Food and Drug Administration) adverse event reporting system (FAERS) and to provide reference for clinical combined medication. Methods Adverse event reports related to tacrolimus and voriconazole collected in the FAERS database between January 1, 2010 and December 31, 2019 were retrieved using measures of disproportionality. The reporting odds ratio (ROR) and proportional reporting ratio (PRR) were used to compare the suspected adverse reaction signals of tacrolimus and voriconazole used alone or in combination. Adverse reactions that arose from the combination of the two drugs were compared with those specified in the instructions of the two drugs in order to screen out new adverse reactions. Results A total of 52 572 adverse reaction reports of tacrolimus, 8 789 adverse reaction reports of voriconazole, and 1 229 adverse reaction reports of tacrolimus combined with voriconazole were retrieved. When the combined use of the two drugs was compared to tacrolimus used alone, it was found that there were 84 adverse reactions, both ROR and PRR of which were greater than 2, compared with 56 adverse reactions for voriconazole. Compared with the adverse reactions specified in instructions of tacrolimus and voriconazole, there were 6 new adverse reactions involved. Conclusion The combination of tacrolimus and voriconazole may induce far more adverse reactions than single use, which deserves clinical attention. References | Related Articles | Metrics

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One Case of Skin Pigmentation Induced by Polymyxin B for Injection CHEN Jianshou, WANG Min 2021, 18(5): 489-491.  DOI: 10.19803/j.1672-8629.2021.05.18 Abstract ( 217 )   PDF (889KB) ( 148 )   Objective To analyze the possible factors of skin pigmentation caused by polymyxin B for injection and promote the rational use of drugs in clinic. Methods The diagnosis and treatment of a case of skin pigmentation caused by polymyxin B were analyzed and combined with literature search to explore the mechanism and countermeasures of skin pigmentation induced. Results On the 14th day after the patient's intravenous administration of polymyxin B, the patient's head and neck skin were observed to be pigmented. Considering the combination of sirolimus blood concentration accumulation, reduce the sirolimus dose by half and monitor the drug Blood concentration. It was found that sirolimus was within the effective blood concentration range. The infection was controlled on the 30th day, and polymyxin B was discontinued. At this time, the patient's body skin was dark brown, and the patient's body skin was followed up for 5 months. Significantly weaker than before, but did not return to normal. Conclusion Alternative treatment options should be selected for polymyxin B-induced skin pigmentation. If continued use is warranted, simultaneous or sequential use of neurotoxic or nephrotoxic drugs should be avoided, and renal function and polymyxin B blood levels should be monitored during treatment. References | Related Articles | Metrics

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Advances in Research on Impact of Drug Excipients on Safety of Diagnosis and Treatment ZHANG Tai, WANG Yanyan 2021, 18(5): 492-494.  DOI: 10.19803/j.1672-8629.2021.05.19 Abstract ( 185 )   PDF (882KB) ( 206 )   Objective To find out more about the influence of drug excipients in preparations on the safety of diagnosis and treatment and to provide reference for safe and rational use of drugs. Methods Recent literature related to the physiological activity, physical and chemical properties of drug excipients that affected the diagnosis and treatment process was reviewed. Results The inherent properties of drug excipients often acted on the human body clinically in conjunction with other factors of health care, which could adversely impact the outcome of a disease and the judgment of health care providers. Adverse drug reactions (ADR) caused by drug excipients were often related to their inherent properties. Conclusion As essential ingredients of preparations, drug excipients could make difference to the safety of clinical medication in the process of diagnosis and treatment. Drug excipients deserve the same amount of attention as the main active ingredients of preparations in order to minimize medication risks. References | Related Articles | Metrics

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Research Progress in Drug Interactions Induced by Citrus Herbs LYU Jintao, ZHANG Dan, ZHANG Bing, SA Rina, LIN Zhijian, ZHANG Xiaomeng 2021, 18(5): 495-498.  DOI: 10.19803/j.1672-8629.2021.05.20 Abstract ( 174 )   PDF (1171KB) ( 128 )   Objective To summarize the recent research progress in drug interactions induced by Citrus herbs in order to gain keen insights into the interactions and related mechanism. Methods By searching CNKI, PubMed and other databases, literature related to drug interactions induced by Citrus herbs and the related mechanism was reviewed. Results Drug interactions induced by Citrus herbs could be divided into pharmacokinetic ones and pharmacodynamic ones according to the mechanism. The former type was related to flavonoids including hesperidin and naringin, and coumarins such as bergamottin. Citrus herbs could influence the pharmacokinetics of such chemical drugs as tacrolimus, ciclosporin, buspirone and omeprazole via drug enzymes including cytochrome P450, and drug transporters including P-glycoprotein. The latter type was characterized by a decrease in adverse reactions and/or an increase in curative effects of combined drugs, especially antineoplastic drugs, which were associated with flavonoids including hesperidin and tangeretin. Conclusion Clinical observation and basic studies on drug interactions induced by Citrus herbs need to be improved to promote rational combined medication in clinical practice. References | Related Articles | Metrics