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ObjectiveTo achieve high-dimensional prediction of class imbalanced of adverse drug reaction（ADR） of traditional Chinese medicine（TCM） and to classify and identify risk factors affecting the occurrence of ADR based on the post-marketing safety data of TCM monitored centrally in real world hospitals. MethodThe ensemble clustering resampling combined with regularized Group Lasso regression was used to perform high-dimensional balancing of ADR class-imbalanced data， and then to integrate the balanced datasets to achieve ADR prediction and the risk factor identification by category. ResultA practical example study of the proposed method on a monitoring data of TCM injection performed that the accuracy of the ADR prediction， the prediction sensitivity， the prediction specificity and the area under receiver operating characteristic curve（AUC） were all above 0.8 on the test set. Meanwhile， 40 risk factors affecting the occurrence of ADR were screened out from total 600 high-dimensional variables. And the effect of risk factors on the occurrence of ADR was identified by classification weighting. The important risk factors were classified as follows：past history， medication information， name of combined drugs， disease status， number of combined drugs and personal data. ConclusionIn the real world data of rare ADR with a large amount of clinical variables， this paper realized accurate ADR prediction on high-dimensional and class imbalanced condition， and classified and identified the key risk factors and their clinical significance of categories， so as to provide risk early warning for clinical rational drug use and combined drug use， as well as scientific basis for reevaluation of safety of post-marketing TCM.
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As a modern dosage form drug with rapid effect, traditional Chinese medicine (TCM) injection has been more and more used in clinical practice. Meanwhile the safety of TCM injection has attracted more and more attention. The retrospective analysis on 74 cases of adverse reaction of TCM injections collected from 2007 to 2016 in the Third Affiliated Hospital of Beijing University of Chinese Medicine showed that the proportion of men and women with adverse reactions was 0.54:1; the average age was 62.5 years old; 21 kinds of TCM injections were involved. Among them, the most reported were blood-regulating agents. The top four kinds of TCM injections with highest adverse drug reactions (ADRs) were Tanreqing injection, Danhong Injection, Shuxuening Injection and Xuesaitong for injection. The top three clinical manifestations of adverse reactions were lesions of skin and its appendages, damage of circulatory system and damage of nervous system. The potential causes of the adverse reactions of TCM injections were analyzed, and it was believed that individual difference, medicine, pharmaceutical excipients, solvent and TCM syndrome differentiation may be the main five causes for the adverse reactions of TCM injections. In order to reduce the adverse reactions of TCM injections, it is suggested that the clinical pharmacists should participate in the application management of TCM injections in the hospital; the production enterprises shall strengthen the whole life cycle management of the drugs; and at the same time, the drug control and administration authorities should improve the drug management methods constantly and encourage the development of TCM injections to the high quality level.
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Female , Humans , Male , Middle Aged , Drugs, Chinese Herbal , Injections , Medicine, Chinese Traditional , Retrospective StudiesABSTRACT
Objective To learn the adverse drug reaction (ADR) of traditional Chinese medicine injection (TCMI) in Dongfang Hospital of Beijing University of Chinese Medicine (BUCM),to master the characteristics of the occurrences of ADR,and to provide basis for safe and rational clinical drug use.Methods Locating all the reported ADR cases by Dongfang Hospital of BUCM to national ADR monitoring system from June 2011 to May 2016,and make retrospective analysis of them.Results Eighteen kinds of TCMI that caused the total 135 ADR cases,50 out of all the 135 instances were male patients,whilst the rest 85 instances were female patients;The main kinds of TCMI that caused ADR problems were TCMI for relieving heat and toxic material and TCMI for promoting blood circulation to remove blood stasis;TCMI was used jointly with antibiotics and biological product etc.;And the circumstances of ultra-dose and improper infusion allocation existed.The clinical manifestation included many skin lesion cases.All the patients suffered from ADR were cure.Conclusion Prudent and rational use of drugs,standardized clinical use procedure,and clinical re-evaluation are key aspects to lower the incidence rate ofADR of TCMI and to safe and rational use of drugs.
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OBJECTIVE: To share the process of analysis and intervene the adverse drug reaction (ADR) caused by octreotide, and to provide reference for the work mode of clinical pharmacist. METHODS: One case of hypoglycemia possibly caused by octreotide was discovered. The clinical pharmacist recommend the doctor to replace octreotide as somatostatin after a review of the relevant information and literatures. Then the clinical pharmacist investigated awareness of hypoglycemia ADR of octreotide among the ICU doctors, and introduced the ADR of octreotide and the difference between octreotide and somatostatin among them. RESULTS: After the intervention, the hypoglycemia was corrected and the patient was cured and clinical pharmacists' working mode was identified. CONCLUSION: Clinically, pharmacists should not only have good professional knowledge, but also master the ways and means of communication, in addition to assisting doctors monitoring of adverse drug reactions, also need to continue to explore the work mode.
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To systematically review the adverse drug reactions/adverse events(ADRs/AEs) of Xinyuan capsules in clinical application. A systematic literature search was performed in the databases of the Cochrane Library, Medline, EMBASE, the Web of Science, Clinical trials, CNKI, VIP, WanFang Data and CBM. The literature was screened and data was extracted according to the inclusion and exclusion criteria. Because of the substantial heterogeneity among different studies, we assessed them only with descriptive analysis by study type, disease diagnosis, and ADRs/AEs conditions. All included studies were assessed by using the internationally recognized report quality evaluation standard or methodological quality assessment tools. A total of 42 studies involving 3 671 patients were included finally. Two thouand four hundred and thirty-mine patients of them took Xinyuan capsules, and 1 242 patients did not take Xinyuan capsules. No serious ADRs occurred in all patients. One patient died as AE during the research. Sixteen patients of the 2 439 patients taking Xinyuan capsules (alone or in combination) had ADRs, including 7 patients with polytherapy of Xinyuan capsules and 9 patients with monotherapy. The most common ADRs were in gastrointestinal tract, mainly including thirst, nausea, vomiting and abdominal pain, etc. The ADRs included 10 gastrointestinal tract ADRs, 3 renal ADRs and 1 ADR respective in skin system, respiratory system and cardiovascular system. Xinyuan capsules was generally safe in clinical application. The reports on the study of Xinyuan capsules were dispersed in various clinical studies, the study on drug safety still should be strengthened in the future. Further mechanism studies or clinical observation studies of the drug safety shall be conducted to better guide clinical application in the future.
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Toxic Epidermal necrolysis (TEN) is a rare, life threatening dermatological disorder that is usually induced by medications. Anti-convulsants such as phenytoin, carbamazepine and phenobarbital have been enlisted as high risk drugs for causing TEN. A 25 year old man, a known case of epilepsy, who consumed inadvertently escalated daily dose of 600 mg/day of phenytoin for 10 days, developed TEN which involving more than 30% of body surface area with mucosal involvement. Rigorous treatment of 18 days using systemic and topical antibiotics along with glucocorticoids helped in complete recovery of the patient. Causality analysis of this Adverse Drug Reactions (ADR) showed a probable association on both World Health Organisation (WHO) – Uppsala Monitoring Centre (UMC) scale and Naranjo’s probability scale and Severity scale of 5 on Modified Hartwig and Siegel scale. Medication error is an important cause of such life threatening reactions which requires concern of all health care professionals.
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Objective To analyze the differences of adverse drug reactions between children and adults caused by Tanreqing injection,and provide reasonable application of Tanreqing injection.Methods Retrospective research method were adopted to screen out the adverse drug reaction reports caused by Tanreqing injection from drug ADR reports of Drug ADR Monitoring Center affiliated to the Second People's Hospital of Gansu Province from January 2010 to October 2012.Figures of children and adults who used Tanreqing injection were analyzed separately.Results A total of 603 children used Tanreqing injection,among which 5 children appeared ADR (0.83％).A total of 4395 adult used of Tanreqing injection,among which 4 appeared in ADR (0.09％).There was statistical difference between the two groups (x2 =16.07,P＜ 0.05) The incidence rate of ADR in males was more than females either in the adults or in children.Hypersensitivity was the most common ADR.Conclusion ADR of Tanreqing injection in Children was significantly higher than adults.Tanreqing injection should be used carefully and rationally.
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BACKGROUND: Due to rapidly growing elderly population, there are increasing numbers of older persons with multiple chronic disorders and geriatric problems arising from polypharmacy. In this study we tried to find out the state of polypharmacy and inappropriate drug prescription and their related factors in community-dwelling elderly by review of drugs taken by older persons visiting a day health center. METHODS: From April 2007 to July 2007, 80 subjects of 65 year-old or over with chronic illness who visited a elderly-wellness and health care center were randomly sampled. All of them were surveyed by structured questionnaires, medical records review, pill counts about all medications they are taking and experience of adverse drug reactions. And all the prescribed medications were reviewed or their drug prescription's appropriateness for each elderly according to Beers criteria. Data results were evaluated by frequency and correlation analyses. RESULTS: The average counts of drugs taken by elderly with chronic disorders were 7.23, minimum 1 to maximum 27 drugs a day. Patients experienced more adverse effects significantly when more prescribed medications were taken (P=0.005), and patients with lack of information about their drugs had taken increased number of medications (P<0.001). Referred to Beers criteria, inappropriate cases of prescription were observed in 26 persons. Those drugs were NSAIDs including aspirin in 17 subjects (21%), amitrityline in 3 (4%), short-acting benzodiazepines in 3 (4%), long acting benzodiazepines in 2 (3%), and anticholinergic antihistamine in 1 (1%). CONCLUSION: Polypharmacy is very common in community-dwelling elderly with chronic disorders. More medications were related to more adverse drug reactions and lack of information about their drugs related to increased number of drug taking. High proportion of inappropriate drug prescriptions was observed in the elderly, which may have resulted from poor education concerning geriatric care of the medical personnels.
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Aged , Humans , Anti-Inflammatory Agents, Non-Steroidal , Aspirin , Beer , Benzodiazepines , Chronic Disease , Delivery of Health Care , Drug Prescriptions , Drug-Related Side Effects and Adverse Reactions , Medical Records , Polypharmacy , Prescriptions , Surveys and QuestionnairesABSTRACT
Objective:To review literature reports of varieties of ADRs induced by mebendazole to provide a sci- entific foundation for clinical revaluation of mebendazole.Method:The related literatures in the internal and external medi- cine medical database in 1994-2004 were explored,and then both analysis and statistics were conducted with the methods of epidemiolngy and literature analysis.Result:ADRs induced by mebendazole could be involved in multiple organs.Most victims were children and the elderly.Their latent periods were determined by the types of ADRs,which had a variety of forms.Conclusion:Mebendazole was potentially unsafe.So we should strengthen our rational drug use and post-marketing revaluation of safety.
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Objective To investigate drug adverse reactions caused by Qingkailing injection,in order to provide a reference for clinical drug rational use.Method 2003-2008 Qingkailing Injection Case reports of adverse reactions collected from the Guizhou Province Monitoring Center Database was analysed descriptively.Result The occurrence of Qingkailing injection adverse reactions was not correlated to gender.The clinical manifestation was mainly for allergic reactions(305 cases,accounting for 35.59%)and systemic damage(417 cases,accounting for 48.66%).There were 652 cases adverse reactions occurred in 30min accounting for 76.08%.Conclusion Clinical physicians,pharmacists should attach importance to Qingkailing injection adverse reactions,persist in rational drug use and focus on the observation,after druguse.
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OBJECTIVE: To study the situation of the combined application of Chinese patent medicine with western medicine, and to promote rational and safe drug use. METHODS: The combined application of some commonly used Chinese patent medicines with the western medicines was analyzed by tabulation. RESULTS: Hospitals, retail pharmacies and patients lacked understanding of the situation of the adverse reactions caused by the joint application of the Chinese patient medicines with the western medicine. It is common for the two used in combination. CONCLUSION: Physicians, nurses, pharmacists and patients should familiarize with the effective components contained in the Chinese medicine and the western medicine and be cautious in the joint application of Chinese medicine with the western medicine.
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OBJECTIVE:To discuss the operating condition of adverse drug reaction(ADR)report system in China.METHODS:The advantages and disadvantages of the current ADR report system in China were analyzed.RESULTS&CONCLUSION:It is only by establishing standardized measures and effective operating methods on the basis of personnel training,facility construction and daily supervision can ADR report system play its expected role.
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OBJECTIVE:To observe the efficacy and safety of adjuvant Shensong Yangxin Capsule(SYC)in patients with stable angina(SA)receiving conventional therapy.METHODS:Fifty-eight chronic stable angina(CSA)patients were randomly assigned to 2 groups:the SYC group(n=28)treated with SYC plus conventional therapy while the control group(n=28)with conventional therapy alone.The patients were allowed to take nitroglycerine if number of the angina attacks ≥ 2 per day.The course of treatment fro both groups was 12 weeks.RESULTS:The total ischemic time during 24 hours,the ST segment decreasing amplitude and the frequency of angina pectoris attacks in two groups were all improved significantly after treatment(P
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OBJECTIVE:To investigate the occurrence features of adverse drug reactions(ADR)and evaluate the quality of ADR reports in our hospital in order to promote clinic rational drug use and improve the quality of ADR monitoring.METHO-DS:A total of 150 ADR cases collected in our hospital during 2005～2006 were analyzed in respect of ADR patients' age and sex,drug kinds,ADR-involved organs or systems and clinical manifestations,ADR report quality etc using Excel.RESULTS:The ADR were predominantly induced by antimicrobial drugs and characterized by the damage of skin and its appendants.The ADR reporting rate was on the low side and the reporting quantity remained to be enhanced.CONCLUSION:ADR monitoring and publicizing should be further reinforced and professional staff's responsibility awareness remains to be improved to lessen ADR incidence.
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OBJECTIVE:To study the general pattern and characteristics of the ADRs associated with Houttuynia cordata injection(HCI).METHODS:An analysis was conducted on55cases of ADRs induced by HCI reported in domestic medical jou_ rnals in recent years.RESULTS:The ADRs of HCI were not related to the dosage given.The onset of ADRs was commonly within30min during infusion.The ADRs mostly occurred in groups of patients under age20and from30to59years of age.The ADRs could involve multiple organs and systems,and the clinical manifestations were varying,of which allergic reaction was the commonest one including anaphylactic shock.CONCLUSION:The mechanism of allergic reaction induced by HCI remains to be further studied.Clinical physicians,nurses and pharmacists should pay more attention to the ADRs of HCI.