Objective To investigate the adverse drug reactions (ADRs) of patients with SARS in Xiao Tang Shan Hospital. Methods We developed and distributed Drug Use Handbook and established ADRs monitoring group to guide resaonable drug use. We followed up the process and collected clinical report on ADRs. We retrospectively analyzed the data on ADRs by the classification and grade of ADRs according to WHO and Hospital Information Sysytem (HIS) of Chinese PLA General Hospital. Results We collected 193 (87 males and 106 females) patients with ADRs among 680 SARS patients with incidence rate of ADRs of 28.38%. The ADRs incidence rate was higher in females and elders. Critical SARS patients and SARS patients with diabetes were more susceptible to ADRs. Large dosage and combination of drugs may induce ADRs. Steroids may be a main cause of ADRs. The ADRs incidence rate induced by injection was higher than that induced by all kinds of oral drugs. ADRs mainly happened in hematological, endocrine and digestive systems. Conclusion SARS patients are prescribed many kinds of medications. Large dosage of so many medications may lend to high incidence rate of ADRs. Steroid should be cautiously used in the treatment of SARS.
In phase II clinical trial of Compound Prescription of Huangyaozi (Dioscorea bulbifera L.), 7 cases out of 37 developed (18.92%) impairment of liver function. As a result, the ethic committee required researchers to report all data of safety of the drug and have all subjects rechecked about their liver function so as to provided reasonable evidence for the scientifical evaluation of the relationship between the drug and the adverse event and the succedent suspending of the clinical trial.
Objective To investigate the method and effect of continuous improvement of adverse drug reaction (ADR) monitoring in a major public hospital’s cooperating branch hospital. Methods PDCA cycle management was used to continuously improve the quality of ADR monitoring. ADR report network platform was established in the fourth quarter of 2014; ADR report specification training for the medical personnel was held in the first quarter of 2015; a examine mechanism was built in the second quarter of 2015. The quality and quantity of ADR monitoring before and after the PDCA cycle management were analyzed. Results ADR report timeliness conform to the requirements increased from 45.5% (from the first to third quarter of 2014) to 98.1% (from the fourth quarter of 2014 to the second quarter of 2015); accurate ADR types checking, normal name writting, and complete process description increased from 68.6%, 65.7%, 8.6% (from January 2014 to Frequency 2015) to 92.9%, 96.4%, 85.7% (from March to June 2015); the quantity of ADR report was obviously improved. Conclusion Learning from public hospital’s experience and considering its own condition in ADR monitoring, cooperating branch hospital utilizes PDCA cycle management which could continuously improve the ADR monitoring.
Objectives We conducted a literature review of 33 kinds of Traditional Chinese medicine injections (CMIs) on the national essential medicine list (2004 edition) of China in ADR articles to retrieve basic ADR information and research trends related to CMIs and to provide evidence for the research and development as well as the rational use of CMIs, particularly pharmacovigilance and risk management of CMIs. Methods We electronically searched Chinese Biomedical Literature Database (CBM, Jan. 1978-April 2009), the China National Knowledge Infrastructure Database (CNKI, Jan. 1979-April 2009), Chinese Science and Technology Periodical Database (VIP, Jan. 1989-April 2009) and the Traditional Chinese Medicine Database (Jan. 1984 April 2009). We also retrieved the websites of Ministry of Health and State Food and Drug Administration, to collect data about CMIs ADRs reports and regulations from “Newsletter of Adverse Drug Reactions” (Issue 1 to 22). Then we descriptively analyzed all the results on the year published, periodicals and types of study design of included ADR literatures, the major CMIs as well as the regulations about their ADRs. Results (1) There were 5 405 citations found in total and 2160 were removed because of duplication. After screening the title, abstract and full text of the selected papers, 1 010 studies finally met the eligible criteria. (2) The total and cumulative amount of research articles published about CMIs ADRs significantly increases over time. (3) The included 1,010 articles were scattered among 297 periodicals. A total of 55 journals on pharmaceutical medicine, containing 399 articles, accounted for 39.50% of total; 64 journals on traditional Chinese medicine and pharmaceutical medicine, containing only 197 articles, amounted for 19.50% of total. Only 22 periodicals were included on the core journals of the Beijing University List (2008 edition) (8.94% of the total journals in the list), which published 129 articles (12.77% of the total articles published). (4) We categorized the articles included into eight categories based on their content and study methodology. There were: 348 case reports and 254 case series which accounted for 34.46% and 25.15% of the total articles, 119 overviews (11.78%), 116 randomized controlled trials (11.49%), 78 cross-sectional studies (7.72%), 61 ADR literature analyses (6.04%), and 28 non-randomized controlled clinical studies (2.77%). (5) In the three of top ten journals, "Adverse Drug Reactions Journal", "China Medical Herald", and "Chinese Pharmaceuticals" published literature accounted for 5.84%, 3.76% and 2.67% of the total respectively. (6) The reports of ADRs to Shuanghuanglian, Qingkailing and Yuxingcao injections were the most in all reports for CMIs (All the three injections had more than 200 articles, accounting for 41.95% of the total). The Ministry of Health and the State Food and Drug Administration took measures to supervise them. (7) The four kinds of CMIs (Shuanghuanglian, Ciwujia, Yuxingcao, and Yinzhihuang injections) among the top 5 reported ADR literatures were removed from the market or were suspended for sale. The varieties and numbers of reports for CMIs ADRs have relationship with the supervision to them. Conclusions (1) Articles published on CMIs ADRs increased year by year, but overall the research is of low quality and is scattered in a large number of sources. (2) It is very urgent to create a clear standard to grade ADRs of CMIs for the risk management. (3) It is necessary to enforce safety re-evaluation work for CMIs and to promote the clinical rational use.
Using Chinese Materia Medica (CM) as injections is an innovation that is proving effective in extensive clinical use in Mainland China. However, recent reports have focused on adverse reactions, ignoring the considerable successes of these preparations. In order to achieve balance in the media and in the minds of the public, we suggest the first step is to clarify the concepts of and differences between adverse drug reactions (ADR) and adverse events (AE) for all concerned—the public, medical practitioners, government officials, and lawmakers. Second, the State Food and Drug Administration should raise the requirements for Chinese Medicine Injection (CMI) registration and license approval and emphasize the importance of evidence-based CMI development and evidence-based CMI license approval. Thirdly, drug companies and institutions should reinforce basic research about the quality control of herbs and CMI-drug interactions. Fourth, the Government should clarify the legal responsibilities for CMI approval agencies, CMI developers, medical doctors, and patients. Fifth, the medical association and Government should enhance training for health care professionals concerning the usage of CMIs. And finally sixth, State Food and Drug Administration should monitor the content and quality of the directions for use of CMI.
Objective To assess the efficacy and safety of glimepiride for type 2 diabetes mellitus (T2DM). Methods We searched the literature from PubMed, Ovid (All EBM Reviews), CNKI, Wanfang, VIP, CBM and other databases. Evaluating the quality of the study according to Cochrane systematic reviews, Meta-analysis was performed for the results of homogeneous studies by The Cochrane Collaboration’s software RevMan 5.0, and the heterogeneous data conducted a descriptive qualitative analysis. Results Six RCTs included in the analysis and Meta-analysis was not performed due to the insufficient data (for the median or standard deviation). Six RCTs are multi-center, randomized, double-blind, placebo-controlled trials. The results showed that glimepiride groups to reduce glycosylated hemoglobin, lower fasting and postprandial blood glucose, postprandial plasma insulin enhance the efficacy were statistically significant differences (Plt;0.05) compared to placebo groups. Four studies informed the impact of fasting plasma insulin (FI) and 3 studies showed that the glimepiride groups improving the fasting plasma insulin (FI) were statistically significant differences (Plt;0.05), but 1 study showed the two groups had no significant difference (Pgt;0.05). All studies showed minor adverse reactions of glimepiride. Conclusion Glimepiride can reduce the glycosylated hemoglobin, lower the fasting and postprandial blood glucose, improve fasting and postprandial plasma insulin for type 2 diabetes patients, and have minor adverse reactions. In a word, glimepiride is an effective and security sulfonylureas drug.
Objective To improve the knowledge of lung injury induced by rituximab. Methods Clinical data of 5 lymphoma patients with lung injury caused by rituximab chemotherapy were analyzed. Results Five patients received chemotherapy including rituximab, and had fever, cough and dyspnea after 3 to 5 chemotherapy cycles. Chest CT showed bilateral diffuse interstitial infiltrates. All 5 cases experienced hypoxemia or respiratory failure. Clinical symptoms were improved 3 to 5 days after the treatment of glucocorticoids, and pulmonary lesions were significantly alleviated 1 to 2 weeks after the treatment. According to the literature, the incidence rate of lung injury caused by rituximab was 0. 03% to 4. 9%, which has increased recently. Conclusions With the comprehensive application of rituximab, lung injury caused by this drug is not rare. The good prognosis depends on early diagnosis and treatment by further recognition of the side effect of rituximab.
Adverse drug reactions (ADR) are one important type of safety data for investigational products and post-market drugs. Standardized coding is beneficial to normative ADR analysis and reporting. However, terms peculiar to traditional Chinese medicine (TCM) are not included in the widely used international adverse reaction terminologies. This paper briefly introduced the differences of World Health Organization adverse reaction terminology (WHOART) and medical dictionary for regulatory activities (MedDRA) which was developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Based on the existing development of TCM terminologies for coding ADRs, basic path for developing internationally recognized TCM terminologies was proposed in this paper.
Objective To assess reduction of adverse drug reaction incidence in patients with colorectal cancer receiving Jianpi herbs combined with chemotherapy. Methods The randomized controlled trials (RCTs) comparing Jianpi herbs combined with chemotherapy were searched through CBMdisc, CJFD, Wangfang Data and PubMed. The search was updated to September 2007. Software RevMan5, provided by Cochrane Library, was used to perform meta-analysis. Results Six RCTs were identified in this systematic review. All the methodology quality of the enrolled RCTs was gaded C. The pooled analysis showed that Jianpi herbs combined chemotherapy significantly reduced the incidences of grade I and grade II leucopenia [grade I with RR= 0.50 and 95%CI (0.31 to 0.80); grade II with RR= 0.37 and 95%CI (0.21 to 0.66)], grade II nausea and vomiting [RR= 0.51, 95%CI (0.31 to 0.84)] compared with routine chemotherapy. There was no statistical difference in reduction of neurotoxicity between the two groups. Conclusion The methodological quality of the RCTs using Jianpi herbs combined with chemotherapy on treating colorectal cancer should be improved. Based on this systematic review, Jianpi herbs combined with chemotherapy may reduce the incidence of mild to moderate adverse drug reaction, such as leucopenia and nausea and vomiting, in patients with colorectal cancer. Well-designed RCTs are needed in the future.
A total of 109 varieties of Chinese medicine injections have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers’ inadequate attention to ADRs of Chinese medicine injections, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from Chinese medicine injections, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.