Objective To analyze the adverse drug reactions (ADR) of Ciwujia injection and the relative influence factors. Methods We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. The relevant information such as the diseases for treatment; menstruum, dosage and compatibility of Ciwujia injection; the age, gender and allergic history of patients; and the category, treatment and prognosis of ADR were collected and analyzed. Results In the 800 clinical studies, only 97 (12.1%) reported 285 ADR cases, 144 ADR reports including 236 ADR cases. Of the ADR cases, the male to female ratio was 1׃1.34, mainly in 40 to 69 years group; The ADR cases mainly including anaphylactic shock and local pain in ADR reports and clinical studies, respectively; 72.3 percent ADR cases were Ⅲ to Ⅳ class, 4 anaphylactic shock cases died; the diseases for treatment of ADR cases mainly were coronary artery heart disease and cerebral infarction; 27 (11.4%) ADR cases had allergic history; The menstruum of Ciwujia injection mainly were 5% glucose, 0.9% NaCl and 10% glucose, drug incompatibility in 36 ADR cases; The usual dosage of Ciwujia injection was 20-60 ml; 196 (83.0%) ADR cases occurred in first time medication, mainly in the early 30 minutes of medication used. Conclusion (1) In both ADR reports and clinical studies of Ciwujia injection, there are some problems of ADR and adverse drug events (AE) were not easily distinguishable, key information of total prescriptions divided by drug persons were lacking, so we can’t calculate the ADR rate, the reporting quality remained to be improved. (2) To support the rational drug use, the basic researches of Ciwujia injection remains to be further studied, especially the dose-finding studies. (3) As one of the most frequently reported ADR of traditional Chinese medicine (TCM) injection, high quality ADR monitoring, normative ADR reporting and timely analyzing the ADR reason of Ciwujia injection is extremely urgent.
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.
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.
Objective Qin Kai Ling injection (QKL) is made upon traditional Chinese medicine formulation “An Gong Niu Huang Wan”, is widely used to treatment a lot of diseases. This review aims to assess the safety of QKL. Methods We searched Chinese databases CNKI, VIP from 1987 to April 2009. Two authors extracted the data. Results Totally 1 486 cases were included in this review. We unable to answer the question about the incidence of adverse drug reaction/adverse event (ADR/AE) induced by QKL due to absence of total numbers of producing and market information. It was estimated based on the limited data that the possibility of ADR/AE by using QKL should be low. We found some ADR/AE may induced by incorrect use of QKL, such as used in infants, and some incompatibility drugs were used together with QKL, four patients died in private clinics or patient’s home. We unable to distinguish the ADR or AE based on the poor reported data. Conclusion Current weak evidence shows that QKL has a low risk of ADR/AE. The use of QKL in some ADR/AE cases may be questionable. The reporting of ADR/AE needs to be much improved based on “Recommendation for reporting traditional Chinese medicine adverse drug reaction”.
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.
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.
Objective To evaluate the safety of Rongbisu capsule used for treating benign prostatic hyperplasia. Methods A total of 218 patients (average age 63.73±7.50 years old) with phase Ⅰor Ⅱ benign prostatic hyperplasia were treated with oral Rongbisu capsule at a dose of 3 granules twice daily. The therapeutic course was 6 weeks and hepatic function was determined every 2 weeks. Results The median value of ALT in 218 patients rose significantly after the patients took Rongbishu capsule for 6 weeks (P=0.001 7). There were 17 patients whose ALT level rose from normal to abnormal, the incidence was 7.80%. There were 3 patients whose hepatic function was seriously impaired (ALT＞200 IU/L). Conclusions The essential component of Rongbishu capsule is edible tulip which has been recorded in the medical literature as being toxic. Airpotato yam of which the alias is also edible tulip is easily mistaken for edible tulip. Airpotato yam is the tuber of dioscorea bulbifera L. (family dioscoreaceae) which has confirmed hepatotoxcity. Our study result indicates that in order to insure the safety of Chinese crude drug, the origin of Chinese crude drug should be defined in the formulation according to the standard of Chinese drugs preparation. Pharmaceutical enterprises should strictly abide by the standards to identify the origin of Chinese crude drugs when approving the raw materials, especially for species which are poisonous and easily mistaken.
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 analyze the clinical characteristics of adverse drug reaction (ADR) caused by 3 kinds of coronavirus disease 2019 drugs, and provide a reference for clinical safe medication. MethodsA total of 33 patients with coronavirus disease 2019 admitted to Xiangtan Central Hospital from January 20 to March 5, 2020 were selected as the research objects. The clinical data of patients with ADR during the antiviral process were analyzed retrospectively. The patients’ gender, age, type of medication, combination medication, organs or systems involved, and clinical manifestations were summarized and analyzed. Results A total of 33 patients were enrolled. A total of 21 cases of ADR were reported. The incidence of ADR is higher in patients older than 60 years (80.0%). The most common clinical manifestations are digestive tract symptoms (66.7%). The incidence of ADR is highest in the combination of lopinavir/ritonavir+arbidol+ribavirin (100.0%), followed by the combination of lopinavir/ritonavir+arbidol (85.7%). Abidol and ribavirin each caused 1 case of severe ADR. Conclusion For patients with coronavirus disease 2019, the combination of two or more antiviral drugs should be avoided, and pharmaceutical monitoring should be strengthened for elderly, severe/critical and allergic patients.
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.