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 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.
ObjectiveTo develop a standardized dataset for adverse drug reactions (ADR) of Chinese herbal formula granules (CHFG) to regulate the collection content of ADR, promote the standardization and normalization of ADR data collection for CHFG, and facilitate the sharing, integration, and analysis of adverse reaction data. MethodsWe used a combination of literature research, Delphi survey and consensus meeting. ResultsA Delphi survey questionnaire was constructed based on the results of literature research, including 6 domains and 76 items. After the Delphi survey and consensus meeting, a final CHFG adverse reaction dataset was developed, including 6 domains and 75 items. The six domains were patient details, suspected drugs, other treatments/concomitant medications, detailed information on the suspected adverse reaction, possible influencing factors (causes of the suspected adverse reaction), and details of the person reporting the suspected adverse reaction. Compared with the data collected by the National Adverse Drug Reaction Monitoring Center, this dataset introduced a new domain called "Possible influencing factors", which included several items such as irrational use of CHFG, toxic varieties of Chinese herbal medicine, storage and usage conditions, physical characteristics, processing methods, and patient diet. It also contained the information on Chinese medicine syndromes and other herbs in the prescription, and modified multiple items based on the particularities of formula granules. ConclusionThe development and application of this standardized dataset of ADR for CHFG can facilitate data collection, integration, and analysis, furthermore improve doctors' awareness of prescribing safely and enhance patient medication safety.
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 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”.
ObjectiveTo systematically review the adverse drug reactions (ADRs) caused by piperacillin. MethodsPubMed, EMbase, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect case reports on ADRs caused by piperacillin from inception to December 31, 2021. Two reviewers independently screened literature, extracted data and then a qualitative systematic review was performed. ResultsA total of 168 case reports involving 170 patients were included. The male to female ratio was 1.06∶1, and the median age was 54 year old. The statistical results showed that ADRs caused by piperacillin mostly involved the whole body (n=55), followed by the blood system (n=48), skin and soft tissue system (n=39) and nervous system (n=18). The most frequently reported cases were anaphylactic shock (n=29), followed by drug fever (n=19), rash (n=17) and thrombocytopenia (n=15). The most serious ADRs were anaphylactic shock (n=29) and bullous epidermal necrolysis (n=6). ConclusionCurrent evidence shows that ADRs caused by piperacillin mostly involved the whole body and the most serious ADRs are toxic epidermal necrolysis and anaphylactic shock.
Objective To evaluate the efficacy and safety of metformin for metabolic syndrome. Methods We searched The Cochrane Library, MEDLINE, EMBASE, China Biological Medicine Database, VIP, and CMAC up to the year of 2007. Handsearches and additional searches were also conducted. Randomized controlled trials of metformin for metabolic syndrome were included. Two reviewers independently extracted data from eligible studies and evaluated the quality of included studies. Meta-analysis was performed for the results of homogeneous studies by The Cochrane Collaboration’s software RevMan 4.2.9. Results Six trials involving a total of 2442 patients with metabolic syndrome were included. Meta-analysis was not performed due to the apparent heterogeneity. Metformin, compared with placebo, exhibited more favorable effects in reducing the proportion of patients with metabolic syndrome (RR 1.27, 95% CI 1.01 to 1.60), the proportion of patients with low HDL-c (RR 1.61, 95%CI 1.16 to 2.23), wide waist circumference (RR 1.64, 95%CI 1.06 to 2.55), and high FPG (RR 1.55, 95%CI 1.17 to 2.05). Metformin was also more effective in improving FPG and insulin sensitivity. The addition of metformin to atenolol plus nitrendipine was superior to atenolol plus nitrendipine alone in reducing the proportion of patients with high TG (RR 5.57, 95%CI 1.56 to 19.84), abdominal obesity (RR 14.47, 95%CI 3.34 to 62.61), and IGT (RR 16.51, 95%CI 6.06 to 45.0). Compared with low-fat diet therapy, metformin was superior in improving FPG, 2-hour postload plasma glucose, and insulin sensitivity. No differences were observed between metformin and acarbose in the reduction of TG and FPG, but metformin was less effective than acarbose in improving 2-hour postload plasma glucose. No adverse drug reactions were reported. Conclusion Metformin has beneficial effects in reducing the incidence of high FPG, IGT, and abdominal obesity. It also proved beneficial in reducing the prevalence of metabolic syndrome and increasing insulin sensitivity. The therapeutic effects of metformin on blood pressure, obesity, and lipid profile are uncertain. There is insufficient evidence to recommend the use of metformin in the treatment of metabolic syndrome due to low methodological quality, small sample size, and limited number of trials. More high quality, large-scale randomized controlled trials are required.
To analyze the adverse drug reactions (ADRs) induced by levetiracetam, providing a scientific basis and reference for clinical safe and rational drug use.Using Chinese search terms such as "levetiracetam", " antiepileptic", "adverse drug reaction", "side effect", and English search terms such as "levetiracetam", "antiepileptic", "adverse reaction", "ADR", "side effect", and "induced", we conducted a literature search in databases including CNKI, Wanfang Data, VIP Biomedical Database, PubMed, and Web of Science from the inception of the databases until March 1, 2025. Relevant information was extracted and statistically analyzed. A total of 39 articles were included, involving 46 patients, of which 24 were male (52.17%) and 22 were female (47.83%). ADRs involved 9 organ/systems, primarily the nervous system (39.13%), muscular system (32.61%), skin (13.04%), and urinary system (10.87%), including symptoms such as irritability, hallucinations, cognitive impairment, rhabdomyolysis, papules, and frequent urination. ADRs induced by levetiracetam affect multiple organ/systems. During clinical use, patient conditions should be regularly monitored, and the dosage should be promptly reduced or discontinued upon the occurrence of adverse reactions to mitigate clinical risks.
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.
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.