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 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.
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.
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.
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 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”.
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 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.
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.
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.
