Objective To investigate the effects of antiepileptic drugs (AEDs) with warfarin functions and blood coagulation system, to provide the reference for clinicians of the selection of AEDs under the combination therapy with warfarin. Methods Analyse the clinical data of the patient with symptomatic epilepsy from the Second Clinical Medical College of Guiyang University of Chinese Medicine on April 1, 2017, whom taking AEDs and warfarin at the same time, clear the drug adverse reactions, and analysed related literature. Results After the treatment with valproate, abnormal blood coagulation, a danger and emergency data appeared, so we stopped using warfarin immediately, and reduce the dosage of valproate gradually, insteadly, we used levetiracetam as antiepileptic therapy. Monitoring blood coagulation function, when it returned to normal, restart warfarin anticoagulant therapy. Conclusions When start antiepileptic treatment in relevant basic diseases of symptomatic epilepsy, for a variety of combination reactions, AEDs can affect the anticoagulant effect of warfarin, so we need to consider the interaction between drugs and avoid adverse reactions.
Objective To assess the value of arsenious acid in treatment for metastatic liver cancer and inspect its adverse reaction through comparison between the therapeutic effect of arsenious acid-FOLFOX4 combined chemotherapy and that of single FOLFOX4 chemotherapy. Methods Twenty-six patients with metastatic liver cancer were selected from July 2006 to December 2007 in Huadong Hospital. All the cases were averagely divided into therapy group and control group randomly, arsenious acid combined FOLFOX4 chemotherapy was performed in therapy group and single FOLFOX4 chemotherapy in control group. Results The total of 26 cases completed at least 2 cycles of arsenious acid-FOLFOX4 combined chemotherapy or single FOLFOX4 chemotherapy. During 6-24 months follow-up (median 12.5 months), the average survival time of the therapy group was 242 d, the median survival time was 281 d, and the average survival time of the control group was 227 d, the median survival time was 246 d, there was no statistical difference between two groups (Pgt;0.05). Pain: There were 2 cases of complete remission (CR), 5 cases of partial remission (PR), 2 cases of stable disease (SD) in therapy group, the objective effect (CR+PR+SD) was 9 cases. There were 1 case of CR, 3 cases of PR, 2 cases of SD in control group, the objective effect (CR+PR+SD) was 6 cases. Objective efficacy: There were no CR cases in two groups. In therapy group, there were 5 cases of PR, 6 cases of NC, 2 cases of PD, the objective effect (CR+PR) was 5 cases, the benefit (CR+PR+NC) was 11 cases. In control group, there were 2 cases of PR, 4 cases of NC, 7 cases of PD, the objective effect (CR+PR) was 2 cases, the benefit (CR+PR+NC) was 6 cases. There was no significant difference of the objective effect between two groups (Pgt;0.05), but the benefit was significantly different (Plt;0.05). The major toxic reactions were digestive tract side effect, hepatic and hematological toxicity in two groups. Conclusions Arsenious acid-FOLFOX4 combined chemotherapy can lead to good therapeutic effect. Arsenious acid will not increase the adverse reaction of normal chemotherapy.
ObjectiveKetogenic diet (KD) has shown promising efficacy in the treatment of super-refractory status epilepticus (SRSE); however, its adverse effects have not been systematically evaluated. This study aimed to analyze the safety profile of adjunctive KD therapy for SRSE and explore potential risk factors. MethodsProspective data from 13 SRSE patients (3 adolescents, 10 adults; mean age 34.6±18.4 years) at Xuanwu Hospital, Capital Medical University (July 2020–December 2024) who received KD adjunctive therapy after failing conventional treatments were collected. Adverse reactions were observed, and a systematic literature review (up to March 2025) was conducted for meta-analysis. ResultsIn the single-center cohort of 13 patients, common adverse events included gastrointestinal intolerance (53.8%), hematologic and metabolic abnormalities such as thrombocytosis (84.6%), hyperammonemia (76.9%), dyslipidemia (69.2%), and hypocalcemia (69.2%), as well as nutritional deficits including hypoalbuminemia (61.5%), anemia (53.8%), and transient weight loss (61.5%). Most adverse events were transient and reversible with timely adjustments to the KD regimen. The meta-analysis (25 studies, 251 cases; mean age 16.1±19.0 years) revealed a spectrum of major adverse events, including gastrointestinal intolerance (26.7%), hypoglycemia (19.1%), acidosis (17.5%), and hyperlipidemia (12.0%). ConclusionsThe ketogenic diet as adjunctive therapy for super-refractory status epilepticus demonstrates a manageable safety profile. Reported adverse events are primarily confined to gastrointestinal intolerance, metabolic derangements, and nutritional deficits, with notable occurrences of thrombocytosis and hyperammonemia requiring timely clinical management. This study provides critical evidence-based support for KD implementation in SRSE treatment protocols.
ObjectiveTo systematically review the characteristics of adverse transfusion reaction in Grade Three Class-A hospitals in China, and to provide scientific evidence for related control and prevention work. MethodsSuch databases as the PubMed, EMbase, The Cochrane Library (Issue 11, 2014), CNKI, VIP, WanFang Data and CBM were searched for studies investigating the characteristics of adverse transfusion reaction with ≥6 months observation time in Grade Three Class-A hospitals in China up to November 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed by using the R 3.1.1 software. ResultsSeventy-two studies involving 1 660 472 cases of blood transfusion were included. The results of pooled analysis showed that the total number of adverse transfusion reaction rate was 0.58% (95%CI 0.48 to 0.69). Sub-group analysis shows that the blood transfusion adverse reaction rates in the eastern, central and western regions were 0.42% (95%CI 0.31 to 0.55), 0.55% (95%CI 0.41 to 0.70), 0.56% (95%CI 0.43 to 0.70), respectively; and there were statistical differences between regions (P<0.05). Different types of adverse transfusion reaction rates were 38.85% (95%CI 34.27 to 43.53) for non hemolytic febrile reaction and 55.67% (95%CI 50.79 to 60.50) for allergic. The adverse reactions incidence of different kinds of blood products transfusion occurred were 0.41% (95%CI 0.32 to 0.50) in red blood cell, 0.57% (95%CI 0.43 to 0.72) in plasma, 1.00% (95%CI 0.73 to 1.30) in platelet. The incidence of adverse reaction of platelet transfusion was significantly higher than that of red blood cell and plasma (P<0.05). ConclusionThere is a big gap between domestic and foreign blood transfusion adverse reaction reports, therefore comprehensive measures should be taken for further prevention and control.
Objective To investigate the efficacy and safety of neo-adjuvant chemotherapy for stage ⅠB2-ⅡB cervical cancer. Methods From June 2012 to December 2014, 66 patients with stage ⅠB2-ⅡB cervical cancer were selected and treated by PT (cisplatin/ carboplatin and taxol/docetaxel) as neo-adjuvant chemotherapy prior to surgery. Neo-adjuvant chemotherapy response and toxicity were collected and analyzed. Results The extinctive condition of tumor by neo-adjuvant chemotherapy: the complete remission rate was 10.6% (7/66), partial remission rate was 59.1% (39/66), and the total effective rate was 69.7%. The main toxicities were myelosuppression (59.1%, 39/66) and gastrointestinal reactions (33.3%, 22/66). The toxicities could be tolerated or relieved by prevention and treatment. The effective rate of chemotherapy for cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma was 72.6%, 33.3% and 0%, respectively, with significant differences among the three types (P<0.05). The effective rate of chemotherapy for high, medium and low differentiated cervical cancer was 100.0%, 77.3% and 55.9%, respectively, with significant differences among the three degrees (P<0.05). Conclusions Neo-adjuvant chemotherapy is proved to be a safe and effective complementary treatment for most patients with locally advanced cervical cancer. Due to the limitation of sample size, the correlations between therapeutic effect and tumor differentiation degree and between therapeutic effect and pathological type need further study.
ObjectiveAnalysis prophylactic anti-epileptic drugs (AEDs) therapy in patients with brain tumor-related epilepsy (BTE) to observe whether seizures occurance, frequency will decrease, and the adverse reactions risk assessment of the patient's after using AEDs in 3 months and 12 month. MethodsRetrospective analysis of the cases and follow-up data of patients with the diagnosis of brain tumors in the Second Affiliated Hospital of Chongqing Medical University in June 2011 to February 2015. Through the strict inclusion criteria and exclusion criteria review, the sixty-eight standard patients were divided into two groups:treatment group (44 cases) and control group (24 cases), and compared in the incidence of epilepsy and seizure frequency two groups of patients, and observe the adverse reactions after using AEDs. And analyzed the outcome of patients with brain tumors at 3 months and 2 months. ResultsThrough at least 1 year follow up, compared the data of patients in the two groups with seizure incidence at 3 months and with seizures frequency≥3 times at 12 months, the difference was statistically significant (P < 0.05).In the treatment group, however, 7 patients experienced mild adverse reactions, such as dizziness, fatigue, nausea and vomiting, mild white blood cell reduction, mild liver damage, menstrual cycle changes, mental and behavioral abnormalities, etc.A patient discontinued due to mental disorder, and a patient change AEDs due to menstrual cycle change. All patients had no serious adverse reactions. Conclusions①prophylactic use of AEDs can significantly reduce the incidence of seizures at 3 months; ②Although prophylactic use of AEDs did not reduce the incidence of seizures at 12 months, but can reduce the frequency of seizures; ③The risk of adverse reactions of prophylactic use of AEDs in patients with BTE is relatively low.
Objective To study the efficacy and adverse events of adjunctive perampanel in children with refractory epilepsy. Methods A prospective study was carried out in 45 children with refractory epilepsy, who were treated in our hospital from January 2020 to February 2021 using perampanel as an add-on treatment, with a criteria for enrollment and the starting dose of perampanel. Follow-up would be taken at once a month. Afte 3 months would check blood routine, liver function, kidney function and humoral immunity. The EEG was reviewed after 6 months. The initial dose of perampanel was 0.04 mg/(kg·d) (the maximum didn't exceed 2 mg/d), increasing by 0.04 mg/(kg·d) every two weeks, and the maximum maintenance dose didn't exceed 6 mg/d. The efficacy and adverse reactions of perampanel were evaluated by comparing the seizure frequency and EEG results before and after a 6-month add-on therapy.ResultsAmong the 45 children,complete seizure control was achieved in 7 cases after the therapy, and the seizure attacks were reduced in 26 cases, showing a total response rate of 73.3%. After the treatment, the epileptiform discharge of 28 children was reduced, and the effective rate was 62.22%. During the observation period, all the blood routine, liver function, kidney function,and humoral immunity of the children were normal.10 cases of adverse reactions occurred after the additional treatment of perampanel, and the adverse reaction rate was 22.22%. Conclusions Perampanel has good efficacy and safety in the add-on treatment of refractory epilepsy.
Objective To explore the clinical efficacy of levetiracetam (LEV) in preventing recurrence of complex febrile seizures. Methods 100 children with complex febrile seizures who visited Wuxi Children's Hospital from January 2017 to January 2020 were randomly divided into two groups, observation group (n=50, treated with oral LEV), including 28 males and 22 females, with an average age of (1.57±0.42) years; control group (n=50, treated with oral diazepam), including 26 males and 24 females, with an average age of (1.58±0.39) years. The incidence of adverse reactions, the recurrence rate, EEG changes and neural development after the treatment in both groups were observed. Results After treatment, the incidence of adverse reactions in the observation group was 4.00%, which was significantly lower (P<0.05) than that in the control group (18%). The recurrence rate of the observation group was 2.00%, which was significantly lower (P<0.05) than that in the control group (14%). The incidence of abnormal EEG in the two groups after treatment was lower than that before treatment (P<0.05), but there was no significant difference between the two groups (P>0.05). The results of neurodevelopmental assessment in both two groups were in the normal range before and after treatment, and there was no significant change (P>0.05). Conclusions LEV is effective in the treatment and prevention of complex febrile seizures recurrence, with high safety, less adverse reactions and improved prognosis.
What drug dosage range is appropriate for treatment? What drug dosage range can maximally reduce the incidence of adverse drug reaction (ADR)? The gold zone method as a new method of evidence-based medical research was proposed to study those two blind areas of drug dosage in this article. Studying the dose-effect relationship, taking gold zone as the middle range and dividing empirical range into 3 sections were the key to study design. The evidence-based survey with extremely large sample showed a U-shaped rule existing between the antibiotics’ dosage and the incidence of ADR; and the dosage in gold zone appeared at the bottom of U-shaped curve. The gold zone method for determining dosage is a special breakthrough currently for solving those two blind areas of drug dosage
This article aims to review the recall of refecoxib which increases the incidence of cardiovascular and cerebrovascular diseases and to find the methods to solve problems in post marked monitoring of drug safety.