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.
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.
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.
Objective To analyze the withdrawal reason of natalizumab in depth based on the serious adverse reaction reports and approval channel, and to provide decision references for more safe and effective report method of other biologicals. Methods We searched MEDLINE, EMbase, and the official websites of Food and Drug Administration (FDA) for case reports, approval channel, and the relevant information of drug marketing or withdrawal. Results Four case reports and fourteen official reports were included. Three cases of progressive multifocal leukoencephalopathy (PML) were reported in the clinical trials after natalizumab’s initially approval with two dead and one disabled, which could be retrieved by hemodialysis (2 cases hitherto). Consequently, multiple sclerosis (MS) patients were willing to bear the risk. Two cases of natalizumab-related PML (0.06‰) were confirmed in 32 000 patients without death report after two years of its remarketing, in July 2008. Another PML patient was reported in October 2008. Because of its non-substitutability for treating MS and Crohn disease (CD), FDA announced that patients could still use natalizumab under the close monitoring. Conclusion (1) The most serious adverse reaction of treating MS and CD with natalizumab is PML, but it can be preventable and curable now. The monitoring findings of efficacy and adverse reaction during the postmarketing indicate that the review system is perfect and practicable relatively, and can give references for other high-risk drugs on the fast or standard approval channel, for example, Chinese medicine injection can draw lessons from it. (2) The remarketing of natalizumab not only provide significant risk management precedent for other drug-development firms, but also brings hope to the remarketing or relaunching clinical trials for the suspected sideeffect drugs. (3) Because of the fast-track reviewing of natalizumab and the overlap between the research of Good Clinical Practice (GCP) and the post-marketing evaluation, we should continue to track the information and provide new evidence.
Valproic acid can reduce the frequency of seizures through various mechanisms and is widely used in clinical practice as a monotherapy or adjunctive treatment for various types of epilepsy and epileptic syndromes. In addition, valproic acid has significant therapeutic effects on comorbidities associated with epilepsy, such as migraines and psychiatric disorders. It can also be effective in terminating status epilepticus and is commonly used as a broad-spectrum antieseizure medication in clinical settings. However, valproic acid has side effects such as teratogenicity, infertility, and menstrual disorders. Additionally, when used in combination with other drugs, the interactions between medications should be carefully considered. Therefore, in clinical practice, it is necessary to strictly adhere to the indications and dosage regimens for the use of valproic acid. This article provides a comprehensive review of the use of valproic acid in different types of seizures, epileptic syndromes, comorbidities associated with epilepsy, post-craniotomy cases, status epilepticus, and special populations. It also summarizes the combination therapy of valproic acid with other drugs, providing a basis for the rational use of valproic acid and individualized drug treatment selection for epilepsy patients.
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.
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.
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.
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.