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 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 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 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.
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 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.
ObjectiveTo summarize the occurrence rules of adverse reactions/events of voriconazole, analyze the reasons of adverse reactions/events, and provide reference for clinical medication. MethodsUse China National Knowledge Infrastructure, Vip Journal Integration Platform and Wanfang Data Knowledge Service Platform to search the literatures published in 2015 and before with "voriconazole" "adverse reaction" and "adverse event", classify the adverse reactions/events according to gender, age, system-organs, drug combination, occurrence time, and outcome, and analyze the occurrence regularity and reasons of adverse reactions/events. ResultsA total of 29 literatures were searched, including 44 cases. In all the adverse reactions/events, elderly patients were the most (18 cases with the age of 61-80 years old, occupying 40.9%; 13 cases with >80 years old, occupying 29.5%). Adverse reactions/events mainly involved central nervous system (45 cases, 59.2%). Proton pump inhibitors (5 cases) were the more common drug combination in the 7 drug combination cases. Most adverse reactions/events occurred in 1-7 days after medication (35 cases, 79.5%). The outcome of adverse reactions/events included 39 improvement/recovery, 1 death, and 4 unknown. ConclusionUsing voriconazole should consider the drug characteristics. Choose the drug according to the specific condition of patients, at the same time pay attention to drug interactions, contraindications, and so on. If necessary, genetic testing and therapeutic drug monitoring can be done in order to reduce the occurrence of adverse drug reactions/events.
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.
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.
ObjectiveTo analyze the clinical efficacy of decitabine contained chemotherapy regimens in the treatment of relapsed or refractory acute myeloid leukemia (AML) patients.MethodsA total of 101 patients with relapsed or refractory AML from May 2014 to December 2017 were collected retrospectively. Three schemes with a relatively larger number of users were included: 15 cases were treated with decitabine monotherapy (DAC regime); 37 cases were treated with decitabine, anthracycline antibiotic, and cytarabine (D-DA regime); and 49 cases were treated with decitabine, cytarabine, aclarubicin, and granulocyte colony-stimulatingfactor (G-CSF) (D-CAG regimen). The remission rate, blood products support strength, degree and duration of bone marrow suppression, adverse reaction, and survival time were compared.ResultsThe complete remission (CR) rates of DAC, D-DA and D-CAG regimen group were 40.0%, 48.6%, and 71.4%, respectively; the overall respond rates (ORR) were 46.7%, 54.1%, and 79.6%, respectively. The ORR in D-CAG regimen group was higher than those in the other two groups (P<0.017). The dosage of G-CSF in D-CAG regimen group were lower than those in DAC regimen group [ (1 363.0±1 037.9) vs. (2 517.0±1 163.4) μg, P<0.05]; the mean number of erythrocyte transfusion and the dosage of G-CSF were lower than those in D-DA regimen group [(6.7±4.0) vs. (14.8±10.1) U, P<0.05; (1 363.0±1 037.9) vs. (2 786.0±1474.0) μg, P<0.05]; the time to the suppression of hemoglobin and platelet in D-CAG regimen group were later than those in D-DA regimen group [(11.5±2.6) vs. (8.8±2.5) days, P=0.007; (10.9±2.6) vs. (7.6±2.5) days, P=0.002]; the time to the suppression of platelet was later than that in DAC regimen group [(10.9±2.6) vs. (7.6±1.6) days, P=0.003]. There was no statistically significant difference in the incidence of adverse reations among the three group (P>0.05). The median overall survival of D-CAG regimen group was longer than that in DAC regimen group (11.6 vs. 8.8 months, P=0.013).ConclusionAmong the three chemotherapy regimens containing decitabine, the CR and ORR of D-CAG regimen are higher, the tolerance is better, and further promotion can be attempted in qualified medical institutions.