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
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.
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 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.
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.
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 evaluate the effects and safety of procalcitonin(PCT)-guided algorithms of antibiotic therapy in critically ill patients in intensive care unit (ICU). Methods Literatures in English and Chinese concerning randomized controlled trials(RCTs) on PCT-guided algorithms of antibiotic therapy in critically ill patients was retrieved by electronic and manual search. All related data were extracted. Meta-analysis was conducted using the statistical software RevMan 5.3 on the basis of strict quality evaluation. Results Eight RCTs involving 2708 ICU patients were included, with 1360 patients in the PCT-guided group and 1348 patients in the control group. Compared with the control group, PCT-guided algorithms were associated with a significant reduction in the duration of antibiotic therapy (MD -2.44 days, 95%CI -3.25 to -1.62, P < 0.00001), and the occurrence of adverse reaction of antibiotics was also lower (RR=0.74, 95%CI 0.56 to 0.97, P=0.03), however the mortality exhibited no difference between the PCT-guided group and the control group (RR=1.00, 95%CI 0.89 to 1.13, P=0.99). Conclusion PCT-guided algorithms can shorten the duration of antibiotic therapy and reduce the occurrence of adverse reaction in critically ill patients without significant effect on mortality.
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.
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.