Prescription Analysis Of Potential Drug-drug Interaction Related To Antidepressant And Systematic Review Of Shugan Jieyu Capsule Used As Adjunctive Therapy For Functional Dyspepsia

BackgroundsDrug-drug interactions (DDIs) refer to effect change induced by drug combination. DDIs in nature are subdivided into pharmacokinetic and pharmacodynamic interaction. The majority of pharmacokinetic interactions is the result of inhibiting or inducing the cytochrome P450liver enzymes. Pharmacodynamic interaction is characterized by additive, synergistic, or antagonistic effect, thereby influencing the response of drug. On one hand, DDIs can improve drug efficacy; on the other hand, it may lead to adverse drug reaction (ADR). Some researches have documented that more than20%of ADR is associated with DDIs. In addition, DDIs may lead to severe ADR and need hospitalization. Approximately37%-60%of patients admitted to the hospital have one or more potential DDIs. Thereforeit is important to reveal the kind and proportion of potential DDIs in order to avoid adverse drug reaction in clinical pharmacy service.In clinical practice, screening of potential DDIs is mainly conducted through medical booksand specialized databases review by pharmacy professional. To date, the DDIs information databases include Drug-Reax system, Hansten and Horn, Drug Interactions Facts, Prescription Automatic Screening System (PASS), Clinical Drug Consultation System and reference for clinical medication.Psychiatric drug represented by antidepressant is metabolized mainly by P450., DDIs may occur due to the enzyme activity change in two or more psychiatric drug combination. In addition, long-term use of psychiatric, to some extent, increases the risk of adverse drug interactions. Therefore, it is of significance to evaluate the DDIs of psychiatric drugs.ObjectivesThrough assessing the prevalence and severity of potential DDIs in outpatient prescription containing psychiatric drug, and analyzing the typical and serious potential DDIs to provide some references for clinical rational drug use.MethodsOutpatient prescriptions containing psychiatric drugs were collected in Shanghai Fengxian Center Hospital (a third grade general hospital, referred to as Center Hospital), Shanghai Fengcheng Hospital (a second grade general hospital, referred to as Fengcheng Hospital) and Fengxian Mental Health Center (a psychiatric specialist hospital, referred to as Mental Health Center). Prescriptions date was restricted in June1,2013to June30,2013. Patients’ age, gender and medications were recorded. Potential DDIs were screened by Drug Interaction Fact and were classified according to significance, onset, severity and documentation. SPSS13.0was used to analysis data. Prevalence of Potential DDIs between the three hospitals was compared by chi-square test. A p-value<0.05was considered statistically significant.Results1. General information:2357prescriptions containing psychiatric drugs were collected. The number of prescription obtained from3different hospitals were280,764and1313, respectively, with1016males and1341females, average age of53.82±16.82(range from6to97). The number of female was more than male patients in all three hospitals’s prescriptions. Middle age population (41-65) makes up about half of the total number of patients.2. Drug frequency:most of prescriptions are single drug. The proportion of psychiatric drug-general drug combination in Mental Health Center was less than the other two hospitals; however, psychiatric drug-psychiatric drug combination rate in Mental Health Center was more than the other two hospitals. The proporation of psychiatric drug alone in Fengcheng Hospital, Center Hospital and Mental Health Center were38.2%,27.4%and60.5%respectively. The proporation of psychiatric drug combination in Fengcheng Hospital, Center Hospital and Mental Health Center were61.8%,72.6%and39.2%, respectively. The proporation of psychiatric drug-psychiatric drug combination in Fengcheng Hospital, Center Hospital and Mental Health Center were26.8%,20.4%,38.3%。, respectively.The proportion of antidepressant was highest among psychiatric drugs in all three hospitals prespriptions. Rate of antidepressant in Fengcheng Hospital and Center Hospital were74.6%and47.6%respectively. Rate of antidepressant and antipsychotic in Mental Health Center were61.6%and54.8%, respectively.3. Potential DDIs:In this study,2357prescriptions were reviewed.433potential DDIs were identified.274were psychiatric drug-psychiatric drug DDIs and159was psychiatric drug-general drug DDIs. The overall incidence of potential DDIs was18.4%. Prevalence of potential DDIs in Fencheng Hospital, Center Hospital and Mental Health Center was15.4%,13.9%and21.6%, respectively (P<0.05). There was no significant difference between Fencheng Hospital and Center hospital.The most common potential DDIs were chlorpromazine plus phenytoin (Fengcheng Hospital), clonazepam/estazolam plus rosuvastatin calcium (Center Hospital) and paroxetine/sertraline/fluoxetine plus risperidone (Mental Health Center). In addition, trazodone plus serotonin reuptake inhibitor, risperidone plus serotonin reuptake inhibitor and clozapine and risperidone were considered as severity of major level, which account for30.6%of potential DDIs in Mental Health Center.ConclusionsPotential DDIs of psychiatric drug represented by antidepressant are common among outpatient in three different hospitals in Fengxian district of Shanghai. Mental Health Center had the highest prevalence of potential DDIs compared with other two hospitals. In order to reduce adverse drug reaction and to improve level of clinical rational drug use, clinical pharmacists should be involve in clinical treatment work and review potential DDIs strictly. BackgroundsFunctional dyspepsia (FD), also known as nonulcer dyspepsia, is one of the most common gastrointestinal disorders encountered in clinical practice. It is defined by the Rome III criteria as the presence of chronic dyspeptic symptoms in the absence of underlying organic, systemic, or metabolic disease that is likely to explain the symptoms. FD has considerable negative impact on quality of life. The pathogenesis of FD is not clear and is thought to be involved with multiple factors. To date, there is no curative treatment available for patients with FD and standard therapyis not yet established. Drugs targeting gastric modulation (antisecretory and prokenetic) are usually considered as first-line empirical management.Recently, researches have showed that FD is associated with depression closely. Antidepressant is also prescribed due to high co-morbidity rate of psychiatric illness in FD patients. However, it is controversial for evidence-based medicine data on antidepressant use. Several systematical reviews showed that antidepressant is effective, while one trial concluded that treatment with the antidepressant venlafaxine is not more effective than placebo in FD patients. Another study reported that sertraline was not superior to placebo for FD management.Shugan Jieyu capsule (referred to as SGJY), approved by China’s State Food and Drug Administration in2008, is the first traditional Chinese medicine compound for mild to moderate depression. It is consisted of St. John’s wort (Hypericum perforatum) and Acanthopanax senticosus, both are beneficial for patients with depressive disorders. In pharmacological experiment, SGJY reduced the depression symptoms of chronic unpredictable mild stress model rats. In China, a few FD patients obtained satisfactory efficacy through taking SGJY capsule as well as gastrointestinal drugObjectivesIn order to provide new evidence for the treatment of FD, the effects and safety of SGJY used as adjunctive therapy for FD were evaluated in this meta-analysis of randomized controlled trials.Methods1. Information retrieval:A comprehensive search for relevant studies was performed in PubMed, Cochrane library, Chinese National Knowledge Infrastructure, Wanfang Data, Chinese Biomedical Literature Database and VIP information database. The search deadline was April30,2012.2. Inclusion and exclusion criterion:A pre-stated inclusion and exclusion criterion was used for studies selection.3. Quality assessment of included studies:The methodological quality of all included studies was assessed using Cochrane collaboration’s tool for assessing risk of bias.4. Data extraction:Information extracted from the studies included the name of the first author, year of publication, location of the study, number of participants, age of participants, male-female ratio, number of treatment responses, recurrence rate, adverse events.5. Data analysis:Meta-analysis was carried out using Review Manager Software, developed by the Cochrane Collaboration.Results1. According to the search strategy, a total of52potentially relevant studies were output. After selection,14RCTs were identified.2. General information:A total of1576participants included in this study. Ages of participants ranged from16to85years old. Of the participants,704were males and872were females. All studies published in Chinese journal.3. Risk of bias of included trials:All included trials had an unclear risk of bias.4. SGJY+gastrointestinal drug (GD) vs GD:The results showed that total effective rate of SGJY combination with GD were significantly higher than GD only [OR=4.17,95%CI (3.17,5.45), P<0.00001].5. SGJY+mosapride vs mosapride:The results showed that total effective rate of SGJY combination with mosapride were significantly higher than mosapride only [OR=3.71,95%CI (2.69,5.11), P<0.00001], and that recurrent rate of SGJY combination with mosapride were significantly lower than mosapride only [OR=0.18,95%CI (0.10,0.32), P<0.00001].6. SGJY+itopride vs itopride:The results showed that total effective rate of SGJY combination with itopride were significantly higher than itopride only [OR=9.63,95%CI (2.96,31.25), P=0.0002].7. SGJY+trimebutine maleate (TM)+Compound Azimtamide (CA) vs TM+CA:The results showed that total effective rate of SGJY combination with TM and CA was significantly higher than TM combination with CA.8. SGJY+omeprazole vs omeprazole:The results showed that total effective rate of SGJY combination with omeprazole were significantly higher than omeprazole only [OR=4.73,95%CI (1.82,12.33), P-0.001].ConclusionsThe results of existing RCTs preliminarily confirm that SGJY combination with GD is more effective compared with GD monotherapy in the management of FD. Due to the unclear risk of bias in these including trials, definite conclusion for clinical practice could not be drawn. More high-quality RCTs need to be carried out according to CONSORT statement in order to give high level of evidence, which would contribute to the treatment of FD. BackgroundsEvidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions for the care of individual patient. Systematic reviews and meta-analyses provide timely, best and available evidence for clinical decision. They have become increasingly important source of evidence for clinical practice. Systematic reviews and meta-analyses of high-quality are evidences of the highest level for clinical decision-making.There are a few differences between systematic reviews and meta-analyses. Systematic review is the application of strategies that limit bias in the assembly, critical appraisal, and synthesis of all relevant studies on a specific topic. Meta-analysis is a systematic review that uses statistical methods to combine the results of two or more studiesSystematic review was introduced in China in the late1980s, and was developing rapidly in our country. More and more literature association with systematic review/Meta analyses was published in medical journals. Although these systematic reviews/meta-analyses could help-to a certain extent-to make decision in some conflicting clinical results, they bring a lot of perplexity at the same time. If authors were not proficient in the method of systematic reviews, their reviews could not produce accurate and unbiased outcome. These low quality reviews or analyses therefore mislead readers. As the number of systematic review and meta-analysis published in Chinese journal increased, urgent attention should be paid to the quality of them.ObjectivesIn this study, we evaluated the reporting and methodological quality of systematic reviews/meta-analyses on antidepressant therapy published in Chinese journal. We tried to locate any defects in systematic review and meta-analysis, aiming to enhance the reliability of systematic review and meta-analysis published in Chinese journal.MethodsA comprehensive search for published systematic review/meta-analysis was performed in Chinese National Knowledge Infrastructure, Wanfang Data and Chinese Biomedical Literature Database. The search deadline was April30,2012. The search key words were used as following:meta-analysis, systematic review, depression and antidepressant (in Chinese). In addition, Chinese Journal of Evidence-Based Medicine was manually searched.A pre-stated inclusion and exclusion criterion was used for review/meta-analysis selection. Data in qualified reviews were extracted into a Microsoft Excel database for analysis. Methodological quality and reporting quality of systematic review/Meta analysis was scored by the Overview Quality Assessment Questionnaire (OQAQ) and Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), respectively.Results1According to the search strategy, a total of1041potentially relevant reviews were output. After selection,68reviews were identified.2. General information:The overall tread of reviews/meta-analyses on antidepressant therapy published in Chinese journals over12years is upward. Among the68reviews,20were published in Chinese Core Journals. The total citations of all68reviews were127(the average citation of them was1.88). The maximum citation was27and the minimum was0.3. Methodological quality:The mean score of OQAQ was3.82±1.47with the lowest score1.5and the highest6.5. No one in68reviews responded "yes" to all first9questions. The deficiencies of methodological quality mainly contained data collection; literature search, data selection and quality assessment for include original studies.4. Reporting quality:The mean score of PRISMA was15.18±3.95with the lowest score was5and the highest was23.5. No one of68reviews was completely in compliance with all27checklist items. The main problems of reporting quality were incomplete report in structured abstract, search strategy, bias control, result of study (lack of forest plot) and funding.ConclusionsThe quality of systematic reviews of antidepressant therapy in China was poor. Further improvement on quality of methodology and reporting of systematic reviews should be highlighted. Chinese reviewers should master the methods of systematic review comprehensively and strict control all kinds of bias according to Cochrane Collaboration procedures.