Interpretation of the complete scientific connotation of functional foods accurately prior to approval and registration based on animal tests and small sample size human food tests is challenging. Further technical evaluation after market introduction should be carried out on safety, health function and other aspects of those widely used commercial scale production products. According to the analysis report on the consumption situation of post-marketing population submitted when applying for product registration extension since the implementation of the functional food registration and filing management measures more than 3 years ago, the post-marketing evaluation report of functional food still lacks systematic and perfect evidence support. Based on the successful experience of evidence-based medicine and post-marketing evaluation evidence, this paper analyzes the post-marketing evaluation content, evidence source construction, evidence classification and classification of functional food, and puts forward the preliminary idea of constructing post-marketing evaluation evidence body of functional food safety and health function technology from multiple view points, so as to provide insights into evidence system research in this field in the future.
Objective To evaluate the efficacy and safety of different doses of metoprolol in the treatment of primary hypertension.Methods We searched for randomized controlled trials of different doses of metoprolol in the treatment of primary hypertension. We screened relevant studies according to predefined inclusion and exclusion criteria, evaluated the quality of the included studies, and performed meta-analyses by using The Cochrane Collaboration’s Revman 4.2.8 software. Results Five randomized controlled trials of different doses of metoprolol in the treatment of primary hypertension were included. Two were of high quality and the other three were of low quality. No study reported mortality or the incidence of cardiovascular events, but four studies reported the means and standard deviations of systolic and diastolic blood pressures and heart rate. Based on the two self-control studies, meta-analyses of the levels of systolic and diastolic blood pressures before and after treatment of different doses of metoprolol showed that the combined OR for systolic blood pressure levels was -4.62 [95%CI (-7.77, -1.47), P=0.004]; and for the diastolic blood pressure levels, the combined OR was -5.71 [95%CI (-6.75, -4.68), Plt;0.000 01]. Four studies reported adverse reactions, and meta-analysis of the incidence of non-specific adverse reactions showed that the combined OR was 2.61 [95%CI (1.33, 5.13), P=0.005]. Conclusion A dose-effect relationship may exist between the dose of metoprolol and antihypertensive effect in the treatment of hypertension. When the antihypertensive effect of low-dose metoprolol was inadequate, an increase in the dose may lower blood pressure further. Although high-dose metoprolol has higher incidence of adverse reactions, it can be tolerated by most patients. Therefore, in the treatment of hypertension with metoprolol, an individualized dosing regimen can be applied according to the patient’s tolerance, and blood pressure may be controlled ideally by a gradual increase of the metoprolol dose to its maximum tolerated dose.
Objective To systematically review the efficacy and safety of laparoscopic hepatectomy (LH) and open hepatectomy (OH) for patients with hepatocellular carcinoma (HCC). Methods PubMed, EMbase, The Cochrane Library, CBM, WanFang Data, CNKI databases were electronically searched to collect the case-control studies about LH vs. OH for patients with HCC from inception to December, 2015. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then meta-analysis was performed by using RevMan 5.3 software. Results A total of 28 studies involving 1 908 patients were included. The results of meta-analysis showed that: the LH group was superior to OH group on complications (OR=0.35, 95%CI 0.26 to 0.48, P<0.000 01), hospital stay (MD=–4.18, 95%CI (–5.08, –3.29),P<0.000 01), and five years overall survival rate (OR=1.65, 95%CI 1.23 to 2.19,P=0.000 7) and disease-free survival rate (OR=1.51, 95%CI 1.12 to 2.03, P=0.006). However, no significant differences were found in one year and three years overall survival rate, disease-free survival rate, and postoperative recurrence rate. Conclusion Current evidence shows that the LH is superior to OH for the treatment of HCC, and may be amenable to surgery because of its safety and longtime efficacy. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
ObjectivesTo evaluate the efficacy and safety of four antiplatelet regimens after coronary drug-eluting stents by network meta-analysis.MethodsPubMed, The Cochrane Library, EMbase and Web of Science databases were electronically searched to collect randomized controlled trials (RCTs) of the comparison of different antiplatelet regimens after coronary drug-eluting stenting from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and assessed risk bias of included studies. Network meta-analysis was then performed by using Gemtc14.3 software, Stata16.0 software and RevMan5.3 software.ResultsA total of 23 RCTs involving 45 837 patients were included. The results of network meta-analysis showed that: in terms of prevention of myocardial infarction (MI) recurrence, the aspirin monotherapy after short-term dual antiplatelet therapy was inferior to the triple antiplatelet therapy (OR=2.13, 95%CI 1.08 to 4.03). In terms of reducing the incidence of ischemic compound events, the triple antiplatelet therapy was superior to the standard dual antiplatelet therapy (OR=0.53, 95%CI 0.39 to 0.72), the aspirin monotherapy after short-term dual antiplatelet therapy (OR=0.49, 95%CI 0.35 to 0.69) and the P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy (OR=0.51, 95%CI 0.35 to 0.73). There was no statistically significant difference among the four interventions in reducing the rate of in-stent thrombosis and all-cause mortality (P>0.05). In terms of safety, the bleeding rate of aspirin monotherapy after short-term dual antiplatelet therapy was lower than that of standard dual antiplatelet therapy (OR=0.70, 95%CI 0.55 to 0.86) and triple antiplatelet therapy (OR=0.58, 95%CI 0.36 to 0.90), and the bleeding rate of P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy was also lower than that of standard dual antiplatelet therapy (OR=0.51, 95%CI 0.39 to 0.65) and triple antiplatelet therapy (OR=0.43, 95%CI 0.26 to 0.67). The probability ranking diagram showed that: in terms of the recurrence rate of MI, the rate of in-stent thrombosis and the incidence of ischemic compound events, triple antiplatelet therapy was the lowest and aspirin monotherapy after short-term dual antiplatelet therapy was the highest. However, in terms of all-cause mortality and bleeding rate, aspirin or P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy was the lowest and triple antiplatelet therapy was the highest.ConclusionsThe available evidence suggests that when the risk of ischemia is low, we should choose aspirin or P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy, and P2Y12 inhibitor monotherapy may have a lower risk of ischemia and bleeding. When the risk of ischemia is high and bleeding is low, the triple or standard dual antiplatelet therapy should be selected, and the efficacy of triple antiplatelet therapy is superior, while the safety may be inferior.
Objective To explore the effectiveness and safety of ziprasidone in the treatment of female patients with schizophrenia. Methods A before-after study design with prospective consecutive data collection was adopted. From June 2006 to May 2007, 30 female patients with schizophrenia discharged from the Second Veterans Hospital of Shanxi Province were included. Ziprasidone 60-120 mg/d was orally administered for 6 weeks. Positive and Negative Syndrome Scale (PANSS) and Treatment Emergent Symptom Scale (TESS) were measured before the treatment and at the end of Week 2, 4 and 6 after the treatment, respectively.Results At Week 6, the significant improvement rate and the total improvement rate were 86.67% and 93.33%, respectively; the incidence of side effects was 86.67%. Conclusion Ziprasidone is safe and effective in the treatment of schizophrenia. Since it will not increase body weight or the level of prolactin, it can be especially applied to female schizophrenic patients.
Objective To evaluate the therapeutic effect and safety of Bupropion hydrochloride sustained-release tablets in the treatment of depression. Methods A total of 48 patients meeting the diagnostic criteria of depression of CCMD-3 were randomly treated with Bupropion hydrochloride sustained-release tablets or Fluoxetine tablets for 42 days. Hamilton depression rating scale, Hamilton anxiety rating scale, clinical global impression and treatment emergent symptom scale were used to evaluate the therapeutic effect. Blood routine test, urine routine test and electrocardiogram were examined before and after the treatment. Results The effective rate of Bupropion hydrochloride sustained-release tablets [83% (20/ 24) ] was higher than that of Fluoxetine tablets [63% (15/ 24)], with a P value of 0.104. The incidence of adverse reactions was 46% (11/24) in both groups. Conclusion The therapeutic effect of Bupropion hydrochloride sustained-release tablets on depression is similar to that of Fluoxetine tablets, with mild adverse reactions to both treatments.
ObjectivesTo systematically review the efficacy and safety of dapagliflozin combined with hypoglycemic drugs in the treatment of diabetes patients.MethodsPubMed, The Cochrane Library, EMbase, WanFang Data, VIP, CNKI and CBM databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of dapagliflozin combined with hypoglycemic drugs in the treatment of diabetes patients from inception to December, 2018. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.3 software and Stata 14.0 software.ResultsA total of 16 RCTs involving 5 388 patients were included. The results of meta-analysis showed that, compared with control group, intervention group provided more reduction in HbAlc (MD=−0.55, 95%CI −0.63 to −0.48, P<0.000 01) and body weight (MD=−2.17, 95%CI −2.46 to −1.88, P<0.000 01). There were no significant differences in hypoglycaemia (RR=1.05, 95%CI 0.93 to 1.18, P=0.44) and hypotension (RR=1.63, 95%CI 0.73 to 3.65, P=0.23). The incidence of urinary tract infection (RR=1.29, 95%CI 1.03 to 1.61, P=0.02) and genital infection (RR=3.89, 95%CI 2.86 to 5.29, P< 0.000 01) in intervention groups were higher than those in the control groups.ConclusionsCurrent evidence shows that dapagliflozin as an add-on drug to conventional antidiabetic drugs can more effectively reduce glycated hemoglobin and body weight in diabetic patients and does not increase the incidence of hypoglycemia and hypotension, however, with an increased risk for development of urinary tract infection and genital infections. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
Objective To study the efficacy and safety of combined anti-tuberculosis regimen containing bedaquiline in the treatment of multidrug-resistant tuberculosis (MDR-TB). Methods A total of 69 MDR-TB patients treated by joint regimen combined bedaquiline with other anti-tuberculosis drugs between March 2018 and August 2019 in Public Health Clinical Center of Chengdu were taken as the trial group, and 60 MDR-TB patients received treatment without bedaquiline between June 2016 and December 2017 in the same hospital were taken as the control group. The efficacy and safety of the two groups were compared. Results The 69 patients in the trial group included 44 males and 25 females, aged from 21 to 63 years, with an average of (34.6±11.0) years; 58 patients (84.1%) completed the 24-week treatment with bedaquiline, while 11 patients did not complete the treatment, including 3 deaths (4.3%), 1 loss of follow-up (1.4%), 1 withdrawal from the study (1.4%), and 6 discontinuation due to adverse events (8.7%). Among the 54 patients with positive results of tuberculosis on baseline sputum culture, 49 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 90.7%), and the median negative conversion time was 13.0 weeks. The 60 patients in the control group included 45 males and 15 females, aged from 16 to 66 years, with an average of (35.5±13.2) years. Among the 53 patients with positive results of tuberculosis on baseline sputum culture, 30 transformed to negative results within 24 weeks of treatment (the negative conversion rate was 56.6%), and the median negative conversion time was 12.0 weeks. The negative conversion rate of sputum bacteria in the trial group was significantly higher than that in the control group (χ2=16.133, P<0.001). The most common adverse reactions in the trial group were liver function abnormalities (42 cases, 60.9%), prolonged QTc interval (37 cases, 53.6%), electrolyte disturbances (20 cases, 29.0%), and blood system damage (20 cases, 29.0%). In the 37 patients who experienced prolonged QTc interval, there were 8 patients with QTc intervals≥500 ms and 29 patients with QTc intervals ≥450 ms and <500 ms, with a median occurrence time of 16.0 weeks, among whom 25 patients experienced prolonged QTc interval in 4-48 weeks after the withdrawal of bedaquiline. Conclusion The negative conversion rate of tuberculosis sputum culture of patients with MDR-TB treated by bedaquiline combined with other anti- tuberculosis drugs is high, but electrocardiogram should be closely monitored during and after the treatment in order to guard against the potential cardiac toxic effects of bedaquiline.
ObjectiveTo evaluate the safety of shearing fracture ligation combining procedure for prolapse and hemorrhoids （PPH） in treatment for mixed hemorrhoids via a multicenter clinical study. MethodsTwo hundred and fortysix patients with mixed hemorroids were included from four a level of firstclass hospitals, which were averagely divided into shearing fracture ligation combining PPH group, PPH group, and shearing fracture ligation group according to the order of admission. The occurrence status of rectovaginal fistula, urethrorectal fistula, postoperative bleeding, acute urinary retention, anorectal stenosis, and anal incontinence were observed. And the anal function was evaluated by the anorectal pressure measurement. ResultsNo rectovaginal fistula or urethrorectal fistula happened among three groups. No anorectal stenosis happened in the shearing fracture ligation combining PPH group or the PPH group. The score of anorectal stenosis and anal incontinence in these two groups were lower than those in the shearing fracture ligation group (Plt;0.05). The rate of postoperative bleeding in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group (Plt;0.05). There were acute urinary retentions happened among three groups, but without significant differences among them (Pgt;0.05). The anal canal resting pressure after operation was lower than that before operation among three groups (Plt;0.01), which in the shearing fracture ligation combining PPH group was lower than that in the shearing fracture ligation group after operation (Plt;0.05). There were no significant differences of the rectum feeling capacity or maximum rectum capacity between the shearing fracture ligation combining PPH group and PPH group before and after operation (Pgt;0.05), but compared with the level before operation in the shearing fracture ligation group, the rectum feeling capacity obviously decreased after operation (Plt;0.05), the maximum rectum capacity obviously increased (Plt;0.05). There were no significant differences of the maxinum anal canal systolic blood pressure between before and after operation in three groups and among three groups (Pgt;0.05). ConclusionsThe operation of shearing fracture ligation combined with PPH can protect the tissue of rectal cushion, remain the normal anatomy structure of anal canal. It has better clinical effect and is much safer than other methods.
ObjectivesThe primary objectives of this rapid health technology assessment (RHTA) were to assess the safety and effectiveness of Da Vinci surgical system compared with traditional e surgeries, so as to provide the currently-available best evidence for health decision makers and clinical workers. MethodsA comprehensive search of electronic databases (EMbase, PubMed, The Cochrane Library, Web of Science, CNKI, VIP, CBM and WanFang Data) and relevant professional HTA websites were conducted from inceptionto October 9, 2012. Two reviews independently screen literature according to the inclusion and exclusion criteria, extracted data, and assess the quality of included studies. The data based on secondary studies were reported, and a final recommendation and its level was made based on assessment outcome. ResultsA total of 21 studies were included, encompassing 7 HTAs and 14 systematic reviews/metaanalyses. The included studies involved radical prostatectomy, hysterectomy, nephrectomy, coronary artery bypass graft, and gastric fundoplication. Though the included HTAs and systematic reviews/meta-analyses focus on different diseases, the outcomes showed significant differences existed between Da Vinci surgical system and other routine surgery in clinical effectiveness and safety of different diseases. Compared with routine surgery, Da Vinci surgical system shortened hospital stay; decreased operation conversion rates, blood loss and blood transfusion rates during surgery; but it increased operative time. Besides, compared with traditional laparoscopic surgery, Da Vinci surgical system shortened operation time and hospital stay, and decreased operation conversion rates, blood loss and blood transfusion rates during surgery. ConclusionCurrent evidence shows that the clinical effectiveness and safety outcomes of Da Vinci surgical system differ in diseases. Currently, most included HTAs and systematic reviews/meta-analyses are based on observational studies, relevant prospective randomized controlled trials lack, and the evidence is graded as low quality, health decision makers are suggested to apply this evidence with caution on the basis of comprehensive consideration.