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.
Objectives To evaluate the effectiveness of different antidepressant drugs in addition to standard clinical care in the prevention of postnatal depression. To compare the effectiveness of different antidepressant drugs and with any other form of intervention for postnatal depression i.e. hormonal, psychological or social support. To assess any adverse effects of antidepressant drugs in either the mother or the foetus/infant.Methods The register of clinical trials maintained and updated by the Cochrane Depression, Anxiety and Neurosis Group and the Cochrane Pregnancy and Childbirth Group.Randomised studies of antidepressants alone or in combination with another treatment, compared with placebo or a psychosocial intervention in non-depressed pregnant women or women who had given birth in the previous six weeks (i.e. women at risk of postnatal depression). Data were extracted independently from the trial reports by the authors.Missing information was requested from investigators wherever possible. Data were sought to allow an intention to treat analysis.Results Two trials fullled the inclusion criteria for this review. Both looked at women with a past history of postpartum depression.Nortriptyline (n=26) did not show any benefit over placebo (n=25). Sertraline (n=14) reduced the recurrence of postnatal depression and the time to recurrence when compared with placebo (n=8). Intention to treat analyses were not carried out in either trial.Conclusions It is not possible to draw any clear conclusions about the effectiveness of antidepressants given immediately postpartum in preventing postnatal depression and, therefore, cannot be recommended for prophylaxis of postnatal depression, due to the lack of clear evidence. Larger trials are needed which also include comparisons of antidepressant drugs with other prophylactic treatments to reect clinical practice, and examine adverse effects for the foetus and infant, as well as assess womens’ attitudes to the use of antidepressants at this time.
Objective To assess the efficacy and safety of levoamlodipine besylate for essential hypertension. Methods We searched MEDLINE (1999 to October 2007), EMBASE (1999 to October 2007), The Cochrane Library (Issue 3, 2007), CNKI (1999 to 2007), Wanfang (1999 to 2007), VIP (1999 to 2007) and CBM (1999 to October 2007). The quality of included studies was critically evaluated. Data analyses were performed with The Cochrane Collaboration’ s RevMan 4.2 software. Results A total of 345 articles were retrieved, but only 17 were finally included. Meta-analyses showed that the effective rate in patients receiving levoamlodipine besylate was significantly higher than that in patients receiving indapamide (RD 0.14, 95%CI 0.06 to 0.22, P=0.0004), while no significant differences were noted between the levoamlodipine besylate group and other control groups. The incidence of adverse effects was significantly lower in the levoamlodipine besylate group compared to the indapamide group (RD –0.12, 95%CI –0.21 to –0.03, P=0.01), the amlodipine group (RD –0.06, 95%CI –0.11 to –0.01, P=0.02) and the nitrendipine group (RD –0.27, 95%CI –0.46 to –?0.08, P=0.006). No significant differences were observed between the levoamlodipine besylate group and other control groups. Conclusion Levoamlodipine besylate tends to have better efficacy and safety profiles compared with other antihypertensive drugs. However, most trials included in the review were of poor quality and, so, multi-center large-scale randomized controlled trials of higher quality are needed to confirm this.
This article introduces the measures that the scientific research base of West China Hospital has taken in its emergent response to the unexpected huge Wenchuan earthquake disaster, including safe evacuation, safety examination and removal of hidden dangers, damage reporting and a series of subsequent measures.
Objective To systematically review the efficacy and safety of different SGLT2 inhibitors in the treatment of heart failure. Methods The Cochrane Library, Web of Science, PubMed and EMbase databases were searched for randomized controlled trials on the efficacy and safety of SGLT2 inhibitors in patients with heart failure from inception to July 2, 2021. Two researchers independently screened literature, extracted data and evaluated the risk of bias of the included studies. Network meta-analysis was then performed using Stata 16.0 software. Results A total of 16 randomized controlled trials, including 15 312 patients, involving 5 interventions, namely dapagliflozin, empagliflozin, canagliflozin, sotagliflozin and ertugliflozin were included. Results of network meta-analysis showed that there was no significant difference in the compound outcome of hospitalization for heart failure or cardiovascular death, hospitalization for heart failure, all-cause mortality, risk of cardiovascular mortality and serious adverse reactions among patients with heart failure among 5 different SGLT2 inhibitors (P>0.05). Compared with placebo, both selective and non-selective SGLT2 inhibitors improved the risk of hospitalization for heart failure, hospitalization for heart failure, or compound cardiovascular mortality (P<0.05), while only selective SGLT2 inhibitors improved the risk of cardiovascular mortality, all-cause mortality, and serious adverse events (P<0.05). However, there was no significant difference between them (P>0.05). The area under the cumulative ordering probability curve of selective and non-selective SGLT2 inhibitors ranked first and second, except for the combined outcome of heart failure or cardiovascular death. Conclusion The current evidence indicates that there is no significant difference in the efficacy and safety of the 5 different SGLT2 inhibitors in the treatment of heart failure, and there is no significant difference between selective SGLT2 inhibitors and non-selective SGLT2 inhibitors. Due to the limited quantity and quality of included studies, more high-quality studies are needed to verify the above conclusion.
Objective To systematically review the efficacy and safety of glucocorticoids for severe COVID-19 and to provide references for the treatment strategy of severe COVID-19 patients. Methods PubMed, EMbase, The Cochrane Library, Web of Science, ClinicalTrials.gov, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) that reported glucocorticoid therapy for severe COVID-19 patients from inception to August 26th, 2021. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.3 software. Results A total of 7 RCTs involving 6 236 patients were included. The meta-analysis results showed that compared with usual care, glucocorticoids significantly reduced the all-cause mortality of severe COVID-19 (RR=0.84, 95%CI 0.77 to 0.91, P<0.000 1), whereas no significant difference was found in the progression of complex diseases between the two groups (RR=0.84, 95%CI 0.69 to 1.01, P=0.06). Glucocorticoids did not increase adverse effects in severe COVID-19 compared with usual care (general adverse events: RR=1.15, 95%CI 0.66 to 2.03, P=0.62; serious adverse events: RR=1.13, 95%CI 0.54 to 2.38, P=0.75). Conclusion Current evidence suggests that glucocorticoids are effective in treating severe COVID-19 without significantly increasing adverse events. However, due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the conclusion.
ObjectiveTo investigate the efficacy and safety of recombinant human tumor necrosis factor-α receptor Ⅱ:IgG Fc fusion protein (rhTNFR:Fc) for treatment of active rheumatoid arthritis (RA).
MethodsThis study included 86 patients with active rheumatoid arthritis treated between September 2011 and January 2013. They were divided into two groups randomly. Forty-three patients in the treatment group received rhTNFR:Fc (25 mg, twice a week) by subcutaneous injection and methotrexate (MTX) (10 mg, orally once a week), and the other 43 patients in the contrast group received MTX (10 mg, orally once a week), hydroxychloroquine (100 mg, orally twice daily), and leflunomide (10 mg, orally once daily). The clinical efficacy of the treatments 12 weeks later were compared between the two groups. American College of Rheumatology (ACR) 20, 50, and 70 evaluation criteria were used for efficacy evaluation.
ResultsThe ACR 20, 50 and 70 effective rates in 4, 8 and 12 weeks after the treatment in the treatment group were significantly higher than those in the control group (P<0.05). The seven indicators including the duration of morning stiffness, joint tenderness index, joint swelling index, erythrocyte sedimentation rate, C-reactive protein, platelets and rheumatoid factors within 12 weeks after treatment were significantly improved in both the two groups, and the improvements in the treatment group were more significant (P<0.05). There was no significant difference in the incidence of adverse drug reactions between the two groups (P>0.05).
ConclusionRhTNFR:Fc is effecive and safe in treating active RA.
Objective To evaluate the efficacy and safety of trimetazidine (TMZ) for chronic congestive heart failure. Methods We searched The Cochrane Library (Issue 3, 2006), MEDLINE (1990-2006), EMBASE (1990-2004), and the Chinese Biomedicine Database (1990- 2006 ) for parallel group randomized controlled trials (RCTs) and cross-over design trials comparing TMZ and placebo or open controls for patients with heart failure.We used The Cochrane Collaboration’s RevMan 4.2 software for data analyses. Results Four RCTs and two cross-over design trials were included. Meta-analyses showed that: compared with the control group, TMZ may improve the NYHA cardiac functional grade (RR 0.85, 95%CI 0.76 to 0.95), increase the total exercise time (WMD 51.40 seconds, 95%CI 15.56 to 87.25), the maximal metabolic equivalents (WMD 0.82, 95%CI 0.28 to 1.37), and the ejection fraction (WMD 7.29%, 95%CI 6.28 to 8.31), but may decrease the left ventricular end-diastolic volume (WMD –12.19 ml, 95%CI –15.29 to –9.09), the left ventricular end-diastolic diameter (WMD –6.05 mm, 95%CI –7.10 to –4.99), the left ventricular end-systolic volume (WMD –16.94 ml, 95%CI –20.34 to –13.55), the left ventricular end-systolic diameter (WMD –5.42 mm, 95%CI –5.98 to –4.86), and the serum brain natriuretic peptide (WMD –239.59 pg/ml, 95%CI –276.53 to –202.65). TMZ may also improve the quality of life (WMD 12.36, 95%CI 5.16 to 19.55). Conclusions TMZ plus standard medical therapy has a beneficial effect on the indices of cardiac function, and may also improve the patient’s quality of life. However, because available RCTs for this systematic review are too small and poor quality, (mainly focusing on the heart failure induced by ischemic heart diseases and merely taking intermediate indices as outcome measures), further high-quality large-scale RCTs with death as the endpoint and which include subgroup analysis of non-ischemic heart failure, are required in order to provide more reliable evidence.
ObjectiveTo investigate efficacy and safety of three-step radiofrequency ablation (RFA) in treatment for giant hepatic hemangioma (GHH,diameter ≥5 cm) with symptoms.
MethodsThe patients with GHH met the inclusion criteria were collected.The main steps were as follows:The first step was to destroy the main arteries of the tumor to block the blood.The second step was to withdraw the blood of the tumor to shrink the tumor.The third step was to damage the shrunk tumor by RFA.
ResultsThere were 13 patients with GHH met the inclusion criteria.The median preoperative diameter was 8.0 cm.The median volume of withdrawing blood was 78 mL.The median diameter after withdrawing blood was 5.3 cm.The diameters between after and before withdrawing blood had a significant difference (P<0.01).The time for damaging tumor blood supply was (4.4±1.0) min.The median frequency of tumor RFA was 4 times.The median time of tumor RFA was 16 min.The median time of total operation was 20 min.There were 3 cases of tumor residual after RFA,10 cases were met full damage,and the damage rate was 85.9%-100% with an average of 97.0%.The hospital stay after RFA was (3.9±1.2) d.One case was remission after conservative treatment because of complication.
ConclusionThe preliminary results of limited cases in this study show that three-step RFA for GHH is effective and safe,but it needs to be researched for large samples data.
