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.
ObjectiveTo evaluate donor safety in living donor liver transplantation.
MethodsThe clinical data of 356 donors underwent living liver donation in our center from January 2001 to September 2015 were retrospectively analyzed. These patients were divided into pre-2008 group(before January 2008) and post-2008 group(after January 2008). The donor safety was evaluated with regard to three aspects, i.e. complications, liver function, and quality of life.
Results①There was no donor death in our center.②The overall complications rate was 23.3%(83/356). The proportion of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 50.6%(42/83), 26.5%(22/83), 21.7%(18/83), and 1.2%(1/83), respectively. In all the donors, the incidence of ClavienⅠ, Ⅱ, Ⅲ, andⅣcomplications was 11.8%(42/356), 6.2%(22/356), 5.1%(18/356), and 0.3%(1/356), respectively. The overall complications rate in the post-2008 group was significantly lower than that in the pre-2008 group〔18.1%(41/227) versus 32.6%(42/129), P < 0.01〕. The most common complication was the biliary complication with an incidence of 8.4%(30/356).③The postoperative liver dysfunction was transient and generally retur-ned to normal level within a week.④The donor's quality of life was generally satisfied as assessed by the SF-36 tool, and 94.8%(239/252) of them would donate again if necessary.
ConclusionEver improving surgical and anesthetic techniques, together with strict donor selection and specialized perioperative management, could guarantee a low donor morbidity and a satisfactory long-term prognosis.
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.
ObjectiveTo summary the safety and efficiency of the minimally invasive direct cardiac surgery (MIDCS) approach in elderly patients with heart disease.
MethodsWe retrospectively analyzed the clinical data of 60 patients underwent MIDCS in Beijng Anzhen Hospital between April 2010 and January 2013. There were 34 males and 26 females with mean age of 66.4±4.8 years and mean weight of 66.1±10.6 kg.
ResultsMean cardiopulmonary bypass time and aortic cross-clamp time was 141.2±57.2 minutes and 99.8±37.6 minutes respectively. A total of 37 patients (90.2%) recovered to beat automatically after heart ceased operation. Median mechanical ventilation time was 17.1±9.1 hours. Mean intensive care unit stay was 22.1±12.2 hours. Mean post operative hospital stay was 7.0±2.5 days. Mean incision length was 5.3±0.9 cm. Mean pericardial draining volume was 466.6±412.1 ml in the first day after operation. No transfusion occurred in 27 (45.0%) patients. Early postoperative mortality was 3.3% (2/60). There were 2 patients of reexplorations for bleeding, 1 patient of the twice tracheal intubation, 1 patient of cardiac arrest after operation, 2 patients of poor healing of skin incision, and 1 patient of injury of right phrenic nerve. When leaving hospital, 47 patients were in heart functional class Ⅰ, 8 patients in class Ⅱ, and 3 patients in class Ⅲ.
ConclusionMIDCS is associated with good operative effect in the near future with superior safety and broad application range in elderly patients with heart disease.
ObjectivesUsing systematic literature review to analyze the effects of levetiracetam (LEV) on neonatal safety during early pregnancy.MethodsThe scope of the literature must be English literature, published from 1997 to 2018. Meta-analysis was performed by random effects models.ResultsSeven literatures were included. A total of 672 cases exposed to LEV in treatment group and 772 234 cases in control groups were selected for meta-analysis. There was no significant difference in neonatal malignancy between treatment group and control group［OR=1.05, 95% CI (0.54, 2.02), P=0.37］. Further, we evaluated the effect of LEV monotherapy and polytherapy on neonatal safety, a total of 464 monotherapy cases and 632 polytherapy cases respectively were selected for meta-analysis. The results showed that there was no significant difference between these two therapies in neonatal malignancy ［OR=0.54, 95% CI(0.31, 0.96), P=0.32］.ConclusionsAs the papers we included, levetiracetam in the treatment of epilepsy during pregnancy is relatively safe for newborn.
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.
Objective
To systematically evaluate the effectiveness and safety of minimally invasive video-assisted thyroidectomy (MIVAT) and conventional open thyroidectomy (COT) in treatment of thyroid carcinoma without lymph node metastasis.
Methods
Databases including PubMed, EMbase, The Cochrane Library (Issue 3, 2015), WanFang, CBM, VIP and CNKI were searched to collect the randomized controlled trails (RCTs) and non-RCTs about MIVAT and COT in treatment of thyroid carcinoma without lymph node metastasis. The retrieval time was from inception to October 2015. The studies were screened according to the inclusion and exclusion criterias, and the data was extracted and the quality of studies was evaluated by 2 reviewers independently. Then the Meta-analysis was conducted by using RevMan 5.2 software.
Results
A total of 13 non-RCTs involving 3 083 cases were included. The results of Meta-analysis showed that: compared with COT group, operative time of MIVAT group was longer (MD=31.36, 95% CI: 27.68-35.03, P<0.05), hospital stay (MD=-0.16, 95% CI: -0.28--0.04, P=0.01) and length of scar (MD=-1.51, 95% CI: -1.63--1.39, P<0.05) of MIVAT group were shorter, but there was no significant difference in the incidences of transient hypocalcemia (OR=1.29, 95% CI: 0.93-1.78, P=0.13), transient laryngeal nerve palsy (OR=1.42, 95% CI: 0.93-2.17, P=0.11), hemotoma (OR=1.21, 95% CI: 0.64-2.29, P=0.56), recurrence (OR=0.61, 95% CI: 0.28-1.33, P=0.22), number of retrieved central lymph nodes (MD=-0.10, 95% CI: -0.98-0.78, P=0.82), and the size of tumors (MD=-0.02, 95% CI: -0.06-0.02, P=0.39) between the 2 groups.
Conclusion
MIVAT is safe and feasible in treatment of thyroid carcinoma without lymph node metastasis when its indications are strictly controlled.
Objective To explore the postoperative influence of intra-abdominal implantation of sustained-releasing 5fluorouracil on the hepato-renal function, immune function, nutritional state and complications in patients with gastric and colorectal cancer. Methods Sixty-five patients with gastric or colorectal cancer were included into this study from January to June 2009. The patients (35 cases of gastric cancer, 18 cases of colon cancer and 12 cases of rectal cancer) were randomly divided into experimental group (n=25) and control group (n=40). In experimental group, 400 mg sustained-releasing 5-fluorouracil was used. Blood samples were gained before operation, the second day and the seventh day after operation to examine the indexes of hepato-renal function, immune function and nutritional state. Complications， venting time and length of stay after operation were also recorded. Results There was no statistical significance for distribution of tumor stages and patients’ gender between experimental group and control group (Pgt;0.05). Preoperative indexes of hepato-renal function, immune function and nutritional state were also not reached statistical significance between two groups (Pgt;0.05). Compared with control group, the indexes of total protein and transferrin were decreased and urea nitrogen and IgM were increased in the second day after operation in experimental group (Plt;0.05). The number of lymphocyte was increased, while CD4, Alb, total protein and IgA were decreased in the seventh day after operation in experimental group, respectively. The time of passage of gas of experimental group was longer than that of control group (Plt;0.05).Conclusion Intra-abdominal implantation of sustained-releasing 5-fluorouracil is safe and feasible, which does not increase the complications and the time of length stay after operation. However, there is a little influence on immune function and gastrointestinal function after operation for intra-abdominal implantation of sustained-releasing 5-fluorouracil.
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.
