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 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 evaluate effectiveness and safety of electronic choledochoscopy in treatment of intrahepatic bile duct stones. Methods From July 2013 to February 2016, 280 patients with intrahepatic bile duct stones in the Department of General Surgery of the Affiliated Hospital of Shandong Academy of Medical Sciences were selected as the research objects. All the patients were randomly divided into a choledochoscopy treatment group and a conventional treatment group by envelope principle method. There were 140 patients in each group. The safety and short- and long-term effectiveness were compared in these two groups. This study was approved by the ethics committee of the hospital. Results ① The age, gender, body mass index, course of disease, and location of stone had no significant differences in these two groups (P>0.05). ② The operations and the net stones were successfully completed in all the patients. The operative time was shorter, the blood loss was less, the incision length was smaller, the postoperative anal exhaust time was earlier, and the hospitalization time was shorter in the choledochoscopy treatment group as compared with the conventional treatment group (P<0.05). ③ The total postoperative complication rate on day 14 in the choledochoscopy treatment group was 2.9% (4/140), which was significantly lower than that in the conventional treatment group (11.4%, 16/140, P<0.05). ④ The curative excellent and good rates was 97.9% and 85.0% in the choledochoscopy treatment group and conventional treatment group respectively, which was a significant difference in these two groups (P<0.05). ⑤ The postoperative serum ALT and AST values on month 6 in the choledochoscopy treatment group were significantly lower than those in the conventional treatment group (P<0.05). Conclusion Electronic choledochoscopy in treatment of intrahepatic bile duct stones could promote rehabilitation of patient, reduce incidence of postoperative complications, and it is conducive to promoting recovery of liver function and improving follow-up effect.
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.
ObjectiveTo compare the safety of the incision along the upper umbilical margin (referred to as the “upper incision”) versus the transverse umbilical incision (referred to as the “transverse incision”) for single-port bariatric surgery, and to assess their effects on postoperative scar appearance and patient’s psychological adaptation. MethodsThis study was designed as a multi-center retrospective analysis. The patients who underwent bariatric surgery via the upper incision and transverse incision at the Third People’s Hospital of Chengdu, Plastic Surgery Hospital of the Chinese Academy of Medical Sciences, and the First Affiliated Hospital of Jinan University from December 2024 to April 2025. The incidence of postoperative complications and the pionts of scar appearance (evaluated using the POSAS 3.0 scale) and psychological adaptation (measured with the BODY-Q scale) between the two incision methods were compared. Furthermore, multiple linear regression model was employed to evaluate the impact of different incision methods on points of scar appearance and psychological adaptation. ResultsA total of 194 patients who underwent single-port bariatric surgery were included, with 134 in the transverse incision group and 60 in the upper incision group. There was no statistically significant difference in the total incidence of incision complications between the transverse and upper incision groups [11.9% (16/134) vs. 18.3% (11/60), χ2=0.930, P=0.335]. The transverse incision group showed significantly better outcomes than the upper incision group in the overall points of BODY-Q scale [(39.86±1.02) points vs. (37.63±4.70) points, t=–6.090, P<0.001] and POSAS scale [(17.60±2.35) points vs. (21.25±6.00) points, t=5.239, P<0.001]. After adjusting for potential confounding factors such as history of diabetes mellitus, education level, smoking status, alcohol consumption status, keloid tendency, and use of scar improvement products in the multiple linear regression model, the advantage of the transverse incision remained significant [β(95%CI)=–1.81 (–2.84, –0.78), P<0.001]. Conclusions This study demonstrates that the transverse incision significantly improves the overall appearance of the postoperative scar and enhances patient’s psychological adaptation compared to the upper incision in single-port bariatric surgery. This advantage persists independently after adjusting for multiple confounding factors. Therefore, the transverse incision could be considered a more favorable approach in terms of cosmetic outcomes and patient’s psychological adaptation.
Objective To systematically review the efficacy and safety of interferon based antiviral therapy for children with hepatitis B. Methods PubMed, EMbase, The Cochrane Library, WanFang Data and CNKI databases were searched to collect randomized controlled trials (RCTs) of interferon based antiviral therapy for children with hepatitis B from inception to December 2016. 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 12 studies involving 723 patients were included. The results of meta-analysis showed that: follow-up <12 months, the virological response rate (RR=2.82, 95%CI 1.98 to 4.02, P<0.000 01), serum HBeAg clearance rate (RR=3.02, 95%CI 1.95 to 4.67,P<0.000 01) and ALT normalization rate (RR=1.42, 95%CI 1.19 to 1.70,P=0.000 1) were significantly higher in the interferon group than the control group. Follow-up >12 months, the virological response rate (RR=1.75, 95%CI 1.18 to 2.60, P=0.006) and serum HBeAg clearance rate (RR=2.17, 95%CI 1.28 to 3.65, P=0.004) were also significantly higher in the interferon group. Severe adverse effects were not reported in included studies. Conclusion Current evidence shows that higher virological response is found in HBV infected children with interferon treatment. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
In recent years, the incidence of mental and psychological diseases has increased year by year, affecting patients’ physical and mental health and social stability. Intermittent theta burst stimulation (iTBS) is a new type of non-invasive nerve stimulation technology, which can stimulate specific areas in the brain at a high frequency in a short time to regulate brain nerve activity, and has the advantages of non-invasion, easy operation and high safety. In recent years, iTBS has attracted more and more attention in the treatment of mental and psychological diseases. This paper reviews the clinical application of iTBS in common mental and psychological diseases, including depression, schizophrenia, and methamphetamine addiction, in order to provide new treatment strategies and directions for clinical treatment and scientific research of mental and psychological diseases.