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 evaluate the safety and efficacy of lenvatinib as targeted therapy for locally advanced thyroid cancer. MethodsThe data of 17 patients with locally advanced thyroid cancer who received targeted therapy in the Department of Head and Neck Surgery, Clinical Oncology School of Fujian Cancer Hospital from September 2021 to June 2023 were prospectively collected and analyzed. ResultsSeventeen patients received lenvatinib for a median of 8 weeks (4–32 weeks), 5 patients achieved partial response, 11 patients achieved stable disease, and 1 patient experienced progressive disease. The objective response and disease control rates were 29.4% (5/17) and 94.1% (16/17) respectively, the median tumor diameter of the target lesion decreased from 43 mm before treatment to 12 mm after treatment. Five patients did not undergo surgery because of tumor progression and their refusal; R0/1 resection was achieved in 11 of the 12 remaining patients (91.7%). All patients suffered from drug-related adverse events, and the commonest drug-related adverse events were hypertension (7/17, 41.2%), diarrhea (6/17, 35.3%), and proteinuria (5/17, 29.4%). There were no major drug-related adverse events. ConclusionPreliminary analysis indicates that lenvatinib is effective and safe for targeted therapy of locally advanced thyroid cancer, with a relatively high rate of R0/1 resection.
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.
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 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.
