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 umeclidinium/vilanterol in the treatment of chronic obstructive pulmonary disease. Methods PubMed, The Cochrane Library, WanFang Data, CNKI and VIP databases were electronically searched to collect randomized controlled trials (RCTs) about umeclidinium/vilanterol for chronic obstructive pulmonary disease from inception to March 2017. 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. Results Eight RCTs involving 8 992 patients were included. The results of meta-analysis showed that: (1) umeclidinium/vilanterol vs. placebo: umeclidinium/vilanterol could significantly improve Trough FEV1 (MD=0.20, 95%CI 0.17 to 0.23, P<0.000 01) and the quality of life: TDI score (MD=0.99, 95%CI 0.71 to 1.28,P<0.000 01), SGRQ score (MD=–4.00, 95%CI –5.35 to –2.66,P<0.000 01), SOBDA score (MD=–0.16, 95%CI –0.23 to –0.09,P<0.000 01), and reduce the use of rescue drugs (salbutamol), while not increase the adverse events. (2) umeclidinium/vilanterolvs. fluticasone propionate/salmeterol: UMEC/VI could improve lung function in patients with COPD: Trough FEV1 (MD=0.09, 95%CI 0.07 to 0.11, P<0.000 01), reduce the use of rescue drugs (salbutamol), and had lower adverse events. But there was no significant difference in the quality of life between two groups. (3) umeclidinium/vilanterolvs. single bronchodilator: umeclidinium/vilanterol could significantly improve spirometric parameters: Trough FEV1 (MD=0.08, 95%CI 0.07 to 0.10, P<0.000 01), and the quality of life: TDI score (MD=0.38, 95%CI 0.17 to 0.59,P=0.000 3), SGRQ score (MD=–1.18, 95%CI –2.06 to –0.29, P=0.009). Umeclidinium/vilanterol could significantly reduce the use of rescue drugs (salbutamol) without increasing the adverse events. Conclusion UMEC/VI is superior to placebo in the treatment of COPD patients, which can significantly improve lung function, control symptoms and improve the quality of life, with good safety and tolerance. Compared with salmeterol/fluticacin, UMEC/VI has a significant effect on improving lung function and controlling symptoms without increasing adverse effects, while UMEC/VI is easier to use with better patient compliance. UMEC/VI is superior to bronchodilator alone in improving lung function, controlling symptoms and improving the quality of life without increasing the incidence of adverse events. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusions.
ObjectiveTo systematically review the safety of different types of COVID-19 vaccines in the population.MethodsWeb of Science, PubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect randomized controlled trials (RCTs) which reported safety of COVID-19 vaccines in population. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using RevMan 5.4 software.ResultsA total of 5 RCTs involving 2 431 subjects were included. The results of the meta-analysis showed that COVID-19 vaccines developed more fever symptoms than placebo (RR=2.21, 95%CI 1.38 to 3.54, P=0.000 9). However, there was no significant difference in the incidence of adverse reactions (RR=1.28, 95%CI 0.96 to 1.70, P=0.10), injection site adverse reactions (RR=1.47, 95%CI 0.65 to 3.36, P=0.36) and systemic adverse reactions (RR=0.96, 95%CI 0.78 to 1.17, P=0.66) between two groups.ConclusionsCurrent evidence shows that COVID-19 vaccines are sufficiently safe. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
Objective To evaluate the efficacy and safety of whole lung lavage in the treatment of pulmonary alveolar proteinosis ( PAP) .Methods Twelve patients who were diagnosed as PAP from September 2008 to October 2011 in Hunan Occupational Disease Hospital were recruited in the study. The changes of dyspnea symptom, lung-function, arterial blood gas, and chest image were compared before and after whole lung lavage treatment. Meanwhile, the safety of lung lavage was evaluated. Results All patients were relieved from dyspnea. The lung function, hypoxia, hyperventilation, and chest image were all obviously improved. The vital signs in the process of lung lavage were stable without serious complications. Conclusion Whole lung lavage is an effective and safe treatment for PAP.
ObjectiveTo discuss clinical significance of total endoscopic thyroidectomy (TET) via chest-breast approach. MethodsThe clinical data of 890 patients with thyroid diseases from September 2008 to September 2015 in this hospital were analyzed retrospectively. These patients were divided into TET group (received TET, n=420) and traditional group (received traditional thyroidectomy, n=470). The data of operation and postoperative recovery were compared between these two groups. ResultsThere was no significant difference between the TET group and the traditional group in the operation time [(73.571 4±28.533 9) min versus (70.212 8±27.199 8) min, t=1.80, P=0.072 7], bleeding volume [(30.714 3±14.225 1) mL versus (29.106 4±13.559 1) mL, t=1.73, P=0.084 8], postoperative drainage [(60.000 0±27.287 9) mL versus (56.595 7±27.803 5) mL, t=1.84, P=0.066 2], postoperative hospitalization time [(5.333 3±1.085 1) d versus (5.446 8± 1.089 0) d, t=1.55, P=0.120 4], postoperative 24 h pain score [(5.333 3±2.308 7) points versus (5.404 3±2.182 1) points, t=0.47, P=0.637 8] and postoperative injury rate of recurrent laryngeal nerve [0.714 2% (3/420) versus 0.851 1% (4/470), x2=0.053 2, P=0.817 6] and hypoparathyroidism rate [0.476 2% (2/420) versus 0.851 1% (4/470), x2=0.465 5, P=0.495 1]. The score of aesthetic effect of incision on day 7 after operation in the TET group was significantly higher than that in the traditional group [(7.809 5±1.296 9) points versus (3.361 7±1.391 8) points, t=49.14, P < 0.000 1]. ConclusionTET is safe and effective, and could improve cosmetic effect for patients with thyroid diseases.
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.
ObjectiveTo assess the effects of nursing grading management for nurses in emergency department. MethodsAll nurses of the employment system in Department of Emergency were classified into different groups in 2011. Based on the combination of the duties of nurses, technical requirements and nursing grading management, nurses of different levels were given the right tasks, so that nurses in the emergency department could make use of their special skills. ResultsAs the result of nursing grading management, the rates of satisfaction of patients and survival of critically-ill patients were increased, and the rates of pressure ulcer, nursing adverse events and wrong nursing documents were reduced. ConclusionNursing grading management not only saves nursing resources and improves nursing efficiency, but also ensures quality and safety of nursing.
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 systematically review the safety of low molecular weight heparin (LMWH) in pregnancy. MethodsPubMed, EMbase, The Cochrane Library, WanFang Data, VIP, and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) and cohort studies on the safety of LMWH in pregnancy from inception to March 30th, 2020. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software. ResultsA total of 77 RCTs and 13 cohort studies were included. The results of meta-analysis showed that LMWH increased the incidence of postpartum hemorrhage (RR=1.50, 95%CI 1.00 to 2.25, P=0.05). However, there was no significant difference. The incidence of hematological adverse events was different from the results of RCTs and cohort studies. The results of RCT subgroup analysis showed that LMWH increased ecchymosis at the injection site (RR=1.60, 95%CI 1.24 to 2.08, P=0.000 4). However, the incidence of overall skin system adverse events did not increase significantly. LMWH reduced the incidence of cardiovascular adverse events (RR=0.18, 95%CI 0.07 to 0.46, P=0.000 3). LMWH failed to increase the occurrence of fetal congenital malformations, digestive system, central nervous system, skeletal system, and systemic adverse events. ConclusionsCurrent evidence suggests that LMWH is relatively safe to use during pregnancy. However, whether it increases postpartum hemorrhage and hematological adverse events is unclear. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.