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 explore the timing and safety of limited-period lung cancer surgery in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Methods Clinical data of of patients infected with COVID-19 undergoing lung cancer surgery (an observation group) in the Department of Thoracic Surgery of Guangdong Provincial People's Hospital, the Department of Thoracic Surgery of General Hospital of Southern Theater Command of PLA, and the Department of Cardiothoracic Surgery of the First Affiliated Hospital of Guangdong Pharmaceutical University from December 2022 to January 2023 were retrospectively analyzed and compared with patients who underwent surgery during the same period but were not infected with COVID-19 (a control group), to explore the impact of COVID-19 infection on lung cancer surgery. Results We finally included 110 patients with 73 patients in the observation group (28 males and 45 females at age of 52.62±12.80 years) and 37 patients in the control group (22 males and 15 females at age of 56.84±11.14 years). The average operation time of the observation group was longer than that of the control group, and the incidence of anhelation was higher than that of the control group (P<0.05). There were no statistcal differences in blood loss, length of hospital stay, moderate or above fever rate, degree of cough and chest pain, or blood routine between the two groups. ConclusionIt is safe and feasible to perform lung cancer surgery early after recovery for COVID-19 patients with lung cancer.
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 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 investigate effectiveness and safety of transcatheter aortic valve replacement in the treatment of aortic regurgitation. Methods PubMed, EMbase, The Cochrane Library, Web of Science, CNKI, Wanfang Data and VIP were searched from inception to August 2021. According to the criteria of inclusion and exclusion, two reviewers independently screened the literature, extracted the data and evaluated the quality of the included studies. Then, Stata 16.0 software was used for meta-analysis. Subgroup meta-analysis of valve type used and study type was performed. ResultsTwenty-five studies (12 cohort studies and 13 single-arm studies) were included with 4 370 patients. Meta-analysis results showed that an incidence of device success was 87% (95%CI 0.81-0.92). The success rate of the new generation valve subgroup was 93% (95%CI 0.89-0.96), and the early generation valve subgroup was 66% (95%CI 0.56-0.75). In addition, the 30-day all-cause mortality was 7% (95%CI 0.05-0.10), the 30-day cardiac mortality was 4% (95%CI 0.01-0.07), the incidence of pacemaker implantation was 10% (95%CI 0.08-0.13), and the incidence of conversion to thoracotomy was 2% (95%CI 0.01-0.04). The incidence of moderate or higher paravalvular aortic regurgitation was 6% (95%CI 0.03-0.09). Conclusion Transcatheter aortic valve replacement for aortic regurgitation is safe and yields good results, but some limitations can not be overcome. Therefore, multicenter randomized controlled trials are needed to confirm our results.
ObjectiveTo understand the current research status of conservative mastectomy with breast reconstruction for breast cancer, so as to provide a reference for surgeons and patients with breast cancer to choose surgical method. MethodThe recently domestic and foreign literature on the research of conservative mastectomy with breast reconstruction for breast cancer was reviewed and summarized. ResultsAt present, conservative mastectomy mainly included nipple sparing mastectomy, skin sparing mastectomy, and skin reduction mastectomy. All three surgical methods were safe and effective in the treatment of breast cancer, and the complications could be controlled. When combined with breast reconstruction, the better cosmetic effect could be obtained, and the postoperative satisfaction and quality of life of patients were markedly improved. ConclusionsAfter comprehensively preoperative evaluation for patients with breast cancer, conservative mastectomy provides a treatment choice for them. After conservative mastectomy, individualized reconstruction scheme is formulated according to size and sagging degree of breast, as well as individual expectations of patients, which can obtain a higher quality of life while treating diseases for patients with breast cancer.
ObjectiveTo systematically review the efficacy and safety of laryngeal mask versus endotracheal tubes for laparoscopic surgery.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and CBM databases were electronically searched to collect the randomized controlled trials (RCTs) about the efficacy and safety of laryngeal mask versus endotracheal tubes for laparoscopic surgery from inception to April, 2017. 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.ResultsA total of 16 RCTs involving 1 593 patients were included. The results of meta-analysis showed that: there was no significant difference in the success rate of the first insertion (RR=0.99, 95%CI 0.96 to 1.02, P=0.55). The airway pressure of patients whose position were head higher than foot was significantly lower in the laryngeal mask group than in the tracheal intubation group (MD=–1.20, 95%CI –1.81 to –0.59, P=0.000 1), but there was no significant difference between two groups in reverse position patients (MD=0.48, 95%CI –0.90 to 1.87, P=0.49). The incidence of sore throat (RR=0.58, 95%CI 0.46 to 0.74, P<0.000 01), the incidence of blood stain (RR=0.48, 95%CI 0.30 to 0.77, P=0.002), the incidence of laryngeal spasm/bronchial spasm (OR=0.30, 95%CI 0.11 to 0.80, P=0.02) and the incidence of cough/hiccup (RR=0.10, 95%CI 0.07 to 0.15, P<0.000 01) in the laryngeal mask group were significantly lower than those in the tracheal intubation group.ConclusionThe current evidence shows that compared with tracheal intubation, laryngeal mask can effectively reduce airway pressure of patients whose position are head higher than foot. The risks of various complications are significant higher in tracheal intubation in laparoscopic surgery. Laryngeal mask can maintain patients' normal respiratory functions while reduce damage and do not increase the occurrence of reflux aspiration. Due to limited quantity and quality of the included studies, more high quality studies are needed to verify above conclusion.
Objective To determine the safety of the fetal olfactory ensheathing cell(OEC) transplantation in patients with chronic spinal cord injury (SCI) by examination of the magnetic resonance imaging (MRI). Methods A prospective clinical study involving 16 patients with chronic SCI was designed to investigate the feasibility and biological safety of the fetal OEC transplantation in treatment of SCI. The olfactory bulbs from the 3-4-month-old aborted human fetuses following the strict ethical guidelines were harvested and trypsinized down to single fetal OEC. These cells were then cultured for 12-17 days and were prepared for a clinical use. From November 2001 to December 2002, 16 patients with chronic SCI were randomly enrolled. The patients suffered from SCI for1.5-8 years (average 4-3 years) after the injury. The suspension (50 μl) containing about 1×106 fetal OECs was transplanted by an injection into the patients’ spinal cords above and below the injury site. All the patients were assessed before thetransplantation and were followed up with MRI for 29-42 months (average 38 mon)after the transplantation. Results No cell-related adverse effects were observed in any patient during the followup period. The follow-up with MRI did not reveal any development of optic glial tumor, tumor-like mass, new hemorrhage,edema, expanding cyst, new cyst formation, infection or disruption of the neuralstructure in the transplant site of all the patients. Conclusion This is the first clinical study demonstrating the long-term safety of theOEC therapy for SCI. The results indicate that our protocol is feasible and safe in treatment of patients with chronic SCI within 38 months after the injury. Although the size of the samples for our study was not big enough, the positive results of the study have encouraged us to make a further research in this field.