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 systematically review the health economic evaluation studies in which externalities of antibacterial drug uses were identified.MethodsPubMed, EMbase, The Cochrane Library, CNKI, WanFang Data and VIP databases were electronically searched to collect health economic evaluation studies in which externalities of antibacterial drug uses were identified from inception to December 31st, 2020. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Descriptive analysis was then performed.ResultsA total of 14 studies were included. Negative externalities and their impacts on costs and/or effectiveness were examined in 13 literature, and positive externalities in terms of an improvement in disease control were included in only one study. No study was found in which both negative and positive externalities were included. The methods used to quantify negative externalities included: only costs associated with drug resistance per prescription or per unit were calculated; both costs and health impacts associated with the second/third line treatments followed a treatment failure (due to drug resistance) were calculated using a decision tree. In one study in which positive externalities were measured, both health gain and cost reduction from an improvement in disease control (as a benefit of antibacterial drug uses) were calculated by constructing a dynamic model at the population level.ConclusionsWe propose that both the positive and negative externalities should be included in health economic evaluation. This can be achieved by measuring the relevant costs and health impacts in a broader perspective, using a disease-transmission dynamic model. In addition, to achieve an improved health utility measurement, disability-adjusted-life years rather than quality-adjusted-life years should be encouraged for use. Finally, both costs and effectiveness should be discounted.
West China Hospital of Sichuan University has explored and established an intelligent assistant evaluation mechanism for professional titles based on the personnel information system, which makes the evaluation more convenient, more efficient, and the whole process more open and transparent. This paper aimed to introduce it and to provide references for evidence-based decision-making of medical institutions.
After the May 12th Wenchuan earthquake, the Department of Architecture and Operation of West China Hospital took prompt action to examine the damage of the hospital buildings. And then experts were invited to perform a safety evaluation of all the hospital buildings. Meanwhile, a real-time monitoring system was initiated to identify any subsequent damage caused by after-shocks. In timely response to the clinical demand, potential dangers were removed so as to ensure the medical rescue work for the wounded.
Objective To evaluate the diagnosis value of radial probe endobronchial ultrasound guide sheath transbronchial lung biopsy (RP-EBUS-GS-TBLB) combination with rapid on-site evaluation (ROSE) in peripheral pulmonary lesions (PPLs). Methods One hundred and fifty-eight patients with PPLs identified by computed tomography in Nanjing Chest Hospital underwent RP-EBUS-GS-TBLB with or without ROSE randomly between February 2016 and August 2017. The sensitivity, the procedure time, the biopsy times, and the complications were evaluated in the two groups. Results The diagnostic yield was 85.7% (72/84) in ROSE group and 70.3% (52/74) in No-ROSE group. There was significant difference in diagnostic sensitivity between the two groups (P<0.05). The mean procedure time and number of biopsy in ROSE group were less than those in No-ROSE group (P<0.01). No severe procedure related complications such as pneumothorax and hemoptysis were observed. Conclusions ROSE can improve the diagnostic sensitivity, and shorten the procedure time. RP-EBUS-GS-TBLB combined with ROSE is a safe and effective technique for PPLs.
ObjectiveTo study the anatomical characteristics of blood vessels in the lateral segment of the vertebral body through the surgical approach of oblique lumbar interbody fusion (OLIF) using MRI imaging, and evaluate its potential vascular safety zone. Methods The lumbar MRI data of 107 patients with low back and leg pain who met the selection criteria between October 2019 and November 2022 were retrospectively analyzed. The vascular emanation angles, vascular travel angles, and the length of vessels in the lateral segments of the left vertebral body of L1-L5, as well as the distance between the segmental vessels in different Moro junctions of the vertebral body and their distances from the edges of the vertebrae in the same sequence (bottom marked as I, top as S) were measured. The gap between the large abdominal vessels and the lateral vessels of the vertebral body was set as the lateral vascular safe zones of the lumbar spine, and the extent of the safe zones (namely the area between the vessels) was measured. The anterior 1/3 of the lumbar intervertebral disc was taken as the simulated puncture center, and the area with a diameter of 22 mm around it as the simulated channel area. The proportion of vessels in the channel was further counted. In addition, the proportions of segmental vessels at L5 without a clear travel and with an emanation angel less than 90° were calculated. Results Except for the differences in the vascular emanation angles between L4 and L5, the vascular travel angles between L1, L2 and L4, L5, and the length of vessels in the lateral segments of the vertebral body among L1-L4 were not significant (P>0.05), the differences in the vascular emanation angles, vascular travel angles, and the length of vessels between the rest segments were all significant (P<0.05). There was no significant difference in the distance between vessels of L1, L2 and L2, L3 at Moro Ⅰ-Ⅳ junctions (P>0.05), in L3, L4 and L4, L5 at Ⅱ and Ⅲ junction (P>0.05). There was no significant difference in the vascular distance of L2, L3 between Ⅱ, Ⅲ junction and Ⅲ, Ⅳ junction, and the vascular distance of L3, L4 between Ⅰ, Ⅱ junction and Ⅲ, Ⅳ junction (P>0.05). The vascular distance of the other adjacent vertebral bodies was significant different between different Moro junctions (P<0.05). Except that there was no significant difference in the distance between L2I and L3S at Ⅰ, Ⅱ junction, L3I and L4S at Ⅱ, Ⅲ junction, and L2I and L3S at Ⅲ, Ⅳ junction (P>0.05), there was significant difference of the vascular distance between the bottom of one segment and the top of the next in the other segments (P<0.05). Comparison between junctions: Except for the L3S between Ⅰ, Ⅱ junction and Ⅱ, Ⅲ junction, and L5S between Ⅰ, Ⅱ junction and Ⅱ, Ⅲ and Ⅲ, Ⅳ junctions had no significant difference (P>0.05), there were significant differences in the distance between the other segmental vessels and the vertebral edge of the same sequence in different Moro junctions (P<0.05). The overall proportion of vessels in the simulated channels was 40.19% (43/107), and the proportion of vessels in L1 (41.12%, 44/107) and L5 (18.69%, 20/107) was higher than that in the other segments. The proportion of vessels in the channel of Moro zone Ⅰ (46.73%, 50/107) and zone Ⅱ (32.71%, 35/107) was higher than that in the zone Ⅲ, while no segmental vessels in L1 and L2 were found in the channel of zone Ⅲ (χ2=74.950, P<0.001). Moreover, 26.17% (28/107) of the segmental vessels of lateral L5 showed no movement, and 27.10% (29/107) vascular emanation angles of lateral L5 were less than 90°. Conclusion L1 and L5 segmental vessels are most likely to be injured in Moro zones Ⅰ and Ⅱ, and the placement of OLIF channels in L4, 5 at Ⅲ, Ⅳ junction should be avoided. It is usually safe to place fixation pins at the vertebral body edge on the cephalic side of the intervertebral space, but it is safer to place them on the caudal side in L1, 2 (Ⅰ, Ⅱ junction), L3, 4 (Ⅲ, Ⅳ junction), and L4, 5 (Ⅱ, Ⅲ, Ⅳ junctions).
ObjectiveTo summarize the research progress on the evaluation methods of head-neck nail positions in femoral intertrochanteric fractures. Methods The literature about the evaluation methods of head-neck nail positions for femoral intertrochanteric fractures in recent years was extensively reviewed, and research progress in the aspects of evaluation methods, clinical applications, and limitations were summarized. ResultsThe position of head-neck nails in femoral intertrochanteric fractures is closely related to postoperative complications of head-neck nail cutting. Currently, the tip-apex distance (TAD) and femoral head zoning are widely used to evaluate the position of head-neck nails. The main opinion in the literature is that the use of TAD and femoral head zoning can effectively reduce the incidence of head-neck nails cutting. Parker’s ratio, as one of the evaluation methods, has been controversial in subsequent studies and has not been widely used in clinical practice. The TAD as referenced to the calcar (CalTAD), which was modified based on TAD, has been gradually accepted by the clinic, but whether it is better than the TAD has not yet been conclusively determined. In recent years, new evaluation methods have been proposed to supplement the previous evaluation methods, such as the tip-neck distance ratio (TNDR) and the standardized TAD (STAD) to avoid the limitations of the TAD and the CalTAD by the volume of the femoral head, and the axis-blade angle (ABA) to supplement the direction of the head-neck nails channel, but at present the clinical application is relatively underutilized, and the validity of the method needs to be further verified. ConclusionCurrently, there are many methods for evaluating the position of head-neck nails in femoral intertrochanteric fractures, TAD<25 mm combined with head-neck nails placed in the middle-middle quadrant or lower-middle quadrant of the femoral head division is currently a highly recognized assessment in the literature, but the optimal assessment is still controversial, and further research needs to be studied.
ObjectiveTo evaluate the efficacy and toxicity of TEC and CEF regimen in preoperative chemotherapy for patients with breast cancer. MethodsA total of one hundred breast cancer patients undergoing preoperative chemotherapy were divided into TEC group (n=50) and CEF group (n=50) by the pairgroup method and received surgical therapy after three courses of chemotherapy. The efficacy and toxicity of preoperative chemotherapy of patients in two groups were analyzed. ResultsFour patients with stage ⅢB breast cancer quit from CEF group after two courses of treatment because of the worse satisfaction. Clinical complete remission (cCR) was 7 cases, clinic partial remission (cPR) was 34 cases, stable disease (SD) was 9 cases, therefore, the remission rate (RR) was 82.0% (41/50), and reduction rate of tumor was 64.0% (32/50) in TEC group. cCR was 2 cases, cPR was 32 cases, SD was 12 cases, thus the RR was 680% (34/50), and reduction rate of tumor was 40.0% (20/50) in CEF group. The clinical efficacy and reduction rate of tumor of patients in TEC group were significantly superior than those in CEF group (Plt;0.05). The negative conversion ratio of lymph nodes were 54.1% (20/37) and 57.1% (20/35) in TEC group and CEF group, which was not statistically different (Plt;0.05). The occurrence of hair loss and leukopenia of patients in TEC group were significantly higher than those in CEF group (Plt;0.05), while the differences in thrombocytopenia, low concentration of hemoglobin, nausea, vomiting, diarrhea, cardiac toxicity, and neurotoxicity were not significant (Pgt;0.05). ConclusionTEC regimen is better than CEF regimen in the efficacy and safety of neo-adjuant therapy for patients with breast cancer, and well tolerated.
Objective To evaluate the diagnostic value and utility of flexible bronchoscopy in the preoperative assessment in patients with solitary pulmonary nodules (SPNs). Methods A total of 111 patients with SPNs of unknown origin treated between January and June 2016 were retrospectively enrolled. The clinical characteristics, bronchoscopy findings and surgical strategies were collected. Results In the total 111 cases, malignant and benign SPNs were 79 and 32 cases, respectively. The mean diameter of malignant SPNs was larger than that of benign SPNs [(2.04±0.58) vs. (1.70±0.75) cm, P<0.05]. Bronchoscopy identified 9 cases (8.1%) unsuspected findings. Surgeries were modified or cancelled in 3 patients (2.7%) because of bronchoscopy findings. Transbronchoscopy biopsies were performed in 26 patients, 9 of whom were diagnosed lung cancer preoperatively, with a sensitivity of 45% (9/20) and a specificity of 100% (6/6). Conclusions Flexible bronchoscopy can be contributed to diagnosis of SPN before surgery and determination of surgical strategies. It is suggested that flexible bronchoscopy could be included in the routine preoperative work-up of SPN.
Objective To summarize and analysis the working experience of healthcare performance evaluation and reporting experience in local health administration department of Australia, and provide decision support to China on such work as establishing objective, scientific, effective healthcare performance evaluation system, strengthening government’s supervision over health service and improving healthcare system management efficiency. Methods Searching official networks and databases of Australia, and finding out relevant policy, reports, and documents on healthcare performance evaluation. Results Typical healthcare performance evaluation systems in Australian are as follos: National Health Performance Framework (NHPF), the National Healthcare Agreement（NHA）and Review of Government Service Provision. Conclusions These programs in Australian is enlightening to these work in China that performance evaluation should be the prior tool in health system to management and reform, the performance measurement indicators systems should emphasize the quality safety and health fair.We should set up scientific and flexible index inclusion criteria and open report and compare performance information.