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 the effectiveness and safety of the additional catheter-directed thrombolysis (CDT) and conventional treatment (CT) for treatment primary deep vein thrombosis.
MethodsDatabases such as CNKI, WanFang Data, Pubmed, EMBASE.com, Medline, CBM, CSJD, CJFD, and the Cochrane Library were electronically searched from the date of their establishment to 30 June, 2013, and the relevant literatures and conference proceedings were also manually searched to include randomized controlled trials (RCTs) on comparison of additional CDT versus CT for primary deep vein thrombosis. Two reviewers independently screened studies according to the inclusion and exclusion criteria, extracted data, and accessed the methodological quality of the included studies. Then the meta-analysis was performed by using RevMan 5.1 software. Publication bias was assessed by STATA software. A meta-regression model was used to describe between study variability.
ResultsTwo RCTs including 3 literatures contain 224 patients reporting data on safety and efficacy of CDT versus CT were included. There were no publication bias (Begg'S test, Z=1.02. P > 0.05;Egger'S test, t=0.98, P > 0.05). The results of meta-analysis showed that:in 6 months after surgery iliofemoral vein patency rate of CDT group was higher than that of CT group (OR=3.62, 95% CI:1.51-8.64, P=0.004), in 6 months after surgery CDT group with a lower rate than CT group of the iliofemoral vein occlusion and (or)venous reflux rate (OR=0.24, 95% CI:0.11-0.53, P=0.000), and the incidence rate of PTS in 24 months after surgery in CTD group was less than that of CT group (OR=0.55, 95% CI:0.31-0.96, P=0.040). There were no statistically significant of the major complications after surgery between CDT group and CT group (OR=1.34, 95% CI:0.12-15.69, P=0.810). But the incidence rates of minor complications and total complications after surgery in CT group were lower than those of CDT group (OR=13.67, 95% CI:4.08-45.83, P < 0.00 01 and OR=11.67, 95% CI:4.40-30.99, P < 0.000 01).
ConclusionsCDT is a effective and positive way to treat early deep venous thrombosis especially in terms of the patency of vascular and prevent the occlusion and PTS. Due to the limitation of the included studies, large sample size, multicenter, and high quality studies are needed to verify the above conclusion, such as the ATTRACT Study. The intracavitary therapy could be applied to clinic combining individual conditions of patients.
ObjectiveTo systematically review the efficacy and safety of acupuncture on postpartum depression (PPD).MethodsPubMed, EMbase, The Cochrane Library, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of acupuncture in treatment of PPD from inception to February 2021. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed by using Stata16.0 software.ResultsA total of 13 RCTs involving 899 patients were included. The results of meta-analysis showed that there was no significant difference between hand acupuncture and fluoxetine hydrochloride in HAMD score (MD=0.45, 95%CI ?0.52 to 1.41, P=0.36), clinical effective rate (RR=0.93, 95%CI 0.70 to 1.23, P=0.59), and clinical cure rate (RR=0.88, 95%CI 0.44 to 1.76, P=0.73). However, hand acupuncture was superior in safety to fluoxetine hydrochloride (RR=0.04, 95%CI 0.01 to 0.28, P<0.05). There was no significant difference in clinical effective rate (RR=1.08, 95%CI 0.87 to 1.36, P=0.49) and cure rate (RR=1.31, 95%CI 0.84 to 2.04, P=0.24) between both groups.ConclusionsThe current evidence shows that there are no differences between hand acupuncture and non-acupuncture in reducing HAMD score, improving the clinical effective rate and clinical cure rate. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.
ObjectiveTo evaluate the safety, efficacy, and cost-effectiveness of different uses of oxidized regenerated cellulose (ORC) in video-assisted thoracoscopic surgery (VATS) for lung cancer resection to provide a reference for the selection, clinical use, and rational utilization of absorbable hemostatic materials. MethodsA retrospective analysis of relevant data from inpatients who underwent VATS for lung cancer resection at a tertiary hospital from July 2019 to January 2020 and from July 2020 to December 2020 was conducted. Patients were divided into two groups based on the use of ORC: 1) combined use group (ORC and collagen sponge) and 2) sole-use group (ORC). Safety, efficacy, and economic outcome indicators were compared between the two groups. ResultsThe main analysis included a total of 904 patients, with 466 in the combined use group and 438 in the sole-use group. Compared to the combined use group, the sole-use group had a significantly longer hospital stay, used fewer hemostatic drugs, had a lower average cost of hemostatic materials, and a lower median total hospitalization cost (P<0.05). No statistically significant difference was found between the two groups in terms of intraoperative blood loss volume, massive blood loss rate, perioperative transfusion rate, reoperation rate, postoperative 48-hour drainage volume, bloody drainage fluid rate, or postoperative laboratory test indicators. ConclusionThere was no significant difference in the safety or efficacy of VATS for lung cancer resection between the sole use of ORC and the combined use of ORC, but the sole use of ORC was associated with a lower cost of hemostatic materials and a lower total hospitalization cost. The sole use of hemostatic gauze in VATS for lung cancer resection may be a more cost-effective choice.
ObjectivesTo evaluate the efficacy and safety of four antiplatelet regimens after coronary drug-eluting stents by network meta-analysis.MethodsPubMed, The Cochrane Library, EMbase and Web of Science databases were electronically searched to collect randomized controlled trials (RCTs) of the comparison of different antiplatelet regimens after coronary drug-eluting stenting from inception to December 31st, 2019. Two reviewers independently screened literature, extracted data and assessed risk bias of included studies. Network meta-analysis was then performed by using Gemtc14.3 software, Stata16.0 software and RevMan5.3 software.ResultsA total of 23 RCTs involving 45 837 patients were included. The results of network meta-analysis showed that: in terms of prevention of myocardial infarction (MI) recurrence, the aspirin monotherapy after short-term dual antiplatelet therapy was inferior to the triple antiplatelet therapy (OR=2.13, 95%CI 1.08 to 4.03). In terms of reducing the incidence of ischemic compound events, the triple antiplatelet therapy was superior to the standard dual antiplatelet therapy (OR=0.53, 95%CI 0.39 to 0.72), the aspirin monotherapy after short-term dual antiplatelet therapy (OR=0.49, 95%CI 0.35 to 0.69) and the P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy (OR=0.51, 95%CI 0.35 to 0.73). There was no statistically significant difference among the four interventions in reducing the rate of in-stent thrombosis and all-cause mortality (P>0.05). In terms of safety, the bleeding rate of aspirin monotherapy after short-term dual antiplatelet therapy was lower than that of standard dual antiplatelet therapy (OR=0.70, 95%CI 0.55 to 0.86) and triple antiplatelet therapy (OR=0.58, 95%CI 0.36 to 0.90), and the bleeding rate of P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy was also lower than that of standard dual antiplatelet therapy (OR=0.51, 95%CI 0.39 to 0.65) and triple antiplatelet therapy (OR=0.43, 95%CI 0.26 to 0.67). The probability ranking diagram showed that: in terms of the recurrence rate of MI, the rate of in-stent thrombosis and the incidence of ischemic compound events, triple antiplatelet therapy was the lowest and aspirin monotherapy after short-term dual antiplatelet therapy was the highest. However, in terms of all-cause mortality and bleeding rate, aspirin or P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy was the lowest and triple antiplatelet therapy was the highest.ConclusionsThe available evidence suggests that when the risk of ischemia is low, we should choose aspirin or P2Y12 inhibitor monotherapy after short-term dual antiplatelet therapy, and P2Y12 inhibitor monotherapy may have a lower risk of ischemia and bleeding. When the risk of ischemia is high and bleeding is low, the triple or standard dual antiplatelet therapy should be selected, and the efficacy of triple antiplatelet therapy is superior, while the safety may be inferior.
ObjectiveTo systematically review the efficacy and safety of JAK inhibitor in the treatment of axial spondyloarthritis (axSpA). MethodsThe PubMed, Cochrane Library, Embase, CNKI, WanFang Data, and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of JAK inhibitors in patients with axSpA from inception to December, 2023. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of the included studies Meta-analysis was then performed using RevMan 5.3 software. ResultsA total of 7 RCTs involving 1 602 patients were included, including 852 patients in the experimental group and 750 patients in the placebo group. The results of meta-analysis showed that in terms of clinical efficacy, ASAS20 (RR=1.67, 95%CI 1.50 to 1.86, P<0.01), ASAS40 (RR=2.30, 95%CI 1.93 to 2.73, P<0.01), ΔBASFI (MD=?1.04, 95%CI ?1.21 to ?0.87, P<0.01), and ΔBASMI (MD=?0.30, 95%CI ?0.41 to ?0.19, P<0.01) of JAK inhibitors in the treatment of axSpA patients were significantly higher than those in the placebo group. In terms of safety, adverse event (RR=1.09, 95%CI 0.97 to 1.21, P=0.14) and major adverse events, such as diarrhea (RR=1.18, 95%CI 0.55 to 2.51, P=0.67), nasopharyngitis (RR=0.98, 95%CI 0.55 to 1.75, P=0.96), liver enzyme abnormalities (RR=1.83, 95%CI 0.84 to 3.99, P=0.13), and headache (RR=1.94, 95%CI 0.77 to 4.87, P=0.16) were statistically insignificant. ConclusionCurrent evidence shows that JAK inhibitors can improve the clinical efficacy in the axSpA patients, and the safety is high. Due to the limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.
ObjectiveTo observe effect and safety of interstitial chemotherapy with 5-fluorouracil sustained release agent in radical operation of colorectal cancer.
MethodsOne hundred and sixty patients with colorectal cancer from October 2011 to December 2013 were randomly divided into observation group and control group according to an incomplete random method, 78 cases of them were in the observation group and 82 cases of them were in the control group. All the patients were performed radical resection of colorectal cancer. The abdominal cavity and pelvic cavity were washed after surgery. 5-fluorouracil sustained release agent was implanted in the observation group patients for interstitial chemotherapy, the implant site was at the tumor resection area and the mesenteric artery. Routine chemotherapy was performed in these two groups after operation. The postoperative complications were observed. The postoperative local recurrence rate, liver metastasis rate, and 24-month survival rate were recorded.
ResultsThe rates of abdominal complications and toxic effects had no significant differences between these two groups (P > 0.05). The rates of 12-month and 24-month local recurrence and the rate of liver metastasis in the observation group were significant lower than those in the control group[1.3% (1/78) versus 8.5% (7/82), x2=8.934, P=0.023; 5.2% (4/78) versus 23.2% (19/82), x2=14.834, P=0.004; 10.3% (8/78) versus 18.3% (15/82), x2=12.034, P=0.016]. The rate of 24-month survival in the observation group was significant higher than that in the control group[94.9% (74/78) versus 84.1% (69/82), x2=11.465, P=0.010].
ConclusionThe good safety of interstitial chemotherapy with 5-fluorouracil sustained release agent could effectively decrease local recurrence rate and liver metastasis rate of colorectal cancer after radical operation and improve survival time of patients.
ObjectivesTo systematically review the efficacy and safety of doxazosin for ureterolithiasis.MethodsPubMed, EMbase, Web of Science, The Cochrane Library and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) of comparing doxazosin with conservative treatment or tamsulosin for ureterolithiasis from inception to October, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, RevMan 5.3 software was used to perform meta-analysis.ResultsA total of 15 RCTs involving 1 062 patients were included. The results of meta-analysis showed that: compared with conservative treatment, doxazosin significantly facilitated ureteral stone expulsion (RR=1.62, 95%CI 1.45 to 1.81, P<0.000 01). No statistical significant difference was found in stone-free rate (RR=0.96, 95%CI 0.83 to 1.11, P=0.57), stone expulsion time (SMD=?0.17, 95%CI ?0.52 to 0.19, P=0.35) or pain episode frequency (SMD=0.21, 95%CI ?0.15 to 0.56, P=0.25) between doxazosin and tamsulosin. Treatment-associated serious side effects were rarely reported.ConclusionCurrent evidence shows that doxazosin is an efficient and safe medical expulsion agent for ureterolithiasis management. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectivesTo systematically review the efficacy and safety of oral drugs for treating women with uncomplicated lower urinary tract infection.MethodsPubMed, The Cochrane Library, EMbase, CBM, WanFang Data, CNKI and VIP databases were electronically searched to collect randomized controlled trials (RCTs) of oral drugs for treating females with uncomplicated lower urinary tract infection from inception to November, 2018. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies, then, network meta-analysis was performed by using " gemtc” packages in R 3.5.1 software.ResultsA total of 38 RCTs were included. The results of network meta-analysis showed that: quinolones (RR=1.24, 95%CI 1.11 to 1.37), furantoin (RR=1.21, 95%CI 1.06 to 1.37), trimethoprim-sulfamethoxazole (TMP-SMZ) (RR=1.20, 95%CI 1.06 to 1.35), fosfomycin (RR=1.17, 95%CI 1.04 to 1.31) and penicillin (RR=1.18, 95%CI 1.05 to 1.33) were superior to non-steroidal anti-inflammatory drugs (NSAIDS) in clinical cure. Quinolones were better than fosfomycin (RR=1.07, 95%CI 1.03 to 1.12), penicillin (RR=1.18, 95%CI 1.13 to 1.23) and cephalosporin (RR=1.13, 95%CI 1.08 to 1.19); furantoin was better than penicillin (RR=1.15, 95%CI 1.08 to 1.21) and cephalosporin (RR=1.10, 95%CI 1.04 to 1.17); TMP-SMZ was better than penicillin (RR=1.15, 95%CI 1.09 to 1.21) and cephalosporin (RR=1.11, 95%CI 1.04 to 1.16); fosfomycin was better than penicillin (RR=1.10, 95%CI 1.04 to 1.16) in bacteriological cure. The adverse effect rates of quinolones were lower than furantoin (RR=0.83, 95%CI 0.70 to 0.98), TMP-SMZ (RR=0.88, 95%CI 0.78 to 0.99) and fosfomycin (RR=0.74, 95%CI 0.59 to 0.93), and which of fosfomycin was higher than penicillin (RR=1.33, 95%CI 1.01 to 1.74) and NSAIDS (RR=1.46, 95%CI 1.11 to 1.92). All differences were statistically significant.ConclusionsCurrent evidence shows that uncomplicated lower urinary tract infection should be recommended to therapy containing quinolones. Due to limited quality and quantity of included studies, more high-quality studies are required to verify the above conclusion.
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.
