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.
Objective To evaluate the complication rate of CT-guided percutaneous lung biopsy and determine the risk factors. Methods A retrospective investigation of patients with CT-guided percutaneous lung biopsy in Ruijin Hospital, Shanghai Jiao Tong University School of Medicine between2002 and 2009 was performed. The risk factors for complications were determined by multivariate analysis of variables related to patients’demographics, lung lesions, biopsy procedures, and individual radiological features. Results 281 biopsy procedures were enrolled. The total complication rate was 55. 9% with pneumothorax 32. 4% ( 91/281) , hemoptysis 34. 5% ( 97 /281) , and cutaneous emphysema2. 1% ( 6 /281) , and with no mortality.The pneumothorax rate was correlated with lesion location, lesion depth, and number of pleural passes. The bleeding risk was correlated with lesion size, lesion depth, and age. Prediction models for pneumothorax and bleeding were deduced by logistic regression. The pneumothorax model had a sensitivity of 80. 0% and a specificity of 62. 4% . And the bleeding model had a sensitivity of 67. 4% and a specificity of 88. 8% .Conclusions Lesion location, lesion depth, and number of pleural passes were independent risk factors for pneumothorax. Lesion size, lesion depth, and age were independent risk factors for bleeding. The prediction models for pneumothorax and bleeding will helpfully reduce the complication of CT-guided lung biopsy.
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.
The incidence of myopia is increasing year by year and the trend of younger age is obvious. The situation of myopia prevention and control is very serious. The sclera is the target organ for the development of myopia. When myopia occurs and develops, the ultrastructure of the sclera tissue will undergo pathological changes, resulting in a decrease in its tensile strength, then progressive axial growth and posterior sclera expansion. Scleral collagen cross-linking can effectively increase the hardness and tensile strength of scleral tissue, which may have great potential in the prevention and control of myopia, especially pathological myopia. At present, the effectiveness of scleral collagen cross-linking technology in the prevention and treatment of pathological myopia researches are still in the stage of animal experiments, and there are a lot of controversies on the safety. The development of any new technology to ensure safety is the primary condition. A comprehensive understanding of the safety of scleral collagen crosslinking in the prevention and control of myopia can provide more basis and guidance for the further study of scleral collagen crosslinking.
Real-world studies (RWSs) data are based on real medical scenes and reflect clinical facts. Besides, RWSs adapts to the characteristics of therapeutic principles of traditional Chinese medicine and the medical reality of the combination of Western and traditional Chinese medicine, which makes the safety assessment of herb-drug interaction more efficient and economical. During RWSs, more attention should be paid on the validity and reliability of data, especially the standardization of the data collection process and its contents. The safety assessment of herb-drug interaction will combine the methods of active surveillance study, big data analysis, and be based on precision medicine in the future
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.
Meibomian gland dysfunction (MGD) is a common ocular surface disease, and the pathogenesis of MGD is closely related to the alteration of meibomian gland morphology and (or) function. At present, the treatment strategy for MGD consists of physical therapy, artificial lubricants, topical and systemic antibiotics and anti-inflammatory agents, topical steroids and Ω-3 dietary supplementation. Recently, the thermal pulsation system (LipiFlow) has been used clinically, which allows heat to be applied to the palpebral surfaces of the upper and lower eyelids directly over the meibomian glands, while simultaneously applying pulsatile pressure to the outer eyelid surfaces. Due to its specific design, the cornea and eyeball can successfully avoid the potential damage from overheating and improper expression, which will greatly improve the safety during the clinical application and patients’ compliance. Studies have showed that the effectiveness of LipiFlow when treating MGD is at least as well as twice-daily lid warming and massage for 3 months, which displays a broad application prospect. At present, the application of LipiFlow in China has not been fully developed, and only some hospitals have experimental applications. This paper summarizes the research progress of LipiFlow treatment in MGD.
