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 investigate the clinical efficacy and safety of hyperthermic intraperitoneal perfusion chemotherapy (HIPC) in treatment of advanced colorectal cancer.Methods The Meta-analysis was applied to analyze 8 randomized controlled quantitative studies published at domestic and abroad. These patients treated by HIPC after radical operation with colorectal cancer were included for the treatment group, and those treated only by radical operation with colorectal cancer for the control group. Relative risk (RR) of outcome variable of 3-year and 5-year survival rate and safety between the two groups were compared. Results There were 8 selected literatures, including 1 501 cases, in which 765 cases for treatment group, and 736 cases for control group. RR of 5-year survival rate of the total patients was 2.39 (95% CI: 1.66-3.45). RR of 3-year survival rate of the total patients was 2.13 (95% CI: 1.45-3.13). The results demonstrated that HIPC could improve 5-year and 3-year survival rate, and sensitivity analysis confirmed the conclusions more reliable. The security was described in 5 literatures, the available information showed smaller potential security issue. Conclusions HIPC after radical operation of advanced colorectal cancer can increase 5-year and 3-year survival rate of patients, improve the prognosis of patients. Whether patients with increased incidence of postoperative complications related to the HIPC is no clear-cut conclusions for lack of related research.
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 evaluate the effect of autoantibody on the efficacy and safety of pegylated interferonα-2a (Peg-IFNα-2a) and ribavirin on chronic hepatitis C (HCV). MethodsWe enrolled 106 chronic HCV infected patients, who were divided into autoantibody-positive group and negative group based on the baseline autoantibody detection. The patients were treated for 48 weeks. The anti-viral response and adverse effects were observed. Data analyses were reported using the SPSS 20.0 statistical package. ResultsThe prevalence of any autoantibody in chronic hepatitis C patients amounted to 31.1%, and serum anti-nuclear antibody was positive in 24 patients. Difference in age, sex, serum alanine transaminase level, aspartate transaminase level, total bilirubin level, thyroid function and HCV RNA level between autoantibody-positive group and negative group was not significant (P > 0.05). The level of hemoglobin in autoantibody-positive group was significantly lower than the negative group (P=0.018). Of the 106 patients, 82 patients achieved sustained virological response (SVR), 56 achieved rapid virological response (RVR), 98 achieved ealy virological response (EVR) and 8 were non-responders. There were no significant differences between RVR, EVR and SVR in autoantibody-positive group and negative group (P > 0.05). The most common adverse effects in this study were fatigue, weight loss, hair loss and fever, and no significant differences in adverse effects were observed between the two groups (P > 0.05). ConclusionAutoantibody positivity may not affect the treatment response and is safe in chronic HCV infected patients with combination therapy of pegylated interferonα-2a plus ribavirin.
ObjectiveTo systematically review the efficacy and safety of vaccines for the coronavirus disease 2019 (COVID-19) . Methods The CNKI, VIP, WanFang Data, PubMed, EMbase and Web of Science databases were electronically searched to collect randomized controlled trials (RCTs) on the safety and efficacy of COVID-19 vaccines from their inception to June 30th, 2022. 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 and Stata 12.0 software. Results A total of 13 RCTs involving 139 015 subjects were included. The results of meta-analysis showed that the sero-antibody conversion rate (RR=37.883, 95%CI 8.086 to 177.491, P<0.001) and infection prevention rate (RR=1.011, 95%CI 1.006 to 1.017, P<0.001) of the vaccine group were higher than those of the placebo group. The incidence of adverse reactions in the vaccine group was higher than that in the placebo group (OR=1.839, 95%CI 1.165 to 2.903, P=0.009), which mainly included pain, redness, swelling, fever, headache and itching (P<0.05). However, the incidence of serious adverse reactions was not significantly different from that of the placebo group. Conclusion The current evidence shows that the efficacy of the COVID-19 vaccines is high. The most prevalent adverse reactions are mild and moderate, and severe adverse reactions are the same as those of the placebo group. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusion.
ObjectiveTo systematically review the efficacy and safety of dexamethasone in the treatment of viral myocarditis.MethodsThe Cochrane Library, PubMed, EMbase, Biosis Preview, Web of Science, CBM, WanFang Data, VIP, and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) on dexamethasone for patients with viral myocarditis from inception to April 30th, 2021. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of the included studies. Meta-analysis was then performed using RevMan 5.4 software.ResultsA total of 7 RCTs involving 749 patients were included. The results of meta-analysis showed that the dexamethasone treatment group exhibited an increased efficacy rate (RR=1.26, 95%CI 1.18 to 1.34, P<0.000 01), decreased levels of C-reactive protein (CRP) (MD=?11.49, 95%CI ?19.25 to ?3.72, P=0.004), cardiac troponin I (cTnI) (MD=?26.14, 95%CI ?40.82 to ?11.47, P=0.0005), and creatine kinase MB (CK-MB) (MD=?20.06, 95%CI ?28.35 to ?11.77, P<0.000 01), and a decreased adverse event rate (RR=0.40, 95%CI 0.24 to 0.65, P=0.000 3).ConclusionsCurrent evidence shows that dexamethasone can significantly improve the efficacy rate, reduce the levels of CRP, cTnI, and CK-MB, and reduce the incidence of adverse events in patients with viral myocarditis. Due to the limited quantity and quality of included studies, more high-quality studies are required to verify above conclusions.
ObjectiveTo evaluate the efficacy and safety of glucosamine hydrochloride in the treatment of osteoarthritis. MethodsA total of 150 patients with osteoarthritis treated between April 2014 and April 2015 were randomly divided into control group and trial group with 75 in each. Patients in the trial group accepted oral glucosamine hydrochloride, while those in the control group were given diclofenac sodium. Lequesne index, total effective rate and the incidence of adverse reactions of both groups were calculated before and 2, 4, 6 and 8 weeks after treatment, and 2 weeks after drug withdrawal. ResultsIn both groups, Lequesne index started to decrease after 2 weeks of treatment (P<0.05), and reached the minimum value at treatment week eight (P<0.05). The Lequesne index 2 weeks after drug withdrawal was still obviously lower than that before treatment (P<0.05). There was no significant differences in the total effective rate at treatment week eight (83.1% for the control group and 80.9% for the trial group) or the total effective rate 2 weeks after drug withdrawal (80.0% for the control group and 79.4% for the trial group) between the control group and the trial group (P>0.05). The incidence of adverse reactions of the trial group (6.7%) was significantly lower than that of the control group (21.3%) (P<0.05). ConclusionGlucosamine hydrochloride is effective and safe in the treatment of osteoarthritis, which is suitable for long-term treatment.
ObjectiveTo systematically review the efficacy and safety of autologous mononuclear cells transplantation in osteonecrosis of the femoral head.MethodsPubMed, EMbase and The Cochrane Library were electronically searched to collect randomized and non-randomized controlled trials on autologous mononuclear cells transplantation for osteonecrosis of the femoral head from inception to July 31th, 2020. Two reviewers independently screened literatures, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed using RevMan 5.4 software.ResultsA total of 17 studies involving 645 hips in mononuclear cells group and 557 hips in cell-free group were included. The results of meta-analysis showed that compared with cell-free therapy, mononuclear cells therapy could improve hip function in term of Hairrs score (MD=8.11, 95%CI 4.36 to 11.87, P<0.000 1), Merle D`Aubigné Postel score (MD=2.23, 95%CI 0.97 to 3.49, P=0.000 5), WOMAC score (MD=?10.81, 95%CI ?15.80 to ?5.81, P<0.000 1), Lequesne index (MD=?2.97, 95%CI ?5.42 to ?0.52, P=0.02) and alleviate the pain (MD=?9.13, 95%CI ?12.40 to ?5.86, P<0.000 01), delay the progression of radiological staging (RR=0.55, 95%CI 0.34 to 0.89, P=0.01) and reduce the rate of total hip arthroplasty (RR=0.61, 95%CI 0.43 to 0.86, P=0.005). In terms of safety, mononuclear cell therapy did not increase the rate of complications (RR=0.77, 95%CI 0.33 to 1.83, P=0.56).ConclusionsThe current evidence shows that autologous mononuclear cells therapy is a safe and effective way for osteonecrosis of the femoral head. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Seizure clusters, a severe form of epilepsy requiring urgent intervention, are challenging to manage in out-of-hospital settings due to limitations of traditional benzodiazepine administration routes. Diazepam nasal spray (DZP-NS), a novel intranasal formulation, achieves rapid absorption through the nasal mucosa, bypassing first-pass metabolism, with bioavailability comparable to rectal gel and faster onset. Clinical studies demonstrate its high efficacy in treating seizure clusters and prolonged seizures (≥5 minutes), with an initial control rate of 87.4% and low second-dose utilization (12.6%). No severe adverse reactions, such as cardiorespiratory depression, were observed. Long-term use (12 months) showed no tolerance development, significantly extending seizure intervals (SEIVAL) (from 12.2 to 25.7 days) and improving quality of life scores, particularly in "epilepsy-related concerns" and "social functioning" domains. The non-invasive delivery method was favored by over 80% of patients and healthcare providers for its convenience compared to rectal administration. Subgroup analyses confirmed consistent safety and efficacy across genders, ages, concomitant medications (including cannabidiol), and patients with allergy histories. In conclusion, DZP-NS provides an efficient, safe, and socially accepted out-of-hospital rescue therapy for seizure clusters, positioning it as a potential cornerstone in standardized epilepsy emergency care.
Objective To explore the diagnostic value and safety of CT-guided percutaneous lung biopsy (CT-PLB) for pulmonary nodules. Methods A total of 438 patients with pulmonary nodules underwent CT-PLB for further diagnosis. Results The CT-PLB was performed successfully in all 438 patients. The positive biopsy rate at the first puncture was 94.9%, and 100.0% at the second puncture. The pathology results revealed 379 (86.5%) cases of malignant lesions, 37 cases of benign lesions, and 22 cases with uncertainty. The sensitivity, specificity and accuracy of CT-PLB were 97.9% (376/384), 94.4% (51/54), and 97.4% (427/438), respectively. The first puncture induced complications included pneumothorax in 33 (7.5%) cases, blood in phlegm in 62 (14.2%) cases, pleural reaction in 7 (1.6%) cases, and bleeding at the site of puncture in 6 (1.4%) cases. There was no occurrence of neoplasm needle track implantation. The second puncture induced complications included pneumothorax in 7 (46.6%) cases and blood in phlegm in 11 (73.3%) cases. The incidences of pneumothorax and blood in phlegm were significantly higher in the patients with chronic obstructive pulmonary disease (COPD), with pulmonary lesion size＜3 cm, or with penetration depth ≥5 cm (P＜0.05). Conclusions CT-PLB is a safe method with a relatively small trauma and has good diagnostic value for pulmonary nodules. The incidence of complications increases in patients with smaller pulmonary lesions, deeper puncture, or COPD.