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.
We searched The Cochrane Library（Issue 3, 2005）, MEDLINE（1996-2005） ,CMCC（1996-2005）, VIP（1996-2005） ,CNKI（1996-2005） to summarize the available evidence of topiramate for an intractable epilepsy. After scanning all these articles, we identified 11 articles including meta-analysis, randomised controlled trials and systematic reviews to evaluate. Topiramate offered an alternative in the treament for intractable epilepsy, especially for partial epilepsy, and its efficacy was proven. Patients had good tolerance. And no intercross effects with the traditional anti-epileptic drugs were found. So topiramate had broad clinical value. The primary dosage of topiramate was 200mg/d. The sustaining dosage was 400-600mg/d. And we didn＇t recommend the dosage of more than 600mg/d.
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.
Endoscopic and robotic surgeries feature small incision and reducing surgical trauma, and minimized incision scars. However, the oncological safety of their application in breast-conserving surgery and breast reconstruction for breast cancer has always been a focal clinical concern. The breast-conserving surgery and breast reconstruction using the suspension, insufflation, and lipolysis methods could achieve precise tumor resection in the selected patients and under the specific surgical conditions, with the support of appropriate instruments. Meanwhile, the innovative application of the reverse-sequence method and auxiliary port technique has further enhanced surgical efficiency and the precision of tumor resection. Current studies suggest that endoscopic and robotic-assited breast-conserving surgery and breast reconstruction yield in terms of oncological outcomes comparable to those of conventional open breast-conserving surgery, including positive margins, local recurrence, regional recurrence, distant metastasis, and overall survival. These approaches offered advantages in minimally invasive techniques and aesthetic outcomes. However, existing research was limited by short follow-up period and small sample sizes. Future large-scale, long-term prospective randomized controlled trials are needed to further validate their oncological safety and long-term efficacy. These studies could help establish novel techniques as standard surgical approaches for breast cancer, particularly the efficient and streamlined reverse-sequence endoscopic and auxiliary port-assisted techniques.
摘要:目的:了解甘精胰島素聯合二甲雙胍治療對口服降糖藥血糖控制不理想的2型糖尿病患者的療效和安全性。方法:對30例口服降糖藥血糖控制不理想的2型糖尿病患者給與甘精胰島素聯合二甲雙胍治療,共12周。治療前后測身高、體重、空腹血糖(FPG)、餐后2小時血糖(PPG)以及糖化血紅蛋白(HbA1c)水平。了解治療期間低血糖發生情況。結果:治療后的FPG、PPG以及HbA1c水平明顯下降,分別下降了303mmol/L、510mmol/L和198%,差異有統計學意義(Plt;005)。治療后5330%的患者HbA1c水平lt;70%。治療前HbA1c水平≥70%lt;90%的患者,治療后706%的患者HbA1c水平lt;70%,治療前HbA1c水平≥90%的患者,治療后307%的患者HbA1c水平lt;70%,兩者的HbA1c達標率有明顯差異(Plt;005)。治療前后體重及BMI無明顯差異(Pgt;005)。30例患者中僅發生兩次輕微低血糖。結論:甘精胰島素聯合二甲雙胍治療對口服降糖藥治療血糖控制不理想的2型糖尿病患者是安全有效的,尤其是對HbA1c水平lt;90%的患者,血糖控制更好,達標率更高。
ObjectiveTo evaluate the safety and effectiveness of total hip arthroplasty (THA) in patients with hypothyroidism.MethodsSixty-three patients with hypothyroidism (hypothyroidism group) and 63 euthyroid patients without history of thyroid disease (control group) who underwent primary unilateral THA between November 2009 and November 2018 were enrolled in this retrospective case control study. There was no significant difference between the two groups in gender, age, body mass index, hip side, reason for THA, American Society of Anesthesiology (ASA) classification, preoperative hemoglobin (Hb) level, and preoperative Harris score (P>0.05). The perioperative thyroid stimulating hormone (TSH) and thyroxine (T4) levels, the hypothyroidism-related and other complications during hospitalization, the decrease in Hb, perioperative total blood loss, blood transfusion rate, length of hospital stays, and 90 days readmissions rate in the two groups were recorded and evaluated. The periprosthetic joint infection, aseptic loosening of the prosthesis, and hip Harris score during follow-up were recorded.ResultsThe differences in the TSH and T4 of hypothyroidism group between pre- and 3 days post-operation were significant (P>0.05) and no hypothyroidism-related complications occurred after THA. The decrease in Hb and perioperative total blood loss in the hypothyroidism group were significantly higher than those in the control group (P<0.05), but there was no significant difference between the two groups in terms of transfusion rate, length of hospital stays, and 90 days readmission rates (P>0.05). No significant difference in the rate of complications (liver dysfunction, heart failure, pulmonary infection, urinary infection, and wound complication) between the two groups was found (P>0.05) except for the rate of intramuscular vein thrombosis which was significantly lower in the hypothyroidism group, and the rate of postoperative anemia which was significantly higher in the hypothyroidism group (P<0.05). The two groups were followed up 1.0-9.9 years (mean, 6.5 years). At last follow-up, Harris score in both groups were significantly higher than those before operation (P<0.05). An increase of 39.5±12.3 in hypothyroidism group and 41.3±9.3 in control group were recorded, but no significant difference was found between the two groups (t=0.958, P=0.340). During the follow-up, 1 case of periprosthetic joint infection occurred in the hypothyroidism group, no loosening or revision was found in the control group.ConclusionWith the serum TSH controlled within 0.5-3.0 mU/L and T4 at normal level preoperatively, as well as the application of multiple blood management, hypothyroid patients can safely go through THA perioperative period and effectively improve joint function, quality of life, and obtain good mid-term effectiveness.
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.