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.
【摘要】 目的 了解在圍手術期術前30 min應用抗生素的情況。 方法 根據2004年衛生部、國家中醫藥管理局、總后勤部發布的《抗菌藥物臨床應用指導原則》中圍手術期抗生素的使用原則，對四川大學華西醫院2010年4-6月500臺手術圍手術期抗生素的使用情況進行分析。 結果 抗生素在麻醉前輸：0臺；抗生素末在術前30 min輸2臺，占0.4%；抗生素末即用即配：0臺；抗生素與麻藥及其他禁忌藥混合輸:0臺；手術3 h后末及時追加抗生素：0臺；特殊患者使用抗生素的注意事項不清楚2臺，占0.4%。 結論 該院99.6%的手術實行在手術室術前30 min輸入抗生素，確保抗生素達到有效濃度，有效控制感染，保證手術的成功，保障患者安全。【Abstract】 Objective To investigate the application of perioperative antibiotics half an hour before operation in West China Hospital of Sichuan University. Methods According to Clinical Guidance of Antibiotics published by Ministry of Health, State Administration of Traditional Chinese Medicine and General Logistics Department in 2004, we investigated the application of perioperative antibiotics in 500 operations between April to June 2010 in our hospital. Results There was no operation with infusion of antibiotics before anesthesia, 2 operations without infusion of antibiotics half an hour before operation (0.4%), no operation without immediate infusion after preparation, no operation with mixed infusion of antibiotics and anesthesia and other contraindicated drugs, no operation without infusion of antibiotics 3 hours after operation, and 2 operations in which cautious items about the children, pregnancy and old patients were unclear (0.4%). Conclusion About 99.6% operations in our hospital have the infusion of antibiotics 30 minutes before the operation, which is the guarantee of antibiotics with effective concentration, inhibition of infection, success of the operation and safety of the patients.
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.
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.
