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 discuss clinical significance of total endoscopic thyroidectomy (TET) via chest-breast approach. MethodsThe clinical data of 890 patients with thyroid diseases from September 2008 to September 2015 in this hospital were analyzed retrospectively. These patients were divided into TET group (received TET, n=420) and traditional group (received traditional thyroidectomy, n=470). The data of operation and postoperative recovery were compared between these two groups. ResultsThere was no significant difference between the TET group and the traditional group in the operation time [(73.571 4±28.533 9) min versus (70.212 8±27.199 8) min, t=1.80, P=0.072 7], bleeding volume [(30.714 3±14.225 1) mL versus (29.106 4±13.559 1) mL, t=1.73, P=0.084 8], postoperative drainage [(60.000 0±27.287 9) mL versus (56.595 7±27.803 5) mL, t=1.84, P=0.066 2], postoperative hospitalization time [(5.333 3±1.085 1) d versus (5.446 8± 1.089 0) d, t=1.55, P=0.120 4], postoperative 24 h pain score [(5.333 3±2.308 7) points versus (5.404 3±2.182 1) points, t=0.47, P=0.637 8] and postoperative injury rate of recurrent laryngeal nerve [0.714 2% (3/420) versus 0.851 1% (4/470), x2=0.053 2, P=0.817 6] and hypoparathyroidism rate [0.476 2% (2/420) versus 0.851 1% (4/470), x2=0.465 5, P=0.495 1]. The score of aesthetic effect of incision on day 7 after operation in the TET group was significantly higher than that in the traditional group [(7.809 5±1.296 9) points versus (3.361 7±1.391 8) points, t=49.14, P < 0.000 1]. ConclusionTET is safe and effective, and could improve cosmetic effect for patients with thyroid diseases.
Inflammatory bowel disease (IBD) is a group of chronic, recurrent, and non-specific intestinal inflammatory diseases. It usually occurs between 20 and 40 years old, overlapping with the patient’s childbearing age. Active IBD may lead to decreased fertility and adverse pregnancy outcomes, and pregnancy may also lead to recurrence of IBD. Through studying domestic and foreign related literature on pregnancy and IBD, this article elaborates on the guidance and management of IBD before pregnancy, the disease management of IBD during pregnancy, the disease management of IBD during lactation, and the current status and prospects of traditional Chinese medicine treatment. It aims to provide references for patients and clinicians to have a more scientific understanding of pregnancy with IBD.
Objectives To conduct a meta-analysis to evaluate the efficacy and safety of thymosin-α1 for HBeAg-positive chronic hepatitis B. Methods We searched MEDLINE, Science Citation Index, Current Content Connect, Cochrane Controlled Trial Register and Chinese Biomedical Database (CBMdisc) to September 15, 2005, and screened the references of eligible trials by hand-searching. Randomized controlled trials (RCTs) comparing thymosin-α1 with non-antiviral interventions (placebo, no treatment and standard care) in patients with HBeAg positive chronic hepatitis B were eligible for inclusion. We conducted quality assessment and data extraction by two independent investigators with disagreement resolved by discussion. We used chi-square test and Galbraith plot to detect the heterogeneity, and used fixed (Mantel-Haenzel) and random effect model (DerSimonian-Laird) to pool the trials. When the results in two models differed, the results of random effect were reported. Subgroup analysis was performed to detect whether the duration affected the efficacy of thymosin. Results Four RCTs were included. It was found that the rate of loss of HBeAg was 38.8% in thymosin, significantly higher than that of 12.4% in control groups (RR 2.22, 95%CI 1.55 to 3.21, P=0.000). Loss of HBV-DNA was 36.9% in thymosin-α1, significantly higher than that of 13.8% in control groups (RR 2.18, 95%CI 1.50 to 3.17, P=0.000). Both short-duration (8-13 weeks) and regular duration (26-52 weeks) of thymosin-α1 achieved higher loss of HBeAg and HBV-DNA. The complete response rate was 32.3% in thymosin-α1, significantly higher than the control, 11.3% (RR 2.91, 95%CI 1.71 to 4.94, P=0.000). No statistical significance was found for HBeAg seroconversion and ALT normalization. No significant adverse drug reactions were found. Conclusions Thymosin-α1 might be efficacious in loss of HBeAg and HBV-DNA, and complete response for patients with HBeAg-positive chronic hepatitis B. Little evidence was available on HBeAg seroconversion, normalization of ALT, loss of HBsAg, and histological response. Further high-quality RCTs were needed for confirmation.
探討醫院檢驗科工作人員的生物安全預防教育,生物安全防護意識,生物安全防護措施,使實驗室每個工作人員不僅成為生物安全的受益者,又是合格的管理者。
As the development of medical imageology, radioexamination has become one of the main approaches of disease diagnosis. However, the society and hospital have not taken the hidden danger and harmfulness of radiation seriously. Through discussing the following eight aspects of radiation safety culture management, this paper aims to reduce the risk of radiation and ensure the safety of patients and medical staff: a) Improving the awareness of safety culture and the understanding of patients on safety culture; b) Consummating the safety management system of the radiation; c) Attaching importance to implementing the relevant laws and regulations of radiation; d) Mastering the examination indications, and especially the contraindications of radiation; e) Strengthening the clinical cooperation and exchange; f) Improving the staff’s ability to distinguish hidden danger and identify patients in high risk; g) Strengthening the nursing behavior safety management of the radiation department; and h) Strengthening the biological security management of the radiation department.
目的：分析硫酸依替米星不良反應的臨床特征、相關因素，為硫酸依替米星所致不良反應的防治提供可靠的參考依據。方法：對2003年11月～2004年5月我院使用硫酸依替米星注射劑的住院患者出現的不良反應及聯合用藥情況進行調查分析。結果：使用單一抗生素1096例，聯合用藥2029例；不良反應發生率為4.54%(142/3125),聽覺和前庭功能損害16例,發生率為0.5% (16/3125)；泌尿系統損害14例，發生率為0.45% (14/3125)；肝膽系統損害4例，發生率為0.13% (4/3125)。 結論：硫酸依替米星是氨基糖苷類抗生素中安全性較高的藥物。為了預防和減少不良反應的發生，需注意用藥劑量、濃度、滴速配伍禁忌
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.