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find Keyword "临床评价" 7 results
  • A Primary Survey of Evidence-Based Medicine and Traditional Chinese Medicine

    Release date:2016-09-07 02:27 Export PDF Favorites Scan
  • Clinical outcomes of harmonic scalpel in esophageal cancer surgery

    Objective To assess the outcome of harmonic scalpel (HS) in esophageal cancer surgery and to provide evidence for the role of HS in the enhanced recovery after surgery (ERAS) and short-term prognosis after esophageal cancer surgery. Methods We collected the clinical data of 81 esophageal cancer patients receiving surgery by HS between January 1 and December 31, 2016 and successfully followed up in our department. There were 67 males and 14 females with an average age of 64.07±7.52 years. Sweet approach was adopted in 16 patients, Ivor-Lewis approach in 23 and McKeown approach in 40. Intrathoracic anastomosis was completed in 41 patients and cervical anastomosis in 40. The length of total hospital stay and postoperative hospital stay, operation time, intraoperative blood loss, duration and volume of thoracic drainage and perioperative complications were recorded and compared in patients with different surgical approaches and anastomosis sites. Results For these 81 patients, the operation time was 276.7±70.4 min, and the intraoperative blood loss was 115.9±69.7 ml. The postoperative duration of thoracic drainage, postoperative complication rate and the drainage volume were 12.3±5.3 d, 35.80% and 1 411.9±1 199.5 ml, respectively. During the follow-up, 15 patients died and the cumulative survival rate was 81.48%. There was no obvious HS-related complication. The operation time of Sweet approach was shorter than that of Ivor-Lewis or McKeown approach (P=0.012) and the dissected lymph nodes were less in Sweet approach (P=0.035). There was no significant difference in perioperative indexes and postoperative short-term prognosis between intrathoracic anastomosis and cervical anastomosis. Conclusion HS is widely used in the surgery for esophageal cancer with safety and effectiveness, which is worthy of clinical application.

    Release date:2017-12-29 02:05 Export PDF Favorites Scan
  • The consideration and suggestion of real-world evidence and pre-marketing evaluation of medical devices

    Real-world data is been increasingly valued nowadays. This paper combined with related requirements of clinical evaluation of medical devices in China, studied the role of real-world evidence in pre-marketing clinical evaluation of medical devices in terms of technical evaluation, in aim of providing reference for the future application of China's real-world evidence in pre-marketing clinical evaluation.

    Release date:2019-07-31 02:24 Export PDF Favorites Scan
  • Core outcome set should be introduced to safety evaluation in clinical research of integrated traditional Chinese and western medicine

    Safeguarding patient’s safety is important in clinical research and practice. At present, there are many problems in the clinical safety evaluation of traditional Chinese medicine. For instance, combination of Chinese and western medicines provides difficulty for definite reflection of clinical safety of Chinese medicine, lack of reliability of reporting of symptomatic adverse events/reactions, as well as discrepancy in safety outcomes reporting in similar clinical studies. Based on the application of adverse events/reactions term sets and core outcomes sets in clinical trials of western medicine, it is proposed that the concept of core outcome sets should be introduced to the clinical safety evaluation of integrated Chinese and western medicines in order to improve the clinical safety evaluation.

    Release date:2020-06-18 09:20 Export PDF Favorites Scan
  • 慢性阻塞性肺疾病患者血浆网膜素-1 水平与病情严重程度的相关性研究

    目的研究血浆网膜素-1 在慢性阻塞性肺疾病(简称慢阻肺)患者临床评价中的价值,并进一步探讨其与慢阻肺急性加重病情严重程度的相关性。方法选取 124 例慢阻肺患者,按照病程分为急性加重组(64 例)与稳定期组(60 例),另选取 60 例无慢阻肺的健康成人作为对照组。急性加重组按照病情严重程度进行临床分级。检测研究对象的血浆网膜素-1 水平;分析慢阻肺患者血浆网膜素-1 水平与第 1 秒用力呼气容积占预计值百分比(FEV1%pred)、用力肺活量占预计值百分比(FVC%pred)、GOLD 分级、改良呼吸困难指数(mMRC)评分、急性加重风险评估分组、氧合指数(PaO2/FiO2)、动脉血二氧化碳分压(PaCO2)、慢阻肺急性加重临床分级等指标的相关性。结果慢阻肺患者的血浆网膜素-1 水平明显低于对照组(P<0.05),其中慢阻肺急性加重组的血浆网膜素-1 水平较稳定期组更低(P<0.01)。慢阻肺患者的血浆网膜素-1 水平与 FEV1%pred、FVC%pred 呈正相关,与 GOLD 分级、mMRC 评分、CAT 评分呈负相关(P<0.01)。慢阻肺急性加重患者血浆网膜素-1 水平与 PaO2/FiO2 呈正相关,与 PaCO2、呼吸衰竭类型、中性粒细胞百分比、住院天数、机械通气时间呈显著负相关(P<0.05)。随着 GOLD 分级的增加,慢阻肺急性加重患者血浆网膜素-1 水平进行性降低,在 ABCD 综合评估中临床症状越重者其血浆网膜素-1 水平越低。慢阻肺急性加重患者的血浆网膜素-1 水平与临床分级与呈显著负相关(P<0.01)。血浆网膜素-1 水平在慢阻肺急性加重不同临床分级之间有显著差异(P<0.05)。与入院第 1 天相比,慢阻肺急性加重患者出院前 1 天的血浆网膜素-1 水平明显增高(P<0.01)。结论血浆网膜素-1 与慢阻肺临床评价指标具有一定相关性,可作为评估急性加重的生物学标志物。

    Release date:2020-09-27 06:38 Export PDF Favorites Scan
  • Clinical evaluation of three chemiluminescence immunoassays for human immunodeficiency virus antigen and antibody screening

    Objective To evaluate the performance of i3000 direct chemiluminescence detection of human immunodeficiency virus (HIV) antigen and antibody (Ag/Ab) screening assay (Maccura), compared with E170 electrochemiluminescence method (Roche, Elecsys® HIV Combi PT assay) and IS1200 indirect chemiluminescence method (Maccura). Methods Ten HIV seroconversion panels and 11 p24 antigen positive samples from West China Hospital of Sichuan University from April to December 2017 were used to evaluate the sensitivity of those three assays. A total of 351 samples were collected for consistency evaluation, including 350 HIV Ag/Ab test samples (200 HIV-1 positive plasma samples and 150 HIV 1+2 negative plasma samples) from West China Hospital of Sichuan University from April to December 2017, and one commercial HIV-2 sera. A total of 98 interfere samples for HIV testing were collected from West China Hospital of Sichuan University from April to December 2017. Results In the sensitivity evaluation, there were 63 samples from the 10 seroconversion panels, in which Roche E170 detected 25 samples, Maccura i3000 detected 23 samples, and Maccura IS1200 detected 22 samples; Maccura i3000 and Roche E170 assays detected all the p24 antigen positive samples (11, 100%), while Maccura IS1200 only detected 10 samples. In the consistency evaluation, Maccura i3000 had nice consistency with both Roche E170 and Maccura IS1200 (kappa>0.9, P<0.001). In the interference evaluation, there were two false positives in Maccura i3000 detection, one case of rheumatoid arthritis and one case of syphilis. Conclusion In addition to high throughput and good consistency, Maccura i3000 direct chemiluminescence reagent has high sensitivity and a short window period, which can meet clinical needs.

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  • Interpretation of the DECIDE-AI guideline: a reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence

    Artificial intelligence has been extensively applied in healthcare services recently, and clinical decision support systems driven by artificial intelligence are one of the applications. Early-stage clinical evaluation of artificial intelligence (AI)-based clinical decision support systems lies between preclinical development (in silico), offline validation, and large-scale trials, but few AI-related clinical studies have addressed human factors evaluations and reported the implementation environment, user characteristics, selection process and algorithm identification of AI systems. In order to bridge the development-to-implementation gap in clinical artificial intelligence and to promote the transparent and standardized reporting of early-stage clinical studies of AI-based decision support systems. A reporting guideline for the developmental and exploratory clinical investigations of decision support systems driven by artificial intelligence (DECIDE-AI) was published in 2022. This paper aimed to interpret the background, development process and key items of the DECIDE-AI guideline and promote its understanding as well as dissemination in China.

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