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胆汁酸 1

长双歧杆菌 1

青藤碱 1

高脂血症 1

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traditional Chinese medicine patterns on patients with pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled

《医学前沿（英文）》 2022年第16卷第5期页码 736-744 doi: 10.1007/s11684-021-0870-5

摘要： Effective therapy options for pneumoconiosis are lacking. Traditional Chinese medicine (TCM) presents a favorable prospect in the treatment of pneumoconiosis. A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research. A double-blind, randomized, and placebo-controlled trial was conducted for 24 weeks, in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups. Symptomatic treatment was conducted for the two groups. The treatment group was treated with TCM syndrome differentiation, and the control group was treated with placebo. The primary outcomes were the six-minute walking distance (6MWD) and the St. George Respiratory Questionnaire (SGRQ) score. The secondary outcomes were the modified British Medical Research Council Dyspnea Scale (mMRC), Chronic Obstructive Pulmonary Disease Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), and pulmonary function. Only 83 patients from the 96 patients with pneumoconiosis finished the study. For the primary outcome, compared with the control groups, the treatment group showed a significantly increased 6MWD (407.90 m vs. 499.51 m; 95% confidence interval (CI) 47.25 to 135.97; P <0.001) and improved SGRQ total score (44.48 vs. 25.67; 95% CI −27.87 to −9.74; P <0.001). The treatment group also significantly improved compared with the control group on mMRC score (1.4 vs. 0.74; 95% CI −1.08 to −0.23; P =0.003), CAT score (18.40 vs. 14.65; 95% CI −7.07 to −0.43; P =0.027), and the total symptom score (7.90 vs. 5.14; 95% CI −4.40 to −1.12; P <0.001). No serious adverse events occurred. This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.

关键词： pneumoconiosis randomized controlled trials traditional Chinese medicine

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Efficacy and safety of benralizumab in patients with eosinophilic asthma: a meta-analysis of randomized placebo-controlled

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《医学前沿（英文）》 2018年第12卷第3期页码 340-349 doi: 10.1007/s11684-017-0565-0

摘要：

Benralizumab is a monoclonal antibody that targets interleukin-5 receptor α to deplete blood eosinophils and improve the clinical outcomes of allergic asthma. We conducted a meta-analysis to evaluate the safety and efficacy of different doses of benralizumab in patients with eosinophilic asthma. All randomized controlled trials involving benralizumab treatment for patients with eosinophilic asthma, which were searched in PubMed, Embase, and the Cochrane Library published until January 2017, as well as the rate of asthmatic exacerbation, pulmonary functionality, asthma control, quality of life scores, and adverse events were included. Randomized-effect models were used in the meta-analysis to calculate the pooled mean difference, relative risks, and 95% confidence intervals. Five studies involving 1951 patients were identified. Compared with the placebo, benralizumab treatment demonstrated significant improvements in the forced expiratory volume in 1?s (FEV1), Asthma Quality of Life Questionnaire scores, decreased asthmatic exacerbation and Asthma Control Questionnaire-6 (ACQ-6) scores. Benralizumab treatment was also not associated with increased adverse events. These findings indicated that benralizumab can be safely used to improve FEV1, enhance patient symptom control and quality of life, and reduce the risk of exacerbations and ACQ-6 scores in patients with eosinophilic asthma. Furthermore, our meta-analysis showed that benralizumab with 30 mg (every eight weeks) dosage can improve the health-related quality of life and appear to be more effective than 30 mg (every four weeks) dosage. Overall, data indicated that the optimal dosing regimen for benralizumab was possibly 30 mg (every eight weeks).

关键词： benralizumab anti-interleukin-5 monoclonal antibody eosinophilic asthma meta-analysis

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Efficacy and safety of perioperative parecoxib for acute postoperative pain treatment in children: a meta-analysis

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《医学前沿（英文）》 2015年第9卷第4期页码 496-507 doi: 10.1007/s11684-015-0414-y

摘要：

Perioperative parecoxib administration reduces postoperative pain, opioid consumption, and adverse events in adult patients. However, the efficacy and safety of parecoxib in children remain unclear. This meta-analysis included related published studies to address this concern. Eight databases in the literature until February 2015 were systematically explored to identify randomized controlled trials (RCTs) comparing perioperative parecoxib administration and placebo/standard treatments for acute postoperative pain in children. Primary outcomes were postoperative pain scores and adverse events. The Face, Legs, Activity, Crying, Consolability scale was used to score pain in children younger than 6 years, whereas the Visual Analog Scale was used in children older than 6 years. Secondary outcomes were sedation scores (measured using the Ramsay scale), agitation scores (measured using the Sedation-Agitation Scale), and opioid consumption. The methodological quality of RCTs was independently assessed in accordance with the “Risk of bias” of Cochrane Collaboration. Data were analyzed using Review Manager 5.2. Twelve RCTs involving 994 patients met the inclusion criteria. Compared with children who received placebo treatment, those who received parecoxib demonstrated lower early (2 h) and later (12 h) postoperative pain scores; lower incidence rates of postoperative nausea, vomiting, and agitation; higher early (1 h) postoperative sedation scores; and lower agitation scores. Similarly, children who received parecoxib had lower early (2 h) and later (12 h) postoperative pain scores, lower incidence rates of postoperative nausea and vomiting, and lower early (1 h) postoperative sedation scores compared with those who received standard treatments; however, these children showed no significant difference in agitation scores. Unfortunately, data on the effect of parecoxib on opioid consumption were insufficient. Overall, these results suggested that perioperative parecoxib administration was associated with less acute postoperative pain and fewer adverse events compared with placebo or standard treatments. Parecoxib administration also resulted in less emergence agitation compared with placebo treatment and less excessive sedation concern compared with standard treatments. However, the long-term effects, effects on opioid consumption, and patient satisfaction of parecoxib administration warrant further investigation.

关键词： NSAID cyclooxygenase 2 inhibitor child pain postoperative opioid placebo

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植物乳杆菌CCFM8610缓解肠易激综合征并改善肠道菌群失调——一项随机、双盲、安慰剂对照的先导性临床试验 Article

刘洋, 郁辛杰, 于雷雷, 田丰伟, 赵建新, 张灏, 钱龙, 王群, 薛正青, 翟齐啸, 陈卫

《工程（英文）》 2021年第7卷第3期页码 376-385 doi: 10.1016/j.eng.2020.06.026

摘要：

腹泻型肠易激综合征（irritable bowel syndrome with diarrhea, IBS-D）是一种伴有腹泻等复杂临床症状的慢性肠功能障碍，对患者的日常生活和精神状态具有极大影响。一些研究报道称，摄入益生菌可显著缓解多种肠道疾病。本研究的目的是探究一株具有多种保健作用的益生植物乳杆菌（Lactobacillus plantarum）CCFM8610对IBS-D的缓解作用。这项研究是一项为期12周的随机、双盲、安慰剂对照的先导性临床试验。75名患者被随机分配接受安慰剂、低聚糖或植物乳杆菌CCFM8610 [每天1 × 10¹⁰ CFU（菌落形成单位）]，进行为期两周的观察、8周的干预及两周的后续随访。采用IBS症状严重程度量表（IBS-SSS）及IBS生活质量量表（IBS-QOL）评定患者的临床症状和生活质量。在干预期结束时，测定肠道菌群组成和多样性的变化。结果表明，口服植物乳杆菌CCFM8610显著降低了IBS-SSS和IBS-QOL评分，减轻了IBS-D症状的严重程度，恢复了肠道菌群的多样性，降低了与腹胀相关的甲烷短杆菌属（Methanobrevibacter）的相对丰度，增加了厌氧棒状菌属（Anaerostipes）、双歧杆菌属（Bifidobacterium）、丁酸弧菌属（Butyricimonas）及臭杆菌属（Odoribacter）等丁酸生产种属的相对丰度。这些结果表明，摄入植物乳杆菌CCFM8610可以显著缓解IBS-D患者的临床症状及肠道菌群失调。植物乳杆菌CCFM8610对IBS-D的缓解作用可能与肠道中丁酸生产种属的相对丰度上升有关。

关键词：植物乳杆菌肠易激综合征肠道菌群丁酸临床试验

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长双歧杆菌CCFM1077通过调节肠道微生物组成和粪便代谢物来减轻高脂血症——一项随机、双盲、安慰剂对照的临床试验 Article

储传奇, 姜金池, 于雷雷, 李易文, 张松礼, 周巍, 王群, 赵建新, 翟齐啸, 田丰伟, 陈卫

《工程（英文）》 2023年第28卷第9期页码 193-205 doi: 10.1016/j.eng.2023.04.010

摘要：

越来越多的研究表明肠道菌群及其代谢物在高脂血症的发展中至关重要。长双歧杆菌（Bifidobacterium longum, B. longum）CCFM1077已在动物中显示出降脂作用。本研究旨在评估B. longum CCFM1077在降低高脂血症患者血脂水平方面的潜力，并调查该菌对患者的血清脂质异常、肠道菌群和粪便代谢物的影响。本研究是一个为期六周的随机、双盲、安慰剂对照的试验。高脂血症患者（N = 62）被随机分配接受安慰剂（N = 31）或B. longum CCFM1077 [每日1.0×10¹⁰个菌落形成单位（CFU）；N = 31]。在基线和干预终点检查了包括总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、总甘油三酯（TG）和高密度脂蛋白胆固醇（HDL-C）在内的血清脂质水平。肠道菌群组成和多样性的变化是基于16S核糖体RNA（rRNA）V3~V4区域的测序在干预期结束时进行。利用超高效液相色谱（UPLC）-Q-Exactive Orbitrap/质谱仪进行了粪便的非靶向代谢组学分析。口服B. longum CCFM1077六周显著降低了高脂血症患者的血清TC（p < 0.01）和LDL-C（p < 0.01）水平。B. longum CCFM1077的治疗显著增加了肠道菌群的多样性和抗肥胖相关属的相对丰度，包括Lactobacillus、Butyricicoccus、Bifidobacterium和Blautia，而减少了与肥胖相关属的相对丰度，包括Alistipes、Megamonas和Catenibacterium。此外，一些关键代谢产物[胆汁酸（BA）、生物素和咖啡因]及其相应的代谢途径（主要胆汁酸生物合成，牛磺酸和次牛磺酸代谢，生物素代谢，嘌呤代谢和咖啡因代谢）被B. longum CCFM1077富集，因此可能降低血脂水平。B. longum CCFM1077是一种具有降低高脂血症患者血清TC和LDL-C水平潜力的益生菌菌株。其潜在机制可能与抗肥胖相关属和粪便代谢物的增加有关。这些发现为将来在管理高脂血症患者中应用益生菌奠定了基础。

关键词：益生菌长双歧杆菌高脂血症肠道菌群粪便代谢物胆汁酸

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血清鸟氨酸水平下降与类风湿关节炎缓解情况密切相关——从青藤碱的一项随机双盲临床试验中得到的启示 Article

石颖, 潘胡丹, 伍建林, 邹庆华, 谢昕怡, 李红刚, 周华, 卞西清, 冷文飞, 王灿坚, 王亚峰, 方勇飞, 刘良

《工程（英文）》 2022年第16卷第9期页码 93-99 doi: 10.1016/j.eng.2021.04.014

摘要：

青藤碱（SIN）是中国类风湿关节炎（RA）治疗的常用药物，但目前尚无SIN单药治疗疗效的文献报道。本研究旨在探讨SIN治疗RA的有效性和安全性，并分析鸟氨酸水平与RA患者疾病活动情况的相关性。本项目设计为24周的多中心、随机、安慰剂对照、双盲临床试验，轻中度活动度的RA患者按照1∶1∶1随机分配接受SIN（120 mg，每日两次）、甲氨蝶呤（MTX）（每周10 mg）或SIN + MTX治疗。项目以24周达到ACR50标准的受试者比例，以及根据临床疾病活动指数(CDAI)显示改善的受试者比例为主要疗效指标，并进一步分析24周治疗后的RA受试者疾病活动变化是否与血清鸟氨酸水平相关。在135名受试者中，38名、39名和36名分别接受了SIN、MTX和SIN + MTX的治疗。在SIN治疗组中，52.63%的受试者在治疗24周后达到ACR50标准，与MTX治疗组和SIN + MTX治疗组的结果相当。患者不良反应以肝功能损害和胃肠功能紊乱为主，但SIN组肝功能损害的发生率（1/38）明显低于MTX组（10/39）和SIN + MTX组（8/36）。采用超高效液相-四极杆飞行时间质谱仪（UHPLC-Q-TOF/MS），测定了三个治疗组4个随访时间点共计221份血清样本中的鸟氨酸、瓜氨酸和精氨酸的含量。治疗24周后，血清鸟氨酸水平随着疾病活动度的降低而下降，敏感度为80%，提示鸟氨酸水平可一定程度上预测治疗应答情况。综上所述，SIN对RA患者的疗效与MTX相当，副作用更少，且首次发现血清鸟氨酸水平与类风湿关节炎的缓解密切相关，提示鸟氨酸具有成为类风湿关节炎疗效评价指标的潜在价值。

关键词：类风湿关节炎青藤碱有效性安全性炎性因子