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中国健康人体对注射用rhPTH(1-84)试验耐受性和安全性监护 预览
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作者 李忠芳 刘亚妮 +2 位作者 吴健鸿 曾繁典 师少军 《护理研究》 北大核心 2019年第18期3123-3127,共5页
[目的]评价中国健康受试者单次和多次皮下注射重组人甲状旁腺素(1-84)[rhPTH(1-84)]后的人体耐受性和安全性,并进行护理监护。[方法]以健康受试者为研究对象,从安全起始剂量开始,进行单次和多次给药耐受性试验。采用随机单中心临床研究... [目的]评价中国健康受试者单次和多次皮下注射重组人甲状旁腺素(1-84)[rhPTH(1-84)]后的人体耐受性和安全性,并进行护理监护。[方法]以健康受试者为研究对象,从安全起始剂量开始,进行单次和多次给药耐受性试验。采用随机单中心临床研究,统一餐后皮下注射给药。单次给药:32例受试者随机分为6个剂量组,即0.5μg/kg(4例),1.0μg/kg(6例),2.0μg/kg(6例),3.0μg/kg(6例),4.0μg/kg(6例),5.0μg/kg(4例);多次给药:12例受试者随机分为2个剂量组,即2.0μg/kg(6例),3.0μg/kg(6例),每日1次,连续给药7d。在Ⅰ期临床病房进行耐受性和安全性护理监护,观察受试者用药前后症状、生命体征、实验室检查变化,并记录药品不良反应。[结果]单次和多次给药耐受性试验的受试者用药前后生命体征和心电图无明显变化,实验室检查等表明无器质性损伤。单次给药耐受性试验有6例受试者于给药后约2h均感觉困乏,不良反应均为轻度,均未作处理,30min内自行缓解和消失,其中1例出现心悸;多次给药后病人无不良反应发生。[结论]中国健康人体对注射用rhPTH(1-84)单次0.5~5.0μg/kg或多次2.0~3.0μg/kg,每日1次,连用7d皮下注射给药的安全性和耐受性良好,但临床应用中应密切监护病人个体差异及可能出现的药品不良反应。 展开更多
关键词 注射用重组人甲状旁腺素(1-84) 健康受试者 耐受性 安全性 护理监护 不良反应
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Clinical benefit and tolerability of adjuvant intraperitoneal chemotherapy in patients who have or have not received neoadjuvant chemotherapy for advanced ovarian cancer 预览
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作者 Trishala Meghal Vishangi Dave +2 位作者 Horace Tang Vivek Kumar Yiqing Xu 《世界临床肿瘤学杂志(英文版)》 2019年第5期201-212,共12页
BACKGROUND Adjuvant chemotherapy using intraperitoneal(IP)treatment has demonstrated survival benefit over intravenous(IV)therapy alone in patients treated with upfront debulking surgery for advanced stage ovarian can... BACKGROUND Adjuvant chemotherapy using intraperitoneal(IP)treatment has demonstrated survival benefit over intravenous(IV)therapy alone in patients treated with upfront debulking surgery for advanced stage ovarian cancer.Neoadjuvant chemotherapy followed by interim surgery and adjuvant chemotherapy has similar outcome in survival as compared to upfront surgery followed by adjuvant IV chemotherapy.IP chemotherapy has not been widely adopted in clinical practice for a number of reasons.Whether IP chemotherapy delivered in the patients who received neoadjuvant chemotherapy can be well tolerated or confers any clinical benefit has not been well studied.AIM To evaluate the experience of adjuvant IP chemotherapy in the community cancer clinic setting,and the clinical benefit and tolerability of incorporating IP chemotherapy in patients who received neoadjuvant treatment.METHODS We retrospectively evaluated toxicities and outcomes of patients with stage III and IV ovarian cancer diagnosed at our institution between 07/2007 and 07/2015 who received intraperitoneal chemotherapy after cytoreductive surgery(group 1)or after neoadjuvant chemotherapy followed by interim surgery(group 2).RESULTS Thirty eight patients were treated with IP chemotherapy,median age was 54 years old(range 38.6 to 71 years).In group 1(n=25),12(48%)of the patients completed 4 or more cycle of IP treatment after upfront debulking surgery;while in group 2(n=13),8(61.5%)of the patients completed all 3 cycles of the assigned IP chemotherapy after receiving neoadjuvant IV chemotherapy followed by surgery,and 2(15.4%)more patients tolerated more than 3 cycles.In those patients who did not get planned IP chemotherapy,most of them were treated with substitutional IV chemotherapy,and the completion rate for 6 cycles of IV+IP was 92%.Abdominal pain,(64%in group 1 and 38%in group 2),vomiting,(36%in group 1 and 30.8%in group 2),dehydration(16%in group 1 and 15.4%in group 2),and hypomagnesemia(12%in group 1 and 15.4%in group 2)were the most common adverse effects 展开更多
关键词 OVARIAN cancer INTRAPERITONEAL chemotherapy Community setting Safety TOLERABILITY Outcome
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拉考沙胺添加治疗中国部分性癫■发作患者的疗效和安全性:一项随机双盲试验和开放标签扩展试验的亚组分析和事后分析
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作者 洪震 廖卫平 +9 位作者 孟红梅 杜新鲁 Toru Osakabe Hiroshi Sasamoto Frank Tennigkeit 王文敏 王学峰 张黎明 周列民 张颖 《中国临床神经科学》 2019年第4期361-378,共18页
目的评估抗癫■药拉考沙胺添加治疗对控制不佳的部分性癫■发作成年患者的疗效和安全性。方法EP0008(NCT01710657)是一项为期24周在中国和日本16~70岁控制不佳的部分性癫■发作患者中开展的随机、双盲、安慰剂对照临床试验。在双盲试验... 目的评估抗癫■药拉考沙胺添加治疗对控制不佳的部分性癫■发作成年患者的疗效和安全性。方法EP0008(NCT01710657)是一项为期24周在中国和日本16~70岁控制不佳的部分性癫■发作患者中开展的随机、双盲、安慰剂对照临床试验。在双盲试验中完成维持期的患者可进入开放标签扩展性试验EP0009(NCT01832038)。本研究针对两项试验中的中国536例部分性癫■发作患者进行分析,经剔除筛选失败的130例患者,共计406例中国部分性癫■发作患者入组,随机分为安慰剂组(136例)、拉考沙胺200 mg·d^-1组(136例)和拉考沙胺400 mg·d^-1组(134例)。结果406例中358例(88.2%)完成试验。从基线期至维持期,拉考沙胺400 mg·d^-1组和拉考沙胺200 mg·d^-1组每28 d癫■发作频次分别减少43.1%和33.6%,与安慰剂组比较,差异有显著统计学意义(P<0.001)。拉考沙胺400 mg·d^-1组、拉考沙胺200 mg·d^-1组、安慰剂组治疗期间发生率>10%的不良事件为头晕(分别为33.8%、14.7%、11.0%)和鼻咽炎(分别为11.3%、10.3%、8.8%)。同时联合使用钠离子通道阻滞剂(SCBs)患者的头晕发生率高于联合使用非SCBs患者。拉考沙胺联合使用SCBs时,滴定期患者的头晕发生率高于维持期。开放标签试验加量策略灵活,头晕发生率降低,患者的耐受性提高。结论拉考沙胺(200和400 mg·d^-1)用于中国控制不佳的部分性癫■发作患者有效,耐受性良好。 展开更多
关键词 抗癫■药物 拉考沙胺 安慰剂 癫■ 部分性发作 随机对照试验 有效性 安全性 耐受性
Randomized Controlled Trial Efficacy of 1.2 L polyethylene glycol plus ascorbic acid for bowel preparations 预览
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作者 Hiroyuki Tamaki Teruyo Noda +5 位作者 Masahiro Morita Akina Omura Atsushi Kubo Chikara Ogawa Toshihiro Matsunaka Mitsushige Shibatoge 《世界临床病例杂志》 2019年第4期452-465,共14页
BACKGROUND A low-volume polyethylene glycol (PEG) solution that combines ascorbic acid with PEG-based electrolyte solution (PEG-ASC) is gaining mainstream acceptance for bowel preparation due to reduced volume and imp... BACKGROUND A low-volume polyethylene glycol (PEG) solution that combines ascorbic acid with PEG-based electrolyte solution (PEG-ASC) is gaining mainstream acceptance for bowel preparation due to reduced volume and improved taste. Although several reports showed that bowel preparation with PEG-ASC volume lower than 2.0 L with laxative agents could be an alternative to traditional preparation regimen, the cleansing protocols have not been fully investigated. AIM To evaluate the cleansing efficacy of 1.2 L PEG-ASC solution comparing with 2.0 L PEG electrolyte (PEG-ELS) for bowel preparations. METHODS A randomized, single-blinded, open-label, single-center, non-inferiority study was conducted. In total, 312 Japanese adult patients (aged > 18 years) who underwent colonoscopy were enrolled. Patients were randomly allocated to bowel lavage with either 1.2 L of PEG-ASC solution with at least 0.6 L of an additional clear fluid (1.2 L PEG-ASC group) or 2.0 L of PEG-ELS (PEG-ELS group). Then, 48 mg of sennoside was administered at bedtime on the day before colonoscopy, and the designated drug solution was administered at the hospital on the day of colonoscopy. Bowel cleansing was evaluated using the Boston Bowel Preparation Scale (BBPS). The volume of fluid intake and required time for bowel preparation were evaluated. Furthermore, compliance, patient tolerance, and overall acceptability were evaluated using a patient questionnaire, which was assessed using a visual analog scale. RESULTS In total, 291 patients (1.2 L PEG-ASC group, 148;PEG-ELS group, 143) completed the study. There was no significant difference in successful cleansing, defined as a BBPS score ≥ 2 in each segment, between the two groups (1.2 L PEG-ASC group, 91.9%;PEG-ELS group, 90.2%;95%CI:-0.03-0.09). The required time for bowel preparation was significantly shorter (164.95 min ± 68.95 min vs 202.16 min ± 68.69 min, P < 0.001) and the total fluid intake volume was significantly lower (2.23 L ± 0.55 L vs 2.47 L ± 0.56 L, P < 0.001) in the 1.2 L PEG-AS 展开更多
关键词 Ascorbic acid BOWEL preparation COLONOSCOPY EFFICACY POLYETHYLENE GLYCOL TOLERABILITY
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Tolerance Study for Standardized <i>Macleaya cordata</i>Extract Added to Chicken Layer Diet 预览
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作者 Ray A. Matulka Sophie von Alvensleben +1 位作者 Mauro Morlacchini Giorgio Fusconi 《动物科学期刊(英文)》 2018年第1期104-117,共14页
The objective of this study was to assess the effects of Sangrovit?, a standardized preparation of Macleaya cordata extract (MCE), on the health status and egg laying parameters of layer chickens. Layer chickens (N = ... The objective of this study was to assess the effects of Sangrovit?, a standardized preparation of Macleaya cordata extract (MCE), on the health status and egg laying parameters of layer chickens. Layer chickens (N = 360) were randomly divided into four groups (90 birds/treatment, 10 birds/pen) and fed either a standard basal feed (T1) or a basal diet that was supplemented with 100 mg/kg (T2), 500 mg/kg (T3) or 1000 mg/kg (T4) Sangrovit? (providing 0, 3.7, 18.5, and 37.0 mg MCE/kg feed, respectively) for 56 consecutive days. Live Weight (LW), Average Daily Feed Intake (ADFI) and the Feed Conversion Ratios (FCR) were calculated during the study, and biochemical and hematological endpoints were obtained at the end of the study (Day 56). Eggs were analyzed for the isoquinoline alkaloids sanguinarine and chelerythrine. No statistically significant (P > 0.05) differences were found between control and treatment groups for LW, ADFI and FCR. There was a significant increase in the % laying in groups T3 and T4 for the study overall, but no significant differences in egg size during the study. Blood biochemical analyses showed a near-significant trend for decreased bilirubin in the T2 and T4 groups, but this was not dose-dependent and not considered treatment-related. The percent hemoglobin was significantly decreased in the high dose group, but was not considered treatment-related as it was not a dose-dependent effect. No treatment-related changes were found after necropsy of the selected organs. No quantifiable sanguinarine or chelerythrine was found in the eggs after 56 days administration of the MCE preparation to the hens. The results of this study show that consumption of a standardized MCE preparation at up to 1000 mg/kg feed in laying hens had no adverse effect on the hen or eggs, and no residual sanguinarine or chelerythrine was transferred to the eggs. 展开更多
关键词 Macleaya cordata CHICKEN LAYER TOLERABILITY ALKALOIDS Residues
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中国健康女性受试者单次及多次口服马来酸甲麦角新碱片剂的安全性和耐受性研究 被引量:2
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作者 董凡 薛薇 +4 位作者 李扬 李敏 严蓓 史爱欣 胡欣 《中国新药杂志》 CSCD 北大核心 2018年第5期549-553,共5页
目的:考察中国健康女性受试者单次及多次口服马来酸甲麦角新碱片的安全性及耐受性。方法:随机、开放Ⅰ期临床试验,36例健康女性受试者随机进入0.125,0.25和0.5 mg组。其中,0.25 mg与0.5 mg组进行单次给药试验,0.125 mg组在完成单次给... 目的:考察中国健康女性受试者单次及多次口服马来酸甲麦角新碱片的安全性及耐受性。方法:随机、开放Ⅰ期临床试验,36例健康女性受试者随机进入0.125,0.25和0.5 mg组。其中,0.25 mg与0.5 mg组进行单次给药试验,0.125 mg组在完成单次给药试验后继续进行多次给药试验。通过生命体征检查、体格检查、实验室检查及不良事件(AE)等评价受试者对试验药物的耐受性和安全性。结果:36例受试者全部完成试验,所有剂量组试验均未达到终止标准。共6例受试者发生与试验药物可能有关的AE 9例次,单次给药试验0.125 mg组及0.25 mg组未发生AE,0.5 mg组4例受试者共发生AE 7例次,0.125 mg组多次给药试验中2例受试者发生AE 2例次。本试验发生的AE均为轻度,均自行好转或痊愈,未发生严重不良事件(SAE)。结论:中国健康女性受试者单次口服0.125~0.5 mg和多次口服0.125 mg马来酸甲麦角新碱片安全耐受。 展开更多
关键词 甲麦角新碱 中国健康女性受试者 安全性 耐受性 Ⅰ期临床试验
长期霉酚酸酯与环磷酰胺治疗间质性肺病的转归及耐受观察 预览 被引量:1
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作者 李丽敏 《临床肺科杂志》 2018年第4期739-741,共3页
目的 探讨长期霉酚酸酯与环磷酰胺治疗间质性肺病的转归及耐受性。方法 将我院78例间质性肺病患者抽签随机分为观察组与对照组各39例。观察组口服霉酚酸酯1.5g/次,2次/d;对照组静脉注射环磷酰胺2mg/kg/d,每月1次,两组均连续治疗1年。比... 目的 探讨长期霉酚酸酯与环磷酰胺治疗间质性肺病的转归及耐受性。方法 将我院78例间质性肺病患者抽签随机分为观察组与对照组各39例。观察组口服霉酚酸酯1.5g/次,2次/d;对照组静脉注射环磷酰胺2mg/kg/d,每月1次,两组均连续治疗1年。比较两组临床疗效,肺总量(TLC)、最大肺活量(FVC)、一秒用力呼气量(FEV 1)、肺一氧化碳弥散量(DLCO)等肺功能指标,并记录毒副作用发生率及死亡率。结果 观察组死亡3例,对照组死亡5例,两组死亡率比较无统计学意义(P>0.05)。两组总有效率比较无统计学意义(P>0.05)。两组治疗前后TLC比较无统计学意义(P>0.05)。两组治疗后FVC、FEV 1、DLCO均高于治疗前(P<0.05);但两组肺功能指标比较无显著差异(P>0.05)。观察组毒副作用发生率显著低于对照组(P<0.05)。结论 长期霉酚酸酯与环磷酰胺治疗间质性肺病的临床疗效相当,均可在一定程度上稳定或改善患者肺功能,但前者毒副作用更小,耐受性好。 展开更多
关键词 霉酚酸酯 环磷酰胺 间质性肺病 转归 耐受性
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Sodium picosulphate or polyethylene glycol before elective colonoscopy in outpatients?A systematic review and meta-analysis 预览
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作者 Rodrigo Silva de Paula Rocha Igor Braga Ribeiro +7 位作者 Diogo Turiani Hourneaux de Moura Wanderley Marques Bernardo Maurício Kazuyoshi Minata Flávio Hiroshi Ananias Morita Júlio Cesar Martins Aquino Elisa Ryoka Baba Nelson Tomio Miyajima Eduardo Guimaraes Hourneaux de Moura 《世界胃肠内镜杂志:英文版(电子版)》 2018年第12期422-441,共20页
AIM To determine the best option for bowel preparation [sodium picosulphate or polyethylene glycol(PEG)] for elective colonoscopy in adult outpatients.METHODS A systematic review of the literature following the PRISMA... AIM To determine the best option for bowel preparation [sodium picosulphate or polyethylene glycol(PEG)] for elective colonoscopy in adult outpatients.METHODS A systematic review of the literature following the PRISMA guidelines was performed using Medline, Scopus, EMBASE, Central, Cinahl and Lilacs. No restrictions were placed for country, year of publication or language. The last search in the literature was performed on November 20th, 2017. Only randomized clinical trials with full texts published were included. The subjects included were adult outpatients who underwent bowel cleansing for elective colonoscopy. The included studies compared sodium picosulphate with magnesium citrate(SPMC)and PEG for bowel preparation. Exclusion criteria were the inclusion of inpatients or groups with specific conditions, failure to mention patient status(outpatient or inpatient) or dietary restrictions, and permission to have unrestricted diet on the day prior to the exam. Primary outcomes were bowel cleaning success and/or tolerability of colon preparation. Secondary outcomes were adverse events, polyp and adenoma detection rates. Data on intention-totreat were extracted by two independent authors and risk of bias assessed through the Jadad scale. Funnel plots, Egger’s test, Higgins’ test(I2) and sensitivity analyses were used to assess reporting bias and heterogeneity. The meta-analysis was performed by computing risk difference(RD) using MantelHaenszel(MH) method with fixed-effects(FE) and random-effects(RE) models.Review Manager 5(RevMan 5) version 6.1(The Cochrane Collaboration) was the software chosen to perform the meta-analysis.RESULTS662 records were identified but only 16 trials with 6200 subjects were included for the meta-analysis. High heterogeneity among studies was found and sensitivity analysis was needed and performed to interpret data. In the pooled analysis,SPMC was better for bowel cleaning [MH FE, RD 0.03, IC(0.01, 0.05), P = 0.003, I2= 33%, NNT 34], for tolerability [MH RE, RD 0.08, IC(0.03, 0.13), P 展开更多
关键词 SODIUM picosulphate Polyethylene glycol Bowel cleaning success TOLERABILITY COLONOSCOPY Randomized clinical trials META-ANALYSIS
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金盏菊对重金属Zn的生理响应及累积性研究 预览
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作者 庞琢 潘春香 王佳豪 《韶关学院学报》 2018年第3期70-74,共5页
实验采用盆栽砂培法,以日本园试通用配方为基础营养液,设置150 mg/kg、200 mg/kg、250 mg/kg和300 mg/kg4 个Zn浓度处理,以不施入Zn 为对照(CK),展开了观赏植物金盏菊对重金属Zn 累积性的研究.结果表明,在150mg/kg重金属Zn 浓度下,金... 实验采用盆栽砂培法,以日本园试通用配方为基础营养液,设置150 mg/kg、200 mg/kg、250 mg/kg和300 mg/kg4 个Zn浓度处理,以不施入Zn 为对照(CK),展开了观赏植物金盏菊对重金属Zn 累积性的研究.结果表明,在150mg/kg重金属Zn 浓度下,金盏菊的生长、生物量、叶绿素、可溶性糖及可溶性蛋白质含量均超过了CK,但之后迅速下降,且呈随着Zn浓度升高而呈降低的趋势;金盏菊地上部和根系重金属Zn含量也均随着Zn 浓度的提高而呈现增大的趋势,且根系Zn含量明显高于地上部含量.本研究为植物修复重金属Zn污染土壤的研究提供了参考. 展开更多
关键词 金盏菊 重金属ZN 累积性
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洛铂联合紫杉醇一线治疗晚期非小细胞肺癌的剂量探索性研究 预览 被引量:2
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作者 秦叔逵 程颖 +2 位作者 陈振东 石建华 孙旭 《临床肿瘤学杂志》 CAS 北大核心 2018年第2期97-100,共4页
目的 探讨洛铂联合紫杉醇一线治疗晚期非小细胞肺癌(NSCLC)方案中洛铂的最大耐受剂量(MTD)。方法固定紫杉醇剂量为175 mg/m~2,进行洛铂剂量递增。洛铂初始剂量为20 mg/m~2,组间递增剂量为10 mg/m~2,每个剂量组至少3位受试者。如无... 目的 探讨洛铂联合紫杉醇一线治疗晚期非小细胞肺癌(NSCLC)方案中洛铂的最大耐受剂量(MTD)。方法固定紫杉醇剂量为175 mg/m~2,进行洛铂剂量递增。洛铂初始剂量为20 mg/m~2,组间递增剂量为10 mg/m~2,每个剂量组至少3位受试者。如无剂量限制性毒性反应(DLT)则进入下一剂量组,直至得到MTD,定期评价疗效及不良反应。结果 共入组15例患者,其中20 mg/m~2组3例、30 mg/m~2组6例和40 mg/m~2组6例,40 mg/m~2组出现2例DLT,因此MTD确定为30mg/m~2。14例患者可进行疗效评估,疾病控制率为71.4%(10/14)。主要毒性反应为骨髓抑制。结论 洛铂联合紫杉醇治疗一线晚期NSCLC方案中洛铂的推荐剂量为30 mg/m~2,该方案疗效可靠,安全性较好,值得开展进一步临床研究。 展开更多
关键词 非小细胞肺癌 洛铂 紫杉醇 剂量探索 耐受性
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营养干预对提高宫颈癌患者同步放化疗耐受性的作用 预览 被引量:2
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作者 秦楠 姜桂春 《中国食物与营养》 2018年第8期83-86,共4页
目的:探究营养干预对提高宫颈癌患者同步放化疗耐受性的作用。方法:随机选取2015年11月—2017年11月中国医科大学肿瘤医院辽宁省肿瘤医院同步放化疗治疗的62例宫颈癌患者,按照数字表法将其分为对照组(31例)和观察组(31例)。对照... 目的:探究营养干预对提高宫颈癌患者同步放化疗耐受性的作用。方法:随机选取2015年11月—2017年11月中国医科大学肿瘤医院辽宁省肿瘤医院同步放化疗治疗的62例宫颈癌患者,按照数字表法将其分为对照组(31例)和观察组(31例)。对照组患者采用自主进食,观察组患者采用营养干预,对比分析两组患者的血常规指标、治疗中断次数、心理状态变化、日常生活能力及不良反应情况。结果:观察组患者干预后的WBC(7.56±1.33 10^9/L)、NE(4.24±1.21 10^9/L)、CRP(38.00±10.75 mg/L)、治疗中断次数(0.52±1.01次)、SAS评分(41.65±3.97)及不良反应发生率(22.58%)明显低于对照组的WBC(8.73±1.26 10^9/L)、NE(5.23±1.2510^9/L)、CRP(45.00±11.91mg/L)、治疗中断次数(4.49±1.35次)、SAS评分(45.51±4.53)及不良反应发生率(80.65%),ADL评分(60.68±4.73)明显高于对照组的ADL评分(53.24±5.43),差异有统计学意义(P〈0.05)。结论:接受同步放化疗治疗的宫颈癌患者采用营养干预,临床效果明显。患者治疗中断次数明显减少,心理状态及日常生活能力改善明显,血常规指标恢复良好,不良反应发生率明显降低,值得临床推广应用。 展开更多
关键词 宫颈癌 同步放化疗 营养干预 耐受性 作用
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GLP-1RAs对T2DM患者安全性和耐受性的研究进展
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作者 程昊 崔璨 +1 位作者 刘颖 张春晶 《中国优生与遗传杂志》 2018年第5期3-5,共3页
胰高血糖素样肽受体激动剂(Glucagon-like peptide-1 receptor agonists,GLP-1RAs)有益于2型糖尿病(Type 2 diabetes mellitus,T2DM)患者的治疗,近年来作为治疗糖尿病的一种新型药物备受关注。本文以GLP-1RAs临床应用为依据,对其安... 胰高血糖素样肽受体激动剂(Glucagon-like peptide-1 receptor agonists,GLP-1RAs)有益于2型糖尿病(Type 2 diabetes mellitus,T2DM)患者的治疗,近年来作为治疗糖尿病的一种新型药物备受关注。本文以GLP-1RAs临床应用为依据,对其安全性和耐受性问题进行循证更新。艾塞那肽(Exenatide)是首批批准的GLP-1RA药物,本文回顾了其长期、有效的临床安全性试验数据。综述领域包括使用GLP-1RAs治疗T2DM时,患者患低血糖症的风险,以及对患者胰腺,甲状腺、心血管以及微血管安全性,同时还回顾了当前关于其安全性和耐受性的临床指导数据。 展开更多
关键词 胰高血糖素样肽受体激动剂 艾塞那肽 安全性 耐受性 2型糖尿病
注射注射用重组人血清白蛋白-人粒细胞集落刺激因子(Ⅰ)融合蛋白在健康受试者的耐受性研究 被引量:1
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作者 姜波 孙明媛 +2 位作者 郑维维 陈小梅 齐军元 《中国临床药理学杂志》 CSCD 北大核心 2018年第6期667-669,681共4页
目的 评价重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(Ⅰ)融合蛋白在健康受试者的耐受性和安全性。方法 将26例健康受试者(男女各半)按先后顺序入组,进行4个剂量组试验(150,300,500,650μg·kg-1),每组分别入组4,6... 目的 评价重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(Ⅰ)融合蛋白在健康受试者的耐受性和安全性。方法 将26例健康受试者(男女各半)按先后顺序入组,进行4个剂量组试验(150,300,500,650μg·kg-1),每组分别入组4,6,8,8例。根据体重计算给药剂量,受试者于给药当天上臂三角肌部位皮下注射给药1次。用药后观察药物不良事件(AE),定时进行实验室检查、心电图检查。结果 共25例受试者发生AE,共145例次。150,300,500及650μg·kg-1剂量组的AE分别为13,11,56和65例次。其中134例次考虑与研究药物相关。常见的AE有骨痛、单核细胞计数升高、血碱性磷酸酶升高、头痛、高尿酸血症、血乳酸脱氢酶升高、脾肿大、肌肉疲劳。研究中未出现AE导致的用药暂停、受试者退出或试验提前中止。未发生严重不良事件(SAE)。未发生剂量限制性毒性。结论 注射用重组(酵母分泌型)人血清白蛋白-人粒细胞集落刺激因子(Ⅰ)融合蛋白在中国健康受试者中单次给药150,650μg·kg-1剂量范围内有较好的安全性,本临床试验未探索到健康人群的最大耐受剂量。 展开更多
关键词 Ⅰ期临床试验 安全性 耐受性 健康受试者 粒细胞集落刺激因子
环境胁迫下食窦魏斯氏菌的耐受性评价 预览
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作者 骞宇 陈孝勇 +2 位作者 易若琨 王强 赵欣 《食品工业科技》 CSCD 北大核心 2018年第24期128-133,138共7页
本研究以分离自新鲜竹笋表面的16株食窦魏斯氏菌(Weissella cibaria)为研究对象,评价其对低酸、温度和渗透压胁迫下的耐受力,筛选出具有良好耐受性的菌株,并对所得良好耐受性的菌株进行体外人工胃液和胆盐耐受力评价。结果表明,低酸、... 本研究以分离自新鲜竹笋表面的16株食窦魏斯氏菌(Weissella cibaria)为研究对象,评价其对低酸、温度和渗透压胁迫下的耐受力,筛选出具有良好耐受性的菌株,并对所得良好耐受性的菌株进行体外人工胃液和胆盐耐受力评价。结果表明,低酸、温度、渗透压胁迫下实验菌株的耐受力各不相同,综合比较得出5株食窦魏斯氏菌的耐受力均较好.分别是HSG08、HSG09、HSG 10、HSG 11和HSG 15。pH3.0人工胃液实验结果表明,5株食窦魏斯氏菌中,HSG08、HSG 09和HSG 11对人工胃液中的存活率均较高,其中HSG 08的存活率最大;胆盐胁迫实验结果表明,在0.1%胆盐时,HSG08的生长效率最高。综上所述,HSG08在不同环境胁迫下的耐受性均较好,可用于下一步益生性食窦魏斯氏菌的研究。 展开更多
关键词 食窦魏斯氏菌 胁迫 耐受性 益生性 筛选
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Residue Study for a Standardized <i>Macleaya cordata</i>Extract in Growing-Finishing Swine 预览
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作者 Lu Zhao Ray A. Matulka +1 位作者 Sophie von Alvensleben Mauro Morlacchini 《动物科学期刊(英文)》 2017年第2期93-104,共12页
The aim of this study was to assess the effects of Sangrovit&reg;, a standardized preparation of Macleaya cordata extract (MCE), on the health status and retained residues in growing-finishing swine. A total of tw... The aim of this study was to assess the effects of Sangrovit&reg;, a standardized preparation of Macleaya cordata extract (MCE), on the health status and retained residues in growing-finishing swine. A total of twelve growing-finishing swine (n = 6 for each group) were randomly divided into two groups and fed either a control feed or the control feed supplemented with 100 mg/kg Sangrovit&reg;(3.5 mg/kg MCE) for 28 days. The parameters for growth and health status were evaluated during the trial and after which the animals were slaughtered. Residual levels of MCE in swine organs and tissues were determined by measuring sanguinarine and chelerythrine levels by LC-MS/MS. The results showed no statistically significant differences in live weight, feed intake and average daily gain between the treatment and control groups. The feed supplemented with 100 mg/kg Sangrovit&reg;was well tolerated by the swine, with no adverse effects noted during the feeding period or in the necropsy results. Residue analysis indicated that levels of sanguinarine or chelerythrine were under the limit of detection in all the examined tissues and organs from the treated swine. This study demonstrates that Sangrovit&reg;, a standardized preparation of MCE when fed to growing-finishing swine for 28 days, at the level of 100 mg/kg in feed, does not result in sanguinarine or chelerythrine residues in the organs or tissues. 展开更多
关键词 Macleaya cordata EXTRACT SWINE SANGUINARINE TOLERABILITY Residues
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Is a split-dose regimen of 2 L polyethylene glycol plus ascorbic acid tolerable for colonoscopy in an early morning visit to a comprehensive medical check-up? 预览
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作者 Ji Yeon Seo Changhyun Lee +7 位作者 Eun Hyo Jin Mi Hyun Yun Joo Hyun Lim Hae Yeon Kang Jong In Yang Su Jin Chung Sun Young Yang Joo Sung Kim 《世界胃肠病学杂志:英文版》 SCIE CAS 2017年第6期1030-1037,共8页
AIM To evaluate the effectiveness and tolerability of a split-dose 2L polyethylene glycol (PEG)/ascorbic acid(AA) regimen for healthy examinees who visited for comprehensive medical check-up in the early morning.METHO... AIM To evaluate the effectiveness and tolerability of a split-dose 2L polyethylene glycol (PEG)/ascorbic acid(AA) regimen for healthy examinees who visited for comprehensive medical check-up in the early morning.METHODS From February 2015 to March 2015, examinees of average risk who were scheduled for a colonoscopy in the morning were retrospectively enrolled.RESULTS The 189 examinees were divided into split-dose and non-split-dose groups. The adequacy of bowel preparation for the split-dose group vs the non-splitdose group was 96.8% vs 85.2%, respectively, P<0.001, and the compliance of the last meal restrictionwas 74.6% vs 58.2%, respectively, P <0.001. The sleep disturbance (P<0.001) was more prevalent in the split-dose group, however the willingness to repeat the same preparation method (P=0.243) was not different in both groups. The split-dose regimen was the most important factor influencing adequate bowel preparation in multivariate analysis(HR=10.89, 95%CI: 6.53-18.17, P<0.001).CONCLUSION A split-dose regimen of 2L PEG/AA for an early morning colonoscopy was more effective and showed better compliance for diet restriction without any difference in satisfaction and discomfort. Introducing a split-dose regimen of 2L PEG/AA to morning colonoscopy examinees is effective and tolerable in a comprehensive medical check-up setting. 展开更多
关键词 依从 清早 colonoscopy 有效性 裂口剂量政体 TOLERABILITY
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恶性黑色素瘤大剂量干扰素辅助治疗诱导期的耐受性观察 被引量:2
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作者 金谷 夏李明 +2 位作者 吴昊 邹瀚辉 李涛 《肿瘤学杂志》 CAS 2017年第11期950-954,共5页
[目的]观察恶性黑色素瘤患者术后大剂量干扰素辅助治疗诱导期的耐受性。[方法]回顾性分析2011年6月至2015年6月我院收治的203例AJCCⅡB~Ⅲ期恶性黑色素瘤患者并接受术后大剂量α-2b干扰素辅助治疗,其中4周静脉诱导期剂量为1500万IU/m~2... [目的]观察恶性黑色素瘤患者术后大剂量干扰素辅助治疗诱导期的耐受性。[方法]回顾性分析2011年6月至2015年6月我院收治的203例AJCCⅡB~Ⅲ期恶性黑色素瘤患者并接受术后大剂量α-2b干扰素辅助治疗,其中4周静脉诱导期剂量为1500万IU/m~2,采用NCI-CTCAE 4.0评定诱导期药物相关不良事件,观察剂量限制性毒性相关事件和治疗中进展情况。[结果]全部203例患者诱导期均接受药物相关不良事件评价,共发生剂量限制性毒性34例次,主要为4级粒细胞减少(8.4%)和3级肝酶升高(4.4%)。21例患者遵循减量计划完成诱导,7例患者未完成诱导期治疗,原因包括3例进展,2例明显疲乏,1例重度肝功能不全和1例3级斑丘疹。1年大剂量干扰素治疗中共有42例进展,N_3组复发转移率达50%。[结论 ]大剂量干扰素在中国人群中有较好的耐受性,但对于3个以上淋巴结转移的相对更高危患者,干扰素似乎有效率不高。 展开更多
关键词 干扰素 恶性黑色素瘤 剂量限制性毒性 耐受性
托伐普坦在肺癌和其他癌症患者合并低钠血症治疗中的应用
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作者 雷建灵 温珍平 《职业与健康》 CAS 2017年第16期2297-2300,共4页
低钠血症是最常见的电解质紊乱类型。低钠血症会对癌症患者的预后和生存产生不利影响。有限的数据表明,肺癌患者中纠正低钠血症,可以增加患者对抗癌治疗的反应,可能有助于缩短住院时间和费用,降低发病率和死亡率。经常使用抗利尿激素受... 低钠血症是最常见的电解质紊乱类型。低钠血症会对癌症患者的预后和生存产生不利影响。有限的数据表明,肺癌患者中纠正低钠血症,可以增加患者对抗癌治疗的反应,可能有助于缩短住院时间和费用,降低发病率和死亡率。经常使用抗利尿激素受体拮抗剂等药物治疗成为必要。这些拮抗剂的使用可以有效治疗低钠血症,这一直是个重大突破。托伐普坦是抗利尿激素(ADH)受体拮抗剂,在肾小管水平能增加自由水的排泄而不引起电解质紊乱如低血钾和碱中毒。作者对托伐普坦治疗癌症患者合并低钠血症的研究情况进行综述。 展开更多
关键词 托伐普坦 安全性 耐受性 有效性
不同时间口服复方聚乙二醇电解质散对结肠镜检查前肠道准备的影响 被引量:12
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作者 郭海燕 冯辉 袁琦 《中南药学》 CAS 2017年第1期126-128,共3页
目的 比较在不同时间口服复方聚乙二醇电解质散对患者肠道准备的影响。方法 选取在本院内镜室接受结肠镜检查的患者264例,随机分为A组和B组。A组在检查前一晚21点服用复方聚乙二醇电解质散1盒(1000 m L),检查当日早晨5点服用复方聚乙... 目的 比较在不同时间口服复方聚乙二醇电解质散对患者肠道准备的影响。方法 选取在本院内镜室接受结肠镜检查的患者264例,随机分为A组和B组。A组在检查前一晚21点服用复方聚乙二醇电解质散1盒(1000 m L),检查当日早晨5点服用复方聚乙二醇电解质散1盒(1000 m L)进行肠道准备,B组在检查当日早晨5点服用复方聚乙二醇电解质散2盒(2000 m L)进行肠道准备。比较2组患者的肠道准备质量和患者的耐受性、依从性。结果 A组比B组有更好的肠道清洁度(BBPS评分7.37±1.31vs 6.85±1.19,P〈0.01),2种肠道准备方法在患者的耐受性及依从性方面差异没有统计学意义(P〉0.05)。结论 采用检查前一晚及检查当日早晨分次口服复方聚乙二醇电解质散的方法肠道准备质量更好,而且不会影响患者的耐受性和依从性。 展开更多
关键词 肠道准备 结肠镜 耐受性 依从性 Boston肠道准备量表
麝香保心丸长期治疗老年不稳定性心绞痛的疗效及耐受性观察 预览
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作者 刘彦伯 《临床医学研究与实践》 2017年第24期122-123,共2页
目的研究麝香保心丸长期治疗老年不稳定性心绞痛的疗效及安全性。方法将我院76例老年不稳定心绞痛患者随机分为观察组(38例)、对照组(38例),均接受常规治疗,观察组另口服麝香保心丸12个月,比较两组患者治疗1年后的临床疗效,治... 目的研究麝香保心丸长期治疗老年不稳定性心绞痛的疗效及安全性。方法将我院76例老年不稳定心绞痛患者随机分为观察组(38例)、对照组(38例),均接受常规治疗,观察组另口服麝香保心丸12个月,比较两组患者治疗1年后的临床疗效,治疗前、后的Hcy、Hs—CRP水平,心脏事件发生率及不良反应发生情况。结果观察组临床总有效率明显高于对照组(P〈0.05);观察组治疗后6、12个月的Hey水平显著低于对照组,12个月Hs—CRP水平显著低于对照组(P〈0.05);观察组心绞痛再入院率显著低于对照组(P〈0.05);两组不良反应发生率比较,差异不明显(P〉0.05)。结论麝香保心丸长期治疗老年不稳定性心绞痛疗效显著,可有效降低Hcy、Hs—CRP水平,降低远期心脏事件发生风险且耐受性良好,临床价值高。 展开更多
关键词 麝香保心丸 老年不稳定性心绞痛 耐受性
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