盆腔器官脱垂(pelvic organ prolapse,POP)是盆底功能障碍性疾病中的主要疾病,严重影响患者的生命质量,手术是其主要的治疗方法。女性一生中有12.6%的可能需要进行脱垂的手术[1],并且接受手术的患者5年内约13%需要再次手术[2]。近20多年...盆腔器官脱垂(pelvic organ prolapse,POP)是盆底功能障碍性疾病中的主要疾病,严重影响患者的生命质量,手术是其主要的治疗方法。女性一生中有12.6%的可能需要进行脱垂的手术[1],并且接受手术的患者5年内约13%需要再次手术[2]。近20多年来,随着现代盆底学理论的发展、手术器械的改进以及替代材料的应用,盆底重建手术有了突破性的进展,经阴道植入合成网片(transvaginal mesh,TVM)的盆底重建手术因解剖治愈率高,已成为治疗POP的手术方法之一。展开更多
目的了解真实世界证据(real world evidence,RWE)在上市后药品安全性监测与评价中的应用价值。方法检索PubMed、Embase、Web of Science、Scopus、中国生物医学文献服务系统、中国知网、维普网、万方数据建库至2020年1月2日中与RWE及上...目的了解真实世界证据(real world evidence,RWE)在上市后药品安全性监测与评价中的应用价值。方法检索PubMed、Embase、Web of Science、Scopus、中国生物医学文献服务系统、中国知网、维普网、万方数据建库至2020年1月2日中与RWE及上市后药品安全性相关的文献,归纳RWE应用价值。结果及结论经课题组讨论和专家咨询将RWE在上市后药品安全性监测与评价中的应用价值,归纳为补充药品安全性证据、辅助药品上市后管理、支持临床决策及卫生政策、技术方法开发优化4个方面,并提供参考案例。展开更多
药品上市后安全性监测体现为对药品在上市后的安全性风险的及时发现,是药物警戒的关键核心[1]。自发报告作为药物警戒的重要工具之一,是目前最重要的尽早发现药品不良反应(adverse drug reactions,ADR)的方法[2]。自发报告的来源包括医...药品上市后安全性监测体现为对药品在上市后的安全性风险的及时发现,是药物警戒的关键核心[1]。自发报告作为药物警戒的重要工具之一,是目前最重要的尽早发现药品不良反应(adverse drug reactions,ADR)的方法[2]。自发报告的来源包括医务人员和药品使用者。药品使用者自发报告,是指药品使用者在不经过医务人员的解释和说明下,主动就其自身经历的某一可疑的药品不良反应向药物警戒部门等做出的报告。药品使用者自发报告可增加药品不良反应报告的数量,与医务人员自发报告互为补充,可以提供药品不良反应的直接信息甚至影响药品不良反应“耐受性”的界定[3-4],但会受到对自发报告和报告系统了解不足和不完善的报告体验的影响。社交媒体平台上由个人发布的药品及其不良反应相关内容近些年正逐渐被视为类似于药品使用者自发报告的新的数据来源,使用社交媒体数据开展药品上市后安全性监测的研究呈逐年上升趋势,因而本文就相关研究现状与面临的挑战进行综述。展开更多
Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the s...Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese 展开更多
Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸)on neck pain in realworld clinical practice.Methods:A multi-center,prospective,observational surveillance in 8 hospitals across Shanghai was cond...Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸)on neck pain in realworld clinical practice.Methods:A multi-center,prospective,observational surveillance in 8 hospitals across Shanghai was conducted.During patients receiving 4-week Qishe Pill medication,Visual Analogue Scale(VAS)and Neck Disability Index(NDI)assessments have been used to assess their pain and function,while safety monitoring have been observed after 2 and 4 weeks.Results:Results from 2,023 patients(mean age 54.5 years)suggest that the drug exposure per unit of body mass was estimated at 3.41±0.62 g/kg.About 8.5%(172/2,023)of all participants experienced adverse events(AEs),while 3.8%(78/2,023)of all participants experienced adverse reaction.The most common AEs were gastrointestinal events and respiratory events.The VAS score(pain)and NDI score(function)significantly decreased after 4-week treatment.An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3–4 g/kg,at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS.Conclusion:These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function.(Registration No.NCT01875562).展开更多
文摘盆腔器官脱垂(pelvic organ prolapse,POP)是盆底功能障碍性疾病中的主要疾病,严重影响患者的生命质量,手术是其主要的治疗方法。女性一生中有12.6%的可能需要进行脱垂的手术[1],并且接受手术的患者5年内约13%需要再次手术[2]。近20多年来,随着现代盆底学理论的发展、手术器械的改进以及替代材料的应用,盆底重建手术有了突破性的进展,经阴道植入合成网片(transvaginal mesh,TVM)的盆底重建手术因解剖治愈率高,已成为治疗POP的手术方法之一。
文摘目的了解真实世界证据(real world evidence,RWE)在上市后药品安全性监测与评价中的应用价值。方法检索PubMed、Embase、Web of Science、Scopus、中国生物医学文献服务系统、中国知网、维普网、万方数据建库至2020年1月2日中与RWE及上市后药品安全性相关的文献,归纳RWE应用价值。结果及结论经课题组讨论和专家咨询将RWE在上市后药品安全性监测与评价中的应用价值,归纳为补充药品安全性证据、辅助药品上市后管理、支持临床决策及卫生政策、技术方法开发优化4个方面,并提供参考案例。
文摘药品上市后安全性监测体现为对药品在上市后的安全性风险的及时发现,是药物警戒的关键核心[1]。自发报告作为药物警戒的重要工具之一,是目前最重要的尽早发现药品不良反应(adverse drug reactions,ADR)的方法[2]。自发报告的来源包括医务人员和药品使用者。药品使用者自发报告,是指药品使用者在不经过医务人员的解释和说明下,主动就其自身经历的某一可疑的药品不良反应向药物警戒部门等做出的报告。药品使用者自发报告可增加药品不良反应报告的数量,与医务人员自发报告互为补充,可以提供药品不良反应的直接信息甚至影响药品不良反应“耐受性”的界定[3-4],但会受到对自发报告和报告系统了解不足和不完善的报告体验的影响。社交媒体平台上由个人发布的药品及其不良反应相关内容近些年正逐渐被视为类似于药品使用者自发报告的新的数据来源,使用社交媒体数据开展药品上市后安全性监测的研究呈逐年上升趋势,因而本文就相关研究现状与面临的挑战进行综述。
文摘Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese
基金Supported by the National Science Fundation for Young Scholars of China(No.81804115,No.81873317,No.81930116 and No.82074454)the State Key Program of National Natural Science of China(No.81330085 and No.81930116)+3 种基金Shanghai Sailing Program(No.18YF1423800)Shanghai TCM Medical Center of Chronic Disease(No.2017ZZ01010)Municipal Science and Technology Commission of Shanghai-TCM Key Project(No.16401970100)National Thirteenth Five-Year Science and Technology Major Special Project for New Drug Innovation and Development(No.2017ZX09304001)。
文摘Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸)on neck pain in realworld clinical practice.Methods:A multi-center,prospective,observational surveillance in 8 hospitals across Shanghai was conducted.During patients receiving 4-week Qishe Pill medication,Visual Analogue Scale(VAS)and Neck Disability Index(NDI)assessments have been used to assess their pain and function,while safety monitoring have been observed after 2 and 4 weeks.Results:Results from 2,023 patients(mean age 54.5 years)suggest that the drug exposure per unit of body mass was estimated at 3.41±0.62 g/kg.About 8.5%(172/2,023)of all participants experienced adverse events(AEs),while 3.8%(78/2,023)of all participants experienced adverse reaction.The most common AEs were gastrointestinal events and respiratory events.The VAS score(pain)and NDI score(function)significantly decreased after 4-week treatment.An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3–4 g/kg,at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS.Conclusion:These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function.(Registration No.NCT01875562).
