背景：氯膦酸二钠（固令）通过抑制肿瘤细胞诱导的破骨细胞骨溶解，来减少骨转移的发生率。方法：本研究为随机双盲、安慰剂对照的多中心临床试验。于1989至2000年间，共入组1069例Ⅰ～Ⅲ期乳腺癌患者，评价了口服氯膦酸二钠的有效性和...背景：氯膦酸二钠（固令）通过抑制肿瘤细胞诱导的破骨细胞骨溶解，来减少骨转移的发生率。方法：本研究为随机双盲、安慰剂对照的多中心临床试验。于1989至2000年间，共入组1069例Ⅰ～Ⅲ期乳腺癌患者，评价了口服氯膦酸二钠的有效性和安全性。入组患者在半年内完成手术、放疗、化疗后，随机分为两组。一组接受氯膦酸二钠（1600mg/天）治疗2年，另一组接受安慰剂两年。本研究的初步结果已于先期发表（Powles et al．JCO，2002），本文报告了未发表的实验相关内容和对Ⅱ／Ⅲ期患者的分析结果。本试验的主要研究终点为5年间第一次骨转移发生时间，次要研究终点为总生存期。这些研究终点用非分层的时序检验和风险比（HR）进行统计分析，可信区间为95％。结果：氯膦酸二钠、安慰剂两组患者的一般状况、疾病特征相似。结果显示2年口服氯膦酸二钠，可降低全组患者骨转移发生风险45％（HR=0．546，P=0．031），5年研究期内降低了全组骨转移发生风险31％（HR=0．692，P=0．043）。对于Ⅱ／Ⅲ期患者，2年氯膦酸二钠口服，也能显著降低骨转移发生风险50％（HR=0．496，P=0．020）；5年研究期内，氯膦酸二钠口服可降低41％的骨转移复发风险（HR=0．592，P=0．009）。口服氯膦酸二钠与安慰剂相比显著提高了患者的总生存率，死亡率下降了23％（HR=0．768，P=0．048），对于Ⅱ／Ⅲ期患者也显著提高了生存率，死亡率下降了26％（HR=0．743，P=0．041）。口服氯膦酸二钠可很好的耐受，轻度到中度的腹泻是最常见的药物不良事件。结论：对于早期可手术乳癌患者，口服氯膦酸二钠较安慰剂组，在5年研究期间，能显著降低药物治疗期和研究期间骨转移的发生率，延长患者的总生存率；对于Ⅱ，Ⅲ期患者，10．5年随诊资料显示，也可提高患者的总生存期。该研究结果显示Ⅱ，Ⅲ期患者，可从口服氯膦酸二纳中，获得更大的益处。展开更多
Background. An Advisory Committee on Immunization Practices policy of encouraging influenza vaccination for healthy 6-to 23-month-old children was in effect during the 2003-2004 influenza season,which was unusually se...Background. An Advisory Committee on Immunization Practices policy of encouraging influenza vaccination for healthy 6-to 23-month-old children was in effect during the 2003-2004 influenza season,which was unusually severe in Colorado. We collaborated with 5 pediatric practices to attempt universal influenza immunization in this age group. Objectives. The objectives were (1) to assess the maximal influenza immunization rates that could be achieved for healthy young children in private practice settings, (2) to evaluate the efficacy of registry-based reminderrecall for influenza vaccination, and (3) to describe methods used by private practices to implement the recommendations. Methods. The study was conducted in 5 private pediatric practices in Denver, Colorado, with a common billing system and immunization registry. Although recommendations by the Advisory Committee on Immunization Practices included children who were 6 to 23 months of age at any point during the influenza season, our practices chose not to recall children 22 to 23 months of age, because they would have become > 24 months of age during the study period. Therefore, our study population consisted of all healthy children 6 to 21 months of age from the 5 practices (N = 5193), who were randomized to intervention groups (n = 2595) that received up to 3 reminderrecall letters or to control groups (n = 2598) that received usual care. The primary outcome was receipt of ≥1 influenza immunization, as noted either in the immunization registry or in billing data. Results. Immunization rates for ≥1 dose of influenza vaccine for the intervention groups in the 5 practices were 75.9%, 75.4%, 68.1%, 55.6%, and 44.3%at the end of the season. Overall, 62.4%of children in the intervention groups and 58.0%of children in the control groups were immunized (4.4%absolute difference), with absolute differences, compared with control values, ranging from 1.0%to 9.1%according to practice. However, before intensive media coverage of the influenza outbreak began (November 15, 2003)-, absolute differences, compared with control values, ranged from 5.1%to 15.3%and were 9.6%overall. Before November 15, significant effects of recall were seen for children in the intervention groups, in both the 12-to 21-month age category (10.4%increase over control) and the 6-to 11-month category (8.1%increase over control); at the end of the season, however, significant effects of recall were seen only for the older age group (6.2%increase over control). The rates of receipt of 2 vaccine doses ≥1 month apart for eligible children ranged from 21%to 48%among the practices. Four of the 5 practices held influenza immunization clinics during office hours, evenings, or weekends, and these clinics achieved higher coverage rates. Conclusions. These results demonstrated that, in an epidemic influenza year, private practices were able to immunize the majority of 6-to 21-month-old children in a timely manner. Although media coverage regarding the epidemic blunted the effect of registry-based recall, recall was effective in increasing rates early in the epidemic, especially for children between 1 and 2 years of age. The practices that achieved the highest immunization rates were proactive in planning influenza clinics to handle the extra volume of immunizations required.展开更多
目前开展的真实世界研究(real world study,RWS)仍存在诸多局限性,而未能在卫生技术评估方面充分发挥应有的作用。因此,有必要改进传统RWS设计,以产生高质量的医学证据。策略之一是仿照随机对照试验(randomized controlled trial,RCT)...目前开展的真实世界研究(real world study,RWS)仍存在诸多局限性,而未能在卫生技术评估方面充分发挥应有的作用。因此,有必要改进传统RWS设计,以产生高质量的医学证据。策略之一是仿照随机对照试验(randomized controlled trial,RCT)开展观察性研究(又称RCT仿真或模拟研究),既借鉴了RCT设计优势,增强了因果推断的强度,又保留了RWS的代表性,可以作为打通药品上市前与上市后证据链的桥梁,以期为医疗决策提供合理的证据支撑。仿照RCT开展观察性研究分为两步:第一步,基于临床问题构建一个目标试验,参照目标试验关键特征构建相应的RWS方案(包括纳排标准、治疗策略、分配程序、随访、结局定义、因果对比和统计分析策略),特别注意减小模拟差异和控制相关偏倚;第二步,使用真实世界数据(real world data,RWD)按照既定研究方案进行数据分析,得到相应结果。展开更多
[目的]了解2010年-2015年国内护理领域临床随机对照试验研究(RCT)文献的质量水平。[方法]制定文献纳入及排除标准,在护理类期刊影响因子大于1的期刊中筛选文献,共纳入160篇。根据临床试验报告统一标准(consolidated standards of report...[目的]了解2010年-2015年国内护理领域临床随机对照试验研究(RCT)文献的质量水平。[方法]制定文献纳入及排除标准,在护理类期刊影响因子大于1的期刊中筛选文献,共纳入160篇。根据临床试验报告统一标准(consolidated standards of reporting trials,CONSORT)声明确定文献质量评价指标,共16项,进行文献质量的评价分析。[结果]评价指标中,纳入标准、排除标准、对照、基线资料、干预措施、观测指标及终点指标得到了很好的执行,其余指标的认知及执行情况欠佳。文献的整体质量不高,与RCT的规范要求有一定的差距。[结论]国内护理领域的RCT文献质量需进一步提高,以满足循证护理研究实践的需要。展开更多
目的探讨地特胰岛素联合瑞格列奈治疗2型糖尿病的临床疗效及安全性。方法选取2013年1月2014年2月玉溪市人民医院收治的口服2种以上降糖药物血糖控制不佳的2型糖尿病患者85例,随机分为试验组（n=41）和对照组（n=44）。试验组给予地特胰...目的探讨地特胰岛素联合瑞格列奈治疗2型糖尿病的临床疗效及安全性。方法选取2013年1月2014年2月玉溪市人民医院收治的口服2种以上降糖药物血糖控制不佳的2型糖尿病患者85例,随机分为试验组（n=41）和对照组（n=44）。试验组给予地特胰岛素初始剂量0.1 U·kg-1,每晚22∶00皮下注射,瑞格列奈0.5~1.0 mg,三餐前15 min口服;对照组在早、晚餐前10 min皮下注射门冬胰岛素30,0.5~1.0 U·kg-1;2组患者治疗周期为3个月。观察患者治疗期间空腹血糖（FPG）、餐后2 h血糖（2 h PG）和糖化血红蛋白（Hb A1C）等指标变化情况。结果治疗后2组患者FPG、2 h PG及Hb A1C与治疗前比较均显著降低（P〈0.05）,但试验组患者治疗期间血糖波动较小。治疗后2组患者空腹C肽及餐后2 h C肽均明显下降（P〈0.05）,且试验组下降水平更为显著（P〈0.05）。治疗期间,试验组发生低血糖1例,对照组8例,对照组显著高于试验组（P〈0.05）。结论地特胰岛素联合瑞格列奈治疗2型糖尿病可平稳降低血糖水平,降低低血糖的发生率。展开更多
文摘背景：氯膦酸二钠（固令）通过抑制肿瘤细胞诱导的破骨细胞骨溶解，来减少骨转移的发生率。方法：本研究为随机双盲、安慰剂对照的多中心临床试验。于1989至2000年间，共入组1069例Ⅰ～Ⅲ期乳腺癌患者，评价了口服氯膦酸二钠的有效性和安全性。入组患者在半年内完成手术、放疗、化疗后，随机分为两组。一组接受氯膦酸二钠（1600mg/天）治疗2年，另一组接受安慰剂两年。本研究的初步结果已于先期发表（Powles et al．JCO，2002），本文报告了未发表的实验相关内容和对Ⅱ／Ⅲ期患者的分析结果。本试验的主要研究终点为5年间第一次骨转移发生时间，次要研究终点为总生存期。这些研究终点用非分层的时序检验和风险比（HR）进行统计分析，可信区间为95％。结果：氯膦酸二钠、安慰剂两组患者的一般状况、疾病特征相似。结果显示2年口服氯膦酸二钠，可降低全组患者骨转移发生风险45％（HR=0．546，P=0．031），5年研究期内降低了全组骨转移发生风险31％（HR=0．692，P=0．043）。对于Ⅱ／Ⅲ期患者，2年氯膦酸二钠口服，也能显著降低骨转移发生风险50％（HR=0．496，P=0．020）；5年研究期内，氯膦酸二钠口服可降低41％的骨转移复发风险（HR=0．592，P=0．009）。口服氯膦酸二钠与安慰剂相比显著提高了患者的总生存率，死亡率下降了23％（HR=0．768，P=0．048），对于Ⅱ／Ⅲ期患者也显著提高了生存率，死亡率下降了26％（HR=0．743，P=0．041）。口服氯膦酸二钠可很好的耐受，轻度到中度的腹泻是最常见的药物不良事件。结论：对于早期可手术乳癌患者，口服氯膦酸二钠较安慰剂组，在5年研究期间，能显著降低药物治疗期和研究期间骨转移的发生率，延长患者的总生存率；对于Ⅱ，Ⅲ期患者，10．5年随诊资料显示，也可提高患者的总生存期。该研究结果显示Ⅱ，Ⅲ期患者，可从口服氯膦酸二纳中，获得更大的益处。
文摘Background. An Advisory Committee on Immunization Practices policy of encouraging influenza vaccination for healthy 6-to 23-month-old children was in effect during the 2003-2004 influenza season,which was unusually severe in Colorado. We collaborated with 5 pediatric practices to attempt universal influenza immunization in this age group. Objectives. The objectives were (1) to assess the maximal influenza immunization rates that could be achieved for healthy young children in private practice settings, (2) to evaluate the efficacy of registry-based reminderrecall for influenza vaccination, and (3) to describe methods used by private practices to implement the recommendations. Methods. The study was conducted in 5 private pediatric practices in Denver, Colorado, with a common billing system and immunization registry. Although recommendations by the Advisory Committee on Immunization Practices included children who were 6 to 23 months of age at any point during the influenza season, our practices chose not to recall children 22 to 23 months of age, because they would have become > 24 months of age during the study period. Therefore, our study population consisted of all healthy children 6 to 21 months of age from the 5 practices (N = 5193), who were randomized to intervention groups (n = 2595) that received up to 3 reminderrecall letters or to control groups (n = 2598) that received usual care. The primary outcome was receipt of ≥1 influenza immunization, as noted either in the immunization registry or in billing data. Results. Immunization rates for ≥1 dose of influenza vaccine for the intervention groups in the 5 practices were 75.9%, 75.4%, 68.1%, 55.6%, and 44.3%at the end of the season. Overall, 62.4%of children in the intervention groups and 58.0%of children in the control groups were immunized (4.4%absolute difference), with absolute differences, compared with control values, ranging from 1.0%to 9.1%according to practice. However, before intensive media coverage of the influenza outbreak began (November 15, 2003)-, absolute differences, compared with control values, ranged from 5.1%to 15.3%and were 9.6%overall. Before November 15, significant effects of recall were seen for children in the intervention groups, in both the 12-to 21-month age category (10.4%increase over control) and the 6-to 11-month category (8.1%increase over control); at the end of the season, however, significant effects of recall were seen only for the older age group (6.2%increase over control). The rates of receipt of 2 vaccine doses ≥1 month apart for eligible children ranged from 21%to 48%among the practices. Four of the 5 practices held influenza immunization clinics during office hours, evenings, or weekends, and these clinics achieved higher coverage rates. Conclusions. These results demonstrated that, in an epidemic influenza year, private practices were able to immunize the majority of 6-to 21-month-old children in a timely manner. Although media coverage regarding the epidemic blunted the effect of registry-based recall, recall was effective in increasing rates early in the epidemic, especially for children between 1 and 2 years of age. The practices that achieved the highest immunization rates were proactive in planning influenza clinics to handle the extra volume of immunizations required.
文摘目前开展的真实世界研究(real world study,RWS)仍存在诸多局限性,而未能在卫生技术评估方面充分发挥应有的作用。因此,有必要改进传统RWS设计,以产生高质量的医学证据。策略之一是仿照随机对照试验(randomized controlled trial,RCT)开展观察性研究(又称RCT仿真或模拟研究),既借鉴了RCT设计优势,增强了因果推断的强度,又保留了RWS的代表性,可以作为打通药品上市前与上市后证据链的桥梁,以期为医疗决策提供合理的证据支撑。仿照RCT开展观察性研究分为两步:第一步,基于临床问题构建一个目标试验,参照目标试验关键特征构建相应的RWS方案(包括纳排标准、治疗策略、分配程序、随访、结局定义、因果对比和统计分析策略),特别注意减小模拟差异和控制相关偏倚;第二步,使用真实世界数据(real world data,RWD)按照既定研究方案进行数据分析,得到相应结果。
文摘[目的]了解2010年-2015年国内护理领域临床随机对照试验研究(RCT)文献的质量水平。[方法]制定文献纳入及排除标准,在护理类期刊影响因子大于1的期刊中筛选文献,共纳入160篇。根据临床试验报告统一标准(consolidated standards of reporting trials,CONSORT)声明确定文献质量评价指标,共16项,进行文献质量的评价分析。[结果]评价指标中,纳入标准、排除标准、对照、基线资料、干预措施、观测指标及终点指标得到了很好的执行,其余指标的认知及执行情况欠佳。文献的整体质量不高,与RCT的规范要求有一定的差距。[结论]国内护理领域的RCT文献质量需进一步提高,以满足循证护理研究实践的需要。
文摘目的探讨地特胰岛素联合瑞格列奈治疗2型糖尿病的临床疗效及安全性。方法选取2013年1月2014年2月玉溪市人民医院收治的口服2种以上降糖药物血糖控制不佳的2型糖尿病患者85例,随机分为试验组（n=41）和对照组（n=44）。试验组给予地特胰岛素初始剂量0.1 U·kg-1,每晚22∶00皮下注射,瑞格列奈0.5~1.0 mg,三餐前15 min口服;对照组在早、晚餐前10 min皮下注射门冬胰岛素30,0.5~1.0 U·kg-1;2组患者治疗周期为3个月。观察患者治疗期间空腹血糖（FPG）、餐后2 h血糖（2 h PG）和糖化血红蛋白（Hb A1C）等指标变化情况。结果治疗后2组患者FPG、2 h PG及Hb A1C与治疗前比较均显著降低（P〈0.05）,但试验组患者治疗期间血糖波动较小。治疗后2组患者空腹C肽及餐后2 h C肽均明显下降（P〈0.05）,且试验组下降水平更为显著（P〈0.05）。治疗期间,试验组发生低血糖1例,对照组8例,对照组显著高于试验组（P〈0.05）。结论地特胰岛素联合瑞格列奈治疗2型糖尿病可平稳降低血糖水平,降低低血糖的发生率。
