Objective： To observe the clinical efficacy of Qingqiao Capsule （清窍胶囊, QQC） in treating patients with secretory otitis media （SOM）. Methods： A total of 90 patients were randomly assigned into the treated gro...Objective： To observe the clinical efficacy of Qingqiao Capsule （清窍胶囊, QQC） in treating patients with secretory otitis media （SOM）. Methods： A total of 90 patients were randomly assigned into the treated group （n：45） and the control group （n=45）. Patients in the treated group were administrated with QQC, 5 capsules each time, 3 times a day for totally 10-14 days, and those in the control group were given per os cefaclor capsules 0.5g each time for adult, 3 times a day, or 20mg/（kg·d） for children, for 10-14 days. The therapeutic efficacy of treatment on the patients was observed and compared after treatment and followed up for 3-6 months. Results： （1） The clinical efficacy in the treated group was superior to that in the control group with significant statistical difference （P〈0.01）; （2） Comparison of the efficacies in patients of three different TCM syndrome types （the external pathogenic wind invasion caused auditory orifice stuffiness type, the Gan-Dan damp-heat steaming up auditory orifice type and the Pi-deficiency dysfunction induced dirty dampness blocking ear type） showed no statistically significant difference（P〉0.05）; （3） The vanishing rate and time needed of the main symptoms and signs in the treated group were superior to those in the control group on ear muffle, tinnitus, hearing impairment, hydrotypanum, pure tone threshold and abnormal tongue figure, and the difference was statistically significant （P〈0.05 or P〈0.01）, only those of earache, otopiesis and abnornal pulse figure were insignificantly different between the two groups （P〉0.05）. Conclusion： QQC is an effective Chinese composite medicine on patients with SOM, and shows no obvious adverse reaction.展开更多
It is evident that both recruitment and retention play critical roles in clinical trials. Recruitment and retention models are beginning to be analyzed worldwide in an effort to assess how to conduct studies more effi...It is evident that both recruitment and retention play critical roles in clinical trials. Recruitment and retention models are beginning to be analyzed worldwide in an effort to assess how to conduct studies more efficiently, all the while, allowing researchers to provide sound and ethical data to help advance medicine through clinical studies. Sponsors and sites have recognized that clinical trial enrollment must become more diverse and inclusive. In this review, we address the important topics of recruitment and retention in clinical trials. Specifically, the obstacles in regard to recruiting vulnerable populations. Methodologies to improve both the understanding of the study population and community engagement are outlined. In particular, newer strategies such as use of social media and more reliable strategies such as trust and relationship building are described in detail. A strong focus on recruitment is becoming widely recognized as being of such importance that consideration is given to this key component even during initial protocol development. Attention to recruitment and retention in the strategic planning process of clinical trials can mitigate enrollment issues that clinical researchers are experiencing.展开更多
目的采用网状Meta分析的方法比较7种干预措施治疗儿童腺样体肥大相关性分泌性中耳炎的疗效和安全性。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、中国生物医学文献数据库(CBM)、维普(VIP)和万方数据库,检...目的采用网状Meta分析的方法比较7种干预措施治疗儿童腺样体肥大相关性分泌性中耳炎的疗效和安全性。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、中国生物医学文献数据库(CBM)、维普(VIP)和万方数据库,检索时间为以上各数据库建库至2019-12-31止,纳入不同干预措施治疗儿童腺样体肥大相关性分泌性中耳炎的随机对照试验及半随机对照试验,由两名研究者根据纳入与排除标准及Cochrane手册要求,单独进行文献筛查及数据提取,并完成交叉核对。使用Cochrane偏倚风险评估工具,对纳入文献进行质量评价,采用Stata14.0、Review Manager 5.3和GeMTC0.14.3软件对纳入文献进行Meta分析。结果最终纳入28个研究,2994例分泌性中耳炎伴腺样体肥大儿童。结果显示:①网状Meta分析对治疗后总有效率进行比较,等级概率图显示腺样体切除联合鼓膜置管术最佳,其次为腺样体切除联合鼓膜激光打孔术;纯音听阈测定(pure tone audiometry,PTA)显示腺样体切除联合鼓膜置管术改善最佳。②并发症发生率比较,等级概率图显示腺样体切除联合鼓膜激光打孔术优于腺样体切除联合鼓膜置管术,但二者差异无统计学意义(OR 1.32,95%CI 0.26~5.36)。③复发率方面,等级概率图显示复发率最少是腺样体切除联合鼓膜置管术。④直接Meta分析将腺样体切除联合鼓膜置管术与单纯鼓膜置管术比较,鼓膜愈合时间比较两者差异无统计学意义(P=0.16),鼓室积液消失时间比较差异有统计学意义(WMD-2.10,95%CI-2.4^-1.8,P<0.00001)。结论治疗儿童分泌性中耳炎伴腺样体肥大的7种干预措施中,腺样体切除联合鼓膜置管术疗效最佳,复发率最低,受纳入文献数量及质量影响,上述结论需在今后研究中进一步验证。展开更多
文摘Objective： To observe the clinical efficacy of Qingqiao Capsule （清窍胶囊, QQC） in treating patients with secretory otitis media （SOM）. Methods： A total of 90 patients were randomly assigned into the treated group （n：45） and the control group （n=45）. Patients in the treated group were administrated with QQC, 5 capsules each time, 3 times a day for totally 10-14 days, and those in the control group were given per os cefaclor capsules 0.5g each time for adult, 3 times a day, or 20mg/（kg·d） for children, for 10-14 days. The therapeutic efficacy of treatment on the patients was observed and compared after treatment and followed up for 3-6 months. Results： （1） The clinical efficacy in the treated group was superior to that in the control group with significant statistical difference （P〈0.01）; （2） Comparison of the efficacies in patients of three different TCM syndrome types （the external pathogenic wind invasion caused auditory orifice stuffiness type, the Gan-Dan damp-heat steaming up auditory orifice type and the Pi-deficiency dysfunction induced dirty dampness blocking ear type） showed no statistically significant difference（P〉0.05）; （3） The vanishing rate and time needed of the main symptoms and signs in the treated group were superior to those in the control group on ear muffle, tinnitus, hearing impairment, hydrotypanum, pure tone threshold and abnormal tongue figure, and the difference was statistically significant （P〈0.05 or P〈0.01）, only those of earache, otopiesis and abnornal pulse figure were insignificantly different between the two groups （P〉0.05）. Conclusion： QQC is an effective Chinese composite medicine on patients with SOM, and shows no obvious adverse reaction.
文摘It is evident that both recruitment and retention play critical roles in clinical trials. Recruitment and retention models are beginning to be analyzed worldwide in an effort to assess how to conduct studies more efficiently, all the while, allowing researchers to provide sound and ethical data to help advance medicine through clinical studies. Sponsors and sites have recognized that clinical trial enrollment must become more diverse and inclusive. In this review, we address the important topics of recruitment and retention in clinical trials. Specifically, the obstacles in regard to recruiting vulnerable populations. Methodologies to improve both the understanding of the study population and community engagement are outlined. In particular, newer strategies such as use of social media and more reliable strategies such as trust and relationship building are described in detail. A strong focus on recruitment is becoming widely recognized as being of such importance that consideration is given to this key component even during initial protocol development. Attention to recruitment and retention in the strategic planning process of clinical trials can mitigate enrollment issues that clinical researchers are experiencing.
文摘目的采用网状Meta分析的方法比较7种干预措施治疗儿童腺样体肥大相关性分泌性中耳炎的疗效和安全性。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、中国生物医学文献数据库(CBM)、维普(VIP)和万方数据库,检索时间为以上各数据库建库至2019-12-31止,纳入不同干预措施治疗儿童腺样体肥大相关性分泌性中耳炎的随机对照试验及半随机对照试验,由两名研究者根据纳入与排除标准及Cochrane手册要求,单独进行文献筛查及数据提取,并完成交叉核对。使用Cochrane偏倚风险评估工具,对纳入文献进行质量评价,采用Stata14.0、Review Manager 5.3和GeMTC0.14.3软件对纳入文献进行Meta分析。结果最终纳入28个研究,2994例分泌性中耳炎伴腺样体肥大儿童。结果显示:①网状Meta分析对治疗后总有效率进行比较,等级概率图显示腺样体切除联合鼓膜置管术最佳,其次为腺样体切除联合鼓膜激光打孔术;纯音听阈测定(pure tone audiometry,PTA)显示腺样体切除联合鼓膜置管术改善最佳。②并发症发生率比较,等级概率图显示腺样体切除联合鼓膜激光打孔术优于腺样体切除联合鼓膜置管术,但二者差异无统计学意义(OR 1.32,95%CI 0.26~5.36)。③复发率方面,等级概率图显示复发率最少是腺样体切除联合鼓膜置管术。④直接Meta分析将腺样体切除联合鼓膜置管术与单纯鼓膜置管术比较,鼓膜愈合时间比较两者差异无统计学意义(P=0.16),鼓室积液消失时间比较差异有统计学意义(WMD-2.10,95%CI-2.4^-1.8,P<0.00001)。结论治疗儿童分泌性中耳炎伴腺样体肥大的7种干预措施中,腺样体切除联合鼓膜置管术疗效最佳,复发率最低,受纳入文献数量及质量影响,上述结论需在今后研究中进一步验证。
