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find Author "罗剑锋" 5 results
  • 动脉导管未闭合并其他心脏畸形的外科治疗

    摘要:  目的 总结动脉导管未闭合并其他心脏畸形的外科治疗经验, 以提高手术效果。 方法 2004 年11 月~2006 年12 月手术治疗动脉导管未闭合并其他心脏畸形44 例, 40 例采用正中切口, 上、下腔静脉插管, 转流前游离动脉导管, 双10 号线结扎; 对导管粗大者可在并行转流下分离导管并结扎, 4 例患者实行分期手术。 结果 本组无手术死亡。术后发生低心排血量综合征3 例, 经积极治疗治愈; 2 例发生血红蛋白尿, 均在2d 内恢复。44 例术后超声心动图复查均无再通, 无灌注肺发生。术后随访36 例, 均在3 个月~ 2 年顺利恢复, 活动正常。 结论 经胸部正中切口手术是一种简单、有效的方法, 可同时修补其他心内畸形。分离、结扎动脉导管时应熟练掌握导管及其邻近解剖关系, 根据生命体征及导管直径的大小决定是否应用并行心肺转流。

    Release date:2016-08-30 06:08 Export PDF Favorites Scan
  • Technical guidance for statistical analysis to assess therapeutic outcomes using real-world data

    Research of generating real-world evidence using real world data has attracted considerable attention globally. Outcome research of treatment based on existing health and medical data or registries has become one of the most important topics. However, there exists certain confusions in this line of research on how to design and implement appropriate statistical analysis. Therefore, in the fourth chapter of the series technical guidance to develop real world evidence by China REal world data and studies Alliance (ChinaREAL), we aim to provide an guidance on statistical analysis in the study to assess therapeutic outcomes based on existing health and medical data or registries.In this chapter, we first emphasize the significance of pre-specified statistical analysis plan, recommending key components of the statistical analysis plan. We then summarize the issue of sample size calculation in this content and clarify the interpretation of statistical p-value. Secondly, we recommend procedures to be considered to tackle the issue related to the selection bias, information bias and most importantly, confounding bias. We discuss the multivariable regression analysis as well as the popular causal inference models. We also suggest that careful consideration should be made to deal with missing data in real-world databases. Finally, we list core content of the statistical report.

    Release date:2019-07-18 10:28 Export PDF Favorites Scan
  • Combination treatment of Qingfei Yihuo capsules in brochiectasis exacerbation: a multi-center randomized controlled clinical trial

    ObjectiveTo evaluate the combination efficacy with Qingfei Yihuo capsule and routine antibiotics as well as mucopolytic agents in the treatment of bronchiectasis acute exacerbation.MethodsThis was a prospective, multi-center, randomized controlled clinical study. The efficacy of Qingfei Yihuo capsule combine with routine antibiotics and mucopolytic agents in the treatment of bronchiectasis acute exacerbation was compared according to the symptom control as well as exacerbation duration. Through randomization, patients received Qingfei Yihuo capsule or placebo combine with routine antibiotics and mucopolytic agents treatment for 10 days. Symptom score of cough, sputum, short of breath pre- and post-treatment as well as the symptom score in daily card were compared between the two groups. The spirometry and St. George respiratory questionnaire (SGRQ) before and after treatment were compared.ResultsThis study was conducted from June 2017 to August 2018. One hundred and ninety patients from 7 centers in 6 hospitals with bronchiectasis acute exacerbation were enrolled in the study. There was statistically improvement of symptom score (including the 9th and 10th treatment days) according to the daily card recording in Qingfei Yihuo capsule group compared to the placebo group, but no statistically significant difference was found in spirometry results or SGRQ.ConclusionQingfei Yihuo capsule has assistant effect on improving respiratory symptoms of bronchiectasis exacerbation.

    Release date:2019-07-19 02:21 Export PDF Favorites Scan
  • Formulate technical guidance for real-world studies of traditional Chinese medicine in China to promote the transformation of clinical research of Chinese patent medicine into decision evidence

    Traditional Chinese medicine (TCM) has a long history. In the process of fighting against diseases, TCM has formed a unique theoretical system and the way to think and diagnose. The holistic thinking, and the treatment according to syndrome differentiation are the most prominent characteristics of TCM, which matches with advanced medical concept and direction. The clinical efficacy has always been the basis for the advancement of TCM. However, issues such as the lagging behind of modern research on the evaluation of TCM curative effect, as well as lacking high-quality scientific research evidence, impede the development and promotion of the TCM toward the world. To address the above problems, recent progress in real-word study (RWS) has provided the opportunity for TCM researches, especially for the post-marketing evaluation of Chinese patent medicine (CPM). The formulation of this technical guidance for RWS of CPM is helpful to researchers in carrying out standardized, reasonable and scientific researches, to improve the quality of production and use of real-word evidence, and to promote the advancement of the TCM industry.

    Release date:2020-10-20 02:00 Export PDF Favorites Scan
  • Developing technical guidance for real-world data and studies to achieve better production and use of real-world evidence in China

    With the boom of information technology and data science, real-world evidence (RWE) which is produced using diverse real-world data (RWD) has become an important source for healthcare practice and policy decisions, such as regulatory and coverage decisions, guideline development, and disease management. The production of high-quality RWE requires not only complete, accurate and usable data, but also scientific and sound study designs and data analyses to enable the questions of interest to be reliably answered. In order to improve the quality of production and use of RWE, China REal world data and studies ALliance (ChinaREAL) has developed the first series of technical guidance for developing real-world data and subsequent studies. The efforts are ongoing which would ultimately inform better healthcare practice and policy decisions.

    Release date:2019-07-18 10:28 Export PDF Favorites Scan
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