ObjectivesTo analyze the research status and hot spots of hypertension-related clinical trials in special Chinese population registered on the Chinese Clinical Trial Registry (ChiCTR), so as to provide a basis for the development of hypertension-related research in special population in China.MethodsThe ChiCTR was searched online (up to August 31st, 2019, no limitation in the status of trial registration), all clinical trials on hypertension in special population were collected, and the general characteristics, researched diseases, research types, intervention measures and main outcomes of the trials were analyzed.ResultsA total of 64 hypertension-related clinical trials in special population registered in the ChiCTR were included, including 41 (64.1%) trials registered in last 3 years. The registration status of 46 (71.9%) trials was pre-registration. The registered authors were mainly from colleges and universities or medical institutions (n = 61, 95.3%), of which 60.9% were registered in Beijing, Shanghai, Guangdong, Zhejiang, Jiangsu and Hebei. The researched diseases mainly included elderly hypertension and hypertensive stroke, accounting for 50% of the total. Additionally, 37 (57.8%) clinical trials were intervention studies, of which 21 (56.7%) were drug-based intervention studies. Blood pressure, blood glucose, cardiovascular and cerebrovascular events, blood lipid, cranial MRI and Glasgow Coma Scale were the commonly used outcomes, accounting for 58.5% of the total outcomes. Most blood pressure measurements did not indicate the measurement method (n = 22, 64.7%).ConclusionsThe quantity of hypertension-related clinical trials in special population registered on the ChiCTR is increasing, however, there exists regional imbalance. The drug intervention-related clinical trials of elderly hypertension have become a research hot spot. However, blood pressure measurement method is not indicated in most trials, and some researchers do not register in time. Therefore, it is suggested that researchers should further strengthen the awareness of carrying out high-quality clinical trials.
ObjectivesTo analyze the metrological characteristics of hypertension-related clinical trials registered on Chinese Clinical Trial Registry (ChiCTR), and discuss the characteristics and developmental trends of hypertension clinical trials registration in China.MethodsChiCTR were searched to collect hypertension-related clinical trials from inception to March 25th, 2018. The characteristics of registered trials were analyzed.ResultsA total of 135 registered trials were included, in which the trials from Beijing, Guangdong, Jiangsu, Chongqing and Shanghai accounted for 55.5%. 115 trials were pre-registered. The top three funding sources were from finance (32, 23.7%), self-financing (25, 18.5%) and hospital (20, 14.8%), respectively. Of all 79 randomized controlled trials, 55 were blank/missing in the entry of blinding method.ConclusionsThe number of hypertension-related clinical trials in ChiCTR tends to increase, however there are large regional disparities and incomplete, non-standardiazed information in the registration of clinical trials. The relevant departments should increase the publicity on the registration of clinical trials, raise the awareness of registration, and promote the development and registration of high quality clinical trials.
目的 总结 14 例原位心脏移植的治疗经验。 方法 回顾性分析 2006 年 1 月至 2015 年 9 月我院行原位心脏移植术终末期心脏病患者的临床资料，其中男 11 例、女 3 例，年龄 22～62（46.7±10.1）岁。4 例使用抗 Tac 单克隆抗体诱导治疗，10 例使用巴利昔单克隆抗体诱导治疗。采用 4℃ 组氨酸-色氨酸-酮戊二酸（HTK）液保护供心。2 例采用经典式原位心脏移植，12 例采用双腔静脉法行心脏移植。术后采用环孢素或他克莫司+吗替麦考酚酯+激素三联抗排斥方案。 结果 术后早期 1 例因多器官功能衰竭合并严重感染死亡。早期并发症有：败血症 1 例，硬膜外血肿 1 例，急性肾功能不全 1 例，移植物右心功能不全 2 例，低心排血量并需要体外膜肺氧合支持 1 例。术后长期随访：截至 2016 年 6 月，2 例失访，1 例于术后 30 个月因自行停服抗排斥药物死于急性排斥，1 例于术后 36 个月死于肺癌。余 9 例存活 9～121 个月，生活质量良好。 结论 心脏移植是治疗终末期心脏病的有效方法，熟练的手术技巧、合理的免疫抑制治疗，围术期管理经验、密切监测和治疗感染和排斥及患者依从性均影响着心脏移植的效果。