氯沙坦合用氢氯噻嗪治疗老年高血压的临床研究

目的探讨氯沙坦合用氢氯噻嗪治疗老年高血压的疗效及其副作用。方法对68例老年高血压患者应用氯沙坦(科素亚)50 mg每日1次;同时合用氢氯噻嗪(双氢克尿塞)12.5 mg,每日1次,均晨顿服,2周后降压疗效不满意,氯沙坦加至100 mg,每日1次,疗程共12周。观察治疗前后随测血压、血糖、血脂、血钾、血尿酸和肝肾功能。结果氯沙坦合用氢氯噻嗪降压总有效率达89.7%,疗效显著,无明显副作用。结论氯沙坦合用氢氯噻嗪治疗老年高血压安全、有效。     

中老年人餐后高甘油三酯血症的临床干预

目的了解噻唑烷二酮类药物马来酸罗格列酮对餐后高甘油三酯(TG)血症中老年患者的疗效。方法采用改良脂肪餐负荷试验,以餐后4 h血清TG水平(TG 4 h)>2 mmol/L确定为餐后高TG血症患者39例,随机分为非诺贝特组12例(口服微粒化非诺贝特200 mg,每晚1次顿服,共8周),罗格列酮组27例(口服马来酸罗格列酮4 mg,每天1次晨服,共8周),两组于治疗前、治疗后4周和8周进行脂肪餐负荷试验,同时测定空腹血糖(FPG)和空腹胰岛素(FIns),以胰岛素敏感指数(ISI)作为胰岛素敏感性判断指标,进行对比分析。结果在不同时段两组内脂肪餐负荷试验前后比较,TG4h水平较同组餐前空腹TG水平比较升高(P<0.05),而脂肪餐后HDL-C水平较同组餐前空腹HDL-C水平明显下降(P<0.05),TC、LDL-C均未见明显变化;非诺贝特组治疗8周后,空腹TG、TG4h均呈明显下降(P<0.05),HDL-C、餐后4h HDL-C呈明显升高(P<0.05);罗格列酮组治疗8周后,空腹TG、TG4h、ISI绝对值均呈明显下降(P<0.05),HDL-C、餐后4hHDL-C呈明显升高(P<0.05)。结论短期应用马来酸罗格列酮不仅可以改善胰岛素敏感性,还可以有效地降低餐后高TG血症患者的餐后TG水平,升高HDL-C水平。     

69例妊娠并发肺结核患者的临床治疗

目的 探讨2H-R-E/10H-R及2H-Z-E/10H-R抗结核治疗方案对妊娠并发肺结核患者的有效性、耐受性及对新生儿先天性畸形的影响。方法 纳入1998年9月至2014年12月首都医科大学附属北京胸科医院诊治的妊娠3个月内的初治肺结核患者79例,自妊娠3个月后开始抗结核药物治疗,采用数字表法随机将患者分为A组(40例,予2H-R-E/10H-R方案治疗)和B组(39例,予2H-Z-E/10H-R方案治疗),治疗过程中退组10例,最终A组35例,B组34例;通过胸部CT扫描表现评价治疗第2、12个月末时两组患者的治疗效果,观察治疗过程中药物不良反应,并随访观察两组患者新生儿发生先天性畸形的情况。采用SPSS 14.0软件进行数据的统计学处理,计数资料采用χ ²检验,以P<0.05为差异有统计学意义。 结果 69例患者完成治疗疗程,A、B两组患者治疗至2个月末和12个月末的有效率分别为97.1%(34/35)和94.1%(32/34),无效率分别为2.9%(1/35)和5.9%(2/34),差异均无统计学意义(Fisher确切概率法,P值均=0.614)。治疗至12个月末时A、B组患者药物不良反应发生率分别为14.3%(5/35)、32.4%(11/34),差异无统计学意义(χ ²=3.16,P=0.075]。69例患者从妊娠3个月至抗结核药物治疗12个月,未见病情进展;新生儿产后随访5个月,均未发生畸形和结核感染。 结论 2H-R-E/10H-R及2H-Z-E/10H-R抗结核方案治疗妊娠并发肺结核疗效确切,且无差异,患者可耐受,无新生儿先天畸形发生,均可临床应用。     

大肠憩室粪石嵌顿内镜下松解治疗的临床意义

目的　评价大肠憩室粪石嵌顿内镜下松解治疗的临床意义。方法　收集2018年1月—2020年9月汕头市中心医院内镜中心大肠镜检查发现的肠憩室粪石嵌顿并行内镜下松解治疗的患者作为观察组85例（后有2例因“急性阑尾炎”剔除出观察组）,未处理患者作为对照组43例。以腹部症状缓解情况作为指标判断治疗是否有效。结果　观察组83例大肠憩室伴粪石嵌顿患者,一次性松解成功的占42.2%（35/83）,综合措施松解成功的占首次松解失败的25.0%（12/48）,松解成功率为56.6%（47/83）。观察组未见与内镜治疗相关的并发症。观察组松解治疗后1周电话随访,成功松解的45例患者中阳性症状者33例,有效占90.9%（30/33）,松解失败的38例患者中阳性症状者29例,有效占55.2%（16/29）。观察组总体的治疗有效率较对照组高［55.4%（46/83）比7.0%（3/43）］,差异有统计学意义（χ2=23.354,P<0.01）。松解成功组、松解失败组、对照组比较,3组治疗有效率差异有统计学意义［65.2%（30/46）、29.7%（11/37）、7.0%（3/43）,χ2=33.792,P<0.01］;两两比较,松解成功组有效率最高,松解失败组有效率居中,对照组有效率最低,差异有统计学意义（P<0.017）。结论　肠憩室粪石嵌顿内镜下松解治疗相对简单,能缓解和减少患者相关症状,避免并发症和漏诊误诊,疗效确切。肠镜诊疗过程中当发现肠憩室伴粪石嵌顿时使用一些方法对嵌顿的粪石进行松解有较大的实际意义。     

Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing

ObjectivesThis study sought to test safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).BackgroundTranscaval access enables delivery of large-caliber devices to the aorta in patients ineligible for transfemoral arterial access. Closure of aortocaval fistulae using off-label nitinol cardiac occluders has been shown to be safe, but persistent aortocaval fistulae at exit from the catheterization lab and bleeding complications were common in a prospective study.MethodsPreclinical testing of the TCD was performed in 24 Yorkshire swine, including 10 under good laboratory practice conditions. Subsequently, subjects undergoing transcatheter aortic valve replacement for symptomatic severe aortic stenosis, ineligible for transfemoral arterial access, were enrolled in a U.S. Food and Drug Administration–approved early feasibility study of the TCD (Transmural Systems, Andover, Massachusetts). Independently adjudicated endpoints included technical, device, and procedural success, incorporating in-hospital and 30-day clinical and imaging follow-up.ResultsTranscaval access and closure in swine confirmed that at 30 days, TCDs were almost entirely endothelialized. Subsequently, 12 subjects were enrolled in the early feasibility study. Transcaval access, transcatheter aortic valve replacement, and aortocaval fistula closure was successful in all 12 subjects. The primary endpoint of technical success was met in 100% of subjects. Complete closure of the transcaval access tract was achieved in 75% of subjects at exit from the catheterization lab and in 100% of subjects at 30 days. There were zero modified Valve Academic Research Consortium-2 major vascular complications and zero Valve Academic Research Consortium-2 life-threatening or major bleeding complications related to transcaval access or the TCD.ConclusionsThe TCD achieved complete closure of the transcaval access tract in most subjects at exit from the catheterization lab and essentially eliminated transcaval-related bleeding. Dedicated devices for transcaval access and closure could enable more widespread adoption of transcaval techniques without fear of bleeding complications. (Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement; NCT03432494).     

一期病灶清除关节置换治疗活动性髋关节结核的临床研究

目的: 探讨活动性髋关节结核行一期病灶清除关节置换的治疗方案及临床疗效。方法: 回顾性分析2015年6月至2018年6月河北省胸科医院收治的25例行一期病灶清除全髋关节置换手术治疗的活动性髋关节结核患者的临床资料。所有患者术前联合应用抗结核药物治疗,用药时间为4~8周,平均(6.20±1.22)周;所有患者术中均彻底清除髋关节死骨、脓肿、病变滑膜及肉芽组织,骨缺损区植骨选用截除的自体股骨正常骨质,选用非骨水泥生物型假体。术后病理检查均证实为结核,联合应用抗结核药物治疗18个月以上,随访观察切口及病灶愈合、血红细胞沉降率(ESR)及C反应蛋白(CRP)指标变化、假体位置、髋关节功能改善及并发症发生情况。结果: 所有患者术后随访时间为24~60个月,平均为(35.62±8.64)个月。术前1d、术后1个月和末次随访时,患者ESR分别为(41.64±12.10)mm/1h、(23.36±5.87)mm/1h和(9.88±2.01)mm/1h;CRP分别为(43.60±10.35)mg/L、(14.00±3.16)mg/L和(3.80±1.19)mg/L;Harris髋关节疼痛评分分别为(18.40±4.73)分、(41.68±3.15)分和(43.52±1.33)分;Harris髋关节评分总分分别为(33.00±6.01)分、(92.52±3.64)分和(97.36±1.80)分。术后1个月和末次随访时的ESR、CRP水平均明显低于术前1d(F=103.008,P<0.001;F=270.299,P<0.001),术后1个月和末次随访时Harris髋关节疼痛评分和总分均较术前1d明显改善(F=432.654,P<0.001;F=1832.393,P<0.001)。所有患者切口均一期愈合,术后未发生血栓形成、肺栓塞、关节脱位及假体周围骨折等并发症。1例患者术后6周出现刀口中下段破溃,形成窦道,经搔刮换药2个月后愈合,其余患者治疗后均无积液和积脓,病灶顺利愈合。随访期内关节假体位置良好,未见病灶复发患者。结论: 在规范有效的抗结核药物治疗基础上施行一期病灶清除全髋关节置换术治疗活动性髋关节结核能明显减轻患者髋关节疼痛,改善髋关节功能,临床疗效良好。     

持之以恒重视慢性乙型病毒性肝炎临床研究

2012年是慢性乙型病毒性肝炎(CHB)研究领域不平凡的一年.在国家"艾滋病和病毒性肝炎等重大传染病防治"科技重大专项的推动下,科研人员更重视临床研究,并意识到,临床研究须循序渐进,持之以恒,将研究重点投入到建立和管理中国人的乙型肝炎研究队列和相关的临床标本库,而不是一味追求发表所谓的SCI论文,应通过扎实工作来逐步提高疗效,通过个体化治疗策略减少肝脏疾病的进展,从而达到降低肝脏疾病相关死亡率的目标.     

SHARP研究的潜在临床意义及存在的不足

<正>他汀类药物治疗降低低密度脂蛋白胆固醇(LDL-C),可降低无肾病患者的心肌梗死(MI)、缺血性卒中危险,并减少其冠状动脉血运重建的需要。对于eGFR高于60 ml.min-1.1.73 m-2的的慢性肾病患者来说,心血管病的病因常常由于动脉粥样硬化所致,他汀类药物治疗带来的益处独立于肾功能。但当eGFR低于30 ml.min-1.1.73 m-2时,肾病患者合并其他的心血管病理生理变化,例如血管硬化、钙化,心脏     

Clinical studies involving probiotics

Researchers from a diverse array of scientific disciplines have focused and continue to focus on opportunities and areas for responsible clinical research involving the possible beneficial health effects of “probiotics.” Investigators and researchers should be aware that not all clinical research involving probiotics reasonably falls within the requirements of the “investigational new drug” (IND) rubric administered and enforced by the US Food and Drug Administration. In determining whether an IND application is required before a clinical study may lawfully commence, investigators and researchers as well as institutional review boards should consider the regulatory classification, e.g., “drug,” “new drug,” “food,” “food additive,” “dietary supplement,” etc. that applies to the substance under investigation. A potential probiotic product can fall along a continuum of regulatory classifications, each having implications on the nature and degree of regulatory requirements for clinical research and, ultimately, for claim substantiation and market access.