中医药治疗胃癌临床随机对照试验的中国文献评价

评价中医药治疗胃癌临床随机对照试验(randomized controlled trials,RCTs)文献的质量。方法:根据Co-chrane中心指南,机检和手检相结合检索2002年1月-2006年12月国内生物医学期刊和会议论著发表的有关中医药治疗胃癌的RCTs文献,按照临床流行病学原理及CONSORT声明,收集所有文献的信息,进行描述性分析和一致性检验。结果:共纳入RCTs文献79篇。其中7篇列举了具体纳入标准,占8.86%;3篇有排除标准,占3.79%;17篇有明确的中医证候分类,占21.52%;59篇文献提及疗效评价标准,占74.68%;无1篇文献交代样本含量估算情况;5篇报告了随机分配方法,占6.33%;2篇有随机分配隐藏的简单描述,占2.53%;42篇有基线资料的具体描述,占53.16%;2篇运用了盲法,占2.57%;45篇有统计学方法描述,占56.96%;46篇记录了副性事件,占58.23%;4篇提及治疗后的病例随访,占5.06%。结论:中医药治疗胃癌的RCTs质量还不够高,有待进一步提高。主要表现为随机分组方法没有说明或应用错误,随机分配隐藏没有得到足够重视,盲法使用过低,诊断标准以及受试者的纳入排除标准未充分报告,中医证候分类亟需规范统一,组间基线资料统计不全,样本量低且没有具体的估算方法,疗效评价标准不够统一,忽视依从性、病例脱落、随访情况的分析和伦理规范。     

基于病证结合的中药复方临床拆方研究

目的:探讨基于病证结合的中药复方临床拆方疗效,以期进一步阐明复方作用机理与证的病理机制。方法:123例冠心病心绞痛病人随机分为血府逐瘀汤原方组、精制血府逐瘀组、药对配伍组、安慰剂组四组进行干预治疗。结果:(1)四组心绞痛疗效经秩和检验依次为血府逐瘀组,精制血府逐瘀组,药对组,安慰剂组(P<0.01);(2)四组血瘀气滞证证候疗效经秩和检验依次为血府逐瘀组,精制血府逐瘀组,药对组,安慰剂组(P<0.01);(3)四组治疗后血脂及氧化低密度脂蛋白变化均无显著性差异(P>0.05)。(4)炎症指标:血府逐瘀组、精制血府逐瘀组、药对组治疗后IL-6均降低,安慰剂组治疗后IL-6升高,经t检验有显著性差异(P<0.05)。四组间比较有显著性差异(P<0.05)。结论:(1)理法拆方可在一定范围内保持原方病证疗效,随着复方配伍的改变,复方功能靶向出现差异;(2)临床拆方研究对于明晰复方作用的物质基础,研究“证”病理机制,观察证—方、方—证的相互关系以及进一步加强中药复方的针对性,提高中医药临床疗效有着切实意义。     

医疗因素与根管治疗期间急症相关性的研究

目的对根管治疗期间急症(IAE)的相关因素进行临床评价.方法对3801例患者(共4062颗患牙)治疗的医疗因素进行临床评价,分别分析封药药物与医生技术水平等因素.结果IAE在牙髓病专家组无论封甲醛甲酚(FC)、樟脑酚(CP)还是氢氧化钙[Ca(OH)2]发生率均较研究生组低,其差异均有显著性(P＜0.05);IAE在封入CP者发生率最低(P＜0.05),而甲醛甲酚与Ca(OH)2之间差异无显著性(P＞0.05).结论IAE的发生与医生操作和封药药物有关,临床操作中应予以重视.     

糖尿病视网膜病变中大视杯发生率探讨

目的 研究糖尿病视网膜病变中大视杯的发生率,对结果进行分析,探讨其发生机制.方法 选择糖尿病视网膜病变患者104例208只眼,进行视盘眼底彩照,图像分析仪测定其C/D比值,根据分析结果进行分组,C/D≤0.3组和C/D≥0.6组.比较两组间的眼压和视网膜循环时间之间的差异.结果 糖尿病视网膜病变中C/D≤0.3的占51.92%;C/D≥0.6的占14.90%.C/D≤0.3组和C/D≥0.6组的眼压分别为(14.91±2.15)mmHg;(13.70±2.73)mmHg(P＞0.05)差异无统计学意义;C/D≥0.6组的视网膜循环时间为(2.69±1.58)S,较C/D≤0.3组(1.90+0.58)S明显延迟(P＜0.05),差异有统计学意义.结论 糖尿病视网膜病变中C/D比值大于0.6的比率显著高于一般人群.造成C/D比值增加的因素考虑以视网膜缺血为主,而非眼压增高所致,说明视网膜血液循环障碍对C/D比值的扩大有一定影响.     

无细胞百白破联合疫苗安全性和免疫原性研究

[目的]评价长春长生生物科技股份有限公司研制的吸附无细胞百白破联合疫苗的安全性和免疫原性。[方法]在江苏省连云港市赣榆县选择3~5月龄、未接种过百白破联合疫苗、无百日咳白喉破伤风疾病史的足月健康儿童进行临床研究,采用随机、双盲、同类疫苗平行对照设计,将观察对象按3︰2的比例随机分别接受观察疫苗和对照疫苗的接种。在观察期内对接种对象进行安全性观察,接种前后采集血清样本,进行免疫原性的观察。[结果]受试者全身中度发热反应发生率为1.62%（15/924）,没有出现全身严重及以上反应。未出现中度以上局部反应。免疫原性结果表明：受试者破伤风抗毒素阳转率为100.00%;白喉抗毒素阳转率为98.05%;抗百日咳毒素抗体阳转率为87.99%,抗丝状血凝素抗体阳转率为93.18%。[结论]该疫苗接种后具有低反应性和较好的免疫原性。     

Implementing a randomized clinical trial on a pediatric psychiatric inpatient unit at a children's hospital: the case of clonidine for post-traumatic stress

Randomized clinical trials (RCTs) of psychotropic medications are uncommon among child and adolescent populations, and even rarer on pediatric, psychiatric inpatient units. We mention some of these studies, and then discuss the advantages and challenges of conducting a RCT among youngsters on an inpatient psychiatric unit in a pediatric hospital, using as an example our ongoing study of clonidine for intrusive symptoms of post-traumatic stress. Our purpose is to alert potential investigators to the obstacles they may encounter while implementing a RCT, while also pointing the way to potential resources. Advantages of inpatient units for RCTs include easy access to patients, with the potential for careful monitoring of both patients’ clinical status and of medication administration. Challenges include the need for the psychiatric researcher to form liaison with other important areas within the hospital, such as the Institutional Review Board, the Pharmacy, and sometimes a General Clinical Research Center and a Clinical Research Program. The functions of these departments are discussed, and additional support for clinicians in hospital settings without these departments is described. Other issues include training clinical nurses to conduct research while making adequate provisions for their time to do so. Attitudes on a clinical psychiatric inpatient unit toward research also merit consideration. Furthermore, as with any study in a hospital setting, recruitment presents its own set of challenges. Finally, one must be cognizant of how clinical information flows between clinicians and researchers.     

膳食纤维改善老年便秘作用的研究

目的探索在老年人中开展增加膳食纤维摄入量改善便秘的方法,为在老年人群中广泛开展相关干预奠定基础。方法通过专科医院收集老年便秘患者,采用双盲随机对照试验,在试验组进行定量增加膳食纤维的干预,对照组食用安慰剂。应用SPSS11.5软件分析自身前后及组间便秘程度的改善。结果试验组自身前后的排便次数、排便状况、粪便性状均改变(P<0.01);试食后组间的排便次数、排便状况、粪便性状也均有统计学意义(P<0.01)。结论通过定量增加膳食纤维的摄入,可以达到改善老年人便秘的作用。     

The role of clinical drug trial methodology with respect to studies of new drugs. Clinical trials of timolol

The use of the Randomized Clinical Trial (RCT) to assess the safety and efficacy of a new drug or treatment can provide a clear evaluation of the relative benefits and risks of the new therapy as compared to the longer-established treatment methodology. In some cases, such as insulin, the benefits are immediately apparent; in other cases, such as photocoagulation for proliferative diabetic retinopathy, the consensus is not so easily obtained, and the clinical trial can supply the answer. Furthermore, the RCT provides the opportunity to identify adverse reactions, in particular those which present with a seemingly unrelated or unexpected set of symptoms. In conducting clinical trials of timolol, researchers must be alert for beta-adrenergic antagonist effects, such as were seen with practolol, and should be especially careful to note early, mild reactions which may be the forerunners of later, more severe or irreversible adverse effects.