护理干预对药物临床试验中受试者依从性的影响

目的探讨护理干预对药物临床试验中受试者依从性的影响。方法将92例符合药物I临床试验纳入标准的脑梗死患者随机分为干预组和对照组,每组46例。对照组按照f临床药物试验管理规范进行处置,而干预组在其基础上加以护理干预。在试验结束后,对两组受试者的遵医嘱行为进行调查,并分析受试者不依从的原因。结果干预组受试者的完全依从率和总遵医率均明显高于对照组,差异具有统计学意义（x^2=10．392,P〈0．01）;在不依从原因比较上,遗忘服药差异有统计学意义（x^2=5．566,P〈0．05）。结论护理干预可提高临床药物试验中受试者对治疗的依从性,从而保证了临床药物试验的质量。     

肿瘤药物临床试验受试者依从性研究护理

临床实验过程中,受试者的不依从或依从性差是导致治疗无效的常见原因,也是造成试验结果偏移的重要因素。受试者的依从性受多方面因素的影响(如社会人口学特征、知情同意不充分、药物不良反应等),针对这些因素提出相应的措施,以提高肿瘤药物临床试验受试者的依从性。     

药物临床试验中受试者脱落的原因分析及处理

目的分析药物临床试验中影响受试者脱落的主要因素，探讨降低受试者脱落率的管理方法。方法回顾性分析我院2002年10月至2006年12月期间的1181例药物临床试验病例资料，其中门诊病历789例，住院病历392例，对药物临床试验中受试者脱落原因进行分析。结果影响受试者脱落的主要因素有治疗环境、用药途径、不良反应、个人原因等。门诊受试者的脱落例数明显多于住院受试者，差异有统计学意义（P〈0．01）；无不良反应的受试者脱落例数明显多于有不良反应的受试者，差异有统计学意义（P〈0．01）；注射用药的受试者脱落例数多于口服用药受试者，差异有统计学意义（P〈0．01）；注射用药受试者脱落例数亦多于吸入用药受试者，差异有统计学意义（P〈0．01）；有个人原因的受试者脱落例数明显多于无个人原因的受试者，差异有统计学意义（P〈0．01）。1181例病例中由于受试者个人原因导致脱落的人数为62人，在各脱落原因中，以用药不便和受试者自认为缺乏疗效为主要的脱落原因。结论采用适当灵活多样的方式对受试者及家属进行系统教育，并及早发现、立即有效处理不良反应，对提高药物临床试验质量有重要意义。     

系统化护理联合微信平台护理在肿瘤药物临床试验受试者中的应用研究

目的 探讨系统化护理联合微信平台护理在肿瘤药物临床试验受试者中的应用效果。方法 2021 年 4 月至 2022 年 10 月于 我院参加肿瘤药物临床试验的 68 例受试者,按照入院时间随机分为对照组和观察组。对照组提供研究医生管理和常规护理, 观察组则在医生管理和常规护理的基础上进行系统护理干预联合微信平台延伸护理。比较两组护理后服药依从率,药物不良反 应,生活质量和疼痛程度。结果 观察组服药依从良好率较对照组高（P<0.05）。观察组用药后不良反应发生率低于对照组（P<0.05）。 观察组 NRS 评分较对照组低（P<0.05）。观察组肿瘤病人生活质量评分较对照组高（P<0.05）。结论 肿瘤药物临床试验受试者 采用系统化护理联合微信平台护理,能够提高服药依从率,减少不良反应,提高生活质量,减轻疼痛程度。     

药物临床试验脱落病例原因分析及策略

目的探讨药物临床试验受试者脱落的原因及策略。方法对2008～2009年度治疗急性细菌性呼吸道或泌尿道感染完成的药物临床试验项目中脱落的12例病例进行原因分析。结果患者个体因素是造成脱落的主要因素,药物因素、环境因素、研究者因素等也是造成脱落的重要因素。结论加强对受试者个人因素及环境因素的良好评价,依从性教育,建立良好的医患关系,正确对待药物不良反应,加强研究人员的培训等,可降低受试者脱落比例,从而节约时间、经费,缩小试验规模。     

抗肿瘤药临床试验受试者依从性影响因素及措施

通过对受试者进行深入访谈,总结出受试者依从性的影响因素:受试者的个体差异、受教育的程度及经济状况,知情同意不充分等因素.并针对这些因素提出相应的措施,提高抗肿瘤药物临床试验受试者的依从性.     

强化健康教育对肿瘤患者化疗药物治疗依从性的影响

目的探讨强化健康教育对肿瘤患者化疗药物治疗依从性的影响。方法将106例初次接受化疗药物治疗的消化道肿瘤患者随机分为两组各53例，实验组实施强化健康教育，对照组开展常规健康教育。于健康教育后比较两组患者的治疗依从性、疗程完成情况、对不良反应认知及主动应对率。结果健康教育末实验组对治疗的依从率、化疗周期完成率、不良反应认知及主动应对率均显著高于对照组（P〈0．05或0．01）。结论强化健康教育能显著提高肿瘤患者接受化疗药物治疗的依从性，顺利完成化疗方案，从而提高患者的生活质量和自我防护能力。     

慢性非特异性腰痛患者居家运动治疗的依从性和影响因素分析

目的：调查慢性非特异性腰痛患者居家运动治疗依从性的现状,分析影响依从性的因素,为预测患者居家运动治疗的依从性及采取针对性措施提高依从性提供依据。方法：对2021年2—12月在北京大学第三医院康复科接受慢性非特异性腰痛运动治疗指导6周后的患者进行电话随访,通过自编问卷收集其社会人口学资料和依从性影响因素。按依从性好否进行分组,采用χ2检验、非参数检验、多因素Logistic回归模型、结构方程模型分析慢性非特异性腰痛患者居家运动治疗依从性的影响因素。结果：依从性现状结果显示：参与本研究的202例患者的平均年龄为（37.52±13.32）岁,男77例（38.1%）,女125(61.9%)例,依从好的患者为73例（35.8%）,依从不好的患者有129例（63.2%）;依从性影响因素的多因素分析结果显示：调整运动处方、记录运动习惯、设立分阶段目标频率、运动习惯、指导满意程度、职业状态、症状缓解程度是影响患者依从性的独立影响因素。结构方程模型能很好反映影响因素与运动依从状态的关系,是否调整运动处方、记录运动习惯、设立分阶段目标频率、运动习惯、对运动指导的满意程度、职业状态、症状缓解程度对依从状态产...     

影响药物临床试验进度原因浅析及对策

目的通过对我院临床药物试验进度的因素进行分析,探讨影响临床试验进度的相关因素并提出相应对策。方法选择2011年10月~2014年2月在我院参加下丘脑垂体性闭经新药随机、平行阳性药物对照试验的122例受试者进行调查分析。结果试验结局:受试者筛选失败占54.9%,脱落占15.6%;受试者筛选失败的原因分析:不接受试验方案占21.2%,实验室结果不符合入组条件占42.4%,家庭因素占18.2%。结论试验方案因素、受试者个人因素及研究者因素是影响药物临床试验进度的三个重要因素。认为应严格执行试验方案及对各个环节采取相应对策,以保证药物临床试验进度。     

2型糖尿病患者口服降糖药物依从性研究

目的：探讨2型糖尿病住院和门诊患者口服降糖药物的依从性及其相关因素。方法：回顾性分析1998年7月至2003年7月2型糖尿病住院患者258例和门诊随访患者137例的降糖药物依从性及其相关因素；调查降糖药物的使用情况和药物副作用的发生率，观察药物依从者和不依从者的血糖水平变化。结果：2型糖尿病住院病人出院后53．1％的病人来院门诊随访，住院期间药物依从率为68．6％，出院时出院带药的依从率为81．8％，门诊随访期间药物依从率为40．9％，药物不依从的原因包括：药物副作用、血糖控制不佳、经济原因等，门诊随访过程中，磺脲类的副作用明显增加，药物依从者血糖控制佳，而不依从者血糖控制不佳。结论：出院后对出院带药的依从性最佳，住院期间的药物依从性次之，门诊随访期间的药物依从性最差。     

Clinical trials: deliberations on their essence and value

RATIONALE, AIM & OBJECTIVES: In the context of the evidence-based medicine (EBM) movement, the clinical trial has come to be hailed as the ultimate source of medical knowledge, and especially of clinical pharmacology. By subjecting the premises of this procedure to a thorough analysis, the author hopes to achieve a sound rating of its epistemological significance in the context of medical research. METHOD: Current claims on the basic importance of the evidence provided by standardized clinical trials are confronted with conflicting observations concerning their current application in medical practice. The stereotyped trials of present research in multiple sclerosis serve as an example to illustrate this point. RESULTS: Traditional assumptions concerning the validity of standardized clinical trials are based on an illusion of absolute objectivity and reliability. Apart from being subject to tough publish (conveniently)-or-perish and commercial influences, the results of clinical trials, especially drug trials, are of limited informative value in diverse respects, such as (i) clinical trials do not identify every possible drug reaction for every instance of a disease; (ii) their results never allow the prediction of the efficacy of a specific drug in any given individual; (iii) clinical trials have no inherent potential to provide concrete insights into the nature and cause(s) of a definite morbid condition; and (iv) extensions of clinical drug trials to ever-larger study groups indicate serious problems in basic theoretical respects. CONCLUSION: A clinical trial cannot indicate a certain prevention or cure for any particular instance of a disease, and the correctness of its individual predictions is always only contingent. This can be explained by the fact that the correspondence between the nature of each of all pathological conditions presented by the different members of a clinical trial population and by the individual patients being treated according to the results of the trial is never complete.     

Stents: material,surface texture and design,in theory and practice

Intravascular stenting has become standard practice in cardiology and interventional radiology. As part of their daily routine, interventional therapists have to choose from more than 50 different coronary stents for the optimal treatment of patients. Striking advances in biomedical engineering have triggered the production of numerous new and improved stent models, whose theoretical benefits have not yet been confirmed by large-scale clinical trials. Selecting appropriate stents for individual patients is frequently subject to the personal and, therefore, subjective experience of the interventional therapist. This paper reviews different stent materials and designs used in current trials and clinical practice. The theoretical benefits of individual parameters are discussed and correlated with up-to-date clinical results, particularly with a view to considering their favourable impact on intervention outcomes.     

Drug cost avoidance resulting from cancer clinical trials

The purpose of the study was to determine if economic benefits result when cancer clinical trial patients receive sponsor-provided drug, thereby avoiding standard care drug costs for which institutions are financially responsible. All open, closed and terminated oncology trial protocols and drug dispensing data from 1992–2007 were reviewed for the lung, hematology, neurology, genitourinary and gynecology tumor groups at the Tom Baker Cancer Centre. Actual and projected, potential drug cost avoidance per patient and per drug from the trials was determined. Forty-two percent of the 101 reviewed studies offered drug cost avoidance. Drug specific cost avoidance ranged from $11.74 to $249,731.70 per patient, while potential drug specific cost avoidance ranged from $14.14 to $286,650.70 per patient. Actual drug cost avoidances, according to tumor group, were calculated showing a median range of $1377.00 to $23,751.00 per patient between tumor groups. The median range for potential drug cost avoidance was substantially higher, from $9868.00 to $46,640.00 per patient.Economic benefits result for the institution when patients participating in clinical trials receive drug provided by an external source. Drug cost avoidance varies due to type and cost of standard of care drug used and due to the design of individual trials. The existence of drug cost avoidance is an additional benefit that clinical trials can bring to an institution (in our case, Alberta Health Services).     

Using disease progression models as a tool to detect drug effect

Generally, information required for approval of new drugs is dichotomous in that the drug is either efficacious and safe or not. Consequently, the purpose of most confirmatory clinical trials is to test the null hypothesis. The primary reasons for designing hypothesis testing trials are to provide the information required for approval using analyses techniques that are relatively straightforward and free of apparent assumptions. However, the information required for approval is very different from that used by prescribers for decision making. In the clinic, decisions must be made about dose adjustment for individual patients in the presence of additional therapies and co-morbidities. Choice of drug and dosing regimen is therefore a classical risk to benefit decision that is often poorly informed from the results of confirmatory trials. Therefore, providing answers to the more difficult question of how to use the drug in a clinical setting is essential.     

Phase I clinical trials in oncology: ethical issues

The scientific goal of phase I clinical trials in oncology is to determine and optimise the drug dose and schedule on the basis of the toxicity profile. These trials also respond to a need: they offer the chance of early access to a new therapy for cancer patients who are characterised by both the lack of a therapeutic option and a desire to fulfil personal ambitions. The therapeutic relationship in this context must reconcile unreasonable hopes and anxiety regarding death and follow the same rules as in other doctor-patient relationships, with the triple requirement being that it should be genuine, therapeutic and empathetic.     

Adaptive control with feedback strategies for suramin dosing.

Suramin, a drug used in the treatment of parasitic diseases, is currently being evaluated in clinical trials as an antineoplastic agent. The use of therapeutic drug monitoring and adaptive control with feedback in clinical trials of suramin was initially motivated by an association between acute neurologic toxicity and plasma suramin concentrations in excess of 350 micrograms/ml. We have prospectively examined the performance of both two- and three-compartment population pharmacokinetic models in controlling plasma suramin concentrations and have found that a three-compartment model best describes this drug. No correlation was found between the clearance of suramin and creatinine clearance, as had been previously hypothesized. The low systemic clearance of suramin and the number of parameters required to describe the three-compartment model suggest the need for a bayesian approach to the estimation of individual pharmacokinetics.     

The controlled single subject trial.

Randomized controlled trials in single subjects ('N of 1 RCT') are double-blind, multi crossover trials in which the effects of two or more treatments are compared within one individual. The aim is to provide a controlled assessment of the efficacy of a new drug in a specific patient. Suitable diseases for single subject trials are particularly those which significantly impair the quality of life and in which there are uncertain treatment effects. Appropriate drugs should have a prompt action, a minimum of carry-over effect, and no side-effects. The trial design is determined by the length, number, and order of successive treatment periods, the outcome measures, and the statistical requirements. Each of these elements may be altered and tailored to the clinical entity and drug(s) applied, thus, providing a large potential for design options.     

Bladder training: its role in evaluating the effect of an antispasticity drug on voiding in patients with neurogenic bladder.

Fourteen patients with spinal cord damage were treated with Ba-34647 (Lioresal, Ciba-Geigy), a new antispasticity drug. The treatment was initiated for excessive skeletal muscle spasticity and voiding difficulty. Seven of the patients had been wearing indwelling catheters and seven were catheter-free. The former were given trials at voiding after removal of catheters; the usual assistive methods common to most bladder training regimens were administered. Despite this, the trials were unsuccessful in reducing residual urine to acceptable levels. With addition of therapeutic doses of the drug without the training regimen, voiding trials were also unsuccessful excepting the response of one patient. The drug plus the training regimen was effective in reducing residual urine to acceptable levels in all patients. On discontinuing or decreasing the dosages of the drug, there was gradual but rapid build-up of residual urine despite the active training regimen. Restoration of effective dosage again led to satisfactory voiding function in all patients. The catheter-free group suffered from frequency, nocturia, and bed-wetting owing to excessive residual urine despite the employment of active training regimens. With addition of optimal dosages of Ba-34647, these problems were markedly reduced. They increased with drug discontinuation or dosage decrease and again improved upon restoration of effective doses. Bladder training, including active assistance to the expulsion of urine, is essential to the evaluation of antispasticity drugs for their effect on voiding.     

N of 1 randomized trials for investigating new drugs

Presently, in the process of new drug development, large sample parallel group randomized trials are often begun without the detailed knowledge of optimal dose, most responsive patient group, and optimal outcomes which would be desirable. We propose that randomized trials in individual subjects (N of 1 RCTs) could be used to elucidate these issues at an early stage of drug development. In appropriate conditions N of 1 RCTs can be used to define the rapidity with which a drug begins and ceases its clinical action, the likely range of the optimal drug dose, and the optimal outcomes on which subsequent trials should focus. N of 1 RCTs can also generate initial estimates of the proportion of patients who respond to a new agent and for determining sample size, inclusion criteria, and dosage regimen(s) for subsequent parallel group trials. We provide an example of 14 N of 1 RCTs of amitriptyline in fibrositis that illustrate the ways in which N of 1 RCTs can elucidate these issues. The multiple uses of N of 1 RCTs suggest that the method has immense potential for use in the early phases of drug development programs.     

Technologies for detecting genetic polymorphisms in pharmacogenomics.

BACKGROUND: Pharmacogenomics is an emerging scientific discipline examining the genetic basis for individual variations in response to therapeutics. METHODS AND RESULTS: Genetic polymorphisms are a major cause of individual differences in drug response. Metabolic phenotyping can be accomplished by administering a probe drug or substrate and measuring the metabolites and clinical outcomes. However, this approach tends to be labor intensive and requires repeated sample collection from the individual being tested. Alternatively, genotyping allows determination of individual DNA sequence differences for a particular trait. Commonly used genotyping methods include gel electrophoresis-based techniques, such as polymerase chain reaction (PCR) coupled with restriction fragment length polymorphism analysis, multiplex PCR, and allele-specific amplification. Fluorescent dye-based high-throughput genotyping procedures are increasing in popularity, including oligonucleotide ligation assay, direct heterozygote sequencing, and TaqMan (Perkin Elmer, Foster City, CA) allelic discrimination. High-density chip array and mass spectrometry technologies are the newest advances in the genotyping field, but their wide application is yet to be developed. Novel mutations/polymorphisms also can be identified by conformation-based mutation screening and direct high-throughput heterozygote sequencing. CONCLUSIONS: Rapid and accurate detection of genetic polymorphisms has great potential for application to drug development, animal toxicity studies, improvement of human clinical trials, and postmarket monitoring surveillance for drug efficacy and toxicity.