目的 探讨基于知信行干预理论(KAP)的药学服务模式在系统性红斑狼疮患者(SLE)中的实施效果,为药师开展SLE患者治疗管理服务提供参考。
方法 纳入SLE患者350例,通过问卷调查和临床检验指标,分析患者KAP与风险感知、疾病活动及脏器损伤的相关性。将患者随机分为干预组和对照组,对干预组患者实施9个月的基于KAP干预理论的药学服务。分析2组患者干预前及干预不同时间后的KAP水平,评价2组患者的疾病控制效果和脏器损伤指数。
结果 排除资料不全患者26例,324例SLE患者的KAP水平与风险感知正相关,与疾病活动、脏器损伤存在负相关。实施为期9个月的干预后,最终纳入分析302例,其中干预组148例(排除14例),对照组154例(排除8例)。在干预3,6,9个月后,干预组患者KAP各维度在预设时间点的得分均高于对照组(
Objective To discuss the implementation effect of the pharmaceutical care model based on the knowledge-attitude-practice (KAP) intervention theory among systemic lupus erythematosus (SLE) patients,and to provide a reference for developing therapy management services for SLE patients.
Methods A total of 350 patients were included in the study.The correlations of their KAP levels with risk perception, disease activity, and organ damage were analyzed through the questionnaire survey and clinical test indexes.The patients were randomly divided into the intervention group and control group.The patient in the intervention group was given pharmaceutical care based on the KAP intervention theory until discontinued or followed up for nine months.The KAP levels before the intervention and those at pre-designed time points after the intervention were analyzed.Then, SLE disease activity and SLE-related organ damage were evaluated.
Results Excluding 26 patients with incomplete data, the KAP levels were positively correlated with risk perception and negatively correlated with disease activity and organ damage in 324 SLE patients.After nine months of intervention, 302 patients were included in the analysis, including 148 patients (14 excluded) in the intervention group and 154 patients (8 excluded) in the control group.After 3, 6, and 9 months of the intervention, the scores of each KAP dimension at pre-designed time points in the intervention group were all significantly higher than those of the control group(
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1.1.1 入组标准 收集2019年1—12月在我院风湿免疫科门诊就诊并自愿参与研究的患者,共350例,试验开始前获得患者的知情同意。纳入标准:①患者疾病诊断明确,符合 1997年美国风湿病协会修订的SLE分类标准[15];②年龄为18~70周岁,具备正常的理解和表达能力,沟通交流无障碍;③病程>1个月,需要接受药物治疗者;④愿意接受药学服务及定期随访。排除标准:①合并原发性心脑血管、肝、肾、造血系统及恶性肿瘤疾病患者;②病情危重,预计无法完成此研究者;③认知缺陷;④已经参与其他研究的患者。入组患者的识别与流失见
1.1.2 数据采集 试验开始前收集患者的一般资料并建立患者健康档案。排除资料不全患者26例,共纳入患者324例,通过量表评分法统计患者KAP、风险感知、疾病活动及脏器损伤数据,并对基线数据进行统计分析。
①KAP。包括知识、信念和行为3个维度。a.知识维度:采用风湿免疫科疾病与用药知识问卷[16]考察患者的知识维度,共15个条目,总分-15~15分。b.信念维度:采用汉化的患者服药信念特异性量表[17]来评估患者的服药信念,共10个条目,必要性维度与顾虑维度得分之差反映患者服药治疗的风险效益分析,范围是-20~+20,c.行为维度:采用中文版MMAS-8药物依从性量表[18]评价患者的服药依从性,包含了8个问题,总分为8分。
②风险感知。采用慢性病患者风险感知量表[19] 进行评估,包括经济风险、身体诊疗风险和社会心理风险3个维度,共12个条目,采用Likert-5级评分法,总分12~60分。
③疾病活动。采用系统性红斑狼疮疾病活动性指数-2000(SLEDAI-2K)[20]评估:根据近 10 d情况累计加分,≥15分为重度活动;10~14分为中度活动;5~9分为轻度活动;0~4 分为基本无活动。
④脏器损伤 。根据系统性狼疮国际临床协作组和美国风湿病学学会(SLICC/ACR)提出的SLE的损伤指数表(SDI)[21]进行评估。该指数采用积分方法对 12个脏器的损伤程度进行评价,总积分为47分。
1.2.1 相关性分析 对324例患者资料进行Pearson分析,评价患者基线数据中KAP水平与风险感知、疾病活动及脏器损伤的相关性,为药学服务内容的制定提供参考。
1.2.2 分组方法 由未参与干预研究和结果分析的药师采用随机数字表法将324例患者分为干预组和对照组(1:1),随机序列产生之后,按照入组时间顺序给受试者编号,再对应随机序列入组。由实施干预的药师对患者进行9个月的药学服务,干预过程为单盲,患者对分组不知情,但参与干预的药师对分组知情。最终由参与结果评估的药师完成数据统计及分析,该药师不实施药学干预并且对患者分组不知情。
1.2.3 干预措施 在SLE患者的诊疗过程中,对照组患者仅接受常规的用药说明。干预组患者除接受常规的用药说明外,还需接受药师提供的基于KAP干预理论的药学服务,包括知识获取(用药知识宣教、不良反应应对策略及减停药原则等)、信念产生(信念培养:增强对服药必要性的感知,减少对服药导致不良反应的顾虑,强化战胜疾病的信心;建立互相信任的药患关系;家庭支持及心理支持等)和行为形成(药物、饮食、运动及疾病自我管理等)干预,总计9个月,基于KAP干预理论的药学服务内容为:①知识获取。a.常用药物的基础知识(适应证、用量、服药时机、疗程等);b.可能出现的不良反应、监测要点及防治措施;c.漏服药物的补服方法及减停药规则;d.服用辅助药物的意义和疾病进展的后果。②信念产生。a.信念培养:定期复诊和遵医嘱服药对疾病预后的重要性,增强对服药必要性的感知,减少对服药导致不良反应的顾虑,强化战胜疾病的信心;b.药患关系:药师与患者建立相互信任的关系;c.家庭支持:家属用药教育及对疾病的正确认识;d.心理支持:正面案例分享及心理疏导。③行为形成。a.药物:服药依从性、不良反应的监测及处理;b.饮食:根据患者病情及身体状况提供针对性的饮食建议;c.运动:指导患者正确休息及适当运动;d.自我管理:建立用药档案并进行疾病指标的自我监测。9个月后,由参与结果评估的药师收集并整理2组患者的随访资料。
1.2.4 结局指标 ①KAP评分:分别于干预前、干预3,6,9个月后进行统计分析,记录在预设时间点,2组患者KAP各个维度的得分变化,分析各维度得分的时间效应和分组效应,并评估2组患者的得分是否具有统计学差异。②SLEDAI-2K、SDI及风险感知评分:分别于干预前及干预9个月进行统计分析,以SLEDAI-2K评分作为SLE活动度的度量标准,得分越高,表示疾病控制越差;以SDI评分对患者脏器的损伤程度进行评估,分数越高,提示预后越差;通过慢性病患者风险感知量表评价患者的风险感知水平,得分越高,说明患者越倾向于改变行为并进行疾病自我管理。③急性加重次数及不良反应发生率:分别于患者干预3,6,9个月后进行电话回访,统计患者在各次回访时间段内急性加重次数发生情况、与药物相关不良反应的发生情况,并计算发生率。
1.2.5 统计学方法 问卷缺失项>20%者不进入资料录入阶段。采用SPSS 30.0版统计软件进行统计分析,计量资料采用Shapiro-WilK检验进行正态性检验,正态分布资料以均数±标准差($\bar{x}±s$)表示,采用两独立样本
1.2.6 样本量计算 本研究中药学干预的主要结局指标为疾病控制情况,SLEDAI-2K评分可以反映SLE患者的病情活动。根据前期收集的20例患者干预结果的来计算样本量。干预组和对照组SLEDAI-2K评分分别为(5.03±3.83
排除资料不全患者26例,对324例患者资料进行Pearson分析,如
随访9个月。排除失访及资料不全患者,本研究最终纳入分析302例,其中干预组148例、对照组154例,样本流失率为6.8%。比较2组患者的基线资料,干预组和对照组患者在年龄、性别、病程、支付方式、文化程度、病情控制和用药种类等方面差异无统计学意义,具有可比性。见
分析2组患者干预前,干预3,6及9个月后KAP水平的变化情况。如
最初干预的3个月内,2组患者急性发作及药物不良反应的发生率均差异无统计学意义;干预6个月和9个月后,干预组在各个干预期内的急性发作发生率分别下降了18.92%和27.70%,药物不良反应的发生率分别下降了22.29%和31.75%,与对照组比较,均差异有统计学意义(均
SLE是一种由多种致病因素共同介导的自身免疫性疾病,在病情进展的过程中,多个脏器容易遭受损伤,所以脏器的损伤程度是影响预后的一个十分重要的因素。SLE损伤指数(SDI)是唯一国际公认的且已得到验证的SLE器官损伤评估标准[21,22],可以用来评价SLE患者的预后。SLE疾病活动指数可以全面地反映患者的疾病状态,优先选择SLE疾病活动指数(SLEDAI-2000)为评分标准,并结合临床医师的综合判断进行疾病活动度评估[20,23]。疾病风险感知是个体能否感知自身疾病风险时的态度、认识和主观判断,被认为是早期症状识别、寻求诊断、健康行为决策和疾病自我管理的一个重要影响因素[19,24]。因此,SLE患者的疾病活动、脏器损伤及风险感知等指标可以反应患者的疾病控制效果、预后情况及疾病自我管理状况,从而用来评价药学干预的实施效果。
KAP理论是用来解释个人知识和信念如何影响行为改变的最常用的模式,由英国人柯斯特于20世纪60年代提出。KAP模式在医疗护理多个领域得到应用,已证实了其可行性与有效性[25,26,27]。本研究基于KAP干预理论为SLE患者实施药学干预,干预组患者的急性发作及不良反应发生率较对照组降低,疾病控制、预后及自我管理情况也较对照组明显改善,说明该药学干预模式用于SLE患者管理是有效的。有研究显示SLE患者4年内总复发风险为60%[28],复发不仅是SLE患者常见的临床特点与诊疗难点,也是疾病活动度明显增加的标志,是导致器官损伤和不良预后的主要原因。一项队列研究显示达到疾病缓解和低疾病活动度均可降低SLE患者的新发损伤,与预后密切相关[29]。本研究结果显示,对SLE患者实施基于KAP干预理论的药学服务可有效改善患者预后及疾病控制效果。
目前,国内外针对 SLE 患者自我管理能力的干预研究仍处于起步阶段,研究较少。DRENKAND等 [30]调查发现,通过疾病自我管理能力干预能够提高患者生活质量和自我效能,并可在较少花费的基础上,改善 SLE 患者疾病结局,减少 SLE 患者医疗资源占用率。研究发现,对SLE 患者实施自我管理能力的干预,能够改善患者疲劳现状、疾病应对技巧、自我效能、疼痛、抑郁情绪以及疾病活动度[31]。目前我国针对 SLE 患者自我管理的研究主要为文献综述,干预研究较少。本研究通过KAP干预理论为SLE患者实施药学服务,从知识、信念和行为 3个维度增强了患者对疾病的自我管理能力,改善了疾病结局,也为其他慢病管理的开展提供了新思路。
本研究为单中心随机对照研究,覆盖面有限且非双盲研究。因为不可能对开展药学干预的药师实施盲法,但参与分组的药师不实施干预和结果分析,参与干预的药师不参与数据统计及结果分析,参与结果评估的药师对患者分组不知情。另外,本研究收集的样本量相对较少,干预时间较短,有待于扩大样本量,延长随访时间,进一步考察该药学干预模式对SLE患者疾病控制效果、预后及自我管理能力的长期影响。
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The heterogeneity of systemic lupus erythematosus (SLE), long recognised by clinicians, is now challenging the entire lupus community, from geneticists to clinical investigators. Although the outlook for patients with SLE has greatly improved, many unmet needs remain, chief of which is the development of safer and more efficacious therapies. To develop innovative therapies, a far better understanding of SLE pathogenesis as it relates to the array of clinical phenotypes is needed. Additionally, to efficiently achieve these goals, the lupus community needs to refine existing clinical research tools and better adapt them to overcome the obstacles created by the heterogeneity of manifestations. Here, we review progress towards the ultimate goal of safely reducing disease activity and preventing damage accrual and death. We discuss the new classification criteria from the European League Against Rheumatism and American College of Rheumatology, novel definitions of remission and low lupus disease activity, and new proposals for the histological classification of lupus nephritis. Recommendations for the treatment of SLE and novel approaches to drug development hold much promise to further enhance SLE outcomes.
Copyright © 2019 Elsevier Ltd. All rights reserved.
DOI:S0140-6736(19)30546-X
PMID:31180031
[本文引用:1]
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Our objective was to update the EULAR recommendations for the management of systemic lupus erythematosus (SLE), based on emerging new evidence. We performed a systematic literature review (01/2007-12/2017), followed by modified Delphi method, to form questions, elicit expert opinions and reach consensus. Treatment in SLE aims at remission or low disease activity and prevention of flares. Hydroxychloroquine is recommended in all patients with lupus, at a dose not exceeding 5 mg/kg real body weight. During chronic maintenance treatment, glucocorticoids (GC) should be minimised to less than 7.5 mg/day (prednisone equivalent) and, when possible, withdrawn. Appropriate initiation of immunomodulatory agents (methotrexate, azathioprine, mycophenolate) can expedite the tapering/discontinuation of GC. In persistently active or flaring extrarenal disease, add-on belimumab should be considered; rituximab (RTX) may be considered in organ-threatening, refractory disease. Updated specific recommendations are also provided for cutaneous, neuropsychiatric, haematological and renal disease. Patients with SLE should be assessed for their antiphospholipid antibody status, infectious and cardiovascular diseases risk profile and preventative strategies be tailored accordingly. The updated recommendations provide physicians and patients with updated consensus guidance on the management of SLE, combining evidence-base and expert-opinion.
© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.
DOI:10.1136/annrheumdis-2019-215089
PMID:30926722
[本文引用:1]
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To describe the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), a modification of SLEDAI to reflect persistent, active disease in those descriptors that had previously only considered new or recurrent occurrences, and to validate SLEDAI-2K against the original SLEDAI as a predictor for mortality and as a measure of global disease activity in the clinic.
All visits in our cohort of 960 patients were used to correlate SLEDAI-2K against the original SLEDAI, and the whole cohort was used to validate SLEDAI-2K as a predictor of mortality. A subgroup of 212 patients with SLE followed at the Lupus Clinic who had 5 regular visits, 3-6 months apart, in 1991-93 was also included. An uninvolved clinician evaluated each patient record and assigned a clinical activity level. The SLEDAI score was calculated from the database according to both the original and modified definitions.
SLEDAI-2K correlated highly (r = 0.97) with SLEDAI. Both methods for SLEDAI scoring predicted mortality equally (p = 0.0001), and described similarly the range of disease activity as recognized by the clinician.
SLEDAI-2K, which allows for persistent activity in rash, mucous membranes, alopecia, and proteinuria, is suitable for use in clinical trials and studies of prognosis in SLE.
PMID:11838846
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To identify predictors of low disease activity and clinical remission following belimumab treatment in SLE.
SLE patients who received belimumab 10 mg/kg (N = 563) in the BLISS-52 and BLISS-76 clinical trials were surveyed. The performance of baseline factors in predicting attainment of low disease activity (defined as Lupus Low Disease Activity State) or clinical remission [defined as clinical (c)SLEDAI-2K = 0] at week 52 from treatment initiation was evaluated using logistic regression. Organ damage was assessed using the SLICC/ACR Damage Index (SDI).
We demonstrated a negative impact of established organ damage on attainment of Lupus Low Disease Activity State [SDI > 0; odds ratio (OR): 0.44; 95% CI 0.22, 0.90; P = 0.024] and the primary Lupus Low Disease Activity State condition, i.e. SLEDAI-2K ⩽ 4 with no renal activity, pleurisy, pericarditis or fever (SDI > 1; OR: 0.46; 95% CI 0.27, 0.77; P = 0.004); cognitive impairment/psychosis was found to mainly account for the latter association. Baseline SDI scores > 1 predicted failure to attain cSLEDAI-2K = 0 (OR: 0.53; 95% CI 0.30, 0.94; P = 0.030), with cutaneous damage mainly driving this association. Anti-dsDNA positivity increased (OR: 1.82; 95% CI 1.08, 3.06; P = 0.025) and cardiovascular damage reduced (OR: 0.13; 95% CI 0.02, 0.97; P = 0.047) the probability of attaining cSLEDAI-2K = 0 along with a daily prednisone equivalent intake restricted to ⩽7.5 mg.
Belimumab might be expected to be more efficacious in inducing low disease activity and clinical remission in SLE patients with limited or no organ damage accrued prior to treatment initiation. Patients with positive anti-dsDNA titres might be more likely to achieve clinical remission along with limited or no CS use.
© The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology.
DOI:10.1093/rheumatology/kez191
PMID:31157891
[本文引用:1]
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An inception cohort of patients with systemic lupus erythematosus from 14 European centres was followed for up to 5 years in order to describe the current early disease course. At inclusion patients (n = 200, 89% female, mean age 35 years, 97% Caucasian, mean SLEDAI 12.2) fulfilled a mean of 6.5 ACR classification criteria. The most prevalent criteria were antinuclear Ab presence (97%) followed by anti-dsDNA Ab (74%), arthritis (69%), leukocytopenia (54%) and malar rash (53%), antiphospholipid Ab (48%) and anti-synovial membrane Ab (21.6%). Clinical signs of lupus nephritis (LN) were present in 39% with biopsy-confirmed LN seen in 25%. Frequent additional findings were hypocomplementaemia (54%), anti-SSA Ab (49%), alopecia (26%) and Raynaud's phenomenon (31%). There were few regional differences in disease presentation and management. One and 5-year survival rates were 99% and 97% respectively. During the mean follow-up of 4.1 years 25% entered a state of early disease quiescence by global physician assessment, but the overall risk of subsequent flare was 60%. Maximum SLEDAI scores decreased over time, but 45% of patients accrued damage (SDI >or=1) for which baseline presence of proteinuria and persistent disease activity were independent predictors. The results indicate minor differences in SLE presentation and treatment within various regions of Europe and a high diagnostic reliance on anti-dsDNA Ab. Despite early reductions in disease activity and improved mortality, the risk for disease flare and damage development is, however, still substantial, especially in patients not entering an early remission.
DOI:10.1177/0961203310366572
PMID:20375124
[本文引用:1]
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For people living with systemic lupus erythematosus, the disease's potential variety and severity of manifestations and unpredictable course present challenges and repercussions in all arenas of life.
A quasi-experimental study was conducted to examine the effects of a systemic lupus erythematosus self-management course for Korean patients on fatigue, coping skills, self-efficacy, depression, pain and disease activity.
In a two-group pre- and post-test design, a total of 41 participants were assigned to the experimental group (21 participants) and to the control group (20 participants). The experimental group received six weekly 2-hour sessions for groups of 10-15 literate adults of all ages, while the control group did not receive any intervention. Outcome measures included fatigue, coping skills, self-efficacy, depression, pain and disease activity.
Patients who participated in the self-management course showed significant improvement in fatigue (P = 0.049), coping skills (P = 0.007), self-efficacy (P = 0.001), and depression (P = 0.025). There were no significant changes in pain and disease activity after the intervention.
The systemic lupus erythematosus self-management course had effects in reducing fatigue and depression and improving coping skills and self-efficacy. This course is potentially a good nursing intervention that can be offered in community settings.
PMID:12752868
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