对接受姑息治疗的成年人进行医学辅助水化。
Medically assisted hydration for adults receiving palliative care.
机构信息
Queensland Health, Brisbane, Australia.
School of Pharmacy and Medical Sciences, Griffith University, Gold Coast, Australia.
出版信息
Cochrane Database Syst Rev. 2023 Dec 14;12(12):CD006273. doi: 10.1002/14651858.CD006273.pub4.
BACKGROUND
Many people receiving palliative care have reduced oral intake during their illness, and particularly at the end of their life. Management of this can include the provision of medically assisted hydration (MAH) with the aim of improving their quality of life (QoL), prolonging their life, or both. This is an updated version of the original Cochrane Review published in Issue 2, 2008, and updated in February 2011 and March 2014.
OBJECTIVES
To determine the effectiveness of MAH compared with placebo and standard care, in adults receiving palliative care on their QoL and survival, and to assess for potential adverse events.
SEARCH METHODS
We searched for studies in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, CANCERLIT, CareSearch, Dissertation Abstracts, Science Citation Index and the reference lists of all eligible studies, key textbooks, and previous systematic reviews. The date of the latest search conducted on CENTRAL, MEDLINE, and Embase was 17 November 2022.
SELECTION CRITERIA
We included all relevant randomised controlled trials (RCTs) of studies of MAH in adults receiving palliative care aged 18 and above. The criteria for inclusion was the comparison of MAH to placebo or standard care.
DATA COLLECTION AND ANALYSIS
Three review authors independently reviewed titles and abstracts for relevance, and two review authors extracted data and performed risk of bias assessment. The primary outcome was QoL using validated scales; secondary outcomes were survival and adverse events. For continuous outcomes, we measured the arithmetic mean and standard deviation (SD), and reported the mean difference (MD) with 95% confidence interval (CI) between groups. For dichotomous outcomes, we estimated and compared the risk ratio (RR) with 95% CIs between groups. For time-to-event data, we planned to calculate the survival time from the date of randomisation and to estimate and express the intervention effect as the hazard ratio (HR). We assessed the certainty of evidence using GRADE and created two summary of findings tables. MAIN RESULTS: We identified one new study (200 participants), for a total of four studies included in this update (422 participants). All participants had a diagnosis of advanced cancer. With the exception of 29 participants who had a haematological malignancy, all others were solid organ cancers. Two studies each compared MAH to placebo and standard care. There were too few included studies to evaluate different subgroups, such as type of participant, intervention, timing of intervention, and study site. We considered one study to be at high risk of performance and detection bias due to lack of blinding; otherwise, risk of bias was assessed as low or unclear. MAH compared with placebo Quality of life One study measured change in QoL at one week using Functional Assessment of Cancer Therapy - General (FACT-G) (scale from 0 to 108; higher score = better QoL). No data were available from the other study. We are uncertain whether MAH improves QoL (MD 4.10, 95% CI -1.63 to 9.83; 1 study, 93 participants, very low-certainty evidence). Survival One study reported on survival from study enrolment to last date of follow-up or death. We were unable to estimate HR. No data were available from the other study. We are uncertain whether MAH improves survival (1 study, 93 participants, very low-certainty evidence). Adverse events One study reported on intensity of adverse events at two days using a numeric rating scale (scale from 0 to 10; lower score = less toxicity). No data were available from the other study. We are uncertain whether MAH leads to adverse events (injection site pain: MD 0.35, 95% CI -1.19 to 1.89; injection site swelling MD -0.59, 95% CI -1.40 to 0.22; 1 study, 49 participants, very low-certainty evidence). MAH compared with standard care Quality of life No data were available for QoL. Survival One study measured survival from randomisation to last date of follow-up at 14 days or death. No data were available from the other study. We are uncertain whether MAH improves survival (HR 0.36, 95% CI 0.22 to 0.59; 1 study, 200 participants, very low-certainty evidence). Adverse events Two studies measured adverse events at follow-up (range 2 to 14 days). We are uncertain whether MAH leads to adverse events (RR 11.62, 95% CI 1.62 to 83.41; 2 studies, 242 participants, very low-certainty evidence). AUTHORS' CONCLUSIONS: Since the previous update of this review, we have found one new study. In adults receiving palliative care in the end stage of their illness, there remains insufficient evidence to determine whether MAH improves QoL or prolongs survival, compared with placebo or standard care. Given that all participants were inpatients with advanced cancer at end of life, our findings are not transferable to adults receiving palliative care in other settings, for non-cancer, dementia or neurodegenerative diseases, or for those with an extended prognosis. Clinicians will need to make decisions based on the perceived benefits and harms of MAH for each individual's circumstances, without the benefit of high-quality evidence to guide them.
背景
许多接受姑息治疗的患者在疾病过程中,特别是在生命末期,口腔摄入减少。对此的管理包括提供医学辅助水化(MAH),以提高生活质量(QoL)、延长生命或同时提高和延长生命。这是 2008 年首次发表的原始 Cochrane 综述的更新版本,并于 2011 年 2 月和 2014 年 3 月进行了更新。
目的
确定 MAH 与安慰剂和标准护理相比,在接受姑息治疗的成年人的 QoL 和生存方面的有效性,并评估潜在的不良事件。
检索方法
我们在 Cochrane 对照试验中心注册库(CENTRAL)、MEDLINE、Embase、CINAHL、CANCERLIT、CareSearch、论文摘要、科学引文索引和所有合格研究的参考文献列表、主要教科书以及之前的系统评价中搜索了研究。CENTRAL、MEDLINE 和 Embase 的最新搜索日期为 2022 年 11 月 17 日。
选择标准
我们纳入了所有关于成人姑息治疗中 MAH 的随机对照试验(RCT),纳入标准为 MAH 与安慰剂或标准护理的比较。
数据收集和分析
三位综述作者独立对标题和摘要进行了相关性评估,两位综述作者提取了数据并进行了风险偏倚评估。主要结局是使用经过验证的量表评估 QoL;次要结局是生存和不良事件。对于连续结局,我们测量了算术平均值和标准差(SD),并报告了组间的平均差异(MD)和 95%置信区间(CI)。对于二分类结局,我们估计并比较了组间的风险比(RR)和 95%置信区间(CI)。对于时间至事件数据,我们计划从随机化日期计算生存时间,并估计和表示干预效果作为风险比(HR)。我们使用 GRADE 评估证据的确定性,并创建了两个总结发现表。
主要结果
我们确定了一项新的研究(200 名参与者),因此本次更新共纳入了四项研究(422 名参与者)。所有参与者均被诊断为晚期癌症。除了 29 名患有血液恶性肿瘤的参与者外,其余所有参与者均患有实体器官癌。每项研究都将 MAH 与安慰剂和标准护理进行了比较。由于缺乏盲法,纳入的研究太少,无法评估不同的亚组,如参与者类型、干预措施、干预时机和研究地点。由于缺乏盲法,我们认为一项研究存在高偏倚风险,而其他研究则被认为存在低偏倚或不确定偏倚。
MAH 与安慰剂比较
生活质量
一项研究使用功能评估癌症治疗 - 一般(FACT-G)在一周时测量 QoL 的变化(量表范围为 0 到 108;分数越高表示 QoL 越好)。另一项研究没有提供数据。我们不确定 MAH 是否能提高 QoL(MD 4.10,95%CI-1.63 至 9.83;1 项研究,93 名参与者,极低确定性证据)。
生存
一项研究报告了从研究入组到最后一次随访或死亡的生存情况。我们无法估计 HR。另一项研究没有提供数据。我们不确定 MAH 是否能提高生存率(1 项研究,93 名参与者,极低确定性证据)。
不良事件
一项研究使用数字评分量表在两天时报告了不良事件的强度(量表范围为 0 到 10;分数越低表示毒性越小)。另一项研究没有提供数据。我们不确定 MAH 是否会导致不良事件(注射部位疼痛:MD 0.35,95%CI-1.19 至 1.89;注射部位肿胀 MD-0.59,95%CI-1.40 至 0.22;1 项研究,49 名参与者,极低确定性证据)。
MAH 与标准护理比较
生活质量
没有提供 QoL 的数据。
生存
一项研究在随机分组后 14 天或死亡时测量了从随机分组到最后一次随访的生存情况。另一项研究没有提供数据。我们不确定 MAH 是否能提高生存率(HR 0.36,95%CI 0.22 至 0.59;1 项研究,200 名参与者,极低确定性证据)。
不良事件
两项研究在随访时(范围为 2 至 14 天)测量了不良事件。我们不确定 MAH 是否会导致不良事件(RR 11.62,95%CI 1.62 至 83.41;2 项研究,242 名参与者,极低确定性证据)。
作者结论
自上次更新本综述以来,我们发现了一项新的研究。在生命末期处于疾病终末期的接受姑息治疗的成年人中,仍然没有足够的证据来确定 MAH 是否能改善 QoL 或延长生存时间,与安慰剂或标准护理相比。
鉴于所有参与者都是在生命末期患有晚期癌症的住院患者,我们的研究结果不适用于在其他环境中接受姑息治疗的成年人、非癌症、痴呆症或神经退行性疾病患者,或预期寿命延长的患者。临床医生将需要根据每个个体情况的 MAH 的预期益处和危害做出决策,而没有高质量证据的指导。
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