恶性胸腔积液的胸膜固定术
Pleurodesis for malignant pleural effusions.
作者信息
Shaw P, Agarwal R
机构信息
Department of Clinical Oncology, Velindre Hospital, Whitchurch, Cardiff, Wales, UK, CF4 7XL.
出版信息
Cochrane Database Syst Rev. 2004(1):CD002916. doi: 10.1002/14651858.CD002916.pub2.
BACKGROUND
Approximately half of all patients with metastatic cancer develop a malignant pleural effusion which is likely to lead to a significant reduction in quality of life secondary to symptoms such as dyspnoea and cough. The aim of pleurodesis in these patients is to prevent re-accumulation of the effusion and thereby of symptoms, and avoid the need for repeated hospitalization for thoracocentesis. Numerous clinical studies have been performed to try to determine the optimal pleurodesis strategy, and synthesis of the available evidence should facilitate this.
OBJECTIVES
The aims of this review were to ascertain the optimal technique of pleurodesis in cases of malignant pleural effusion; to confirm the need for a sclerosant; and to clarify which, if any, of the sclerosants is the most effective.
SEARCH STRATEGY
The Cochrane Central Register of Controlled Trials was searched for studies on 'pleurodesis'. Studies for inclusion were also identified from MEDLINE (1980 to June 2002) and EMBASE (1980 to May 2002). No language restriction was applied.
SELECTION CRITERIA
RCTs of adults subjects undergoing pleurodesis for pleural effusion in the context of metastatic malignancy (or a malignant process leading to pleural effusion) were included.
DATA COLLECTION AND ANALYSIS
Two reviewers independently selected studies for inclusion in the review, and extracted data using a standard data collection form. Primary outcome measures sought were effectiveness of pleurodesis as defined by freedom from recurrence of effusions, and mortality after pleurodesis. Secondary outcomes were adverse events due to pleurodesis. Dichotomous data were meta-analysed using a fixed effect model and expressed as relative risk. The number-needed-to-treat (NNT) was calculated for pleurodesis efficacy. In addition, for adverse events, the overall percentage of patients across studies exhibiting a particular adverse effect such as fever, pain, or gastrointestinal symptoms was calculated.
MAIN RESULTS
A total of 36 RCTs with 1499 subjects were eligible for meta-analysis. The use of sclerosants (mitozantrone, talc and tetracycline combined)compared with control (instillation of isotonic saline or equivalent pH isotonic saline or tube drainage alone) was associated with an increased efficacy of pleurodesis. The relative risk (RR) of non-recurrence of an effusion is 1.20 (95% CI 1.04 to 1.38) in favour of the use of sclerosants based on five studies with a total 228 subjects. Comparing different sclerosants, talc was found to be the most efficacious. The RR of effusion non-recurrence was 1.34 (95% CI 1.16 to 1.55) in favour of talc compared with bleomycin, tetracycline, mustine or tube drainage alone based on 10 studies comprising 308 subjects. This was not associated with increased mortality post pleurodesis. The RR of death was 1.19 (95% CI 0.08 to 1.77) for talc compared to bleomycin, tetracycline, mustine and tube drainage alone based on six studies of 186 subjects. Death was not reported in all studies and, when reported, was attributed to underlying disease, only one death being reported as procedure-related. In the comparison of thoracoscopic versus medical pleurodesis, thoracoscopic pleurodesis was found to be more effective. The RR of non-recurrence of effusion is 1.19 (95% CI 1.04 to 1.36) in favour of thoracoscopic pleurodesis compared with tube thoracostamy pleurodesis utilizing talc as sclerosant based on two studies with 112 subjects. Comparing thoracoscopic versus bedside instillation (with different sized chest tubes) of various sclerosants (tetracycline, bleomycin, talc or mustine) the RR of non-recurrence of effusion is 1.68 (95% CI 1.35 to 2.10) based on five studies with a total of 145 participants.Adverse events were not reported adequately to enable meta-analysis.
REVIEWER'S CONCLUSIONS: The available evidence supports the need for chemical sclerosants for successful pleurodesis, the use of talc as the sclerosant of choice, and thoracoscopic pleurodesis as the preferred technique for pleurodesis based on efficacy. There was no evidence for an increase in mortality following talc pleurodesis.
背景
大约一半的转移性癌症患者会出现恶性胸腔积液,这很可能导致生活质量显著下降,继发呼吸困难和咳嗽等症状。这些患者进行胸膜固定术的目的是防止积液再次积聚,从而避免症状复发,并避免因反复胸腔穿刺而住院。已经进行了大量临床研究以确定最佳的胸膜固定术策略,对现有证据的综合应有助于实现这一目标。
目的
本综述的目的是确定恶性胸腔积液病例中胸膜固定术的最佳技术;确认硬化剂的必要性;并阐明哪种硬化剂(如果有)最有效。
检索策略
在Cochrane对照试验中央注册库中检索关于“胸膜固定术”的研究。纳入研究也从MEDLINE(1980年至2002年6月)和EMBASE(1980年至2002年5月)中识别。未应用语言限制。
选择标准
纳入转移性恶性肿瘤(或导致胸腔积液的恶性过程)背景下因胸腔积液接受胸膜固定术的成年受试者的随机对照试验。
数据收集与分析
两名综述作者独立选择纳入综述的研究,并使用标准数据收集表提取数据。主要结局指标为根据积液无复发定义的胸膜固定术有效性以及胸膜固定术后的死亡率。次要结局为胸膜固定术引起的不良事件。二分数据使用固定效应模型进行荟萃分析,并表示为相对风险。计算胸膜固定术疗效的需治疗人数(NNT)。此外,对于不良事件,计算各研究中出现发热、疼痛或胃肠道症状等特定不良效应的患者总体百分比。
主要结果
共有36项随机对照试验(1499名受试者)符合荟萃分析条件。与对照(单纯输注等渗盐水或等pH值等渗盐水或单纯胸腔闭式引流)相比,使用硬化剂(米托蒽醌、滑石粉和四环素联合使用)与胸膜固定术疗效增加相关。基于五项共228名受试者的研究,积液不复发的相对风险(RR)为1.20(95%CI 1.04至1.38),支持使用硬化剂。比较不同硬化剂时,发现滑石粉最有效。基于10项共308名受试者的研究,与博来霉素、四环素、氮芥或单纯胸腔闭式引流相比,积液不复发的RR为1.34(95%CI 1.16至1.55),支持滑石粉。这与胸膜固定术后死亡率增加无关。基于六项共186名受试者的研究,与博来霉素、四环素、氮芥和单纯胸腔闭式引流相比滑石粉的死亡RR为1.19(95%CI 0.08至1.77)。并非所有研究都报告了死亡情况,报告时死亡归因于基础疾病,仅1例死亡报告为与手术相关。在胸腔镜胸膜固定术与内科胸膜固定术的比较中发现,胸腔镜胸膜固定术更有效。基于两项共112名受试者的研究,与使用滑石粉作为硬化剂的胸腔闭式引流胸膜固定术相比,积液不复发的RR为1.19(95%CI 1.04至1.36),支持胸腔镜胸膜固定术。比较胸腔镜与床边滴注(使用不同尺寸胸管)各种硬化剂(四环素、博来霉素、滑石粉或氮芥),基于五项共145名参与者的研究,积液不复发的RR为1.68(95%CI 1.35至2.10)。不良事件报告不足,无法进行荟萃分析。
综述作者结论
现有证据支持成功进行胸膜固定术需要化学硬化剂,使用滑石粉作为首选硬化剂,以及基于疗效胸腔镜胸膜固定术作为胸膜固定术的首选技术。没有证据表明滑石粉胸膜固定术后死亡率增加。