Feuer D J, Broadley K E
Department of Palliative Medicine, Royal Marsden NHS Trust, Horder Ward, Fulham Road, London, UK, SW3 6JJ.
Cochrane Database Syst Rev. 2000;2000(2):CD001219. doi: 10.1002/14651858.CD001219.
Gastrointestinal and ovarian cancers are common cancers. The incidence of associated malignant bowel obstruction in patients with advanced cancers of these types is not known, and the best management of these patients is controversial. Inappropriate management may result in uncontrolled (faeculant) vomiting, pain and distress. Management of the symptoms can include palliative surgery, nasogastric tube suction together with intravenous fluids, or pharmacological means, such as corticosteroids. There is uncertainty regarding both the efficacy and possible harmful effects of corticosteroids, and also the most effective type, dose/dosing regime, route and period of administration.
To locate, appraise and summarise evidence from scientific studies on intestinal obstruction due to advanced gynaecological and gastrointestinal cancer, in order to assess the efficacy of corticosteroids.
A comprehensive list of all studies was provided by an extensive search of the electronic databases, relevant journals, reference lists, the grey literature, contact with investigators and other search strategies outlined in the methods.
As the review concentrates on the 'best evidence' available of the role of corticosteroids in malignant bowel obstruction due to advanced gynaecological and gastrointestinal cancer the inclusion criteria were kept fairly broad so as to include all studies relevant to the question
Data extraction forms were used to collect data from the studies included in the review. The data was checked by a secondary searcher to reduce error. A qualitative analysis was performed of the dichotomous data of resolution of obstruction and death at one month, obtained from the randomised controlled trials of corticosteroids versus placebo. Both fixed and random effect models were used. Number needed to treat (NNT) was derived from the odds ratio. Kaplan-Meier survival curves from individual patient data were also analysed. Studies of lower methodological quality were assessed in a qualitative manner.
Three unpublished, randomised, placebo, double blind controlled trials and seven published (prospective and retrospective) trials were considered eligible. Using only the randomised trials, there is a trend, which is not statistically significant, for the resolution of bowel obstruction using corticosteroids. There is no statistically significant difference in mortality at one month, nor in the Kaplan-Meier curves, which describe the survival of patients on corticosteroids or placebo. Number needed to treat is 6 (3, infinity) ie six patients need to be treated with corticosteroids to resolve one episode of bowel obstruction. The results are robust to fixed and random effects models and to 'best' and 'worst case' scenarios on the missing data from patients. The morbidity associated with corticosteroids appears to be very low, though the quality of the data limits this conclusion. No other outcomes were available from the published data or from the authors.
REVIEWER'S CONCLUSIONS: There is a trend for evidence that corticosteroids of dose range 6-16 mg dexamethasone given intravenously may bring about the resolution of bowel obstruction. Equally, the incidence of side effects in all the included studies is extremely low. Corticosteroids do not seem to affect the length of survival of these patients.
胃肠道癌和卵巢癌是常见癌症。这类晚期癌症患者发生相关恶性肠梗阻的发生率尚不清楚,且对这些患者的最佳治疗存在争议。不恰当的治疗可能导致无法控制的(粪便性)呕吐、疼痛和痛苦。症状的管理可包括姑息性手术、鼻胃管抽吸加静脉输液,或药物治疗手段,如皮质类固醇。皮质类固醇的疗效和可能的有害影响,以及最有效的类型、剂量/给药方案、给药途径和给药期限均存在不确定性。
查找、评估和总结关于晚期妇科和胃肠道癌所致肠梗阻的科学研究证据,以评估皮质类固醇的疗效。
通过广泛检索电子数据库、相关期刊、参考文献列表、灰色文献、与研究者联系以及方法中概述的其他检索策略,提供了所有研究的综合列表。
由于该综述专注于皮质类固醇在晚期妇科和胃肠道癌所致恶性肠梗阻中作用的“最佳证据”,入选标准保持相当宽泛,以便纳入与该问题相关的所有研究。
数据提取表用于从综述中纳入的研究收集数据。数据由第二位检索者检查以减少误差。对从皮质类固醇与安慰剂的随机对照试验中获得的梗阻缓解和1个月时死亡的二分数据进行了定性分析。使用了固定效应模型和随机效应模型。治疗所需人数(NNT)从优势比得出。还分析了来自个体患者数据的Kaplan-Meier生存曲线。方法学质量较低的研究以定性方式进行评估。
三项未发表的随机、安慰剂、双盲对照试验和七项已发表的(前瞻性和回顾性)试验被认为符合条件。仅使用随机试验,使用皮质类固醇缓解肠梗阻有一个趋势,但无统计学意义。1个月时死亡率以及描述接受皮质类固醇或安慰剂治疗患者生存情况的Kaplan-Meier曲线均无统计学显著差异。治疗所需人数为6(3,无穷大),即需要6名患者接受皮质类固醇治疗才能缓解一次肠梗阻发作。结果对固定效应模型和随机效应模型以及患者缺失数据的“最佳”和“最差”情况均具有稳健性。与皮质类固醇相关的发病率似乎非常低,尽管数据质量限制了这一结论。已发表数据或作者未提供其他结果。
有证据表明,静脉给予剂量范围为6 - 16毫克地塞米松的皮质类固醇可能会使肠梗阻得到缓解,这是一个趋势。同样,所有纳入研究中的副作用发生率极低。皮质类固醇似乎不影响这些患者的生存时长。