Clarkson Jan E, Worthington Helen V, Furness Susan, McCabe Martin, Khalid Tasneem, Meyer Stefan
Dental Health Services Research Unit, University of Dundee, The Mackenzie Building, Kirsty Semple Way, Dundee, UK, DD2 4BF.
Cochrane Database Syst Rev. 2010 Aug 4;2010(8):CD001973. doi: 10.1002/14651858.CD001973.pub4.
Treatment of cancer is increasingly effective but associated with short and long term side effects. Oral side effects, including oral mucositis (mouth ulceration), remain a major source of illness despite the use of a variety of agents to treat them.
To assess the effectiveness of interventions for treating oral mucositis or its associated pain in patients with cancer receiving chemotherapy or radiotherapy or both.
Electronic searches of Cochrane Oral Health Group and PaPaS Trials Registers (to 1 June 2010), CENTRAL via The Cochrane Library (to Issue 2, 2010), MEDLINE via OVID (1950 to 1 June 2010), EMBASE via OVID (1980 to 1 June 2010), CINAHL via EBSCO (1980 to 1 June 2010), CANCERLIT via PubMed (1950 to 1 June 2010), OpenSIGLE (1980 to 1 June 2010) and LILACS via the Virtual Health Library (1980 to 1 June 2010) were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information.
All randomised controlled trials comparing agents prescribed to treat oral mucositis in people receiving chemotherapy or radiotherapy or both. Outcomes were oral mucositis, time to heal mucositis, oral pain, duration of pain control, dysphagia, systemic infection, amount of analgesia, length of hospitalisation, cost and quality of life.
Data were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation, blindness and withdrawals. Risk of bias assessment was carried out on six domains. The Cochrane Collaboration statistical guidelines were followed and risk ratio (RR) values calculated using fixed-effect models (less than 3 trials in each meta-analysis).
Thirty-two trials involving 1505 patients satisfied the inclusion criteria. Three comparisons for mucositis treatment including two or more trials were: benzydamine HCl versus placebo, sucralfate versus placebo and low level laser versus sham procedure. Only the low level laser showed a reduction in severe mucositis when compared with the sham procedure, RR 5.28 (95% confidence interval (CI) 2.30 to 12.13).Only 3 comparisons included more than one trial for pain control: patient controlled analgesia (PCA) compared to the continuous infusion method, therapist versus control, cognitive behaviour therapy versus control. There was no evidence of a difference in mean pain score between PCA and continuous infusion, however, less opiate was used per hour for PCA, mean difference 0.65 mg/hour (95% CI 0.09 to 1.20), and the duration of pain was less 1.9 days (95% CI 0.3 to 3.5).
AUTHORS' CONCLUSIONS: There is weak and unreliable evidence that low level laser treatment reduces the severity of the mucositis. Less opiate is used for PCA versus continuous infusion. Further, well designed, placebo or no treatment controlled trials assessing the effectiveness of interventions investigated in this review and new interventions for treating mucositis are needed.
癌症治疗效果日益显著,但伴随着短期和长期的副作用。口腔副作用,包括口腔黏膜炎(口腔溃疡),尽管使用了多种药物进行治疗,仍然是主要的病痛来源。
评估干预措施对接受化疗或放疗或两者皆有的癌症患者治疗口腔黏膜炎或其相关疼痛的有效性。
对Cochrane口腔健康小组和PaPaS试验注册库(截至2010年6月1日)进行电子检索,通过Cochrane图书馆检索CENTRAL(截至2010年第2期),通过OVID检索MEDLINE(1950年至2010年6月1日),通过OVID检索EMBASE(1980年至2010年6月1日),通过EBSCO检索CINAHL(1980年至2010年6月1日),通过PubMed检索CANCERLIT(1950年至2010年6月1日),检索OpenSIGLE(1980年至2010年6月1日)并通过虚拟健康图书馆检索LILACS(1980年至2010年6月1日)。检索了相关文章的参考文献列表,并联系了符合条件试验的作者以识别试验并获取更多信息。
所有比较为接受化疗或放疗或两者皆有的患者开具的治疗口腔黏膜炎药物的随机对照试验。结局指标为口腔黏膜炎、黏膜炎愈合时间、口腔疼痛、疼痛控制持续时间、吞咽困难、全身感染、镇痛量、住院时间、成本和生活质量。
由两位综述作者独立重复提取数据。联系作者获取随机化、盲法和撤组的详细信息。在六个领域进行偏倚风险评估。遵循Cochrane协作组的统计指南,并使用固定效应模型计算风险比(RR)值(每个荟萃分析中的试验少于3项)。
32项涉及1505名患者的试验符合纳入标准。三项关于黏膜炎治疗的比较(包括两项或更多试验)为:盐酸苄达明与安慰剂、硫糖铝与安慰剂以及低强度激光与假手术。与假手术相比,只有低强度激光显示严重黏膜炎有所减少,RR为5.28(95%置信区间(CI)2.30至12.13)。只有3项比较纳入了不止一项关于疼痛控制的试验:患者自控镇痛(PCA)与持续输注法、治疗师与对照组、认知行为疗法与对照组。没有证据表明PCA和持续输注之间的平均疼痛评分存在差异,然而,PCA每小时使用的阿片类药物较少,平均差异为0.65毫克/小时(95%CI 0.09至1.20),且疼痛持续时间缩短1.9天(95%CI 0.3至3.5)。
有薄弱且不可靠的证据表明低强度激光治疗可降低黏膜炎的严重程度。与持续输注相比,PCA使用的阿片类药物较少。此外,需要进一步设计良好的、安慰剂对照或无治疗对照的试验,以评估本综述中研究的干预措施以及治疗黏膜炎的新干预措施的有效性。