Deakin Health Economics, Centre for Population Health Research, School of Health and Social Development, Deakin University, Geelong, Victoria, Australia.
Palliative & Supportive Services, Flinders University, Bedford Park, South Australia, Australia.
BMC Cancer. 2020 Oct 31;20(1):1050. doi: 10.1186/s12885-020-07549-y.
This analysis aims to evaluate health-related quality of life (HrQoL) (primary outcome for this analysis), nausea and vomiting, and pain in patients with inoperable malignant bowel obstruction (IMBO) due to cancer or its treatments randomised to standardised therapies plus octreotide or placebo over a maximum of 72 h in a double-blind clinical trial.
Adults with IMBO and vomiting recruited through 12 services spanning inpatient, consultative and community settings in Australia were randomised to subcutaneous octreotide infusion or saline. HrQoL was measured at baseline and treatment cessation (EORTC QLQ-C15-PAL). Mean within-group paired differences between baseline and post-treatment scores were analysed using Wilcoxon Signed Rank test and between group differences estimated using linear mixed models, adjusted for baseline score, sex, age, time, and study arm.
One hundred six of the 112 randomised participants were included in the analysis (n = 52 octreotide, n = 54 placebo); 6 participants were excluded due to major protocol violations. Mean baseline HrQoL scores were low (octreotide 22.1, 95% CI 14.3, 29.9; placebo 31.5, 95% CI 22.3, 40.7). There was no statistically significant within-group improvement in the mean HrQoL scores in the octreotide (p = 0.21) or placebo groups (p = 0.78), although both groups reported reductions in mean nausea and vomiting (octreotide p < 0.01; placebo p = 0.02) and pain scores (octreotide p < 0.01; placebo p = 0.03). Although no statistically significant difference in changes in HrQoL scores between octreotide and placebo were seen, an adequately powered study is required to fully assess any differences in HrQoL scores.
The HrQoL of patients with IMBO and vomiting is poor. Further research to formally evaluate the effects of standard therapies for IMBO is therefore warranted.
Australian New Zealand Clinical Trials Registry ACTRN12608000211369 (date registered 18/04/2008).
本分析旨在评估无法手术的恶性肠梗阻（因癌症或其治疗而导致）患者的健康相关生活质量（这是本分析的主要结果）、恶心呕吐和疼痛，这些患者在一项双盲临床试验中被随机分配接受标准化治疗加奥曲肽或安慰剂，最长时间为 72 小时。
在澳大利亚的 12 个服务机构中，通过住院、会诊和社区环境招募了患有无法手术的恶性肠梗阻且伴有呕吐的成年人，将他们随机分配接受皮下奥曲肽输注或生理盐水。在基线和治疗结束时（EORTC QLQ-C15-PAL）测量健康相关生活质量。使用 Wilcoxon 符号秩检验分析基线和治疗后评分之间的组内平均配对差异，并使用线性混合模型估计组间差异，该模型调整了基线评分、性别、年龄、时间和研究臂。
112 名随机参与者中有 106 名（奥曲肽组 n=52，安慰剂组 n=54）被纳入分析；6 名参与者因主要方案违规而被排除。奥曲肽组的平均基线健康相关生活质量评分较低（奥曲肽组 22.1，95%CI 14.3，29.9；安慰剂组 31.5，95%CI 22.3，40.7）。奥曲肽组（p=0.21）或安慰剂组（p=0.78）的平均健康相关生活质量评分均无统计学意义的组内改善，尽管两组的平均恶心呕吐（奥曲肽组 p<0.01；安慰剂组 p=0.02）和疼痛评分（奥曲肽组 p<0.01；安慰剂组 p=0.03）均有所降低。虽然奥曲肽和安慰剂组的健康相关生活质量评分变化之间没有统计学上的显著差异，但需要一项足够大的研究来全面评估健康相关生活质量评分的任何差异。
患有无法手术的恶性肠梗阻和呕吐的患者的健康相关生活质量较差。因此，需要进一步研究来正式评估标准治疗对无法手术的恶性肠梗阻的效果。
澳大利亚新西兰临床试验注册中心 ACTRN12608000211369（注册日期 2008 年 4 月 18 日）。
