Department of Coloproctological Surgery, First Affiliated Hospital of Guangxi Medical University, Nanning, 530021, Guangxi Zhuang Autonomous Region, People's Republic of China.
Int J Colorectal Dis. 2010 Mar;25(3):343-50. doi: 10.1007/s00384-009-0838-4.
The purpose of this study was to systematically compare the efficacy and safety of chronomodulated chemotherapy with conventional chemotherapy in patients with advanced colorectal cancer.
Eligible studies were identified from electronic databases (Medline, Embase, and the Cochrane Library). The efficacy data included overall survival (OS) and objective response rate (ORR), and toxicities data contained diarrhea, vomiting and nausea, mucositis, asthenia, and peripheral sensory neuropathy. The meta-analysis was performed with the fixed-effect model or random-effect model according to heterogeneity.
From 79 articles screened, five randomized controlled trials (RCTs) met the inclusion criteria contributing a total of 958 participants. There was a significant OS benefit (hazard ratio (HR)=0.82; 95% confidence interval (CI) 0.69 to 0.97; P=0.023) in favor of the chronomodulated chemotherapy. The ORR was not significantly different between two arms (relative risk=1.27; 95% CI 0.88 to 1.83; P=0.196). A higher incidence of grade 3/4 mucositis (odds ratio=2.26, 95% CI 1.34 to 3.83; P=0.724), asthenia (2.15, 1.30 to 3.56; P=0.428), and a lower incidence of grade 3/4 neutropenia (0.26, 0.16 to 0.42; P=0.641) were associated with the chronomodulated chemotherapy. The two arms were similar in terms of grade 3/4 diarrhea (1.10, 0.72 to 1.69; P=0.756), vomiting and nausea (0.69, 0.42 to1.13; P=0.239), and peripheral sensory neuropathy (0.56, 0.25 to 1.27, 0.164).
Chronomodulated chemotherapy showed significant improvement in OS comparing with conventional chemotherapy. Side effects of the chronomodulated chemotherapy are predictable and manageable. But these results still need more high-quality RCTs for confirmation.
本研究旨在系统比较时相化疗与常规化疗在晚期结直肠癌患者中的疗效和安全性。
从电子数据库（Medline、Embase 和 Cochrane 图书馆）中检索合格的研究。疗效数据包括总生存期（OS）和客观缓解率（ORR），毒性数据包括腹泻、呕吐和恶心、黏膜炎、乏力和周围感觉神经病变。根据异质性，采用固定效应模型或随机效应模型进行荟萃分析。
从 79 篇筛选的文章中，有 5 项随机对照试验（RCT）符合纳入标准，共纳入 958 名参与者。时相化疗组的 OS 有显著获益（风险比（HR）=0.82；95%置信区间（CI）0.69 至 0.97；P=0.023）。两组的 ORR 无显著差异（相对风险=1.27；95%CI 0.88 至 1.83；P=0.196）。时相化疗组 3/4 级黏膜炎（优势比=2.26；95%CI 1.34 至 3.83；P=0.724）、乏力（2.15；95%CI 1.30 至 3.56；P=0.428）发生率较高，3/4 级中性粒细胞减少症（0.26；95%CI 0.16 至 0.42；P=0.641）发生率较低。两组在 3/4 级腹泻（1.10；95%CI 0.72 至 1.69；P=0.756）、呕吐和恶心（0.69；95%CI 0.42 至 1.13；P=0.239）和周围感觉神经病变（0.56；95%CI 0.25 至 1.27；P=0.164）方面无显著差异。
与常规化疗相比，时相化疗在 OS 方面有显著改善。时相化疗的副作用是可预测和可管理的。但这些结果仍需要更多高质量的 RCT 来证实。
