外源性褪黑素对肿瘤辅助治疗效果的Meta分析

Efficacy and Safety of Exogenous Melatonin in the Adjuvant Therapy of Tumor:A Meta-analysis

目的系统评价肿瘤患者进行化疗或放疗时,采用褪黑素进行辅助治疗的有效性和安全性。方法计算机检索MEDLINE(1980～2010.1)、Cochrane图书馆(2009年第4期)、万方数据库(1980～2010.1)、VIP(1980～2010.1)、CNKI(1980～2010.1)、ELSEVIER ScienceDirect(SDOS)(1980～2010.1)、Nature(1980～2010.1)以及在研临床试验数据库(www.clinicaltrials.gov和www.controlled-trials.com),纳入研究外源性褪黑素辅助治疗肿瘤效果的随机对照试验,由两位研究者进行资料提取和质量评价后,采用Stata 10.1软件进行Meta分析。结果共纳入8个RCT。Meta分析结果显示:褪黑素能显著提高肿瘤患者的疾病缓解率[RR=1.98,95%CI(1.52,2.58)]及1年生存率[RR=1.90,95%CI(1.28,2.83)],同时能显著减轻化疗或放疗对骨髓抑制的毒性作用[RR=0.12,95%CI(0.06,0.27)];治疗期间未见褪黑素相关不良反应的报道。结论当前证据显示,褪黑素作为肿瘤的辅助治疗药物,对提高患者疾病缓解率、减轻化疗放疗的毒性、延长患者的寿命具有一定作用。受纳入研究质量限制,上述结论尚需开展更多高质量研究验证。

To evaluate the efficacy and safety of melatonin as an adjuvant therapy for the tumor patients receiving chemotherapy or radiotherapy. Methods Such databases as MEDLINE （1980 to Jan. 2010）, The Cochrane Library （Issue 4, 2009）, WanFang Data （1980 to Jan. 2010）, CBM （1980 to Jan. 2010）, CNKI （1980 to Jan. 2010）, ELSEVIER ScienceDirect （SDOS, 1980 to Jan. 2010）, Nature （1980 to Jan. 2010） and ongoing clinical trials （www.clinicaltrials.gov and www. controlled-trials.com） were searched to collect randomized controlled trials （RCTs）. The data were extracted and the quality of the included RCTs was assessed by two reviewers. Then meta-analyses were performed by using Stata 10.1 software. Resuits Eight RCTs were included. The results of meta-analyses showed that melatonin significantly improved the remission rate for tumor patients （RR=l.98, 95% CI 1.52 to 2.58） and the one-year survival rate （RR=I.90, 95%CI 1.28 to 2.83）, and significantly reduced the toxic effects of bone marrow suppression caused by chemotherapy or radiotherapy （RR=0.12, 95%CI 0.06 to 0.27）. No reports of adverse events were associated with melatonin. Conclusion The existing evidence reveals that the melatonin, as an adjuvant therapy drug for tumor, plays a certain role in improving disease remission rate, reducing the toxicity of chemotherapy and radiotherapy, and prolonging the life. It requires more high-quality RCTs for further verification because of the limitation of the included studies.