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[摘要]
目的 系统评价沙利度胺联合常规止吐用于化疗所致恶心呕吐(CINV)的有效性与安全性,为临床用药提供循证参考。方法 检索PubMed、Embase、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普中文期刊全文数据库(VIP)和万方数据库,收集沙利度胺联合常规止吐(试验组)对比常规止吐药物(对照组)用于CINV的随机对照试验(RCT),筛选文献、提取资料后,采用Rev Man 5.3统计软件进行Meta-分析。结果 共纳入12篇RCTs,1 135例患者。Meta-分析结果显示,实验组抑制急性恶心有效率[OR=1.87,95% CI(1.33,2.65),P<0.01]、延迟性恶心有效率[OR=3.54,95% CI(2.66,4.72),P<0.01]、急性呕吐有效率[OR=1.93,95% CI(1.16,3.21),P=0.01]和延迟性呕吐有效率[OR=3.67,95% CI(2.58,5.22),P<0.01]均显著高于对照组;安全性方面,消化道功能障碍(便秘)发生率[OR=1.57,95% CI(1.18,2.08),P=0.01]大于对照组,其他骨髓抑制、中枢神经系统损害、心血管损害及皮肤过敏反应发生率均无显著性差异。结论 沙利度胺联合常规止吐对化疗所致的急性和延迟性恶心、呕吐均有效,除可增加便秘的发生风险外,未增加其他不良反应的发生率。
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[Abstract]
Objective To systematically evaluate the efficacy and safety of thalidomide for prevention the chemotherapy induced nausea and vomiting (CINV), and provide evidence-based reference for clinical drug use. Methods RCTs about thalidomide combined with routine antiemetic therapy (test group) vs routine antiemetic therapy (control group) in the treatment of CINV were retrieved from PubMed, Embase, CNKI, Wanfang database and VIP. After data extraction, Meta-analysis was conducted by using RevMan 5.3 statistical software. Results A total of 12 RCTs were included, involving 1 135 patients. Results of Meta-analysis showed that the effectiveness of inhibiting acute nausea[OR=1.87, 95% CI(1.33, 2.65), P<0.01], effectiveness of inhibiting delayed nausea[OR=3.54, 95% CI(2.66, 4.72), P<0.01], effectiveness of inhibiting acute vomiting[OR=1.93, 95% CI(1.16, 3.21), P=0.01] and effectiveness of inhibiting delayed vomiting[OR=3.67, 95% CI(2.58, 5.22), P<0.01] of test group were significantly higher than those of control group; In the safety, incidence of digestive tract dysfunction (constipation)[OR=1.57, 95% CI(1.18, 2.08), P=0.01] of test group were significantly higher than those of control group, and there was no significant difference in the incidence of bone marrow suppression, central nervous system damage, cardiovascular damage and skin allergy between two groups. Conclusion Thalidomide combined with routine antiemetic therapy is effective in treating acute and delayed nausea and vomiting induced by chemotherapy, and except for increasing the risk of constipation, there was no increase in the incidence of other adverse reactions.
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