中药抑制肿瘤血管生成随机对照试验Meta分析

Meta-analysis of Randomized Controlled Trials of Traditional Chinese Medicine for Inhibiting Tumor Angiogenesis

目的:评价中药抑制肿瘤血管生成的影响及有效性和安全性。方法:利用计算机检索中文数据库、万方数据、VIP、CBM及英文数据库、Ovid、Embase、Cochrane Library,截止日期限定为2018年3月。研究对象为经病理组织学检测确诊为各型肿瘤的患者。干预方式:试验组采用中药提取物、中药复方、中药注射液治疗,或以上疗法联合化疗或西药治疗,对照组采用中药或化疗或西药治疗,或两者联合。研究类型为随机对照试验(randomed clinical trial,RCT)。分组为:试验组和对照组,文献语言限定为中、英文。结局指标:血管内皮生长因子(VEGF),微血管密度(MVD),总有效率,生活质量评价,不良反应等。采用Cochrane协作组织制定的偏倚风险评价标准对纳入研究的文献质量(包括随机化、分配、隐藏、盲法、退出与失访)进行评价,使用RevMan 5.20对纳入文献进行汇总分析。结果:纳入29篇RCTs实验。经过文献质量评价后,发现纳入的文献方法学质量较低,多数文章并没有较好的描述随机序列的产生,分配隐藏,盲法及随访结果。Meta分析合并效应量后,发现与单纯化疗相比,中药作为辅助手段联合化疗可以降低患者血清的VEGF[MD=-43.86,95%CI(-46.34,-41.38),P<0.000,01],降低MVD数量[MD=-7.93,95%CI(-11.77,-4.08),P<0.000,1],改善患者的生存质量[RR=1.36,95%CI(1.24,1.50),P<0.000,01],并提高治疗效果,总有效率[RR=1.37,95%CI(1.08,1.73),P=0.009]。结论:中药治疗可抑制肿瘤血管生成,但仍需更多高质量的临床试验进行验证。

Objective:To evaluate the effect,efficacy and safety of traditional Chinese medicine for inhibiting tumor angiogenesis.Methods:The Chinese database,Wanfang data,VIP,CBM and English database,Ovid,Embase and Cochrane Library were retrieved by computer.The deadline was limited to March 2018.The subjects were patients diagnosed with various types of tumors by histopathological examination.Intervention method:The experimental group was treated with traditional Chinese medicine extract,traditional Chinese medicine compound,Chinese medicine injection or the above therapy combined with chemotherapy or western medicine.The control group was treated with traditional Chinese medicine,chemotherapy or western medicine or both.The type of study was a randomized clinical trial(RCT).The language of the document is limited to Chinese and English.Outcome indicators:vascular endothelial growth factor(VEGF),microvessel density(MVD),total effective rate,quality of life assessment,adverse reactions,etc.The quality of the literature included in the study(including randomization,assignment,concealment,blinding,withdrawal,and loss of follow-up)was evaluated using the bias risk assessment criteria developed by the Cochrane Collaboration,and the included literature was aggregated using RevMan 5.20.Results:A total of 29 RCTs were included.After the quality evaluation of the literature,it was found that the methodological quality of the included literature was low.Most of the articles did not describe the random sequence generation,allocation concealment,blinding and follow-up results.After the metaanalysis combined with the effect amount,it was found that compared with chemotherapy alone,traditional Chinese medicine as an adjunct to chemotherapy combined with chemotherapy to reducing serum VEGF[MD=-43.86,95%CI(-46.34,-41.38),P<0.000,01],reducing the number of MVD[MD=-7.93,95%CI(-11.77,-4.08)],P<0.000,1],improving the quality of life of patients[RR=1.36,95%CI(1.24,1.50),P<0.000,01],and improving treatment effect(total efficiency rate[RR=1.37,95%CI(1.08,1.73),P=0.009].Conclusion:Traditional Chinese medicine treatment can inhibit tumor angiogenesis,but more high-quality clinical trials are still needed.