4种常用中药注射剂临床抗肿瘤有效性的循证药学评价

Evidence-based Pharmaceutical Evaluation of Clinical Antitumor Efficacies of 4 Kinds of Common TCM Injections

目的:评价康艾、香菇多糖、参芪扶正、复方苦参4种常用中药注射剂联合化疗、放疗或手术等治疗非小细胞肺癌、胃癌及肠癌的有效性。方法:通过检索2006年1月至2012年12月期间CNKI、中国生物医学文献数据库及维普期刊数据库,纳入关于该4种中药注射剂有效性研究的文献,并按抗肿瘤类型分类,分析评价纳入文献的质量;同时,从临床疗效、生活质量、胃肠道反应及骨髓抑制方面做进一步频数分析和卡方检验。结果:共纳入132篇文献。频数分析(治疗组与对照组差异有统计学意义的文献数/文献总数)结果为:生活质量(89/132);临床疗效(37/132);骨髓抑制(96/132);胃肠道反应(81/132)。卡方检验结果显示:(1)非小细胞肺癌(84篇)治疗中,化疗、放疗或手术合用康艾、香菇多糖、参芪扶正或复方苦参在所评价的4个指标中均有显著改善(P<0.05)。(2)胃癌(24篇)治疗中,化疗、放疗或手术合用康艾、香菇多糖对提高患者生活质量、降低胃肠道反应及骨髓抑制方面有明显的作用(P<0.05)。(3)肠癌(24篇)治疗中,化疗、放疗或手术合用康艾、香菇多糖、参芪扶正能显著改善患者生活质量,降低患者胃肠反应(P<0.05);合用复方苦参能提高疗效和患者生活质量,减少骨髓抑制(P<0.05)。结论:康艾、香菇多糖、参芪扶正、复方苦参4种中药注射剂对不同的肿瘤具有不同的疗效。本研究为该4种中药注射剂的临床抗肿瘤应用提供了相应的循证药学依据。

OBJECTIVE： To evaluate the effectiveness of Kang＇ ai injection, Lentinan injection, Shenqi fuzheng injection and Compound kushen injection combined with chemotherapy, radiotherapy or operation for non-small cell lung cancer （NSCLC）, gastric cancer and intestinal cancer. METHODS： Retrieved from CNKI, CBM and VIP database from Jan. 2006 to Dec. 2012, literatures about the effectiveness of 4 kinds of TCM injection were included, and the quality of included literatures was evaluated by cancer type. Then frequency analysis and chi-square analysis were applied to analyze each therapeutic index including clinical efficacy, quality of life, gastrointestinal tract reaction and bone marrow suppression. RESULTS： 132 literatures were enrolled in this study. The frequency analysis （literatures with statistical significance between 2 groups/total amounts of literatures） showed that quality of life （89/132）, clinical efficacy （37/132）, bone marrow suppression （96/132） and gastrointestinal tract reaction （81/132） were the major therapeutic indexes. Furthermore, the chi-square analysis indicated： ① in NSCLC （84 literatures）, the main 4 therapeutic indexes were improved significantly when chemotherapy, radiotherapy or operation combined with Kang＇ ai injection, Lentinan injection, Shenqi fuzheng injection or Compound kushen injection（P〈0.05） ;② in gastric cancer （24 literatures）, chemotherapy, radiotherapy or operation combined with Kang＇ ai injection and Lentinan injection would improve the quality of life, reduce gastrointestinal tract reaction and bone marrow suppression significantly （P〈0.05） ; ③ in intestinal cancer （24 literatures）, chemotherapy, radiotherapy or operation combined with Kang＇ ai injection, Lentinan injection and Shenqi fuzheng injection could improve quality of life and reduce gastrointestinal tract reaction significantly （P〈0.05） ; and chemotherapy, radiotherapy or operation combined with Compound kushen injection may enhance clinical efficacy and the quality of life, meanwhile lessen bone marrow suppression （P〈0.05）. CONCLUSIONS： For therapies of various tumors, Kang＇ ai injection, Lentinan injection, Shenqi fuzheng injection and Compound kushen injection display different significant efficacies. The systematic review provides the corresponding evidence-based pharmaceutical information for the clinical antitumor therapeutics with the 4 kinds of TCM injections.