| 刘文波,马建秀,姚 南.复方苦参注射液联合化疗治疗晚期结直肠癌近期疗效及安全性的Meta分析[J].浙江中西医结合杂志,2016,26(8): |
| 复方苦参注射液联合化疗治疗晚期结直肠癌近期疗效及安全性的Meta分析 |
| Short-term efficacies and safety of Fufangkushen Injection combined with chemotherapy for advanced colorectal cancer: a meta-analysis |
| 投稿时间：2015-08-22 修订日期：2016-06-12 |
| DOI： |
| 中文关键词: 大肠癌 结肠癌 直肠癌 复方苦参注射液 岩舒 Meta分析 系统评价 随机对照试验 |
| 英文关键词:Colorectal neoplasms Colonic neoplasms Rectal neoplasms Fufangkushen Injection Systematicreview Meta-analysis Randomized controlled trial |
| 基金项目: |
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| 中文摘要: |
| 目的 系统评价复方苦参注射液(岩舒)联合化疗治疗晚期结直肠癌近期疗效和安全性。方法 利用计算机检索Cochrane图书馆、MEDLINE、PubMed、中国知网(CNKI)、维普(VIP)、万方数据库(WanFang Data)和中国生物医学期刊文献数据库(CBM)。全面收集建库至2015年5月国内外发表的关于复方苦参注射液联合化疗治疗晚期结直肠癌的随机对照试验(RCT),由2位研究者严格按照纳入与排除标准独立筛选文献、提取资料和评价纳入研究的方法学质量后,采用RevMan5.3软件进行Meta分析。结果 最终纳入20个RCT,包括1614列患者。Meta分析结果显示：与单纯化疗组相比,复方苦参注射液(岩舒)联合化疗组的有效率[0R＝2.01,95％CI (1.58, 2.55),P<0.00001]、生存质量改善[0R＝2.71,95％CI(2.11, 3.50),P<0.00001]、白细胞下降[0R=0.23,95％CI(0.14,0.40),P<0.00001]、血小板下降[0R＝0.46,95％CI(0.30,0.71),P=0.0004]、恶心呕吐[0R＝0.33,95％CI(0.25,0.45), P<0.00001]、腹泻[0R＝0.25,95％CI(0.15,0.39), P<0.00001]、周围神经毒性[0R＝0.33,95％CI(0.22,0.51), P<0.00001] 、肝功能[0R＝0.19,95％CI(0.11,0.33), P<0.00001]、肾功能[0R＝0.28,95％CI(0.11,0.72), P=0.008]和疼痛[0R＝5.37,95％CI(1.92,15.04), P=0.001]差异有统计学意义；脱发[0R＝0.94,95％CI(0.47,1.88), P=0.86]差异无统计学意义。结论 与单纯化疗相比,复方苦参注射液(岩舒)联合化疗治疗晚期结直肠癌可提高近期疗效和改善生存质量,降低骨髓抑制、胃肠道反应、周围神经毒性、肝肾功能损害等并发症的发生率和缓解疼痛。以上结论由于受纳入研究文献质量的限制,仍需开展更多高质量研究,特别是多中心、大样本量的随机双盲对照试验来进一步探索。建议临床应用时结合具体情况。 |
| 英文摘要: |
| Objective To systematically evalute the short-term efficacies and safety of Fufangkushen Injection combined with chemotherapy for advanced colorectal cancer. Methods we searched the Date of The Cochrane Library，MEDLINE，PubMed，CNKI，VIP，WanFang Data and CBM in computer to completely collect domestic and overseas published randomized controlled trials（RCT）about Fufangkushen Injection combined with chemotherapy on advanced colorectal cancer during the date of their establishment to May, 2015. Two reviewers independently screened literatures strictly according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies by two reviewers. Then the meta-analysis was performed by using RevMan 5.3 software. Ｒesults a total of 20 RCTs involving 1614 patients were included. Compared with the chemotherapy group，Fufangkushen Injection combined with chemotherapy the difference of effective rate [0R＝2.01，95％CI (1.58, 2.55),P<0.00001]、the quality of life improvement rate [0R＝2.71，95％CI（2.11, 3.50）,P<0.00001]、leucocytopenia [0R=0.23,95％CI（0.14,0.40）,P<0.00001]、decrease of platelet [0R＝0.46，95％CI（0.30,0.71）,P=0.0004]、occurrence of nausea and vomiting rate[0R＝0.33，95％CI（0.25,0.45）, P<0.00001]、diarrhea [0R＝0.25，95％CI（0.15,0.39）, P<0.00001]、hypohepatia [0R＝0.19，95％CI（0.11,0.33）, P<0.00001]、renal hypofunction[0R＝0.28，95％CI（0.11,0.72）, P=0.008]、the incidence of neurotoxicity [0R＝0.33，95％CI（0.22,0.51）, P<0.00001]and pain[0R＝5.37，95％CI（1.92,15.04）, P=0.001] had statistical significance；while alopecia had no statistical significance [0R＝0.94，95％CI（0.47,1.88）, P=0.86]. Compared with chemotherapy, chemotherapy combined with Fufangkushen Injection can increase effective rate and the quality of life improvement rate and reduce myelosuppression，gastrointestinal reaction，hepar and renal functional lesion，the incidence of neurotoxicity and relieve pain. The above conclusion due to the limitation of the quality of the included literature, still need to develop more high-quality research, especially the multicenter, large sample size，double-blind randomized clinical trial are needed to further explore.We Suggested that the clinical application of combined with the specific circumstances. |
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