[關(guān)鍵詞]
[摘要]
目的 系統(tǒng)評價(jià)艾迪注射液聯(lián)合FOLFOX4化療方案治療中晚期結(jié)直腸癌療效及安全性。方法 檢索PubMed、Cochrane Library、Embase、Medline、中國期刊全文數(shù)據(jù)庫(CNKI)、中國生物醫(yī)學(xué)文獻(xiàn)服務(wù)系統(tǒng)(SinoMed)、維普中文科技期刊數(shù)據(jù)庫(VIP)、萬方數(shù)據(jù)知識服務(wù)平臺(Wanfang Data)中艾迪注射液聯(lián)合FOLFOX4化療方案治療中晚期結(jié)直腸癌的臨床隨機(jī)對照試驗(yàn)(randomized controlled trial,RCT),檢索時(shí)限為建庫起至2022年4月1日,采用RevMan 5.3軟件進(jìn)行Meta分析。結(jié)果 共納入18項(xiàng)RCTs,包括1 515例患者,其中試驗(yàn)組775例、對照組740例。匯總?cè)垦芯康腗eta分析顯示,試驗(yàn)組客觀緩解率(objective response rate,ORR)[RR=1.22,95% CI(1.11,1.34)]及疾病控制率(diseasecontrol rate,DCR)[RR=1.10,95% CI(1.05,1.16)]均優(yōu)于對照組(P<0.05);試驗(yàn)組可改善患者生活質(zhì)量[RR=1.30,95% CI(1.18,1.44),P<0.01],降低白細(xì)胞減少發(fā)生率[RR=0.53,95% CI(0.41,0.70),P<0.01],降低血小板減少發(fā)生率[RR=0.53,95% CI(0.28,0.98),P<0.05],降低惡心嘔吐發(fā)生率[RR=0.57,95% CI(0.47,0.70),P<0.01],降低腹瀉發(fā)生率[RR=0.30,95% CI(0.14,0.65),P<0.05]。敏感性分析顯示ORR及DCR研究結(jié)果穩(wěn)健,證據(jù)可靠。結(jié)論 艾迪注射液聯(lián)合FOLFOX4方案治療中晚期結(jié)直腸癌較單純化療可明顯提高療效,改善患者生活質(zhì)量,降低相關(guān)不良反應(yīng)發(fā)生率,具有良好的療效和安全性。但鑒于本研究局限性,尚需要高質(zhì)量、大樣本的臨床RCT對研究結(jié)果進(jìn)一步驗(yàn)證。
[Key word]
[Abstract]
Objective To systematically evaluate the efficacy and safety of Aidi Injection in combination with FOLFOX4 chemotherapy regimen for the treatment of intermediate to advanced colorectal cancer. Methods PubMed, Cochrane Library, Embase, Medline, CNKI, SinoMed, VIP, Wanfang were searched for RCTs of Aidi Injection combined with FOLFOX4 chemotherapy regimen for the treatment of intermediate to advanced colorectal cancer from the establisment of database to April 1, 2022, and Meta-analysis was performed using RevMan 5.3 software. Results A total of 18 RCTs with 1 515 patients were included, with 775 patients in the test group and 740 in the control group. A Meta-analysis after pooling all studies showed that the objective response rate (ORR)[RR=1.22, 95%CI (1.11, 1.34)] and disease control rate (DCR)[RR=1.10,95%CI (1.05, 1.16)] were better in the test group than in control group (P<0.05). The test group improved quality of life[RR=1.30, 95%CI (1.18, 1.44), P<0.01]. The test group reduced the incidence of leukopenia[RR=0.53, 95%CI (0.41, 0.70), P<0.01]; thrombocytopenia[RR=0.53, 95%CI (0.28, 0.98), P<0.05], nausea and vomiting[RR=0.57, 95%CI (0.47, 0.70), P<0.01], and diarrhea[RR=0.30, 95%CI (0.14, 0.65), P<0.05] than in control group. Sensitivity analysis showed that the ORR and DCR study results were robust and reliable. Conclusions Aidi Injection combined with FOLFOX4 regimen for the treatment of intermediate to advanced colorectal cancer can significantly improve the therapeutic effect, improve patients' quality of life and reduce the incidence of related adverse reactions than chemotherapy alone, with good efficacy and safety. However, in view of the limitations of the study, further validation of the study results by high-quality, large-sample RCTs is still needed.
[中圖分類號]
R286.5;R979.1
[基金項(xiàng)目]
國家自然科學(xué)基金資助項(xiàng)目(8207142125);中國中醫(yī)科學(xué)院科技創(chuàng)新工程重大攻關(guān)項(xiàng)目(CI2021A01801)