康莱特注射液联合化疗对晚期胰腺癌有效性和安全性的Meta分析

Efficacy and Safety of Kanglaite Injection Combined with Chemotherapy in the Treatment of Advanced Pancreatic Cancer:a Meta-analysis

目的:系统评价康莱特注射液(KLT)联合化疗治疗晚期胰腺癌的有效性和安全性。方法:计算机检索PubMed、Embase、the Cochrane Library、SinoMed、CNKI、WanFang Data和VIP数据库,搜集有关KLT联合化疗治疗晚期胰腺癌的随机对照试验(RCT),检索时限均为建库至2019年8月15日。由两名研究者独立筛选文献、提取资料及评价纳入研究的风险偏倚后,采用RevMan 5.3软件进行Meta分析。结果:共纳入10个RCT,合计531例患者。Meta分析结果显示,与采用单纯化疗的对照组相比,采用KLT联合化疗的试验组能提高有效率[OR=1.86,95%CI(1.24,2.79),P=0.003]、生存质量改善率[OR=3.37,95%CI(2.00,5.70),P<0.00001]、疼痛改善率[OR=3.46,95%CI(1.99,6.01),P<0.0001]及体重改善率[OR=3.06,95%CI(1.76,5.33),P<0.0001],同时还能降低骨髓抑制[OR=0.49,95%CI(0.26,0.95),P=0.03]、肝功能损害[OR=0.41,95%CI(0.23,0.73),P=0.003]、肾功能损害[OR=0.20,95%CI(0.06,0.64),P=0.007]等不良反应的发生率,差异均有统计学意义,而恶心呕吐、神经毒性发生率较对照组的差异无统计学意义。结论:KLT联合化疗治疗晚期胰腺癌可提高患者的近期疗效及生活质量,并且能减少不良反应的发生。受纳入研究数量和质量的限制,上述结论尚需更多高质量研究予以验证。

Objective:To systematically review the efficacy and safety of Kanglaite injection(KLT)combined with chemotherapy in the treatment of advanced pancreatic cancer.Methods:PubMed,Embase,the Cochrane Library,SinoMed,CNKI,WanFang Data and VIP databases were electronically searched to collect randomized controlled trials(RCTs)of KLT for combined with chemotherapy in the treatment of advanced pancreatic cancer from inception to August 15,2019.Two reviewers independently screened literature,extracted data and assessed the risk of bias of included studies.Then,Meta-analysis was performed by using RevMan 5.3 software.Results:A total of 10 RCTs including 531 patients were included.The results of Meta-analysis showed that:the KLT combined chemotherapy group was superior to the control group(chemotherapy alone)on the effective rate(OR=1.86,95%CI 1.24 to 2.79,P=0.003),the rate of life quality(OR=3.37,95%CI 2.00 to 5.70,P<0.00001),the rate of pain relief(OR=3.46,95%CI 1.99 to 6.01,P<0.0001),the rate of weight gain(OR=3.06,95%CI 1.76 to 5.33,P<0.0001),and the incidence of bone marrow depression(OR=0.49,95%CI 0.26 to 0.95,P=0.03),impaired liver function(OR=0.41,95%CI 0.23 to 0.73,P=0.003)and impaired renal function(OR=0.20,95%CI 0.06 to 0.64,P=0.007).But there was no significant difference in the incidence of nausea and vomiting and neurotoxicity.Conclusion:KLT combined with chemotherapy in advanced pancreatic cancer can improve the short-time effect,the quality of life,and decrease the occurrence of adverse reaction.Due to limited quality and quantity of the included studies,more high quality studies are required to verify the conclusion.