康艾注射液辅助治疗肺癌化疗相关性癌因性疲乏的Meta分析及GRADE评价

Meta-analysis and GRADE Evaluation of Kang’ai Injection in Adjuvant Treatment of Cancer-related Fatigue Associated with Chemotherapy for Lung Cancer

目的系统评价康艾注射液辅助治疗肺癌化疗相关性癌因性疲乏的有效性与安全性。方法计算机检索中国知网、维普、万方数据库、中国生物医学文献数据库、Pubmed、Embase、the Cochrane Library中关于康艾注射液辅助治疗肺癌化疗相关性癌因性疲乏的随机对照试验。检索时间为建库至2023年8月9日。采用Revman5.3软件进行统计学分析及异质性检验。计数资料以危险比作为效应值,计量资料以平均差或标准化均方差作为效应值,P<0.05为差异具有统计学意义。结果共纳入12项随机对照试验,包括1030例患者,Meta分析结果显示:康艾注射液辅助治疗肺癌化疗相关性癌因性疲乏,能显著提高中重度疲乏缓解率[RR=4.13,95%CI(2.91,5.86),P<0.01],降低Piper疲乏量表评分[MD=-1.87,95%CI(-2.75,-0.99),P<0.01]和简明疲乏量表评分[MD=-2.32,95%CI(-3.55,-1.10),P<0.01],提高生活质量[MD=10.34,95%CI(7.25,13.43),P<0.01]、降低骨髓抑制发生[RR=0.46,95%CI(0.27,0.76),P<0.01]。GRADE证据质量评价结果普遍较低。结论康艾注射液能较好的改善肺癌化疗相关性癌因性疲乏患者的疲乏状态,提高疲乏中重度缓解率,改善生活质量,降低不良反应发生率,疗效及安全性良好,但证据质量偏低。

Objective To systematically evaluate the effectiveness and safety of Kang’ai Injection in adjuvant treatment of cancer-induced fatigue(CRF)associated with chemotherapy for lung cancer.Methods Randomized controlled trials of Kang’ai Injection in adjuvant treatment of chemotherapy-induced CRF in lung cancer were retrieved from the CNKI,VIP,Wanfang Data,SinoMed,Pubmed,Embase,and the Cochrane Library database.The search time was from the establishment of the database to August 9,2023.Revman5.3 software was used for statistical analysis and heterogeneity test.The risk ratio(RR)was used as the effect value of enumeration data,and the mean difference(MD)or the standardized mean difference(SMD)were used as the effect values of measurement data.The P<0.05 was defined as statistically significant difference.Results A total of 12 randomized controlled trials were included,including 1030 patients.Meta-analysis results showed that Kang’ai Injection adjuvant treatment significantly increased the moderate to severe remission rate of chemotherapy-induced CRF in lung cancer[RR=4.13,95%CI(2.91,5.86),P<0.01],and reduced Piper Fatigue Scale score[MD=-1.87,95%CI(-2.75,-0.99),P<0.01]and the Brief Fatigue Inventory score[MD=-2.32,95%CI(-3.55,-1.10),P<0.01],improved the quality of life[MD=10.34,95%CI(7.25,13.43),P<0.01],and decreased the occurrence of bone marrow suppression[RR=0.46,95%CI(0.27,0.76),P<0.01].The GRADE quality of evidence was generally low.Conclusion Kang’ai Injection adjuvant treatment exerts certain efficacy on relieving the fatigue status of lung cancer patients with chemotherapy-induced CRF,enhancing the moderate to severe fatigue remission rate,improving the quality of life,and decreasing the incidence of adverse reactions.The efficacy and safety are satisfactory,but the quality of evidence is low.