康艾注射液在肿瘤姑息治疗中的临床研究现状

Literature Review of Kang Ai Injection Applied in Palliative Treatment of Advanced Tumors

目的:收集2014年12月之前国内国外发表的关于康艾注射液姑息治疗晚期恶性肿瘤的随机对照试验文献,利用系统评价的方法评价康艾注射液在晚期恶性肿瘤姑息治疗中的疗效和安全性。方法:全面检索MEDLINE(Pubmed)、Cochrane library、中国生物医学文献数据库(CBM)、维普中文科技期刊数据库(VIP)、中国期刊全文数据库(CNKI)、万方数据库以得到康艾注射液姑息治疗晚期恶性肿瘤的合适文献,并采用Cochrane协作网提供的Rev Man 5.2软件对数据进行处理。结果:共纳入8个RCT,545例,文献质量均较低。对KPS评分改善情况进行meta分析,异质性检验(χ2=12.12,P=0.06,I2=51%),采用随机效应模型统计分析,治疗组优于对照组(RR=2.69,Z=4.54,P<0.000 01,95%CI=[1.75,4.12]);采用描述性统计方法分析,改善纳差症状方面共有4个研究,其中3个研究提示治疗组优于对照组。减轻疼痛方面共纳入6个试验,其中4个试验提示康艾注射液有利于减轻癌痛。康艾注射液姑息治疗在改善乏力症状和改善睡眠方面,结果均提示优于对照组。结论:康艾注射液在姑息治疗晚期恶性肿瘤方面,能够改善患者纳差、癌痛、乏力、失眠不适症状,并提高患者生活质量,但因纳入文献质量较低,需要更多更规范的RCT予以进一步印证。

Objective：To collect literature with Randomized Control Trials （RCTs） which were published before December 2014, using system evaluation to assess the efficacy and safety of Kang Ai Injection in palliative treatment of advanced malignant tumors. Methods：Electronic database such as MEDLINE （Pubmed）, Cochrane library, CBM, VIP, CNKI, Wanfang were searched through to collect appropriate studies about Kang Ai Injection combined with best supportive care （BSC） versus BSC alone in the palliative treatment of advanced tumors. All data were analyzed and processed by RevMan5.2 software provided by Cochrane. Re- sults： Eight RCTs, including 545 cases were involved into the study, but all of the studies were of low quality. The patients＇ im- provement of KPS was evaluated by meta-analysis. Heterogeneity text indicated data （χ2= 12.12,P =0. 06,I2 =51% ）. The re- suits with random effects model showed that Kang Ai Injection could improve KPS （ RR = 2.69 ,Z = 4.54, P 〈 0. 00001,95% CI = [ 1.75, 4.12] ）. The improvement of the symptoms were analyzed by the method of descriptive statistics. All in all, three of four studies included indicated that Kang Ai Injection could improve the symptom of poor appetite in a larger deal. Four in six studies included showed that Kang Ai Injection could alleviate the pain in a larger amount. Meanwhile, all studies included indicated that Kang Ai Injection could better improve the symptoms of fatigue and insomnia compared with the control group. Conclusion ： Adop- ting Kang Ai Injection in the palliative treatment of malignant tumors can improve the symptoms of poor appetite, cancer pain, fa- tigue and insomnia as well as the quality of life. However, because of the low qualities of the studies, the results should be further proved by more normative RCTs.