摘要
目的从循证医学的角度系统评价康艾注射液联合TP化疗方案治疗非小细胞肺癌的疗效和安全性,为临床应用提供依据。方法广泛搜集康艾注射液联合TP方案治疗非小细胞肺癌的临床试验,运用Cochrane图书馆系统评价方法,对纳入研究进行质量评价和Meta分析。结果 5个随机对照试验和1个病例-对照试验纳入系统评价,均为Jadad评分小于3的低质量研究。Meta分析结果提示康艾注射液联合TP方案在近期疗效、Karnofsky评分改善方面均优于单纯使用TP方案治疗。近期疗效比较OR值为1.79,95%可信区间为1.17～2.73;Karnofsky评分改善情况比较OR值为3.13,95%可信区间为1.88～5.20。在安全性方面,使用康艾注射液联合TP方案时Ⅱ度和Ⅱ度以上不良反应发生率较单用TP方案更低,其中消化道反应比较OR值为0.38,95%可信区间为0.24～0.60;骨髓抑制反应比较OR值为0.40,95%可信区间为0.25～0.62。结论康艾注射液联合TP方案治疗非小细胞肺癌可能取得较单纯TP方案化疗更好的效果和更低的不良反应发生率,但由于纳入的研究方法学质量低,存在发生偏倚的高度可能性,需更多设计合理的高质量的临床试验加以验证。
Objective To systematically appraise the effectiveness and safety of Kang Ai injection together with TP model chemotherapy for the treatment of non-small cell lung cancer （NSCLC）, thus to provide an evidence-based guidance for clinical practice. Methods Reports of chnical trials on Kang Ai injection for the treatment of NSCLC were extensively retrieved. Cochrane library systematic review method was applied to analyze the quality and quantity of included trials. Result Five randomized controlled trials and one case-control study were included in the systematic review. All the 6 studies were concluded as poor-quality ones by the methodological quality appraisal. A Meta-analysis showed that the combination of Kang Ai injection and conventional TP model chemotherapy had better effectiveness on both short-term carcinoma evaluation and Kamofsky score than the regular conventional TP model chemotherapy had. The odds ratio （OR） and 95% confidence interval （95%CI） of the comparison of the improvement on short-term carcinoma evaluation were 1.79 （1.17~2.73）, and the OR and 95% CI of comparison of the improvement on Kamofsky score were 3.13 （1.88~5.20）. Besides, the combination of Kang Ai injection and TP chemotherapy had lower occurrence of digestive reaction and myelo-suppression of II degree or above. The OR value and 95%CI on the two outcomes were 0.38 （0.24~0.60） and 0.40 （0.25~0.62）, respectively. Conclusion The combination of Kang Ai injection and TP model chemotherapy may have better effectiveness and safety for NSCLC than the regular TP model chemotherapy had. Nevertheless, because of the unclear methodological quality of the included studies, the results of our Meta-analysis may possibly be of much bias. Further well-designed clinical studies are required for more accurate clinical evaluation.
出处
《中国中医药信息杂志》
CAS
CSCD
2011年第5期29-32,共4页
Chinese Journal of Information on Traditional Chinese Medicine
