参麦注射液辅助治疗肿瘤临床应用文献分析

目的:对参麦注射液辅助治疗肿瘤的临床应用文献进行分析,初步了解其辅助治疗肿瘤的用药规律及疗效特征。方法:检索获得参麦注射液治疗肿瘤相关文献并按照制订的纳入/排除标准进行整理与分类,分析文献涉及研究类型、样本量、受试者性别、年龄等基线资料以及用药剂量、疗效评价指标等情况。结果:以"登峰牌"参麦注射液为例,纳入研究文献54篇,涉及临床研究多为100人以下的小规模研究,所治疗的肿瘤以肺癌居多,并且文献报道中多以KPS评分改善、毒性反应减少、总有效率提高、临床症状改善、一年生存率提高及NK,LAK活性、TH/TS等理化指标改善作为临床疗效的评价指标。结论:参麦注射液用于辅助治疗肿瘤日益广泛,并取得一定的疗效。但是由于临床有效性文献质量并不是很高,作为证据级别尚显不够,因而可结合前瞻性临床试验将研究推向深入。

Literature analysis of tumor treatment by Shenmai injection

Objective: To analyze the literature about clinical efficacy of Shenmai injection for tumor treatment, and understand preliminarily the medicine law and effect of Shenmai injection. Method: The included and excluded rules are built, and the literatures about cancer treatment by "Deng feng" Shenmai injection are classified by the rules. Many kinds of information are analyzed such as published years, research types, sample size, sex and age of test-takers, dosage and evaluated parameters. Result: The 54 literatures are brought into analysis. The small scale research below 100 people is the main type and lung cancer is the most. The evaluated parameters in these literatures include KPS improvement rate, reduction of toxicity reaction, improvement of total efective rate, improvement of clinical symptoms, improvement of one year survial rate, NK activity,LAK activity,TH/TS value and so on. Conclusion: The application of Shenmai injection for tumor treatment is increasingly extensive and some effect is got. But the quality of literature about clinical efficacy is not enough good and it cannot be adopted as evidence. It can support post-marketing reevaluation and improve the research combined with prospective experiment.