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目的评价参附注射液减轻肿瘤患者化学疗法(化疗)的不良反应的疗效。方法检索Medline、PubMed、Embase、维普数据库、中文科技期刊全文数据库、中国期刊全文数据库、中国生物医学文献数据库、万方数据库,检索时间均为1994年1月-2013年5月,检索使用参附注射液配合化疗减轻化疗不良反应的临床随机对照试验,无语种限制。纳入文献的质量采用Jadad评分表评价。对纳入的试验进行系统评价。结果共纳入30篇文献,均为中文文献,共2 039例患者。参附注射液配合化疗(参附组)与单纯化疗组比较,参附组化疗后白细胞计数正常率较单纯化疗组高,差异有统计学意义[RR=1.54,95%CI(1.28,1.84),P<0.000 01];参附组化疗后血红蛋白正常率较单纯化疗组高,差异有统计学意义[RR=1.30,95%CI(1.14,1.48),P<0.000 1];参附组化疗后血小板计数正常率较单纯化疗组高,差异有统计学意义[RR=1.39,95%CI(1.19,1.62),P<0.000 1];参附组无恶心呕吐的患者比例高于单纯化疗组,差异有统计学意义[RR=1.54,95%CI(1.30,1.81),P<0.000 01];参附组生活质量评分明显优于单纯化疗组。结论参附注射液配合化疗与单纯化疗相比,可减轻外周血细胞的减少、胃肠道反应,提高患者生活质量。由于所纳入试验的方法学质量普遍较低,目前尚不能就此得出结论,需要设计更加合理、严格执行的大样本随机试验。
Objective To evaluate the efficacy of Shenfu Injection on alleviating the adverse reactions of chemotherapies (chemotherapy) in cancer patients. Methods The search of Medline, PubMed, Embase, VIP database, Chinese scientific journals full-text database, Chinese Journal Full-text Database, Chinese Biomedical Literature Database, Wanfang database were retrieved from January 1994 to May 2013, Injection with chemotherapy to reduce the adverse effects of chemotherapy in clinical randomized controlled trials, no language restrictions. The quality of the included literature is assessed using the Jadad scale. The included trials were systematically evaluated. Results A total of 30 articles were included, both of which were Chinese. A total of 2 039 cases were included. Compared with the chemotherapy alone group, the normal leukocyte count in the treatment group was significantly higher than that in the chemotherapy alone group (RR = 1.54, 95% CI 1.28, 1.84) , P <0.000 01]. The normalized rate of hemoglobin in the Shenfu group was higher than that in the pure chemotherapy group (RR = 1.30, 95% CI, 1.14, 1.48, P <0.0001) The normal rate of platelet count was higher than that of the chemotherapy alone group (RR = 1.39, 95% CI 1.19, 1.62, P <0.000 1). The proportion of patients with nausea and vomiting was significantly higher in the reference group than in the chemotherapy alone group , The difference was statistically significant [RR = 1.54,95% CI (1.30,1.81), P <0.000 01]; the quality of life of the reference group was significantly better than chemotherapy alone group. Conclusion Shenfu injection combined with chemotherapy can reduce the reduction of peripheral blood cells and gastrointestinal reactions and improve the quality of life of patients compared with chemotherapy alone. Due to the generally low methodological quality of the included trials, it is not yet possible to conclude here, and a more rational and rigorous randomized trial of large samples needs to be designed.