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目的观察参芪扶正注射液在减轻妇科TP方案化疗副作用的效果。方法2007年10月至2009年2月在中山大学附属第三医院住院的42例妇科肿瘤化疗患者,随机分为研究组(化疗+参芪扶正注射液组,22例)和对照组(单纯化疗组,20例)。化疗方案为TP[艾素+卡铂/顺铂(CBP/DDP)]方案,研究组另加参芪扶正注射液静脉滴注。观察化疗副作用及疗效。结果研究组的II级恶心呕吐反应少于对照组,差异有统计学意义(P<0.05),但I级恶心呕吐反应及总的恶心呕吐反应比较两组无统计学意义(P>0.05)。淋巴细胞下降的比较,研究组少于对照组,差异有统计学意义(P<0.05)。在白细胞、血红蛋白下降、过敏反应、肝肾功能(转氨酶、肌酐、尿素氮)、脱发、周围神经毒性等副作用方面,两组比较均无统计学意义(P>0.05)。化疗疗效两组比较,差异无统计学意义(P>0.05)。结论参芪扶正注射液可在一定程度上减轻妇科恶性肿瘤接受TP方案化疗的副作用,可减轻恶心呕吐,保护淋巴细胞等,且对化疗疗效无冲突作用。
Objective To observe the effect of Shenqi Fuzheng injection on alleviating side effects of chemotherapy in gynecological TP regimen. Methods Forty-two patients with gynecologic oncology who were hospitalized in the Third Affiliated Hospital of Sun Yat-sen University from October 2007 to February 2009 were randomly divided into study group (chemotherapy plus Shenqi Fuzheng injection group, n = 22) and control group (chemotherapy alone Group, 20 cases). The chemotherapy regimen was TP [methotrexate + carboplatin / cisplatin (CBP / DDP)] regimen, and the study group received Shenqi Fuzheng injection by intravenous infusion. To observe the side effects of chemotherapy and efficacy. Results The grade II nausea and vomiting responses in the study group were less than those in the control group (P <0.05). However, the grade I nausea and vomiting responses and the total nausea and vomiting responses were not statistically significant (P> 0.05). Compared with the control group, the difference of lymphocyte descent was statistically significant (P <0.05). There was no significant difference between the two groups in the side effects such as white blood cell, hemoglobin decline, anaphylaxis, liver and kidney function (aminotransferase, creatinine, urea nitrogen), alopecia and peripheral neurotoxicity. There was no significant difference between two groups (P> 0.05). Conclusion Shenqi Fuzheng injection can reduce the side effects of TP regimen in gynecological malignant tumors to a certain extent, reduce nausea and vomiting, protect lymphocytes, and have no conflict effect on the curative effect of chemotherapy.