升白汤口服液原方调整黄芪剂量改善恶性肿瘤化疗疗效及不良反应随机平行对照研究

Randomized Parallel Group Study of Adverse Effect and Chemotherapeutic Effect after the Dose Adjustment of Radix Astragali about Shengbai Tang

[目的]观察升白汤口服液原方调整黄芪剂量改善化疗疗效及不良反应疗效。[方法]使用随机平行对照方法,将106例住院患者按病志号抽签方法简单随机分为三组。对照组A组30例TP方案化疗：紫杉醇175mg/m2,静脉滴注3h,1次/d;顺铂25mg/m2,D1~3L;紫杉醇化疗前30min行预处理：地塞米松10mg,静注,苯海拉明40mg,肌注,西咪替丁400mg,静滴。治疗组B组38例升白汤口服液（黄芪常规剂量）,黄芪30g,白术、茯苓各15g,当归10g,太子参30g,女贞子、墨旱莲各15g,鸡血藤30g,水煎150~200m L,1剂/d,早晚温服,每程化疗前5d开始服用,连续14d。;西药治疗同对照组。治疗组C组38例升白汤口服液（黄芪调整剂量）,黄芪20g,白术、茯苓各15g,当归10g,太子参30g,女贞子、墨旱莲各15g,鸡血藤30g,水煎150~200mL,1剂/d,早晚温服,每程化疗前5d开始服用,连续14d;西药治疗同对照组。连续治疗3周为1疗程。观测临床症状、血常规;治周血NK细胞活性、CD3＋、CD 4＋、CD8＋、CD4＋/CD8＋、不良反应。连续治疗2疗程,判定疗效。[结果]A组CR2例,PR16例,SD5例,PD7例,DCR76.67%。B组CR3例,PR19例,SD11例,PD5例,DCR86.84%。C组CR3例,PR22例,SD10例,PD4例,DCR89.47%。B、C组疗效优于A组（P〈0.05）。KPS评分、骨髓抑制、免疫功能B、C组优于A组（P〈0.05）,B组与C组无明显差异（P〉0.05）。C组燥热症状改善优于B组（P〈0.05）。[结论]升白汤口服液原方调整黄芪剂量对化疗疗效及不良反应改善,疗效满意,无严重不良反应,值得推广。

[Objective]To observe the influence of adverse effect and chemotherapeutic effect after the dose adjustment of astragali radix about Shengbaitang.[Methods]One hundred and six patients with advanced malignant tumor were divided into there groups,30 cases were treated only by chemotherapy（control group）,other two 38 cases were treated by chemotherapy and Shengbaitang（treatment groups）.One was conventional dose of radix astragali（radix astragali 30 g,rhizoma atractylodis macrocephalae 15 g,poria cocos 15 g,angelica sinensis 10 g,adix pseudostellariae 30 g,glossy privet fruit 15 g,eclipta15g,caulis spatholobi 30g）and another was adjustive dose of radix astragali（radix astragali 20 g,The rest like the previous）.21 d was a continuous course of treatment.2 courses of continuous treatment to determine efficacy.[Results]There were statistically significant on the shortterm therapeutic effect in the treatment group and control group,group B and C were better than group A（P〈0.05）.Also,there were statistically significant（P〈0.05）on the quality of life 、occurrence rate of myelosuppression and immune function,the treatment groups were not statistically significant（P〉0.05）,the symptom of hot and dry heat on adjustive dose group was obviously higher than conventional dose group（P〈0.05）.[Conclusion]Shengbaitang（adjustive dose of radix astragali） in treatment of advanced malignant tumor can effectively supp ress tumor,enhance patient resistance.weaken the adverse reaction and improve the quality of survival,no side effects,it is worth promoting.