参苓白术散联合化疗干预大肠癌晚期随机平行对照研究

Randomized Parallel Controlled Study of Shenlingbaizhu Powder Combined with Chemotherapy in the Treatment of Advanced Colorectal

[目的]观察参苓白术散联合化疗干预大肠癌晚期疗效。[方法]使用随机平行对照方法,将54例住院患者按病志号抽签随机分两组。对照组27例奥沙利铂85mg/m^2 d1,d8静滴2h;卡培他滨850mg/m^2 d1-d14口服,间隔7d;或奥沙利铂130mg/m^2 ivgtt2h d1;亚叶酸钙200mg/m^2 ivgtt2h d1-5;5-FU300mg/m^2 ivgtt4h d1-5,21d为1个周期。治疗组27例参苓白术散(党参15g,炒白芍10g,茯苓15g,炒白术10g,薏苡仁、败酱草各30g,龙葵15g,山药20g,法半夏、陈皮、当归、木香各10g,炙甘草3g;腹泻不止加诃子10g,芡实9g,石榴皮10g;瘀毒内阻、舌质紫暗瘀斑加紫丹参、三七粉各3g;便秘加瓜蒌仁、火麻仁各6g,制大黄3g;纳食欠佳加焦山楂、焦神曲、鸡内金各10g,炒谷芽、炒麦芽各15g),每个化疗周期前2天开始给药,1剂/d,水煎300m L,中、晚餐前2h口服150m L,连续治疗10d为1个周期;化疗同对照组。观测临床症状、生存质量评分、毒副反应发生率。连续治疗2个周期,判定疗效。[结果]治疗组CR0例,PR11例,SD12例,PD4例,部分缓解率40.74%;对照组CR0例,PR8例,SD10例,PD9例,部分缓解率29.63%;部分缓解率两组无明显差异(P>0.05)。生存质量评分改善治疗组优于对照组(P<0.01)。[结论]参苓白术散联合化疗干预大肠癌晚期,疗效满意,无严重不良反应,值得推广。

[Objective] To observe the effect of Shenlingbaizhu Powder combined with chemotherapy on advanced colorectal cancer. [Methods] Fifty-four hospitalized patients were randomly divided into two groups according to the random number method. The control group 27 cases oxaliplatin 85 mg/m^2 d1, d8 intravenous infusion of 2 h; capecitabine 850 mg/m^2 d1-d14 oral, interval 7 d; or oxaliplatin 130 mg/m^2 ivgtt2 h d1; leucovorin 200 mg/m^2 ivgtt2 h d1-5; 5-FU 300 mg/m^2 ivgtt4 h d1-5, 21 d is one cycle. Treatment group of27 cases of Shenlingbaizhu powder（Codonopsis 15 g, fried white peony root 10 g, Poria 15 g, fried Atractylodes10 g, Coix Seed, Patrinia 30 g, Solanum nigrum 15 g, yam 20 g, France Pinellia, dried tangerine peel, angelica,Each 10 g, Zhigancao 3 g; diarrhea more than Jiaotia 10 g, Gorgon 9 g, pomegranate skin 10 g; blood stasis internal resistance, tongue purple dark eczema plus purple salvia, Sanqi powder 3 g; constipation plus gouxian Ren, 2 g, 2 g of each chemotherapy cycle began to be administered, 1 dose/d（1 g/d）, 1 g/d, Decoction 300 mL,in the morning before dinner 2 h oral 150 mL, continuous treatment for 10 d for a cycle; chemotherapy with the control group. Observation of clinical symptoms, quality of life score, the incidence of toxic side effects.Continuous treatment of 2 cycles to determine the efficacy. [Results] The treatment group CR 0 cases, PR11 cases, SD 12 cases, PD 4 cases, partial remission rate 40.74%; control group CR 0 cases, PR 8 cases, SD10 cases, PD 9 cases, partial remission rate of 29.63% There was no significant difference between the two groups（P0.05）. Quality of life improvement was better in the treatment group than in the control group（P0.01）. [Conclusion] Shenlingbaizhu combination chemotherapy combined with advanced colorectal cancer,the effect is satisfactory, no serious adverse reactions, it is worth promoting.