解毒生化丹方联合奥沙利铂干预湿热瘀毒型结直肠癌临床疗效

Clinical Efficacy of Jiedu Shenghua Pellet(解毒生化丹)Combined with Oxaliplatin in Colorectal Cancer Patients of Damp-Heat and Blood-Stasis-Toxin Syndrome

目的探究解毒生化丹方联合奥沙利铂干预“湿热瘀毒”型结直肠癌的临床疗效。方法选取医院2021年1月—2022年1月收治的107例结直肠癌患者为研究对象,采用随机分组法分为观察组54例与对照组53例,对照组使用FOLFOX方案(奥沙利铂+氟尿嘧啶+醛氢叶酸)治疗,观察组采用FOLFOX方案一半的剂量联合使用解毒化生丹治疗。观察两组患者治疗前后肿瘤因子标志物水平、血清癌基因ras。观察两组患者临床疗效、生活质量评分、不良反应发生率。结果两组患者治疗前CA199、CEA、CA242水平差异无统计学意义(P>0.05)。治疗后观察组CA199、CEA、CA242水平显著低于对照组(P<0.05)。两组患者治疗前COX-2、rasP21水平差异无统计学意义(P>0.05)。治疗后观察组COX-2、rasP21较对照组显著降低(P<0.05)。两组患者治疗前生理功能、身体疼痛、角色限制、总体健康、社会功能、活力、精神健康、情感职能评分差异无统计学意义(P>0.05)。治疗后观察组生理功能、身体疼痛、角色限制、总体健康、社会功能、活力、精神健康、情感职能评分显著高于对照组(P<0.05)。两组患者治疗后观察组客观有效率为27.75%显著高于对照组11.28%(χ^(2)=4.592,P=0.032)。观察组疾病控制率为66.60%略高于对照组48.88%,但两组患者疾病控制率无显著性差异(χ^(2)=3.403,P=0.065)。两组患者治疗后观察组总不良发应为7.40%略低于对照组7.52%,但两组患者总不良发应率无显著性差异(χ^(2)=0.001,P=0.978)。结论解毒生化丹方联合奥沙利铂能有效降低患者毒副反应、提升患者临床疗效、降低肿瘤因子和血清癌基因ras、改善患者生活质量水平。

Objective To investigate the clinical efficacy of Jiedu Shenghua Pellet(解毒生化丹)combined with oxaliplatin in colorectal cancer patients of damp-heat and blood-stasis-toxin syndrome.Methods A total of 107 patients with colorectal cancer in the hospital from January 2021 to January 2022 were enrolled and randomly divided into two groups.The control group(54 cases)received standard doses of FOLFOX4(oxaliplatin/5-fluorouracil/leucovorin),while the observation group(53 cases)received half doses of FOLFOX combined with Jiedu Shenghua Pellet.Then the levels of tumor markers and RAS oncogene were observed,meantime,the clinical efficacy,quality of life score and incidence of adverse reactions were compared between two groups.Results The levels of carbohydrate antigen 199(CA199),carcinoembryonic antigen(CEA)and CA242 yielded no statistical difference between two groups at the baseline(P>0.05),while the levels of three tumor markers were significantly lower in the observation group than those in the control group after treatment(P<0.05).Serum levels of ras product p21 protein(rasP21)and cyclooxygenase-2(COX-2)demonstrated no statistical difference between two groups before treatment(P>0.05),while the serum levels of two ras oncogene were significantly lower in the observation group compared with those of the control group(P<0.05).The scores of physical functioning(PF),role physical(RP),body pain(BP),general health(GH),vitality(VT),social functioning(SF),role emotion(RE)and mental health(MH)in SF-36 manifested no statistical difference between two groups before treatment,while the above dimension scores of SF-36 were significantly higher in the observation group than those in the control group after treatment(P>0.05).The subjective efficacy rate was 27.75%in the observation group,which was significantly higher than 11.28%in the control group,with statistical difference(χ^(2)=4.592,P=0.032).The disease control rate was 66.60%in the observation group,which was slightly higher than 48.88%in the control group,with no statistical difference(χ^(2)=3.403,P=0.065).The total adverse reaction rate was 7.40%in the observation group,which was slightly lower than 7.52%in the control group,with no statistical difference(χ^(2)=0.001,P=0.978).Conclusion Application of Jiedu Shenghua Pellet combined with oxaliplatin in the treatment of colorectal cancer of damp-heat and blood-stasis-toxin syndrome can effectively reduce the toxin and side effects,improve the clinical outcomes,reduce the levels of tumor markers and ras oncogene and ameliorate the quality of life of patients.