Clinical observation of self-formulated Fuzheng Xiaoliu Decoction combined with Chinese herbal enema on the treatment of patients with advanced metastatic colorectal cancer
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摘要: 目的 观察自拟扶正消瘤方联合中药灌肠治疗晚期转移性结直肠癌患者的临床疗效。方法 选取2016年3月—2020年9月盐城市中医院收治的晚期转移性结直肠癌患者88例，按照随机数字表方法1∶1随机分配为观察组与对照组各44例。对照组患者采用改良三药cmFOLFOXIRI化疗方案及中药灌肠治疗，观察组患者在对照组基础上加用自拟扶正消瘤方内服进行治疗，治疗时间均为2个月。观察2组治疗前后临床疗效、血清肿瘤标志物检测[癌胚抗原(CEA)、糖链抗原19-9(CA19-9)、糖链抗原50(CA50)]、不良反应、肿瘤患者生存质量评分[Karnofsky功能状态评分(KPS评分)、肿瘤患者的生活质量评分(QOL)]、生存周期[中位无进展生存期(PFS)、中位总生存时间(OS)]。结果 治疗后观察组总有效率为88.64%，显著高于对照组的68.18%，差异有统计学意义(P< 0.05)；2组均可降低血清CEA、CA19-9、CA50水平，且观察组低于对照组(P< 0.05)；2组均可提高患者生存质量评分，且观察组高于对照组(P< 0.05)；观察组患者的不良反应发生率显著少于对照组，观察组生存周期长于对照组，差异有统计学意义(P< 0.05)。结论 自拟扶正消瘤方联合中药灌肠可降低晚期转移性结直肠癌患者血清肿瘤标志物水平，减少化疗引发的不良反应，提高生活质量及生存周期，临床疗效显著。Abstract: Objective To observe the clinical effect of self-formulated Fuzheng Xiaoliu Decoction combined with Traditional Chinese Medicine enema on the treatment of patients with advanced metastatic colorectal cancer.Methods A total of 88 patients with advanced metastatic colorectal cancer admitted to our hospital was selected and randomly assigned into 44 cases in the observation group and 44 cases in the control group according to the random number table method 1∶1. The 44 cases in the control group were treated with modified three-drug cmFOLFOXIRI chemotherapy regimen and Traditional Chinese Medicine enema. The 44 cases in the observation group were treated with self-formulated Fuzheng Xiaoliu Decoction on top of the control group. Clinical efficacy, serum tumor markers (carcinoembryonic antigen[CEA], sugar chain antigen 19-9[CA19-9], sugar chain antigen 50[CA50]), adverse reactions, and quality of life score of cancer patients (Karnofsky functional status score [KPS score], quality of life score of cancer patients[QOL]), survival cycle (median progression-free survival[PFS], median overall survival[OS]) were observed and recorded before and after treatment in the two groups.Results After treatment, the total effective rate of the observation group was 88.64%, which was significantly higher than that of the control group(68.18%), the difference was statistically significant (P< 0.05); Serum CEA, CA19-9, and CA50 levels were reduced in both groups, and the observation group was lower than control group (P< 0.05); Both groups could improve the quality of life score, and the observation group was higher than the control group(P< 0.05); The incidence of adverse reactions in the observation group was significantly lower than control group, and the survival cycle of observation group was longer than control group, the difference was statistically significant (P< 0.05).Conclusion Self-formulated Fuzheng Xiaoliu Decoction combined with Traditional Chinese Medicine enema can reduce the level of serum tumor markers in patients with advanced metastatic colorectal cancer, and reduce the adverse reactions caused by chemotherapy, improve the quality of life and life cycle. The clinical efficacy is significant.
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表 1 2组一般资料比较
一般资料 观察组(n=44) 对照组(n=44) χ2/t P 性别(男/女) 16/28 18/26 0.192 0.661 年龄/岁 62.43±6.19 63.18±6.25 -0.566 0.573 病理分化程度/例 0.046 0.830 低分化 25 24 高分化 19 20 肿瘤部位/例 0.409 0.522 结肠 24 21 直肠 20 23 转移部位/例 0.248 0.969 肝转移 29 26 肺转移 16 14 骨转移 7 7 脑转移 6 4 TNM分期/例 0.741 0.389 Ⅲ期 17 21 Ⅳ期 27 23 
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表 2 2组临床疗效比较
例(%) 组别 例数 CR PR SD PD 总有效 观察组 44 0 13(29.55) 26(59.09) 5(11.36) 39(88.64)1) 对照组 44 0 7(15.91) 23(52.27) 14(31.82) 30(68.18) 与对照组比较，1)P < 0.05。
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表 3 2组治疗前后血清肿瘤标记物比较
X±S 组别 例数 CEA/(ng·mL-1) CA19-9/(U·mL-1) CA50/(U·mL-1) 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 观察组 44 348.17±172.62 23.93±3.111) 783.47±40.59 397.82±20.141) 47.85±4.41 12.65±2.181) 对照组 44 357.83±172.09 69.45±10.37 789.95±43.52 571.66±39.72 49.19±9.28 27.31±10.06 t 0.263 22.813 0.722 18.893 0.865 9.447 P 0.793 22.813 0.472 < 0.001 0.389 < 0.001 与对照组治疗后比较，1)P < 0.05。
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表 4 2组KPS评分、QOL评分比较
分，X±S 组别 例数 KPS评分 QOL评分 治疗前 治疗后 治疗前 治疗后 观察组 44 66.31±3.29 87.55±5.141) 28.72±4.46 51.27±5.641) 对照组 44 67.15±4.42 78.59±4.96 29.66±3.98 38.56±4.09 t 1.011 8.322 1.043 12.101 P 0.315 < 0.001 0.302 < 0.001 与对照组治疗后比较，1)P < 0.05。
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表 5 2组不良反应比较
例(%) 组别 例数 骨髓抑制 腹泻 皮疹 恶心呕吐 脱发 中性粒细胞减少 血小板减少 观察组 44 12(27.27) 7(15.91) 10(22.73) 15(34.09) 18(40.91) 13(29.55) 4(9.09) 对照组 44 21(47.73) 17(38.64) 16(36.36) 25(56.82) 30(68.18) 24(54，55) 13(29.55) χ2 3.927 5.729 1.965 4.583 6.600 5.643 5.906 P 0.048 0.017 0.161 0.032 0.010 0.018 0.015
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