健脾利湿解毒合剂防治结直肠腺瘤术后复发的随机对照研究

Mixture for fortifying spleen,disinhibiting dampness,removing toxin prevents and treat postoperative recurrence of colorectal adenoma:A randomized controlled study

目的评价健脾利湿解毒合剂对结直肠腺瘤术后复发的影响及安全性。方法选择2020年11月—2021年6月就诊于南京市中西医结合医院行内窥镜下手术治疗的结直肠腺瘤患者90例,按照计算机产生随机数方法,将患者分为中药组和对照组,每组45例。术后中药组患者服用健脾利湿解毒合剂,对照组患者服用安慰剂,同时进行生活饮食健康宣教,2组治疗疗程均为3个月。1年后复查结肠镜,统计患者结直肠腺瘤复发情况、癌变风险,统计2组研究期间不良反应发生情况。结果本研究共有9例患者因无法联系、拒绝复查肠镜等原因脱落,中药组41例、对照组40例完成研究随访。2组患者的性别、年龄和结直肠癌家族史、初发结直肠腺瘤情况比较差异均无统计学意义(P均>0.05)。至研究结束时,所有患者均未出现不良反应及突发不良事件。中药组术后1年复发率为26.83%(11/41),对照组复发率为52.50%(21/40),2组比较差异有统计学意义(P<0.05);且中药组复发者腺瘤人均数目、腺瘤直径均明显低于对照组(P均<0.05),上皮内瘤变率明显低于对照组(P<0.05)。中药组复发的11例患者中有1例高风险腺瘤,对照组复发的21例患者中有7例高风险腺瘤,2组患者高风险腺瘤情况比较差异有统计学意义(P<0.05)。结论健脾利湿解毒合剂可降低结直肠腺瘤术后患者的复发率和复发者高风险腺瘤发生率,且安全性较好。

Objective It is to evaluate the effect and safety of the mixture for fortifying spleen,disinhibiting dampness,removing toxin on postoperative recurrence of colorectal adenoma.Methods Ninety patients with colorectal adenoma who underwent endoscopic surgery in Nanjing Hospital of Integrated Traditional Chinese and Western Medicine from November 2020 to June 2021 were collected.According to the method of computer random number generation,the patients were divided into traditional Chinese medicine group and control group,with 45 cases in each group.The traditional Chinese medicine group was treated with the mixture for fortifying spleen,disinhibiting dampness,removing toxin,while the control group was treated with placebo.Meanwhile,the patients of both groups received health education on life and diet.Both groups were treated for 3 months.The colonoscopy was reviewed one year later,the recurrence,canceration of colorectal adenoma and side effects occurred in the patients were analyzed statistically.Results In this study,a total of 9 patients fell out due to unavailability of contact,refusal of reexamination colonoscopy and other reasons.At the end of the study,a total of 81 patients participated in the study,including 41 patients in the traditional Chinese medicine group and 40 patients in the control group.There were no significant differences in gender,age,family history of colorectal cancer and situation of primary colorectal adenoma of patients between the two groups(all P>0.05).By the end of the study,all patients had no adverse reactions or sudden adverse events.The recurrence rate was 26.83%(11/41)in the traditional Chinese medicine group and 52.50%(21/40)in the control group,and the difference between the two groups was statistically significant(P<0.05).The number of adenomas per capita and the diameter of adenomas of the traditional Chinese medicine group were significantly lower than those of the control group(both P<0.05),and the rate of intraepithelial neoplasia was significantly lower than that of the control group(P<0.05).There was 1 high-risk adenoma among 11 patients with recurrence in the traditional Chinese medicine group and 7 high-risk adenomas among 21 patients with recurrence in the control group,and the difference in high-risk adenomas between the two groups was statistically significant(P<0.05).Conclusion The mixture for fortifying spleen,disinhibiting dampness,removing toxin can reduce the recurrence rate after colorectal adenoma surgery and the occurrence rate of high-risk adenoma of the patients with recurrence,and its safety is well.