芍药汤保留灌肠治疗急性期湿热蕴结型放射性直肠炎临床研究

Clinical Study of Shaoyao Decoction Retention Enema in Treatment of Radiation-induced Proctitis of Damp-heat Accumulation Syndrome in Acute Stage

目的:观察芍药汤保留灌肠治疗急性期湿热蕴结型放射性直肠炎的有效性和安全性。方法:将70例直肠癌放疗后湿热蕴结型放射性直肠炎患者按入科顺序分为治疗组和对照组各35例。对照组给予0.9%氯化钠溶液100 mL+地塞米松10 mg保留灌肠;治疗组在对照组灌肠液的基础上溶入芍药汤颗粒剂保留灌肠。两组均每3 d灌肠1次,共灌肠5次。比较两组治疗前后的症状与体征、肠道放射性损伤分级、生命质量测定量表(QLQ-CR38)评分、肠镜表现及不良反应情况,评价疗效。结果:治疗组临床症状与体征总缓解率82.9%,对照组77.1%,两组临床症状与体征总缓解率比较,差异有统计学意义(P=0.046);两组治疗后肠道放射性损伤分级情况:治疗组0级7例、1级19例、2级5例,3级4例,对照组0级5例、1级9例、2级14例,3级7例,治疗组肠道放射性损伤分级改善优于对照组,差异有统计学意义(P=0.024);治疗后,治疗组QLQ-CR38评分为(79.62±5.36)分,对照组(74.32±6.11)分,治疗组评分优于对照组,差异有统计学意义(P=0.037);治疗组肠镜总缓解率91.4%,对照组82.9%,两组肠镜疗效比较,差异有统计学意义(P=0.006)。两组治疗过程中均未出现明显不良反应。结论:芍药汤保留灌肠治疗急性期湿热蕴结型放射性直肠炎安全有效。

Objective:To observe the efficacy and safety of Shaoyao Decoction retention enema in treatment of radiation-induced proctitis of damp-heat accumulation syndrome in acute stage. Methods:A total of 70 patients who suffered from radiation-induced proctitis of damp-heat accumulation syndrome after receiving radiotherapy for treating rectal cancer were divided into treatment group and control group according to the time of admission,with 35 cases in each group. The control group was treated by retention enema of 0.9%sodium chloride solution(100 m L) + dexamethasone(10 mg). The treatment group was given Shaoyao Decoction retention enema on the basis of the control group. The granules of Shaoyao Decoction was dissolved in the enema of the control group. Both the two groups were given retention enema one time every three days and were totally given five times. The symptoms and signs,intestinal radiation-induced injury grade,quality of life questionnaire-CR38(QLQ-CR38) scores,colonoscopy manifestation and adverse reactions of the two groups were compared before and after treatment. Then the curative efficacy of the two groups was evaluated. Results:The total remission rate of symptoms and signs of the treatment group was 82.9% and that of the control group was 77.1%. For the comparison of total remission rate of symptoms and signs,the difference between the two groups was statistically significant(P=0.046). After treatment,the intestinal radiation-induced injury grade of the two groups was as follows:In the treatment group,7 cases were in grade 0,19 cases were in grade 1,5 cases were in grade 2 and 4 cases were in grade 3. In the control group,5 cases were in grade 0,9 cases were in grade 1,14 cases were in grade 2 and 7 cases were in grade 3. The improvement of intestinal radiation-induced injury grade of the treatment group was superior to that of the control group and the difference was statistically significant(P=0.024). After treatment,the QLQ-CR38 score of the treatment group was 79.62±5.36 and that of the control group was 74.32±6.11. The score of the treatment group was superior to that of the control group and the difference was statistically significant(P=0.037). The total remission rate of colonoscopy manifestation of the treatment group was 91.4% and that of the control group was 82.9%. For the comparison of total remission rate of colonoscopy manifestation,the difference between the two groups was statistically significant(P=0.006). There were no obvious adverse reactions in the two groups during treatment. Conclusion:For treatment of radiation-induced proctitis of damp-heat accumulation syndrome in acute stage,Shaoyao Decoction retention enema is effective and safe.