Treatment of 30 Patients with Chronic Radiation Enteritis with <italic style="font-style: italic">Xueyu Danhuang Oil </italic>（血余蛋黄油） Retention Enema： A Randomized Controlled Trial

Tongjing DING; Xiaomin WANG; Mingwei YU; Qing ZHANG; Jin XU; Weiru XU; Jiayun NIAN

doi:10.13288/j.11-2166/r.2022.08.011

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Treatment of 30 Patients with Chronic Radiation Enteritis with Xueyu Danhuang Oil （血余蛋黄油） Retention Enema： A Randomized Controlled Trial

更新时间：2022-04-11

- Treatment of 30 Patients with Chronic Radiation Enteritis with Xueyu Danhuang Oil （血余蛋黄油） Retention Enema： A Randomized Controlled Trial
- Journal of Traditional Chinese Medicine Vol. 63, Issue 8, Pages: 754-759(2022)
- 作者机构：
  
  1.首都医科大学附属北京中医医院，北京市东城区美术馆后街23号，100010
  2.北京中医药大学
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2022.08.011
  CLC：
- Received：03 August 2021，
  
  Revised：2021-12-30，
  
  Published：17 April 2022
- 稿件说明：
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丁彤晶,王笑民,于明薇等.血余蛋黄油保留灌肠治疗慢性放射性肠炎30例随机对照试验[J].中医杂志,2022,63(08):754-759.

DING Tongjing,WANG Xiaomin,YU Mingwei,et al.Treatment of 30 Patients with Chronic Radiation Enteritis with Xueyu Danhuang Oil （血余蛋黄油） Retention Enema： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2022,63(08):754-759.
丁彤晶,王笑民,于明薇等.血余蛋黄油保留灌肠治疗慢性放射性肠炎30例随机对照试验[J].中医杂志,2022,63(08):754-759. DOI： 10.13288/j.11-2166/r.2022.08.011.

DING Tongjing,WANG Xiaomin,YU Mingwei,et al.Treatment of 30 Patients with Chronic Radiation Enteritis with Xueyu Danhuang Oil （血余蛋黄油） Retention Enema： A Randomized Controlled Trial[J].Journal of Traditional Chinese Medicine,2022,63(08):754-759. DOI： 10.13288/j.11-2166/r.2022.08.011.

摘要

目的

评价血余蛋黄油保留灌肠治疗慢性放射性肠炎的临床疗效及安全性。

方法

60例慢性放射性肠炎患者随机分为治疗组和对照组各30例。治疗组将血余蛋黄油60 ml制成灌肠液进行灌肠，对照组使用蒙脱石散3 g联合地塞米松5 mg加生理盐水配置成60 ml灌肠液进行灌肠，两组均每日1次，疗程14天，治疗结束后第14、42、70天分别随访1次。于治疗前后和随访3个时间点观察中医症状总评分（症状包括腹痛、腹泻、里急后重、黏液血便、纳食减少、乏力），治疗后比较两组患者放射反应缓解率，3次随访时比较两组放射反应反复率。治疗前后观察两组放射反应程度分布及维也纳肠镜评分（VRS）分布，并进行患者提供的主观整体营养状况评量表（PG-SGA）评分。治疗前后进行血常规、尿常规、便常规、血生化、心电图检查，并记录研究过程中不良事件发生情况。

结果

对照组脱落2例，最终完成研究治疗组30例，对照组28例。治疗组治疗前后放射反应程度分级差异有统计学意义（

=0.003），对照组治疗前后差异无统计学意义（

=0.063）。治疗后治疗组30例中放射反应缓解率为56.67%，对照组为17.86%，治疗组明显高于对照组（

=0.002）。第3次随访时治疗组放射反应反复率为3.33%，对照组为21.4%，治疗组明显低于对照组（

=0.048）。治疗前治疗组有22例、对照组有20例完成肠镜检查，治疗后治疗组和对照组各有16例完成肠镜检查，治疗组治疗前后VRS分布比较差异有统计学意义（

0.013），对照组治疗前后差异无统计学意义（

0.107）。治疗组在降低中医症状总评分和里急后重、黏液血便症状评分方面优于对照组（

＜0.05）。两组患者治疗前后PG-SGA评分比较差异均无统计学意义（

＞0.05）。治疗前后两组患者无不良事件发生。

结论

血余蛋黄油保留灌肠可降低慢性放射性肠炎患者放射性损伤严重程度，改善里急后重、黏液血便症状，提高放射反应缓解率，降低其复发率，且安全性好。

Abstract

Objective

To evaluate the clinical effect and safety of

Xueyu Danhuang Oil

（XDO，血余蛋黄油） retention enema on the chronic radiation enteritis （CRE）.

Methods

Sixty CRE patients were randomly divided into the treatment group and the control group， with 30 cases in each group. In the treatment group， 60 ml XDO was used to make enema liquid for retention enema， and in the control group， 3 g of montmorillonite powder and 5 mg of dexamethasone were mixed with normal saline into 60 ml enema for retention. Both groups were treated once a day for 14 days， and were followed up on the 14th， 42nd， and 70th days after the treatment. The traditional Chinese medicine （TCM） symptom scores including abdominal pain， diarrhea， tenesmus， mucosanguineous feces， decreased appetite， and fatigue were assessed before and after treatment and at the 3 follow-up time points. The remission rate of radiation response at the end of treatment， and the recurrence rate of radiation response at 3 follow-up time points were calculated. The grade of radiation response， the Vienna rectoscopy score （VRS） and the patient-generated subjective global assessment （PG-SGA） score were assessed， and the blood routine， urine routine， stool routine， blood biochemistry and electrocardiogram were tested before and after treatment. The occurrence of adverse events during the study was recorded.

Results

As two cases in the control group dropped out， 30 cases in the treatment group and 28 cases in the control group finally completed the trial. After treatment， the grade of radiation response was significantly reduced in the treatment group （

= 0.003）， but was not significantly different in the control group （

= 0.057）. The remission rate of radiation response in the treatment group was 56.67%， significantly higher than 17.86% in the control group （

= 0.002）. At the third follow-up， the recurrence rate of radiation response was 3.33% in the treatment group， significantly lower than 21.4% in the control group （

= 0.048）. Before treatment， 22 cases in the treatment group and 20 cases in the control group completed colonoscopy. After treatment， 16 cases each in the treatment and control group completed colonoscopy. The VRS score in the treatment group was reduced after treatment （

= 0.013）， while that was not significantly different in the control group （

= 0.107）. The total score of TCM symptoms and the score in terms of tenesmus and mucosanguineous feces in the treatment group were lower than those in the control group （

＜0.05）. The PG-SGA score was not significantly different after treatment in both groups （

＞0.05）. There was no adverse event in both groups.

Conclusion

XDO retention enema can reduce the grade of radiation damage， improve the symptoms of tenesmus and mucosanguineous feces， increase the remission rate of radiation response， and reduce the recurrence rate， and is of good safety in treatment of CRE.

关键词

Keywords

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Treatment of 30 Patients with Chronic Radiation Enteritis with Xueyu Danhuang Oil （血余蛋黄油） Retention Enema： A Randomized Controlled Trial

DOI：10.13288/j.11-2166/r.2022.08.011

摘要

Abstract

关键词

Keywords

references