Objective

2

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

2

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

2

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 （

P

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

P

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

P

= 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 （

P

= 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 （

P

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

P

= 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 （

P

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

P

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

Conclusion

2

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.