Radiation proctitis
Conditions
Interventions
Control group:Dexamethasone sodium phosphate injection retention enema was given on the basis of hemostasis and diarrhea treatment recommended by the guidelines
Experimental group:On the basis of hemostasis and diarrhea treatment recommended by the guidelines patients with grade 2 chronic radiation proctitis were given Changrui enema powder + dexamethasone so
Experimental group:On the basis of hemostasis and diarrhea treatment recommended by the guidelines, patients with grade 3 chronic radiation proctitis were given a retention enema with
Sponsors
Shanxi Research Institute of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: The pathological diagnosis was pelvic malignant tumor which was in line with the Western diagnostic criteria of grade 2-3 chronic radiation proctitis. In line with TCM diagnostic standards TCM syndrome differentiation is poison accumulation and blood collaterals syndrome; Voluntarily sign the informed consent; 18= age =85 years old gender is not limited; Hepatic and renal function and hematopoietic function met the following criteria (in the absence of continuous supportive therapy) : neutrophils >1.5×109/L platelets >100×109/L hemoglobin >8.0g/dL; Normal total bilirubin or <1.5×ULN; AST(SGOT) ALT(SGPT) <2.5×ULN; Serum creatinine <1.5×ULN; Expected survival =6 months; KPS score =60 points.
Exclusion criteria
Exclusion criteria: Pregnant and expectant or lactating women; Allergic constitution and allergic to the test drug or its excipients; Complicated with any clinically serious disease including but not limited to nervous system cardiovascular system blood and lymphatic system immune system kidney liver respiratory system metabolism bone and other system diseases or serious systemic infection; Have active gastrointestinal disease including acute diverticulitis Crohn's disease or ulcerative colitis have infectious and other non-infectious proctitis or have previously undergone colostomy surgery for any reason; Proctitis with primary or secondary rectal cancer or with other cancer infiltration; Patients who have participated in clinical trials of other drugs or medical devices within 4 weeks prior to screening; Radiation proctitis rectal stenosis even obstruction severe bleeding and fistula formation requiring surgical treatment; Severe perianal disease unable to tolerate enema administration; A history of substance abuse; Researchers consider it inappropriate to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LENT-SOMA score; | — |
Secondary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30 Version 3;Vienna proctoscopy score;The efficacy of traditional Chinese medicine on syndromes and the efficacy of traditional Chinese medicine on individual symptoms;Nutritional risk screening score;numeric rating scale of pain;Stool occult blood negative conversion rate;Endoscopic/surgical treatment rate; | — |
Countries
China
Contacts
Public ContactHao Shulan
Shanxi Research Institute of Traditional Chinese Medicine
Outcome results
None listed