opioid-induced constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with definite diagnosis of malignant tumors; 2. The age of patients was 18-75 years old male or female; 3. Cancer pain patients with NRS=4 (moderate to severe) according to the numerical rating scale (NRS) recommended by WHO and requiring opioid treatment; 4. Patients with no history of habitual constipation and treated with oral opioids for more than 24 hours; 5. Patients with constipation in accordance with Rome IV opioid-related Constipation and Expert Consensus on the Diagnosis and Treatment of Constipation in Traditional Chinese Medicine (2017); 6. No other drugs or treatments affecting defecation in the past 1 month; 7. Patients with good physical status and expected survival time > 3 months; 8. Patients who volunteered to participate in the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Constipation caused by underlying intestinal diseases (such as colorectal inflammation intestinal tuberculosis) or local diseases (such as ileus) or constipation caused by recent surgical treatment; 2. Patients unable to eat due to the influence of tumor; 3. Constipation caused by other drugs; 4. Pregnant and lactating women; 5. Patients with severe psychological disorders mental disorders and cognitive impairment; 6. Patients with serious primary diseases such as heart liver kidney or hematopoietic system; 7. Severe bleeding tendency or platelet count (PLT) < 50×109/L; 8. Investigators who were participating in other clinical trials during the same period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom checklist for patients with constipation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel function index scale;Constipation Quality of Life Scale;Mean number of spontaneous complete bowel movements per week;Bristol Stool Trait Scale; | — |
Countries
China
Contacts
Hospital of Chengdu University of Traditional Chinese Medicine