Chemotherapy-related constipation
Conditions
Interventions
Experimental group:The patient was screened and enrolled as D0, and the oral drug was recorded as D1 on the same day, and the starting time was T0, D1, D2, D3 for 3 consecutive days with oral 20% mann
Control group:Lactulose (100ml:66.7g) (Beijing Hanmi Pharmaceutical Co., Ltd., 6302H7500) The drug regimen of the control group: take lactulose 20-30ml/time after meals, once a day, for 3 days.
Sponsors
The First Affiliated Hospital of Chengdu Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Tumor patients with symptoms of constipation during chemotherapy: 1) male and female subjects diagnosed with any tumor; 2) Meet the Rome IV criteria for the diagnosis of chronic constipation :I must include two or more of the following: >25% of defecation effort; >25% of the excrement is dry ball feces or hard feces; >25% of defecation is not satisfactory; >25% of defecation had anal rectum obstruction (or blockage); >25% of defecation requires manual assistance; Spontaneous defecation =18 years old; 4)Voluntarily accept and abide by the experimental protocol, and accept review and follow-up on time; 5)Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Diagnosis of megacolon/megacolon or pseudoobstruction;2) Known or suspected organic disease of the large intestine, i.e. obstruction or inflammatory bowel disease;3) Patients undergoing gastrointestinal/abdominal surgery within 90 days;4) Patients who are unable to eat/drink, take oral medications, or are unable to take oral medications due to vomiting;5) Women of childbearing age who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study period;6) Patients who use other laxatives, gastrointestinal stimulants, laxative Chinese or proprietary Chinese medicines, intestinal moistening and slimming tea within 1 week of the screening period and/or chemotherapy treatment period;7) Severe renal failure, severe heart failure (NYHA grade III~IV), severe anemia (Hb < 8g/dL), active inflammatory bowel disease, severe chronic liver disease, clinically significant electrolyte disorders, recent (< < 6 months) symptomatic acute ischemic heart disease, history of major gastrointestinal surgery, use of purgatives, and treatment with persistent effects on colonic motonicity;patients with tumor peritoneal metastasis or intestinal stenosis; 8) Situations that the researchers considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time of patient's first defecation;Number of spontaneous bowel movements per week;Score of PAC-SYM; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood nutrient parameter;Score of PAC-QOL; | — |
Countries
China
Contacts
Public ContactTao Ren
The First Affiliated Hospital of Chengdu Medical College
Outcome results
None listed