Primary LIver Cancer
Conditions
Interventions
Hydromorphone sustained-release tablet group:Administer oral treatment with hydrocodone extended-release tablets (specification: 4mg per tablet). The starting dose is determined based on the patient's
for those who have used opioids before, the starting dose is determined by equivalent dose conversion (hydrocodone: oxycodone ˜ 1:2).
Oxycodone sustained-release tablet group:Administer oxycodone sustained-release tablets (specification: 10mg per tablet) orally. The initial dose and adjustment principles are the same as those of the
Sponsors
Beijing You’an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Confirmed as PLC by pathological histology or clinical diagnostic criteria, with BCLC stage IIa-IV or AJCC stage II-IV (malignant biliary tumor); 2. Age 18-75 years old, gender not restricted; 3. According to the Numerical Rating Scale (NRS), the pain score at rest is >= 4 points and = 3 days, and long-term use of strong opioid drugs for pain relief is required; 4. Expected survival period >= 3 months; 5. Clear consciousness, able to accurately express the degree of pain and physical sensations, and cooperate to complete the questionnaire and follow-up; 6. The patient and their family have given informed consent and signed the informed consent form, and have passed the approval of the hospital ethics committee.
Exclusion criteria
Exclusion criteria: 1. Those allergic to the components of opioid drugs such as hydrocodone and oxycodone; 2. Those with severe heart, kidney, or respiratory failure and mental disorders; 3. Those who have used other long-acting opioid analgesic drugs within the last 1 month and cannot complete the withdrawal period (7 days); 4. Those with active gastrointestinal ulcers, intestinal obstruction, or a history of severe gastrointestinal bleeding; 5. Those with other malignant tumors or severe infectious diseases; 6. Pregnant or lactating women; 7. Patients who cannot cooperate with the follow-up or who the researcher deems not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The degree to which the visual analogue scale (VAS) score decreased compared to the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time from the first administration of the medication until the VAS score decreased by = 20 mm;The duration during which the pain was controlled within a VAS score of = 30mm after a single dose administration;Quality of life;Quality of Sleep ;Adverse event;Liver function indicators;Hydrocodone blood concentration; | — |
Countries
China
Contacts
Public ContactSongtao Liu
Department of Medical Oncology, Beijing You’an Hospital, Capital Medical University
Outcome results
None listed