“日间病房癌痛镇痛模式”的可行性、安全性及有效性研究

Study on the feasibility, safety and effectiveness of the " Day Oncology Unit Cancer Pain Analgesia Model"

摘要:

目的：分析盐酸羟考酮缓释片做为背景药物用于日间病房癌痛病人12 h滴定及维持治疗的可行性、有效性及安全性。方法：收集在北京大学肿瘤医院就诊于姑息/支持治疗科，于日间病房随访治疗的初诊控制不佳的中重度癌痛病人，分为三组：A组（n=106）未接受过阿片类药物治疗的初治癌痛病人；B组（n=8）口服弱阿片类药物或阿片类复方制剂控制不佳的癌痛病人；C组（n=23）口服即释强阿片类药物控制不佳的癌痛病人。按照“日间病房癌痛镇痛模式”以盐酸羟考酮缓释片为背景药物进行滴定（每12 h评估并调整药物）及后续维持治疗，分别在首次用药后12 h、24 h、4 d、7 d随访病人疼痛缓解情况及相关不良反应发生情况。结果：研究共纳入137例癌痛病人，治疗后12 h、24 h、4 d、7 d疼痛缓解率分别为81.75%（112例）、98.54%（135例）、96.35%（132例）、99.27%（136例）。A组病人（106例）中，12 h、24 h、4 d、7 d疼痛缓解率分别为80.19%（85例）、99.06%（105例）、 96.23%（102例）、100%（106例）。入组病人达到理想镇痛时盐酸羟考酮缓释片服用剂量为10~60 mg q12 h，中位剂量为10 mg q12 h，首次用药控制不佳病人中位增服剂量为10 mg。中位滴定时间为24 h。B组、C组病人24 h的疼痛缓解率分别为100%、95.65%。主要不良反应为便秘、恶心、呕吐、头晕和排尿困难等，经对症治疗后均可耐受。结论：“日间病房癌痛镇痛模式”下应用盐酸羟考酮缓释片作为背景用药应用于日间病房癌痛滴定及维持治疗的依从性较高，安全性及有效性好，是在日间病房“半住院半居家”特殊诊疗模式下癌痛控制的合理选择。

Abstract:

Objective: To analyze the feasibility, effectiveness and safety of oxycodone hydrochloride sustained-release tablets as a background drug for 12 h titration and maintenance treatment of cancer pain patients in the day oncology unit. Methods: Patients with poorly controlled, moderate to severe cancer pain who were admitted to the outpatient of Supportive Care Department of Peking University Cancer Hospital and then admitted to the day oncology unit for the treatment were collected and divided into three groups: group A(n=106), newly treated cancer pain patients who had not received opioid therapy; group B(n=8), patients with poorly controlled cancer pain by oral weak opioids or opioid compound preparations; group C(n=23), patients with poorly controlled cancer pain by oral immediate-release strong opioids. According to the " Day Oncology Unit Cancer Pain Analgesia Model", oxycodone hydrochloride sustained-release tablets were used as the background drug for titration (the drug was evaluated and adjusted every 12 h) and subsequent maintenance treatment. Patients were followed up for pain relief and related adverse reactions at 12 h, 24 h, 4 d, and 7 d after taking the medication. Results: A total of 137 cancer pain patients were enrolled in the study. The pain relief rates at 12 h, 24 h, 4 d, and 7 d after treatment were 81.75% (112 cases), 98.54% (135 cases), 96.35% (132 cases), 99.27% (136 cases), respectively. For group A patients (106 cases), the pain relief rates at 12 h, 24 h, 4 d and 7 d were 80.19% (85 cases), 99.06% (105 cases), 96.23% (102 cases), and 100% (106 cases), respectively. The pain relief rates at 24 h for group B and group C were 100% and 95.65%, respectively. When the enrolled patients achieved ideal analgesia, the dosage of oxycodone hydrochloride sustained-release tablets was 10-60 mg q12 h, and the median dose was 10 mg q12 h. The median increased dose of oxycodone hydrochloride sustained-release tablets in patients with poor control of the first medication was 10 mg. The median titration time was 24 h. The main adverse reactions of patients are constipation, nausea, vomiting, dizziness and dysuria, etc., which can be tolerated after symptomatic treatment. Conclusion：Under the " day oncology unit cancer pain analgesia model", oxycodone hydrochloride sustained-release tablets are used as background drugs for titration and maintenance treatment. It has high compliance, good safety and effectiveness. It is a reasonable choice for cancer pain control under the special diagnosis and treatment mode of "half hospitalization and half home" in the day oncology unit.