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盐酸氢吗啡酮缓释片治疗慢性癌痛的疗效及轮换模式研究
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| 篇名： | 盐酸氢吗啡酮缓释片治疗慢性癌痛的疗效及轮换模式研究 |
| TITLE： | Study on the efficacy and rotation pattern of Hydromorphone hydrochloride extended-release tablets in the treatment of chronic cancer-related pain |
| 摘要： | 目的 评估盐酸氢吗啡酮缓释片（HHERT）在真实世界中治疗慢性癌痛（CCRP）的疗效与安全性，并探讨其与其他阿片类药物（OOD）之间的轮换模式效果及轮换原因。方法回顾性收集2025年1－12月在福建省肿瘤医院接受阿片类药物治疗的142例CCRP患者资料，根据用药情况分为HHERT持续组和药物轮换治疗组，比较两组的疗效、不良反应发生情况。药物轮换治疗组进一步分为OOD-HHERT亚组（由OOD轮换为HHERT）和HHERT-OOD亚组（由HHERT轮换为OOD），比较两亚组的剂量换算系数是否符合指南推荐、轮换后疼痛缓解情况、轮换类型及轮换原因。结果142例CCRP患者中，107例患者疼痛缓解，总有效率为75.35%。治疗4周后，HHERT持续组与药物轮换治疗组疗效的差异有统计学意义（P＜0.05）。86例患者发生110例次不良反应，总不良反应发生率为77.46%，HHERT持续组与药物轮换治疗组不良反应发生率比较，差异均无统计学意义（P＞0.05）。99例发生阿片类药物轮换，总体轮换率为69.72%。HHERT-OOD亚组与OOD-HHERT亚组轮换后疼痛缓解率分别为74.36%和73.33%，疗效相当（P＞0.05）；31例（31.31%）患者剂量换算系数不符合指南推荐；两亚组轮换类型分布存在显著差异（P＜0.05）：HHERT-OOD亚组以给药途径变更为主，OOD-HHERT亚组以给药途径不变为主。HHERT-OOD亚组因给药途径受限和药品供应短缺轮换的患者比例显著高于OOD-HHERT亚组（P＜0.05）；OOD-HHERT亚组因镇痛效果不佳轮换的患者比例显著高于HHERT-OOD亚组（P＜0.05）。结论在真实世界中，HHERT与阿片类药物轮换策略在CCRP治疗中具有较好的镇痛效果，轮换模式主要由镇痛效果不佳、给药途径受限等现实因素驱动。临床需进一步规范轮换剂量换算标准、把控轮换指征，优化癌痛个体化诊疗管理。 |
| ABSTRACT： | OBJECTIVE To evaluate the efficacy and safety of Hydromorphone hydrochloride extended-release tablets （HHERT） in the treatment of chronic cancer-related pain （CCRP） in real-world settings， and to explore the effectiveness and reasons for rotation patterns between HHERT and other opioid drugs （OOD）. METHODS Data were retrospectively collected from 142 CCRP patients receiving strong opioid therapy at Fujian Cancer Hospital from January to December 2025. Patients were divided into the continuous HHERT group and the drug rotation group based on medication status. The efficacy and incidence of adverse reactions were compared between the two groups. The drug rotation group was further subdivided into the OOD-HHERT group （rotated from OOD to HHERT） and the HHERT-OOD group （rotated from HHERT to OOD）. Dose conversion coefficients were compared with guideline recommendations， and pain relief status， rotation types and reasons for rotation were analyzed between the two subgroups. RESULTS In the 142 CCRP patients， 107 achieved pain relief， with an overall response rate of 75.35%. After 4 weeks of treatment， there was a statistically significant difference in efficacy between the continuous HHERT group and the drug rotation group （ P ＜0.05）. A total of 110 adverse reactions occurred in 86 patients， with an overall adverse reactions of 77.46%， there were no statistically significant differences between the continuos HHERT group and the drug rotation group in the incidence of drug adverse reactions （ P ＞0.05）. 99 experienced opioid rotation， with an overall rotation rate of 69.72%. The pain relief rates after rotation were 74.36% in the HHERT-OOD group and 73.33% in the OOD-HHERT group， indicating comparable efficacy （ P ＞0.05）. In 31 patients （31.31%）， the dose conversion coefficients did not conform to guideline recommendations. There was a significant difference in the distribution of rotation types between the two groups （ P ＜0.05）： the HHERT-OOD group was dominated by route of administration changes， while the OOD-HHERT group was dominated by unchanged route of administration. The proportion of rotations due to restricted route of administration and drug supply shortage was significantly higher in the HHERT-OOD group than that in the OOD-HHERT group （ P ＜0.05）； the proportion of rotations due to inadequate analgesic effect was significantly higher in the OOD-HHERT group than that in the HHERT-OOD group （ P ＜0.05）. CONCLUSIONS In real-world settings， both HHERT and opioid rotation strategies demonstrate favorable analgesic effects in the treatment of CCRP. Rotation patterns are primarily driven by practical factors such as inadequate analgesic effect and restricted route of administration. It is necessary to standardize dose conversion standards and indications for opioid rotation to improve individualized cancer pain management. |
| 期刊： | 2026年第37卷第12期 |
| 作者： | 赵秋玲；陈燕玲；董凉凉；陈娟；黄声强；杨琳 |
| AUTHORS： | ZHAO Qiuling，CHEN Yanling，DONG Liangliang，CHEN Juan，HUANG Shengqiang，YANG Lin |
| 关键字： | 盐酸氢吗啡酮缓释片; 阿片类药物; 药物轮换; 慢性癌痛; 镇痛治疗; 不良反应 |
| KEYWORDS： | Hydromorphone hydrochloride extended-release tablets; opioid drugs; drug rotation; chronic cancer-related pain; analgesic therapy; adverse drug reactions |
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