当前位置: X-MOL 学术Drugs R D › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Effects of Age Among Elderly Cancer Patients on Breakthrough Pain Management with Sublingual Fentanyl Tablets.
Drugs in R&D ( IF 2.2 ) Pub Date : 2019-09-01 , DOI: 10.1007/s40268-019-0276-x
Jordi Guitart 1 , María Isabel Vargas 2 , Vicente De Sanctis 3 , Jordi Folch 1 , Rafael Salazar 4 , José Fuentes 5 , Joan Coma 6 , Julia Ferreras 7 , Jordi Moya 8 , Albert Tomás 9 , Pere Estivill 2 , Francisco Rodelas 4 , Antonio Javier Jiménez 10 , Almudena Sanz 10
Affiliation  

INTRODUCTION Sublingual fentanyl tablets (SFTs) have been shown to be a safe and effective option in controlling breakthrough cancer pain (BTcP). However, further examination is required to investigate the use of SFTs among the elderly. The aim of this study was to examine the influence of age in BTcP management with SFTs in the elderly population. METHODS We performed subgroup analyses of a recently completed trial in two subsets of individuals: patients aged 65-74 years (low age group) and patients ≥ 75 years (high age group). Pain intensity (PI), onset of pain relief, frequency and duration of BTcP episodes, and adverse events (AEs) were assessed at 3, 7, 15, and 30 days. Health status instruments used were the Hospital Anxiety and Depression Scale (HADS-A and HADS-D) and the Short Form 12, version 2 (SF-12v2) questionnaire. RESULTS Levels of PI at the end of the study improved significantly as compared with baseline in both the low and the high age groups (30.0% and 27.7% reduction, respectively). The onset of analgesia at the end of the study began in < 10 min in 85.0% of young-old subjects and in 62.5% of patients ≥ 75 years, but no significant differences were found. BTcP episodes lasted < 15 min in 75.0% of patients in the low age group and 58.3% in the high age group (p = 0.24). Most of patients in both groups experienced one to five BTcP daily episodes, at all assessment points. HADS-D decreased from 10.78 (± 4.33) to 8.21 (± 3.57) in the low age group, and from 10.96 (± 4.26) to 9.36 (± 3.35) in the high age group (p = 0.02). Significant differences in HADS-A scores from baseline to the end of the study were also observed in both subgroups (p < 0.05). Patients in the low age group had less favorable mental component summary (MCS) and physical component summary (PCS) scores than patients in the high age group. At the end of the study, 10.0% of young-old patients and 29.2% of patients aged ≥ 75 years reported AEs related to their treatment. The most commonly reported AEs included nausea, vomiting, constipation, somnolence, and skin disorders and they were generally mild to moderate in severity. CONCLUSIONS The results of this study showed that SFTs provided safe and clinically meaningful pain relief in both elderly subgroups. Clinical implications of these findings await validation in large, confirmatory studies to identify age subgroup divergences among elderly cancer patients treated with SFTs.

中文翻译:

芬太尼舌下片对老年癌症患者的年龄对突破性疼痛管理的影响。

引言舌下芬太尼片剂(SFTs)已被证明是控制突破性癌症疼痛(BTcP)的安全有效选择。但是,需要进一步检查以调查老年人中SFT的使用。这项研究的目的是研究年龄对老年人群中SFTs对BTcP管理的影响。方法我们对两组受试者进行了近期完成的试验的亚组分析:65-74岁的患者(低年龄组)和≥75岁的患者(高年龄组)。在第3、7、15和30天评估疼痛强度(PI),缓解疼痛的发作,BTcP发作的频率和持续时间以及不良事件(AE)。所使用的健康状况指标为医院焦虑和抑郁量表(HADS-A和HADS-D)和简表12版本2(SF-12v2)问卷。结果与低基线组相比,研究结束时的PI水平显着提高(分别降低了30.0%和27.7%)。在研究结束时,开始镇痛的时间是在<10分钟内开始于85.0%的年轻老年受试者和62.5%≥75岁的患者中,但未发现明显差异。低年龄组75.0%的患者和高龄组58.3%的患者BTcP发作持续<15分钟(p = 0.24)。在所有评估点,两组的大多数患者每天经历1-5次BTcP发作。低年龄组的HADS-D从10.78(±4.33)降至8.21(±3.57),高年龄组从10.96(±4.26)降至9.36(±3.35)(p = 0.02)。在两个亚组中,从基线到研究结束,HADS-A评分也存在显着差异(p <0。05)。与高年龄组相比,低年龄组患者的心理成分摘要(MCS)和身体成分摘要(PCS)评分较差。在研究结束时,有10.0%的年轻患者和29.2%的≥75岁患者报告了与治疗相关的不良事件。最常见的不良事件包括恶心,呕吐,便秘,嗜睡和皮肤疾病,严重程度一般为轻度到中度。结论这项研究的结果表明,在两个老年亚组中,SFTs均可提供安全且具有临床意义的疼痛缓解。这些发现的临床意义正在等待大型的验证性研究的验证,以鉴定接受SFT治疗的老年癌症患者的年龄亚组差异。与高年龄组相比,低年龄组患者的心理成分摘要(MCS)和身体成分摘要(PCS)评分较差。在研究结束时,有10.0%的年轻患者和29.2%的≥75岁患者报告了与治疗相关的不良事件。最常见的不良事件包括恶心,呕吐,便秘,嗜睡和皮肤疾病,严重程度一般为轻度到中度。结论这项研究的结果表明,在两个老年亚组中,SFTs均可提供安全且具有临床意义的疼痛缓解。这些发现的临床意义在大型的验证性研究中等待确认,以鉴定接受SFT治疗的老年癌症患者的年龄亚组差异。与高年龄组相比,低年龄组患者的心理成分摘要(MCS)和身体成分摘要(PCS)评分较差。在研究结束时,有10.0%的年轻患者和29.2%的≥75岁患者报告了与治疗相关的不良事件。最常见的不良事件包括恶心,呕吐,便秘,嗜睡和皮肤疾病,严重程度一般为轻度到中度。结论这项研究的结果表明,在两个老年亚组中,SFTs均可提供安全且具有临床意义的疼痛缓解。这些发现的临床意义正在等待大型的验证性研究的验证,以鉴定接受SFT治疗的老年癌症患者的年龄亚组差异。0%的年轻患者和29.2%的≥75岁患者报告了与治疗有关的AE。最常见的不良事件包括恶心,呕吐,便秘,嗜睡和皮肤疾病,严重程度一般为轻度到中度。结论这项研究的结果表明,在两个老年亚组中,SFTs均可提供安全且具有临床意义的疼痛缓解。这些发现的临床意义正在等待大型的验证性研究的验证,以鉴定接受SFT治疗的老年癌症患者的年龄亚组差异。0%的年轻患者和29.2%的≥75岁患者报告了与治疗有关的AE。最常见的不良事件包括恶心,呕吐,便秘,嗜睡和皮肤疾病,严重程度一般为轻度到中度。结论这项研究的结果表明,在两个老年亚组中,SFTs均可提供安全且具有临床意义的疼痛缓解。这些发现的临床意义在大型的验证性研究中等待确认,以鉴定接受SFT治疗的老年癌症患者的年龄亚组差异。结论这项研究的结果表明,在两个老年亚组中,SFTs均可提供安全且具有临床意义的疼痛缓解。这些发现的临床意义正在等待大型的验证性研究的验证,以鉴定接受SFT治疗的老年癌症患者的年龄亚组差异。结论这项研究的结果表明,在两个老年亚组中,SFTs均可提供安全且具有临床意义的疼痛缓解。这些发现的临床意义正在等待大型的验证性研究的验证,以鉴定接受SFT治疗的老年癌症患者的年龄亚组差异。
更新日期:2019-11-01
down
wechat
bug