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背根神经节电刺激治疗慢性顽固性疼痛的前瞻性长期随访研究(九)

 英语晨读 ·


山东省立医院疼痛科英语晨读已经坚持10余年的时间了,每天交班前15分钟都会精选一篇英文文献进行阅读和翻译。一是可以保持工作后的英语阅读习惯,二是可以学习前沿的疼痛相关知识。我们会将晨读内容与大家分享,助力疼痛学习。

本次文献选自Eldabe S, Copley S, Gulve A,  et al. A prospective long-term follow-up of dorsal root ganglion stimulation for the management of chronic intractable pain. Pain. 2022,163(4):702-710. 本次学习由王珺楠副主任医师主讲。

4.1. Strengths and limitations

This study has several strengths; it is a prospective study with 24 months observation, with a further follow-up of remaining participants to 7 years after initial implant. To the best of the authors’ knowledge, no other study of DRGS has reported on participant outcomes to this duration. The study was based in clinical practice using a heterogeneous population with limited eligibility criteria, thus providing “real-world” data. Implanting clinicians (A.G., G.B., and S.E.) were experienced in SCS and DRG implantation techniques and acted as mentors on the manufacturer’s DRG implant training program, limiting the possibility that the rates of AEs and lower reductions of reported pain relief were a result of the practitioner technique.

4.1 优势和局限性

这项研究有几个优势;这是一项前瞻性研究,观察24个月,对剩余参与者进行进一步随访至首次植入后7年。据作者所知,没有其他的DRGS研究报告同样随访时间的结果。该研究基于临床实践,使用的是有限的异质人群,因此提供了“真实世界”的数据。临床医生(G.B和S.E.)在SCS和DRG植入技术方面有丰富的经验,并担任制造商DRG植入培训项目的导师,限制不良事件发生率和疼痛缓解的降低是医生技术的结果的可能性。


There are also limitations to this study. First, the data reported above are from a single centre, although we were able to present personal communication regarding retrospective data on DRGS from a second centre. However, these data and the JCUH complications data from 24 months to the final follow-up were obtained retrospectively, therefore, subjected to limitations of clinician recording and researcher data collection. Differing follow-up times limit any direct comparison. The participant cohort who received implantation was reduced from 32 to 16 at the final follow-up, of whom only 14 provided data. The long-term follow-up data do not reflect the whole implanted cohort, only those sufficiently satisfied with the device to continue with the treatment, as more than half the cohort was either withdrawn from the study, had an explant, or was lost to the follow-up.

这项研究也有一些局限性。首先,上述报告的数据来自一个单一的中心,尽管我们能够就来自第二个中心的DRGS的回顾性数据进行个人交流。然而,这些数据和从24个月到最终随访的JCUH并发症数据都是回顾性获得的,因此,受到临床医生记录和研究者数据收集的局限性。不同的随访时间限制了任何直接的比较。在最后的随访中,接受植入的参与者队列从32人减少到16人,其中只有14人提供了数据。长期随访数据并不能反映整个植入队列,只有那些对该设备足够满意的患者继续治疗,因为超过一半的参与者要么退出研究,要么取出植入物,要么失访。


5. Conclusion

As in previous studies, we found that DRGS provides significant levels of pain relief in most patients who have a successful trial. However, this response does not persist in the longer term for over a quarter of patients, and there is a need to investigate the responses of those who request explantation because of dissatisfaction. Future studies should assess all key measures at the point where a participant is withdrawn. Until then, they will remain unrepresented in the literature, with only those with successful outcomes being evaluated. Key data may consequently be lost, resulting in misleadingly high reports of satisfaction. With 7 participants having 10 replacements because of premature battery failure, 17 revisions were performed within the first 24 months and 19 further revisions after this; the rate of AEs may be considered excessive to the point of limiting the utility of the device.

5.结论

与之前的研究一样,我们发现DRGS在大多数试验成功的患者中提供了显著的疼痛缓解。然而,这种反应并不会在超过四分之一的患者中长期持续存在,而且有必要调查那些因不满而要求解释的患者的反应。未来的研究应该在参与者被退出时评估所有的关键指标。而之前,他们将在文献中没有代表性,只有那些成功的结果才被评估。关键数据可能因此丢失,导致具有误导性的高满意度。7名参与者因电池过早故障而更换了10次,在前24个月内进行了17次修整,之后进行了19次修整;不良事件的发生率可能被认为过高,限制了DRGS的使用。

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