有创性电神经调节治疗疼痛性糖尿病神经病变的系统评价和荟萃分析（四）
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Raghu ALB, Parker T, Aziz TZ, et al. Invasive Electrical Neuromodulation for the Treatment of Painful Diabetic Neuropathy: Systematic Review and Meta-Analysis. Neuromodulation, 2021; 24: 13–21。本次学习由谢珺田副主任医师主讲。
Risk of Bias
Both RCTs had a low risk of bias in multiple categories (Supporting Information Table S4). However, allocation concealment and blinding to outcome were unclear, and the nature of t-SCS necessitates a high risk of performance bias. The majority of the published data were from case series and case reports. Inherent in these study designs (level IV evidence) is a high risk of bias (Supporting Information Fig. S1).
偏倚风险
有两项随机对照研究结果表明各种偏倚风险都很低（详细信息见表S4）。然而，分组的随机性和盲法的实施结果并不清楚，而且t-SCS的性质可能带来很高的完成偏差风险。另外大部分文献数据来自病例系列报道和个案病例报报道。这些研究设计本身（四级证据）固有的偏倚风险也较高（详细信息如图S1所示）。
Complications
Risk of failing therapeutic trial was 16%, and risk of infection was 4% (Supporting Information Table S5). Risk of lead problems requiring surgery to resolve were 13%: 4% per year of follow-up. Implanted pulse generator (IPG) replacement was 0% at six months, 12% at two years, 17% at three years, and 45% at five years. Following “permanent” implantation, likelihood of explanation was 20% by five years . One patient died from subdural haematoma.
并发症
短时程治疗无效的风险为16%，感染的风险为4%（详细信息见表S5）。需要手术解决的电极故障风险为13%：每年随访发生率4%。植入型脉冲发生器（IPG）置换6个月为0%，2年为12%，3年为17%，5年为45%。在“永久性”植入后，5年后去除的比例为20%。1例死于硬膜下血肿。
Burst Spinal Cord Stimulation
De Vos et al. reported 12 patients receiving b-SCS, after prior t-SCS for a minimum of six months (mean = 2.5 years). Prior to t-SCS, mean baseline pain was VAS 70 (SD = 9), which subsequently improved to 28 (SD = 23). Following b-SCS implantation, mean score improved to 16 (SD = 18) (p < 0.05) at two weeks. Of the patients, 67% found their pain improved with b-SCS, while 8% worsened; 67% of patients reported preferring b-SCS to t-SCS, and 33% vice versa. One patient reported having lower and more stable blood glucose during b-SCS. Tjepkema-Cloostermans et al. conducted a double-blind randomized cross over study assessing t-SCS, high- and low-amplitude b-SCS in a mixed pain cohort of 40 patients. Of the three PDN patients, one preferred each condition.
爆发性脊髓电刺激
de Vos等报告道了12例患者在接受t-SCS治疗6个月以上（平均2.5年）之后接受b-SCS治疗。在t-SCS之前，平均基线疼痛为VAS 70（SD=9），随后改善为28（SD=23）。植入b-SCS后，两周时平均得分提高到16（SD=18）（p<0.05）。其中67%的患者使用b-SCS后疼痛有所善，8%的患者疼痛加重；67%的患者更喜欢采用b-SCS而不是t-SCS，33%的患者陈述与之相反。1例患者记录在b-SCS期间血糖较低且更稳定。Tjepkema-Cloostermans等进行了一项双盲随机交叉对照研究，评估了40例患者的混合疼痛队列中的t-SCS、高振幅和低振幅b-SCS的治疗结果。在3例PDN患者中，每种模式都有1例患者较为偏好。
High-Frequency Spinal Cord Stimulation
Galan et al. (n = 9) reported one patient failing trial stimulation, and the rest improving from mean baseline pain of VAS 8.1 (SD = 1.0) to 1.9 (SD = 1.4) at three months and 2.0 (SD = 1.3) at six months, with 88% achieving >50% pain relief. Sisson et al. presented a case where the patient also had painful Scheuermann’s disease, with 10/10 pain overall. An implant at T9-10 gave excellent back relief and good lower limb PDN relief (5/10) at six months.
高频脊髓电刺激
Galan等报道1例患者（n=9）试验刺激无效，其余患者在3个月时疼痛由基线VAS8.1（SD=1.0）降至1.9（SD=1.4）和6个月时2.0（SD=1.3），88%达到>50%的疼痛缓解。Sisson等发表的个案报道，患者合并Scheuerman氏病，总体疼痛10/10。T9-10植入电极，在6个月随访时，背部及下肢PDN缓解良好（5/10）。