Right C7 neurotomy at the intervertebral foramen plus intensive speech and language therapy versus intensive speech and language therapy alone for chronic post-stroke aphasia: multicentre, randomised controlled trial.

Methods

Multicentre, assessor blinded, randomised controlled trial.

多中心、评估者盲法、随机对照试验。

Four centres in mainland China.

中国内地四个中心。

50 adults aged 40-65 years with aphasia for more than one year after a single left hemispheric stroke.

50名年龄在40至65岁之间的成人，他们在单侧左半球中风后出现失语症超过一年。

Participants were randomised 1:1 to receive either C7 neurotomy plus three weeks of intensive SLT or three weeks of intensive SLT only, stratified by treatment centre.

参与者按1:1的比例随机分配接受C7神经切断术加三周强化SLT或仅接受三周强化SLT，按治疗中心进行分层。

The primary outcome was change in score on the 60 item Boston naming test (BNT, scores 0-60, with higher scores indicating better naming function) from baseline to one week after C7 neurotomy plus intensive SLT for three weeks or intensive SLT for three weeks after deferral for one week (control group).

主要结果是60项波士顿命名测试（BNT，得分范围0-60，得分越高表示命名功能越好）从基线到C7神经切断术加三周强化SLT或三周强化SLT后一周（对照组）的得分变化。

Secondary outcomes included change in severity of aphasia using the aphasia quotient, calculated using the western aphasia battery, and patient reported outcomes on quality of life and depression after stroke.

次要结果包括使用西方失语症量表计算的失语症严重程度的变化（通过失语商表示），以及患者报告的中风后生活质量与抑郁情况。

Results

From 25 July 2022 to 31 July 2023, 322 out of 1086 patients received a diagnosis of post-stroke aphasia and were screened for eligibility. 50 eligible participants were randomly assigned to treatment groups (25 in each).

从2022年7月25日至2023年7月31日，1086名患者中有322名被诊断为中风后失语症，并被筛选以确定是否符合入选条件。共有50名符合条件的参与者被随机分配到治疗组（每组25人）。

Mean increase in BNT score was 11.16 points in the neurotomy plus SLT group and 2.72 points in the control group at one month (difference 8.51 points, 95% confidence interval(CI) 5.31 to 11.71, P<0.001).

在神经切割联合SLT组中，BNT评分在一个月时平均增加了11.16分，在对照组中增加了2.72分（差异为8.51分，95%置信区间（CI）为5.31至11.71，P<0.001）。

The between group difference in BNT score remained stable at six months (difference 8.26 points, 4.16 to 12.35, P<0.001).

在六个月时，两组之间的BNT评分差异保持稳定（差异为8.26分，95%置信区间为4.16至12.35，P<0.001）。

In addition, the aphasia quotient improved significantly in the neurotomy plus SLT group versus control group (difference at one month 7.06 points, 4.41 to 9.72, P<0.001), as did patient reported activities of daily living and post-stroke depression.

此外，神经手术加言语治疗组的失语症商数与对照组相比显著改善（一个月时差异为7.06分，95%置信区间4.41至9.72，P<0.001），患者的日常生活活动和卒中后抑郁也有所改善。

No treatment related severe adverse events were reported.

没有报告与治疗相关的严重不良事件。

Conclusions

C7 neurotomy plus three weeks of intensive SLT was associated with a greater improvement in language function compared with three weeks of intensive SLT alone over a period of six months.

C7神经切断术联合三周的强化SLT（言语语言治疗）在六个月的时间里与单独三周的强化SLT相比，与更大的语言功能改善相关。

No severe adverse events or long term troublesome symptoms or functional loss were reported.

未报告严重的不良事件或长期的困扰症状或功能丧失。

trial_registration

Chinese Clinical Trial Register ChiCTR2200057180.

中国临床试验注册中心ChiCTR2200057180号。