Wang Chengwei, You Chao, Ma Lu, Liu Mengyue, Tian Meng, Li Ning
Department of Integrated Traditional and Western Medicine, West China Hospital, Sichuan University, Chengdu, China.
Neurosurgery, West China Hospital, Sichuan University, Chengdu, China.
BMC Complement Altern Med. 2017 Feb 15;17(1):112. doi: 10.1186/s12906-017-1614-6.
Thalamic hemorrhage (TH) is a neurological insult with a high rate of morbidity and mortality. Moderate TH (10-30 ml) accounts for more than half of all TH. Treatment remains controversial. The role of acupuncture in patients with moderate TH is not clear.
We will conduct a single-center, randomized, parallel group, and assessor-blinded clinical trial. A total of 488 patients with moderate TH will be randomly assigned to one of eight groups: 10-15 cc left sided TH study group (N = 61) and a corresponding control group (N = 61), 10-15 cc right sided TH study group (N = 61) and a corresponding control group, 15-30 cc left sided TH study group (N = 61) and a corresponding control group (N = 61), and 15-30 cc right sided TH study group (N = 61) and a corresponding control group. Study groups will receive acupuncture in addition to standard treatment, while control groups will receive standard treatment alone. The primary outcome will be change in National Institutes of Health Stroke Scale scores at 30 and 90 days after TH. The secondary outcomes will be death or major disability, defined as a score of 3 to 6 on the modified Rankin scale (in which a score of 0 indicates no symptoms, a score of 5 indicates severe disability, and a score of 6 indicates death) at 90-days, need for surgery at 30-days, Glasgow Outcome Scale (GOS) score at 90-days following TH onset, and the results of several additional group specific tests. The rate of adverse events will then be compared between the groups.
This study will attempt to answer the question of whether or not acupuncture can improve neurologic outcome following moderate TH. TRIAL REGISTRATION: Chinese clinical trial registry (ChiCTR-IOR-16008362).
丘脑出血（TH）是一种发病率和死亡率较高的神经损伤。中度丘脑出血（10 - 30毫升）占所有丘脑出血的一半以上。治疗方法仍存在争议。针刺在中度丘脑出血患者中的作用尚不清楚。
我们将进行一项单中心、随机、平行组、评估者盲法的临床试验。总共488例中度丘脑出血患者将被随机分配到以下八组之一：左侧10 - 15立方厘米丘脑出血研究组（N = 61）及相应对照组（N = 61），右侧10 - 15立方厘米丘脑出血研究组（N = 61）及相应对照组，左侧15 - 30立方厘米丘脑出血研究组（N = 61）及相应对照组（N = 61），右侧15 - 30立方厘米丘脑出血研究组（N = 61）及相应对照组。研究组除接受标准治疗外还将接受针刺治疗，而对照组仅接受标准治疗。主要结局指标将是丘脑出血后30天和90天时美国国立卫生研究院卒中量表评分的变化。次要结局指标将是死亡或重度残疾，定义为90天时改良Rankin量表评分为3至6分（其中0分表示无症状，5分表示重度残疾，6分表示死亡），30天时是否需要手术，丘脑出血发作后90天时格拉斯哥预后量表（GOS）评分，以及其他几组特定测试的结果。然后将比较各组之间的不良事件发生率。
本研究将试图回答针刺能否改善中度丘脑出血后神经功能结局这一问题。试验注册：中国临床试验注册中心（ChiCTR - IOR - 16008362）。
