Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, No.16 Nanxiaojie, Dongzhimen nei, Beijing, 100700, China.
Beijing University of Chinese Medicine Affiliated Dongzhimen Hospital, the 5th Zip, Hai Yun Cang, Beijing, 100700, China.
Pharmacol Res. 2021 Mar;165:105464. doi: 10.1016/j.phrs.2021.105464. Epub 2021 Jan 27.
An individual's level of lower limb motor function is associated with his or her disability level after stroke, and motor improvement may lead to a better prognosis and quality of life. Data from animal models show that Qizhitongluo (QZTL) capsule facilitates recovery after focal brain injury. We aimed to validate the efficacy and safety of the QZTL capsule for promoting lower limb motor recovery in poststroke patients.
In this randomized, multicenter, double-blind, placebo- and active-controlled trial from 13 sites in China, participants with ischemic stroke and Fugl-Meyer motor scale (FMMS) scores of <95 were eligible for inclusion. Patients were randomly assigned in a 2:1:1 ratio to the QZTL group, Naoxintong (NXT) group or placebo group for 12 weeks at 15-28 days after the onset of stroke. The primary outcome was the change in the Lower Limb FMMS (FMMS-LL) score from baseline over the 12-week intervention period.
622 participants were randomly assigned to the QZTL group (309), NXT group (159), or placebo group (154). The FMMS-LL score increased by 4.81 points (95 % CI, 4.27-5.35) in the QZTL group, by 3.77 points (95 % CI, 3.03-4.51) in the NXT group and by 3.00 points (95 % CI, 3.03-4.51) in the placebo group at week 12. The QZTL group showed significantly larger improvements compared with the placebo group at each interview from weeks 4-12 (difference, 0.89 [0.30,1.49] at week 4, P = 0.0032; difference, 1.83[1.01,2.66] at 90 days poststroke, P < 0.0001; difference, 1.81[0.88,2.74] at week 12, P = 0.0001).
The QZTL capsule is an effective treatment for lower limb motor impairment. The finding indicates that the QZTL capsule may be used as a potential new strategy for stroke rehabilitation.
个体下肢运动功能水平与中风后残疾程度相关，运动功能改善可能带来更好的预后和生活质量。动物模型数据表明，芪蛭通络胶囊促进局灶性脑损伤后的恢复。我们旨在验证芪蛭通络胶囊对促进中风后患者下肢运动功能恢复的疗效和安全性。
本研究是在中国 13 个中心开展的一项随机、多中心、双盲、安慰剂和阳性药物对照临床试验，纳入的患者为缺血性脑卒中且 Fugl-Meyer 运动量表（FMMS）评分＜95 分。患者在中风发病后 15-28 天内，按 2:1:1 的比例随机分配至芪蛭通络胶囊组、脑心通胶囊组或安慰剂组，接受 12 周的治疗。主要结局是 12 周干预期间下肢 FMMS（FMMS-LL）评分的变化。
622 名参与者被随机分配至芪蛭通络胶囊组（309 名）、脑心通胶囊组（159 名）或安慰剂组（154 名）。芪蛭通络胶囊组 FMMS-LL 评分在第 12 周增加了 4.81 分（95 % CI，4.27-5.35），脑心通胶囊组增加了 3.77 分（95 % CI，3.03-4.51），安慰剂组增加了 3.00 分（95 % CI，3.03-4.51）。在第 4-12 周的每次随访中，芪蛭通络胶囊组均较安慰剂组改善更明显（第 4 周时差异为 0.89 [0.30,1.49]，P = 0.0032；发病后 90 天差异为 1.83[1.01,2.66]，P＜0.0001；第 12 周差异为 1.81[0.88,2.74]，P = 0.0001）。
芪蛭通络胶囊胶囊是一种治疗下肢运动功能障碍的有效方法。这一发现表明，芪蛭通络胶囊胶囊可能成为中风康复的一种新策略。
