目的 观察补阳还五汤对脑梗死恢复期患者神经功能、生活质量和血清血管内皮生长因子(VEGF)的影响,评价超微粉化对补阳还五汤效应的作用.方法 选择251例脑梗死恢复期患者,按进入研究的时间顺序,采用简单随机化方法按1∶1∶1分为传统补阳还五汤组(83例)、超微补阳还五汤组(85例)和对照组(83例).对照组给予康复训练;传统补阳还五汤组和超微补阳还五汤组除康复训练外,分别给予传统补阳还五汤颗粒剂,每次15 g、每日2次和补阳还五汤超微颗粒,每次5 g、每日2次,疗程均为12周.评价各组临床疗效和中医证候疗效,观察治疗前后患者的神经功能、生活质量,并测定血清VEGF水平;同时测定23例健康成人的VEGF水平作为健康对照.结果 与对照组比较,超微组、传统组临床总有效率(83.5%、85.5%比77.1%)和中医证候疗效总有效率(87.0%、89.2%比77.1%)均显著升高(均P<0.05).3组患者治疗后神经功能和生活质量均有明显改善,超微组、传统组与对照组比较差异有统计学意义[神经功能缺损程度评分(分):11.95±5.03、12.68±4.67比15.23±5.12,生活质量评分(分):64.71±6.73、63.56±6.53比59.09±6.81,均P<0.05].对照组、传统组、超微组患者治疗前血清VEGF水平(ng/L)较健康者明显增加(79.87±2.81、80.19±3.23、80.23±3.18比68.13±3.39,均P<0.05);治疗后超微组、传统组血清VEGF水平(ng/L)明显高于对照组(76.38±3.02、76.84±3.18比70.26±3.15,均P<0.05).超微组与传统组间各指标比较差异无统计学意义(均P>0.05).结论 补阳还五汤能改善脑梗死恢复期患者神经功能和生活质量,提高血清VEGF水平,超微粉化能减少药物的用量.
Objective To study effect of Buyang Huanwu decoction (BYHWD, 补阳还五汤 ) on neurological function, quality of life, and serum vascular endothelial growth factor (VEGF) in patients convalescent from cerebral infarction, and to evaluate the effect of ultra-micronized BYHWD. Methods Two hundred and fifty-one patients met the inclusion criteria were randomly assigned to traditional BYHWD (TB) group (n= 83), ultra-micronized BYHWD (UB) group (n= 85) and the control group (n= 83)for patients in the TB and UB groups, traditional BYHWD (15 g, twice a day) or ultra-micronized BYHWD (5 g, twice a day) was given respectively, for a course of 12 weeks. Clinical curative effect and curative effect of syndrome according to traditional Chinese medicine (TCM) were evaluated. Nerve function and quality of life in patients were evaluated, serum VEGF was determined before and after treatment. The level of VEGF in 23 healthy volunteers was also determined to serve as normal control. Results The total effective rate was 83. 5%, 85.5% and 77. 1% in UB group, TB group and the control group, respectively, and the total symptomatic effective rate in TCM was 87. 0%, 89.2 % and 77. 1%, respectively. Compared with the control group, there was significant difference in UB or TB group (all P〈0. 05), but there was no significant difference between UB and TB groups (both P〉0. 05). Serum VEGF levels (ng/L) were significantly lower before treatment in control group, TB group and UB group than those in normal control group (79.87 ±2. 81, 80. 19±3. 23, 80. 23±3.18 vs. 68. 13±3.39, all P〈0. 05). Neurologic deficit score (NDS), quality of life and serum VEGF were improved after treatment in three groups, but they were better in UB or TB group than the control group [NDS: 11.95 ± 5.03, 12. 68± 4.67 vs. 15.23 ± 5. 12, quality of life score:64.71±6.73, 63.56±6.53 vs. 59.09±6.81, serum VEGF (ng/L): 76.38±3.02, 76.84±3.18 vs.70. 26±3. 15, all P〈0. 05], but the