补肾活血颗粒对帕金森病患者运动功能的影响：多中心、随机、双盲、安慰剂对照研究

背景：帕金森病（Parkinson’s disease，PD）以静止性震颤、肌强直、动作迟缓等运动障碍为主要临床表现，目前缺乏有效治疗手段，严重影响患者的生活质量。我们既往运用补肾活血法治疗PD取得较好疗效。目的：评价补肾活血颗粒改善PD患者运动功能的有效性。设计、场所、对象和干预措施：采用多中心、随机双盲、安慰剂对照临床试验方法，共纳入120例PD患者，分别来自解放军总医院、广东省中医院、西安西京医院和唐都医院门诊及部分北京地区的干休所和社区。将其随机分为补肾活血颗粒组和安慰剂组，两组均以西药治疗为基础，补肾活血颗粒组加服补肾活血颗粒，安慰剂组加服安慰剂。由于补肾活血颗粒组有5例脱落，安慰剂组有l例因违反治疗方案而被剔除，还有8例脱落，最终完成治疗观察者共106例，其中治疗组55例，对照组51例，疗程均为3个月。主要结局指标：从运动量表、运动试验及肌张力检测等方面全面评价临床疗效，每个月随访1次。结果：补肾活血颗粒组治疗后不同时间UPDRSⅢ评分、10米折返运动试验中起立时间及静息状态肌张力检测指标与治疗前比较，差异均有统计学意义（P〈0．05，P〈0．01），且时间因素与处理因素存在交互作用（P〈0．05，P〈0．01）。记时运动试验及10米折返运动试验中折返行走及转弯时间等指标，补肾活血颗粒组治疗后不同时间与治疗前比较，差异均无统计学意义（P〉0．05），时间因素与处理因素也不存在交互作用（P〉0．05）。与安慰剂相比，补肾活血颗粒降低患者UPDRSⅢ的评分，缩短患者起立时间及改善患者肌张力的疗效更明显。研究过程中未发现明显不良反应。结论：补肾活血颗粒加西药在缓解PD患者运动功能障碍方面的效果优于单用西药治疗。

Effects of Bushen Huoxue Granule on motor function in patients with Parkinson's disease: a multicenter, randomized, double-blind and placebo-controlled trial

Background： The main clinical symptoms of Parkinson＇s bradykinesia, and so on. There is no effective treatment qualities of PD patients. The therapy used for reinforcing disease （PD） are resting tremor, muscle rigidity, for PD yet, and dyskinesia symptoms affect the life kidney and activating blood circulation in treatment of PD can achieve good clinical effects. Objective： To evaluate the efficacy and safety of Bushen Huoxue Granule （BSHXG）, a compound traditiona Chinese herbal medicine for reinforcing kidney and activating blood circulation in treatment of PD.Design, setting, participants and interventions： A clinical study was undertaken. A total of 120 PD multi-center, randomized, double-blind, placebo-controlled patients from Outpatient Department of General Hospital of People＇s Liberation Army, Guangdong Provincial Hospital of Traditional Chinese Medicine, and Xijing Hospital and Tangdu Hospital in Xi＇an, were randomly divided into BSHXG group and placebo group. There were 55 cases in BSHXG group, for 5 cases lost to follow-up, and 51 cases in placebo group, for 1 case was excluded and 8 cases lost to follow-up. The patients in two groups were all treated for three months. Main outcome measures： The movement scale, exercise testing, and muscle tension were observed before and after treatment to make a comprehensive evaluation for clinical efficacy. One month follow-up was also made.Results： At three different times （one, two and three months） after treatment, the score of Unified Parkinson＇s Disease Rating Scale （UPDRS） [r[, rise time of lo-meter back and forth exercise and resting muscle tension in BSHXG group were improved as compared with before treatment （P〈0.05, P〈0.01）, and there was an interaction between treatment time and intervention （P〈0.05, P〈0.01）. There were no differences in evaluation results of chronograph movement （times of left and right hand movement in one minute）, and walking time and turn around time of 10-meter back and forth exercise between BSHXG group and placebo group, and no interaction existed between treatment time and intervention. BSHXG showed a better efficacy than the placebo （P〈0.01） in improving motor function, shortening rise time of 10-meter back and forth test and relieving muscle tension. No adverse effects were found in this trial. Conclusion： BSHXG plus Western medicine is effective and safe in improving motor dysfunction of PD patients.