五苓散联合常规西药治疗特发性正常颅压脑积水的随机、双盲、安慰剂对照试验

Treatment of Idiopathic normal-pressure hydrocephalus by Wuling San combined with conventional western medicine: a randomized,double-blind,placebo-controlled trial

目的观察五苓散联合常规西药治疗特发性正常颅压脑积水的临床疗效。方法将72例特发性正常颅压脑积水患者随机分为治疗组与对照组,每组36例。两组均予以扩血管、营养神经等常规西药治疗,治疗组加服五苓散汤剂,对照组加用中药安慰剂。两组疗程均为28天,随访2个月,观察临床疗效,比较简易精神状态检查量表(MMSE)评分、旋转180°步数及Evan’s指数水平的变化情况。结果 1最终完成试验者69例,治疗组35例,对照组34例。2治疗组、对照组临床总有效率分别为77.14%和55.88%;组间临床疗效比较,治疗组明显优于对照组(P<0.05)。3治疗前及随访2个月后组内比较,两组MMSE评分差异有统计学意义(P<0.05);组间治疗前及随访2个月后MMSE评分差值比较,差异有统计学意义(P<0.05)。4治疗前及随访2个月后组内比较,两组旋转180°步数与Evan’s index水平差异均有统计学意义(P<0.05);组间治疗前及随访2个月后比较,旋转180°步数差异有统计学意义(P<0.05)。5两组不良反应发生率比较,差异无统计学意义(P>0.05)。结论五苓散联合常规西药治疗特发性正常颅压脑积水的疗效满意,可改善患者的步态障碍与认知障碍,提高其生活质量。

Objective To investigate the clinical efficacy of the Wuling San combined with conventional western medicine in the treatment of idiopathic normalpressure hydrocephalus（ INPH）. Methods 72 patients with idiopathic normal-pressure hydrocephalus were randomly assigned to the treatment group and the control group equally. Patients in the two groups were treated with conventional western medicine while treatment group received Wuling San and control group with placebo. Both groups treated with 28 d and clinical efficacy,Mini Mental State Examination（ MMSE） score,the steps to turn around 180° and Evan＇s index were observed before and after treatment 2 months later. Results 1 Totally 35 patients in the treatment group and 34 patients in the control group completed the trial.2 At 2 months after treatment,the total clinic effective rate was 77. 14% in the treatment group,with statistical difference when compared with the control group which was 55. 88% were improved（ P 0. 05）. 3 Levels of MMSE score which increased in the two groups after treatment（ P 0. 05） was obviously higher in the treatment group than in the control group（ P 0. 05）. 4 The steps to turn around 180° and the Evan＇s index were obviously less after treatment in the two groups（ P 0. 05）,and it was also had a significant difference between the treatment group and the control group at 2 month after treatment,the treatment group used less steps（ P 0. 05）. 5 There was no significant difference in the incidence of adverse reactions between the two groups（ P 0. 05）. Conclusion The Wuling San in treating INPH patients was superior to the effect of using common treatment alone. It also could improve patients living abilities.