止颤颗粒联合常规西药治疗肝肾不足、气血两虚型帕金森病的随机、双盲、安慰剂对照临床研究

Combination of “Zhichan Granules” and western medicine for the treatment of Parkinson's disease of liver kidney deficiency pattern and qi blood deficiency pattern: a randomized,doubleblinded,placebo-controlled clinical trial

目的观察止颤颗粒联合常规西药治疗肝肾不足、气血两虚型帕金森病的临床疗效。方法将120例病例随机分为治疗组和对照组,每组60例;治疗组予止颤颗粒加常规西药治疗,对照组予中药安慰剂加常规西药治疗。两组疗程均为12周,观察比较治疗前后UPDRS量表积分、中医证候积分的情况,并评价用药安全性。结果 1最终完成试验病例108例,治疗组57例,对照组51例。2治疗前后组内比较,治疗组UPDRS量表总分及分项Ⅲ(运动检查)积分差异有统计学意义(P<0.05);组间治疗后比较,UPDRS量表总分及分项Ⅲ(运动检查)积分差异有统计学意义(P<0.05)。3治疗前后组内比较,治疗组中医证候总分及主要症状积分差异有统计学意义(P<0.05);组间治疗后比较,中医证候总分及主要症状积分差异有统计学意义(P<0.05)。4试验期间共出现不良反应2例,其中治疗组1例,对照组1例;治疗前后,受试者血、尿、粪常规,肝功能(ALT、AST),肾功能(BUN、Cr),心电图检查均未发现可能直接与试验有关的异常改变。结论止颤颗粒联合常规西药治疗肝肾不足、气血两虚型帕金森病的疗效满意,安全性较好,可显著改善患者的临床症状,提高其生活质量。

Objective To observed the clinical efficacy of ＂Zhichan Granules＂ and western medicine for the treatment of Parkinson＇ s disease of liver kidney deficiency pattern and qi blood deficiency pattern. Methods One hundred and twenty cases were randomized into treatment group and control group, with 60 cases in each group. Treatment group was treated by ＂Zhichan Granules＂ and western medicine, and control group was treated by placebo and western medicine, with the course of 12 weeks. The scores of UPDRS and TCM symptoms were compared before and after treatment, and the safety of ＂Zhichan Granules＂ was also evaluated. Results （1） At the end of the trial, 108 cases were finished, with 57 cases in the treatment group and 51 cases in the control group. （2） In treatment group, UPDRS total scores and UPDRS III scores were significant different between before and after treatment （ P 〈 0.05） ; UPDRS total scores and UPDRS III scores were striking different between the treatment group and control group after treatment （ P 〈 0.05 ）. （3） In treatment grouP, the total TCM symptom scores and main symptom scores were striking different between before and after treatment （ P 〈 0. 05 ）, with significant difference between the two groups （ P 〈 0. 05 ）. （4） There are two adverse events during the triM, one in the treatment group and one in the control group; no abnormal changes had been found in blood, urine, stool, hepatic function （ALT, AST）, renal function （BUN, Cr）, electrocardiogram before and after treatment in patients. Conclusion Combined ＂Zhichan Granules＂ and western medicine is effective and safe for Parkinson＇ s disease of liver kidney deficiency pattern and qi blood deficiency pattern. It can relieve its clinical symptoms and improve their quality of life.