苁蓉益肾颗粒联合盐酸多奈哌齐片治疗帕金森病痴呆的临床研究

Clinical Study on Congrong Yishen Granules Combined with Donepezil Hydrochloride Tablets in the Treatment of Parkinson Disease with Dementia

目的:观察苁蓉益肾颗粒联合盐酸多奈哌齐片对帕金森病痴呆(PDD)患者精神状态、生活质量的影响及安全性。方法:将60例PDD患者按随机数字表法分为对照组和治疗组,各30例。两组患者均服用治疗帕金森病的药物,对照组患者在此基础上口服盐酸多奈哌齐片5 mg,qd;治疗组患者在对照组基础上加服苁蓉益肾颗粒2 g,bid。两组疗程均为6个月。观察两组患者治疗前后简易智能量表(MMSE)、蒙特利尔认知评估量表(Mo CA)、日常生活活动量表(ADL-R)认知部分(ADAS-Cog)、ADL-R评分和中医症状积分,并比较两组患者不良反应发生情况。结果:治疗前,两组患者MMSE、Mo CA、ADAS-Cog、ADL-R评分和中医症状积分比较,差异均无统计学意义(P>0.05)。治疗后,两组患者MMSE、Mo CA评分均显著升高,ADAS-Cog、ADL-R评分和中医症状积分均显著降低,且治疗组评分显著优于对照组,差异均有统计学意义(P<0.05)。两组患者均未见明显不良反应发生。结论:苁蓉益肾颗粒联合盐酸多奈哌齐片能明显改善PDD患者精神状态和认知能力,缓解临床症状,且安全性较高。

OBJECTIVE:To observe the effects and safety of Congrong yishen granule combined with Donepezil hydrochloridetablet on mental state and quality of life in patients with Parkinson disease with dementia(PDD).METHODS:A total of60PDDpatients were randomized into control group and treatment group,with30cases in each group.Both groups were given drugs forParkinson disease.Control group was additionally given Donepezil hydrochloride tablet5mg,qd;treatment group was additionallygiven Congrong yishen granules2g,bid,on the basis of control group.The treatment lasted for6months in both groups.MMSE,MoCA,ADAS-Cog,ADL-R and TCM symptom score were observed in2groups before and after treatment.The occurrence ofADR were compared between2groups.RESULTS:Before treatment,there was no statistical significance in MMSE,MoCA,ADAS-Cog,ADL-R or TCM symptom score between2groups(P>0.05).After treatment,MMSE and MoCA score of2groupswere increased significantly,while ADAS-Cog,ADL-R and TCM symptom score were decreased significantly;the treatment groupwere better than the control group,with statistical significance(P<0.05).No obvious ADR was found in2groups.CONCLUSIONS:Congrong yishen granule combined with donepezil hydrochloride tablet can significantly improve mental state and cognitiveability of PDD patients,and relieve clinical symptoms with good safety.