升陷汤治疗气虚型早期帕金森病自主神经功能障碍的临床观察

Clinical Observation of Shengxiantang in Treatment of Early Parkinson’s Disease with Autonomic Dysfunction of Qi Deficiency Pattern

目的:研究升陷汤治疗气虚型早期帕金森病自主神经功能障碍的安全性和有效性。方法:将82例符合纳入标准的患者随机分为对照组和中药组,各41例,在西医规范化治疗基础上,中药组加用升陷汤,对照组加用安慰剂,连续治疗12周。治疗前后分别采用帕金森病自主神经功能评定量表、帕金森病统一评分量表、帕金森病中医气虚症状评分评估临床疗效,并对血清谷胱甘肽过氧化物酶和血清超氧化物歧化酶水平、每日普拉克索和多巴丝肼用量及安全性指标进行检测、评估。结果:与本组治疗前比较,治疗后对照组帕金森病自主神经功能评定量表总分、消化系统症状评分、泌尿系统症状评分和体温调节功能评分显著升高(P<0.01),中药组帕金森病自主神经功能评定量表总分、消化系统症状评分、泌尿系统症状评分和体温调节功能评分明显降低(P<0.05,P<0.01),两组心血管系统症状评分、瞳孔调节功能评分、性功能评分无意义;治疗后与对照组比较,中药组帕金森病自主神经功能评定量表总分、消化系统症状评分、泌尿系统症状评分和体温调节功能评分明显降低(P<0.05,P<0.01),心血管系统症状评分、瞳孔调节功能评分、性功能评分差异无统计学意义。与本组治疗前比较,治疗后对照组帕金森病中医气虚症状评分总分、主证评分、次证评分无意义,中药组帕金森病中医气虚症状评分总分、次证评分降低(P<0.01),中药组主证评分差异无统计学意义。与本组治疗前比较,两组帕金森病统一评分量表积分、血清谷胱甘肽过氧化物酶和超氧化物歧化酶水平、普拉克索和多巴丝肼每日用量差异无统计学意义;治疗后与对照组比较,中药组帕金森病统一评分量表积分、血清谷胱甘肽过氧化物酶和超氧化物歧化酶水平、普拉克索和多巴丝肼每日用量差异无统计学意义。安全性指标未见异常。结论:在西医规范化治疗基础上,给予升陷汤治疗可以有效改善气虚型早期帕金森病自主神经功能障碍患者的消化系统、泌尿系统和体温调节等自主神经症状及气虚症状,且具有良好的安全性。

Objective:To investigate the efficacy and safety of Shengxiantang in the treatment of early Parkinson’s disease with autonomic dysfunction of Qi deficiency pattern.Method:A total of 82 eligible patients were randomized into control group(41 cases)and traditional Chinese medicine(TCM)group(41 cases).On the basis of standardized treatment of western medicine,TCM group was prescribed Shengxiantang while control group were treated with placebo for 12 consecutive weeks additionally.Scale for Outcomes in Parkinson’s Disease-Autonomic(SCOPA-AUT)questionnaire,Unified Parkinson’s Disease Rating Scale(UPDRS),Traditional Chinese Medicine Qi Deficiency Symptom Score of Parkinson’s Disease(TCMQDSSPD),serum levels of glutathione peroxidase(GPx)and superoxide dismutase(SOD),daily dosage of pramipexole and levodopa and benserazide hydrochloride,and safety index were evaluated both before and after treatment.Result:After treatment,the total score of SCOPA-AUT,gastrointestinal score,urinary score,and thermoregulatory score in the control group were higher than those before treatment(P<0.01),while the above sores in the TCM group were lower than those before treatment(P<0.05,P<0.01).In addition,the cardiovascular score,pupillomotor score,and sexual score in two groups showed no significant difference from those before treatment.After treatment,the total score of SCOPA-AUT,gastrointestinal score,urinary score,and thermoregulatory score in the TCM group were lower than those in the control group(P<0.05,P<0.01),and cardiovascular score,pupillomotor score,and sexual score showed no significant difference between two groups.After treatment,the total score of TCMQDSSPD,main symptom scores,and minor symptom scores in the control group had no significant difference from those before treatment.The total score of TCMQDSSPD and minor symptom scores of TCM group were lower than those before treatment(P<0.01),while the main symptom scores of the TCM group showed no significant difference from those before treatment.After treatment,the UPDRS score,serum GPx and SOD levels,and daily dosage of pramipexole and levodopa and benserazide hydrochloride demonstrated no significant difference from those before treatment in the two groups and between the two groups.No abnormality was found in the safety indexes.Conclusion:Based on the standardized treatment of western medicine,Shengxiantang can effectively and safely improve the autonomic symptoms of gastrointestinal system,urinary system,and thermoregulation,as well as the symptoms of Qi deficiency syndrome in early Parkinson’s disease with autonomic dysfunction.