自拟补肾平颤方配合美多巴片治疗帕金森病的定量评估

背景:左旋多巴替代疗法一直是治疗帕金森病最基本最有效的方法,但它不能减慢疾病的进程,且随着长期应用副作用日趋严重,推迟左旋多巴的使用,减少左旋多巴的用量对患者可能有益。目的:系统性观察中药自拟补肾平颤方配合美多巴片对帕金森病患者发病后病情的疗效。设计:观察对比实验。单位:首都医科大学宣武医院老年病研究中心。对象:选择1999-12/2002-05在中国中医研究院西苑医院老年病科门诊收治的70例帕金森病患者,纳入标准:①明确诊断为帕金森病的患者。②改良Hoehn-Yahr分级第1.5～4级。③年龄<80岁。④中医辨证属于肝肾不足。排除标准:①继发性帕金森病患者。②伴随其他严重中枢神经系统疾病者。③有严重心、肺、肾疾病或多脏器衰竭者。④精神病患者。⑤滥用药物史及酗酒者。⑥对多种药物严重不良反应者。方法:将70例帕金森病患者按照1∶1随机分成治疗组(n=35)及对照组(n=35),治疗组,男22例,女13例,平均年龄(67.9±16.5)岁;对照组,男25例,女10例,平均年龄(65.5±16.5)岁。两组患者一般情况差异无显著性。对照组患者口服62.5～500mg美多巴片(250mg/片),2～4次/d(剂量根据病情严重程度增减);治疗组患者62.5～500mg口服美多巴片(250mg/片),2～4次/d,同时服用自拟补肾平颤方200mL(含首乌20g,鹿茸1g,天麻10g,钩藤15g,柴胡12g,厚朴15g),2次/d。两组患者用药疗程均为3个月。采用目前国际通用的统一帕金森评定量表分别对治疗前及治疗后2,4,8,12周的两组患者评估;观察两组患者治疗前和多美巴片治疗后的用量及不良反应。主要观察指标:治疗组和对照组患者治疗前和治疗后2,4,8,12周统一帕金森评定量表评分;两组患者治疗前和多美巴片治疗后的用量及不良反应。结果:治疗组和对照组患者经治疗后总有效率分别为69%、51%,治疗效果差异无显著性(χ2=0.86,P=0.2223)。①治疗组患者经治疗后8周统一帕金森评定量表评分较治疗前记分明显下降(t=2.18,P<0.05)。②治疗组患者治疗后每日用量较治疗前减少,差异有显著性(t=2.8628,P<0.01);对照组患者治疗后每日用量与治疗前相比差异无显著性(t=2.3203,P<0.01)。③治疗组患者中2例出现轻微口干,恶心,头晕加重,持续2周后缓解;对照组患者中5例出现恶心,2例轻度头晕,均能自行缓解。两组患者治疗前后血压无显著变化。结论:中药补肾平颤方加西药治疗有降低帕金森病患者统一帕金森评定量表评分的趋势,可以改善帕金森病患者的中医症状。

Quantitative evaluation of self-made Bushenpingchan formula combined with madopar for Parkinson disease

BACKGROUND: Levodopa substitutive therapy is essential and effective method for PD for a long time, but it can not delay the course of PD. Side effect is more and more and severe, for taking levodopa long term. It is benefit to patients to postpone the usage of levodopa or decrease the dosage of it.OBJECTIVE: To systematically investigate the curative effect of the selfmade Bushenpingchan formula combined with madopar on pathogenetic condition of PD patients after onset.DESIGN: Randomized controlled observation.SETTING: Senile Disease Research Center, Xuanwu Hospital, Capital University of Medical Sciences.PARTICIPANTS: Seventy patients diagnosed as having PD were recruited from the Xiyuan Hospital of Chinese Academy of Traditional Chinese Medicine between December 1999 and May 2002. Inclusive criteria: The patients must be diagnosed as PD finally; ②be at 1.5-4 grade of modified Hoehn & Yahr measuring scale; ③less than 80 years old; ④The Traditional Chinese Medicine (TCM) diagnosis was deficiency of liver and kidney. Exclusive criteria: ①secondary PD; ②accompanying with other sever central nervous system diseases. ③patients with severe diseases of heart,lung, kidney or multi-viscera-failure; ④mental sickness patients; ⑤drug and alcohol abuse; ⑥severe adverse effect.METHODS: Totally 70 patients were divided into two groups based on the proportion of one to one: There were 35 patients in treatment group containing 22 males and 13 females. The average age was (67.9±16.5)years. There were 35 patients in control group including 25 males and 10females. The average age was (65.5±16.5) years. There was no significant difference in their general condition. Patients in the control group received 62.5-500 mg madopar (250 mg in each pill), 2-4 times a day (to change the dose according to patients' condition). The patients in the treatment group were given with 62.5-500 mg madopar (250 mg in each pill), 2-4times a day orally and 200 mL self-made Bushenpingchan formula (twice a day) in addition, which was composed of 20 g tuber fleeceflower root, 1 g hairy deerhorn, 10 g tall gastrodia tuber, 15 g gambirplant, 12 g Chinese thorowax root, 15 g twolobed officinal magnolia bark, twice a day. The course of medication was 3 month in patients of the two groups. The patients were determined with unified Parkinson disease rating scale (UPDRS) before treatment and at weeks 2, 4, 8 and 12 after treatment, respectively. The symptoms in traditional Chinese medicine after treatment were measured. The dose of madopar before and after medication as well as the adverse effect were observed.MAIN OUTCOME MEASURES: Score of UPDRS before treatment and at weeks 2, 4, 8 and 12 after treatment in patients of the treatment group and control group; the dose of madopar before and after treatment and the adverse effect after treatment.RESULTS: Total effective rate was 69% and 51% in the treatment group and control group, respectively after treatment. There was no significant difference in therapeutic efficacy (x2=0.86, P=0.222 3). ①The score of UPDRS reduced significantly 8 weeks after treatment in the treatment group as compared with that before treatment (t=2.18 ,P ＜ 0.05). ②The daily dosage decreased in the patients of the treatment group after treatment as compared with that before treatment, which had significant difference (t =2.862 8,P ＜ 0.01 ). The daily dosage in the patients of control group had insignificant difference with that before treatment (t=2.320 3,P ＜ 0.01 ). ③There were 2 cases with lightly dry mouth, nausea, dizziness,which could relieve two weeks later in the treatment group; 5 patients with nausea and 2 patients with light dizziness in control group, which could relieve. The blood pressure had no significant change in the two groups before and after treatment.CONCLUSION: The Chinese medicine Bushenpingchan formula combined with western medicine can decrease the UPDRS score in PD patients,can improve the syndromes in Chinese medicine.