龟羚帕安胶囊治疗帕金森病多中心、随机、双盲、对照临床研究

作者	单位
赵国华	首都医科大学宣武医院
孟庆刚	北京中医药大学
于向东	首都医科大学宣武医院
白京云	北京中医药大学
雒哓东	广东省中医院
袁灿兴	上海中医药大学附属龙华医院
邱丽敏	大连市中医院
董少龙	广西中医学院第一附属医院
杜继臣	航天部中心医院
郭存举	山东省聊城市人民医院
吴正治	深圳市中西医结合研究所
东贵荣	黑龙江中医药大学第二附属医院
陈彪	首都医科大学宣武医院
罗毅	解放军总医院

摘要点击次数: 1960

全文下载次数: 3

中文摘要:

目的客观评价中药龟羚帕安胶囊治疗帕金森病的临床疗效。方法按照药品临床试验管理规范(good clinical practice,GCP)原则,采用多中心、随机、双盲、分组、分层、对照研究方法,进行临床试验。2002年5月-2005年1月对242例帕金森病患者按照未服左旋多巴(A组28例,B组25例)和已服左旋多巴(C组75例,D组79例、E组19例,F组16例)分为两大组,A、B组口服中药龟羚帕安胶囊或安慰剂胶囊;对已服左旋多巴组,按照改良Hoehn&Yahr分级1.5~3级为一层(C组,D组),4级为一层(E组,F组),分别接受中药龟羚帕安胶囊加左旋多巴或安慰剂加左旋多巴治疗;疗程均为12周。观察各组统一帕金森病评定量表(UPDRSⅡ/Ⅲ)相对于基线的变化,对已服左旋多巴组观察使用左旋多巴总剂量;同时观察血压、脉搏、血尿常规、肝肾功能、心电图及不良反应等。结果(1)A、B组疗效:A组明显改善3.6%(1/28),改善39.3%(11/28);B组分别为0、28.0%(7/25);两组疗效比较差异无统计学意义。治疗后UPDRS总评分及Ⅱ、Ⅲ评分A组均明显低于治疗前(P<0.01,P<0.05);B组仅Ⅲ评分明显低于治疗前(P<0.05);治疗后组间3项评分差值比较均无统计学意义。(2)C、D组疗效:C组明显改善12.0%(9/75),改善48.0%(36/75);D组分别为12.7%(10/79)、24.1%(19/79);C组疗效优于D组(P<0.05)。治疗后UPDRS总评分、Ⅱ、Ⅲ评分两组均明显低于治疗前(P<0.01);治疗后UPDRS总评分、Ⅱ评分组间比较C组优于D组(P<0.05)。(3)E、F组疗效:E组明显改善5.3%(1/19),改善36.8%(7/19);F组分别为0、25.0%(4/16);两组疗效比较差异无统计学意义。治疗后UPDRS总评分、Ⅱ、Ⅲ评分两组均低于治疗前(P<0.01),治疗后两组间比较差异无统计学意义(P>0.05)。(4)治疗后C组+E组左旋多巴用量明显低于治疗前(P<0.05),D组+F组治疗前后用量比较差异无统计学意义(P>0.05);进一步分析,C组治疗后低于治疗前(P<0.05),D、E、F组治疗前后比较差异均无统计学意义(P>0.05)。结论(1)改良Hoehn&Yahr分级1.5~3级患者采用龟羚帕安胶囊加左旋多巴,总体疗效明显优于采用安慰剂加左旋多巴组;(2)中药龟羚帕安胶囊能够改善运动症状和患者生活质量;(3)中药龟羚帕安胶囊和左旋多巴制剂合用可减少左旋多巴制剂用量。

英文摘要:

Objective To objectively evaluate the clinical efficacy of Guiling Pa’an Capsule(GPC),a Chinese medicine,in treating Parkinson’s disease(PD).Methods According to the good clinical practice(GCP)principle,a multi-centered,double-blinded,layered,randomized and grouping-controlled clinical trial was carried out from May 2002 to January 2005 on 242 PD patients.Among them,53 patients who had never received levodopa were randomized into two groups,28 in group A treated with GPC,and 25 in group B treated with placebo;patients who had received levodopa were assigned depending on the Hoehn & Yahr(H-Y)grade,to 4 groups,75 and 19 of grade 1.5-3 in group C and E,respectively,79 and 16 of grade 4 in group D and F,respectively,patients in group C and E were treated with GPC and Levodopa,and those in group D and F treated with placebo and Levodopa for control.The treatment course was 12 weeks for all.Changes of unified Parkinson’s disease rating scale(UPDRS)Ⅱ/Ⅲ scores in comparing with the baseline were assessed.For the groups C,D,E and F,the dosage of levodopa administered was also recorded.Meanwhile,the blood pressure,pulse rate,blood and urine routine,liver and renal functions,electrocardiogram(ECG)and adverse reactions were monitored as the indices for safety supervise.Results(1)After treatment,symptoms were markedly improved in 1 out of the 28 patients in group A and improved in 11,the markedly improving rate was 3.6% and the improving rate 39.3%;while in group B,the corresponding outcomes were 0(0/25)and 28.0%(7/25)respectively,showing insignificant difference between the two groups.UPDRS scores,including the total,Ⅱ and Ⅲ scores were all significantly lowered in group A after treatment(P<0.01,P<0.05);while in group B,significant lowering only showed in terms of UPDRS Ⅲ(P<0.05);but the inter-group comparison of the changes in all the three items showed no significant difference.(2)The significant improving rate was 12.0%(9/75)and improving rate 48.0%(36/75)in group C,while those in group D,12.7%(10/79)and 24.1%(19/79)respectively,the efficacy in group C was better(P<0.05).The items of 3 UPDRS scores in groups C and D were all significantly lowered after treatment(P<0.01),and the lowering in group C was more significant in terms of the total and Ⅱ scores(P<0.05).(3)The significant improving rate was 5.3%(1/19)and improving rate 36.8%(7/19)in group E,while in group F 0%(0/19)and 25.0%(4/16),respectively,showing insignificant difference between them;UPDRS scores lowered significantly in the two groups after treatment(P<0.01),also showed no statistical significance in comparison(P>0.05).(4)The dosage of Levodopa required in groups C and E was significantly reduced after treatment(P<0.05),while in groups D and F,it was unchanged(P>0.05);yet,the further analysis displayed that significant reduction only presented in group C(P<0.05),not in the other three groups.Conclusions The overall efficacy of levodopa in combined with GPC for treating PD patients of H-Y grade 1.5-3 is significantly higher than that of levodopa alone.GPC shows obvious effects in improving patients’ motor syndrome and the quality of life;as used in combining with levodopa,the dosage of levodopa required could be reduced.

关闭