帕金森病分层治疗临床研究

【作者】 马龙；

【导师】 马云枝；

【作者基本信息】 北京中医药大学 ， 中医内科学， 2008， 博士

【摘要】 目的:探讨PD早期单用中药防治的可行性;及针对中晚期PD患者采用中西药联用治疗,观察中药“减毒增效”效应,阐明中西医综合治疗优势所在。方法:采用分层、随机、单盲、对照试验研究。参照改良Hoehn&Yahr分级标准及临床症状,将帕金森病患者分为A、B、C三层。A层患者给予熄风定颤丸治疗选取美多巴作为对照药物,治疗后从运动症状、中医证候、生存质量、治疗并发症等方面,全面评估单一中药治疗的疗效及毒副反应。B层患者给予熄风定颤丸联用美多巴治疗,选取单一美多巴治疗对照,从患者运动症状、中医证候、生存质量、治疗并发症、西药增减变化等方面,评估中药“减毒增效”效应。C层患者给予熄风定颤丸联用美多巴、泰舒达治疗,选取美多巴、泰舒达联用治疗为对照,从患者运动症状、中医证候、生存质量、治疗并发症等方面,全面评价中西医综合治疗优势。结果:试验一发现,在运动症状方面:熄风定颤丸与美多巴,疗效相当(p﹥0.05)。在中医证候方面:中药组总有效率高于西药。在生存质量方面:两组间在一般健康状况纬度具有显著差异。在治疗并发症方面:中药组并发症积分明显低于西药组。两组药物治疗均为安全。试验二发现,在运动症状方面:联用组疗效优于西药组。在中医证候方面:联用组治疗后中医证候改善明显;西药组治疗后中医证候有所恶化。在生存质量方面:中西药联用对患者生存质量各纬度均具有显著改善;西药治疗则对患者生存质量各纬度中肌体疼痛、一般健康状况、社会功能、心理健康改善无统计学意义(p﹥0.05);两组间在情感角色纬度差异无统计学意义(p﹥0.05)。在美多巴用量方面:联用组美多巴用量减少明显,西药组治疗后美多巴用量积分有所增加。在治疗并发症方面:联用组治疗并发症积分减少明显,西药组治疗并发症积分增加明显。在安全性评价方面:试验期间,两组患者各项安全性指标均未因试验药物出现明显异常,两者药物治疗均为安全。试验三发现,在运动症状方面:中西药联用组疗效优于西药联用组。在改善中医证候方面:中西药联用组具有明显优势。在生存质量方面:中西药联用对患者生存质量各纬度均具有显著改善;西药联用治疗则对患者生存质量各纬度中肌体疼痛、生命力、心理健康改善无统计学意义;两组间在躯体功能纬度差异无统计学意义。在治疗并发症方面:中西药联用组治疗并发症积分减少明显,西药联用组治疗并发症积分增加明显。在安全性评价方面:试验期间,两组患者各项安全性指标均未因试验药物出现异常,两者药物治疗均为安全。结论:结论一、对于A层帕金森病患者,采用单一中药(熄风定颤丸)治疗与西药(美多巴)疗效相当,且较西药具有毒副作用小的优势。因此,对于早期帕金森病患者采用中药替代西药治疗,可在保证治疗效果的前提下,推迟左旋多巴的治疗时间,从而延迟伴随左旋多巴制剂治疗出现的并发症的产生,提高患者的生存质量。针对早期PD患者,单一中药治疗切实可性。结论二、对于B层帕金森病患者,采用中西药联用治疗,在提高疗效、改善患者中医证候及生存质量方面优于单一西药治疗,且可整体调节、主次兼顾,不仅对帕金森病主症改善明显,对于兼症亦有显著效果。另外,中西药联用还可明显减少西药服药量,进而降低左旋多巴的毒副作用,“增效减毒”作用明显,有效迟滞了帕金森病进程,大大提高患者生存质量。结论三、对于C层帕金森病患者,中西医结合治疗在提高疗效、改善患者中医证候、生存质量等方面均优于西药联用治疗,且可降低西药联用所致毒副反应程度,“减毒”效果明显。且所选中药-熄风定颤丸中多有养肝之品,肝得滋养、疏泻正常、气机调畅,因此对患者心理、情绪等非运动症状还可产生积极影响,这是西药治疗所无法比拟的。更多还原

【Abstract】 ObjectThe thesis is to study the feasibility of Chinese medicine treatment for early parkinson’s disease(PD). For patients with advanced PD, we adopted combination of Chinese and western medicine to observe the synergistic and attennated effect of Chinese medicine.MethodsThe tentative research was followed up in stratified, randomized and single-blind way. The patients were divided into the A, B and C three categories according to Hoehn & Yahr scale and clinical symptoms. The early patients(A)were given Xifeng Dingchan Pill(XDP) and madopar was used as a contrasting to treat UPDRS score, Tcm symptoms, quality of life and some other complicating disease. It was used to evaluate efficacy of single Chinese medicine and its side-effect. Medium-term patients(B)were given Xifeng Dingchan Pill(XDP) and madopar, and chose single madopar as a contrast to evaluate the result of Chinese medicine’s posion-reducing and increasing effectiveness from their UPDRS score, Tcm symptoms, quality of life and madopar usty. The later-term patients(C)were given Xifeng Dingchan Pill(XDP), madopar and Tai Shu da,at the same time used Mei Duo ba and Tai Shu da as a contrasting to treat to evaluate the advantage of combination between Chinese and western medicine from UPDRS score, Tcm symptoms, quality of life and some other complicating disease madopar and pilribedil sustained-release tablets. UPDRS score, TCM symptoms, quality of life.ResultsExperiment 1:Concerned with the movement symptoms,the efficacy of the two groups are equal. In TCM symptoms, the team of Chinese medicine is superior in general validity. In quality of life,the two groups are obviously different in general health status. In the treatment of complicated symptoms, the score of Chinese medicine was less than madopar group. The treatments of the two groups are safe.Experiment 2:In the movement symptoms, efficacy of combined group is superior to wester medicine group. In treatment group was better than the control group. Compared with the madopar simplely group,the score of UPDRS(ⅡⅢ) of combined group were better significantly. In terms of TCM symptoms, there was significant difference in the two groups, efficacy of combination of Chinese and western medicine was superior than western medicine simplely. The quality of life had improved obviously in combined group than in wester medicine group. The usage of madopar and treatment complications score of combined group were decreased, but western medicine group were increased. In evaluation of safety, The treatments of the two groups are safe. Experiment 3:In the movement symptoms, efficacy of the combined group was better than western medicine group. In terms of improvement of TCM symptoms, combination of Chinese and western medicine has obviously advantages over combination of western medicine. In quality of life, the combined group has obviously improved the patients. The treatment of combination of western medicine didn’t give any statistical meaning in patients’ache of body, vatality and improvement of psychological health.There is no statistical meaning in body function difference between the two groups. Treatment complications of treatment group was reduced. On the contrary, control group was rised.Conclusion1 The usage of Chinese medicine simply was safe and effective in the treatment of early PD patients. XDP has less side-effect than madopar.So the early PD patients(A)should use Chinese medicine instead of the western to treat.2 To medium-term patients(B), efficacy of combination of Chinese and western medicine was superior than western medicine simplely in motor symptoms, TCM symptoms and QOL. Madopar usty and treatment complications were decrease significantly in the combined group.3 TO patients with advanced PD(C), the treatment of combination of Chinese and western medicine is superior to western medicine simplely in increasing efficacy, improving the patients’symptoms and quality of life, at the same time it can decrease the side-effect. Chinese medicine intervention can not only nourish the patients’liver and reduce treatment complications but also improve their mental health.更多还原