熄风定颤丸对帕金森病肝肾不足型的随机对照临床研究
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摘要
目的:
1采用公认的改良Webster评分量表及可靠的观察指标,首次从起效时间、Webster总评分、PD主症单因子分析、中医证候、握力体重指数、总体疗效等方面研究评价中药熄风定颤丸对帕金森病确切的治疗作用。探讨中医药治疗PD的优势。
2根据帕金森病患者常伴有生存质量下降的特点,给予具有“滋养肝肾、熄风定颤”功效的熄风定颤丸,通过对MOS-SF36各维度的评定,研究熄风定颤丸对PD患者生存质量的提高作用。
3通过对治疗并发症的观察对比,探讨中药治疗在减轻西药的毒副作用、提高患者服药的依从性方面所发挥的积极作用,为进一步研究提供依据。
方法:
临床研究采用随机、平行对照、开放性试验方案。根据诊断标准,将纳入的PD中期患者按标准对照1:1的比例,分为治疗组、对照组。两组均以美多巴作为基础治疗药,治疗组加服中药熄风定颤丸。疗程12周。通过对不同时点Webster总评分、Webster因子评分、中医证候、握力体重指数、生存质量、治疗并发症的评分变化进行疗效的比较,全面评估熄风定颤丸对PD确切的治疗作用,以及中医药治疗PD的优势。
结果:
1临床总疗效评定
按Webster减分率评估临床总疗效,治疗组的总有效率为76.67%,对照组总有效率为53.33%,治疗组疗效优于对照组(p＜0.05)。
2对中医证候的影响
治疗后治疗组中医证候明显改善(p＜0.01),西药组中医证候有所恶化。治疗组明显优于对照组(p＜0.01),其改善作用随疗程延长而增强。
3对Webster评分的影响
Webster量表总评分:Webster量表总评分与治疗前比较,治疗组与对照组均具有统计学意义(p＜0.01),两组间比较,有显著差异(p＜0.01),各时点Webster总评分呈持续下降趋势。
Webster因子评分:Webster因子评分与治疗前比较,治疗组与对照组的静止性震颤因子、强直因子有明显改善(p＜0.05),治疗组对双手动作减少因子和步态因子亦有显著改善(p＜0.01),对照组对双手动作减少因子和步态因子均无明显改善(p＞0.05)。两组均对姿势因子无明显改善(p＞0.05)。治疗组对静止性震颤、强直、双手动作减少的改善明显优于对照组(p＜0.05)。
4对握力体重指数的影响
两组均可提高PD患者的握力体重指数(p＜0.01);治疗组疗效优于对照组(p＜0.05)。
5对生存质量的影响
治疗组对患者生存质量各纬度均具有显著改善(p＜0.01);对照组对躯体功能、躯体角色有显著差异(p＜0.01),生命力评分也有显著提高(p＜0.05),对肌体疼痛、一般健康状况、社会功能、情感角色、心理健康无显著改善(p＞0.05)。组间对比生存质量各纬度均有显著差异(p＜0.01、p＜0.05)。
6对治疗并发症的影响
治疗组治疗并发症积分较治疗前减少明显(p＜0.05),而对照组的治疗并发症积分无明显变化(p＞0.05)。
结论:
1熄风定颤丸可明显改善PD患者的临床症状,有效降低PD患者Webster评分。
2熄风定颤丸具有显著改善PD中医证候的优势,并且随着疗程的延长,疗效增强。其作用与中医治疗重视“辩证论治”,从多靶点、多层次、多途径整体调节机体功能的优势有关。
3熄风定颤丸可显著提高PD患者的生存质量。提示中药治疗具有对生理、心理、情绪等多层次调节的优势,可显著改善抑郁、失眠、健忘、痴呆等非运动症状,从而大大提高PD患者的生存质量。
4熄风定颤丸可明显减少PD治疗并发症的发生。提示中药治疗可减轻西药的毒副作用。
Objective
1 To study the therapeutic effects of Xifeng Dingchan Pill(XDP) on Parkinson's disease (PD) using acknowledged reformative Webster rating scale and Chinese medicine criteria.
2 To study the effects of XDP on the life quality of PD patients using MOS-SF36 evaluative scale.
3 To study the poison-reducing effects of Chinese medicine by observing the effects on PD and its complications.
Methods
The clinical research was followed up in randomized,controlled and opened clinical trial. According to the diagnostic criteria,outpatients and inpatients of medium-term PD patients, from the First Hospital affiliated to Henan University of Traditional Chinese Medicine,have been observed and been randomly divided into treatment and control group at the ratio of 1:1.The treatment group(n=30) were given madopar and XDP,control group(n=30) were only given madopar.It was used to evaluate the Webster score,quantification scores of symptoms in TCM, grip weight index(GWI),quality of life and some other complication in order to study the therapeutic efficacy and poison-reducing effects of XDP and its preponderance on PD.
Results
1 Clinical curative effect of XDP on PD
Clinical treatment effect outcomes were assessed using reformative Webster rating scale. The total rate of effect in the treatment group was 76.67%,whereas it was 53.33%in the control group.The treatment group was better than the control group in total effect rate.
2 Effect of XDP on TCM symptoms
Compared with the control group,the score of TCM symptoms decreased(p＜0.01),but it deteriorated in the control group.The efficacy of the treatment group was superior to that of western medical treatment(p＜0.01).Sustaining therapy leads to greater effect.
3 Effect of XDP on the reformative Webster rating score
According to symptom estimation,Webster score of both the treatment group and the control group was significantly reduced compared with those prior to the treatment(p＜0.01), Webster score at different time points had a trend of durative decrease.The efficacy of the treatment group was superior to that of western medical treatment(p＜0.01).Compared with those prior to the treatment,tremor factor and rigidity factor were all improved significantly in the two groups(p＜0.01,p＜0.05),akinesia factor and gait factor were also improved in the treatment group(p＜0.001).There is little improvement in the control group in terms of akinesia factor and gait factor(p＞0.05).No obvious effect was observed in both groups on postural reflex impairment factor.
4 Effect of XDP on Grip Weight Index(GWI)
In terms of GWI,there was significant difference in the two groups compared with those prior to the treatment(p＜0.01).The efficacy of the treatment group was superior to that of the control group(p＜0.05).
5 Effect of XDP on the life quality
The general health status was improved in the treatment group(p＜0.01).The life quality of the patients has been greatly improved in the treatment group,better than that of patients in western medicine group(p＜0.05).
6 Effect of XDP on the complications
The complications score of the treatment group decreased markedly(p＜0.01) compared with that prior to the treatment,whereas that of the western medicine group increased(p＜0.01).
Conclusion
1 XDP has obvious effects on reducing Webster score and improving clinical symptoms of PD.
2 XDP has significant preponderance on relieving TCM symptoms of PD.Sustaining therapy leads to greater effect,which has some correlation with the multi-target,multi-level and multi-approach regulation based on syndrome differentiation and treatment of TCM.
3 XDP can markedly improve the life quality of PD patients.
4 XDP can significantly reduce complications of PD,which shows Chinese medicine can relieve the toxic or side effects of Western medicines,greatly increase medical compliance of the patients,and help slow down the progress of PD.
1采用公认的改良Webster评分量表及可靠的观察指标,首次从起效时间、Webster总评分、PD主症单因子分析、中医证候、握力体重指数、总体疗效等方面研究评价中药熄风定颤丸对帕金森病确切的治疗作用。探讨中医药治疗PD的优势。
2根据帕金森病患者常伴有生存质量下降的特点,给予具有“滋养肝肾、熄风定颤”功效的熄风定颤丸,通过对MOS-SF36各维度的评定,研究熄风定颤丸对PD患者生存质量的提高作用。
3通过对治疗并发症的观察对比,探讨中药治疗在减轻西药的毒副作用、提高患者服药的依从性方面所发挥的积极作用,为进一步研究提供依据。
方法:
临床研究采用随机、平行对照、开放性试验方案。根据诊断标准,将纳入的PD中期患者按标准对照1:1的比例,分为治疗组、对照组。两组均以美多巴作为基础治疗药,治疗组加服中药熄风定颤丸。疗程12周。通过对不同时点Webster总评分、Webster因子评分、中医证候、握力体重指数、生存质量、治疗并发症的评分变化进行疗效的比较,全面评估熄风定颤丸对PD确切的治疗作用,以及中医药治疗PD的优势。
结果:
1临床总疗效评定
按Webster减分率评估临床总疗效,治疗组的总有效率为76.67%,对照组总有效率为53.33%,治疗组疗效优于对照组(p＜0.05)。
2对中医证候的影响
治疗后治疗组中医证候明显改善(p＜0.01),西药组中医证候有所恶化。治疗组明显优于对照组(p＜0.01),其改善作用随疗程延长而增强。
3对Webster评分的影响
Webster量表总评分:Webster量表总评分与治疗前比较,治疗组与对照组均具有统计学意义(p＜0.01),两组间比较,有显著差异(p＜0.01),各时点Webster总评分呈持续下降趋势。
Webster因子评分:Webster因子评分与治疗前比较,治疗组与对照组的静止性震颤因子、强直因子有明显改善(p＜0.05),治疗组对双手动作减少因子和步态因子亦有显著改善(p＜0.01),对照组对双手动作减少因子和步态因子均无明显改善(p＞0.05)。两组均对姿势因子无明显改善(p＞0.05)。治疗组对静止性震颤、强直、双手动作减少的改善明显优于对照组(p＜0.05)。
4对握力体重指数的影响
两组均可提高PD患者的握力体重指数(p＜0.01);治疗组疗效优于对照组(p＜0.05)。
5对生存质量的影响
治疗组对患者生存质量各纬度均具有显著改善(p＜0.01);对照组对躯体功能、躯体角色有显著差异(p＜0.01),生命力评分也有显著提高(p＜0.05),对肌体疼痛、一般健康状况、社会功能、情感角色、心理健康无显著改善(p＞0.05)。组间对比生存质量各纬度均有显著差异(p＜0.01、p＜0.05)。
6对治疗并发症的影响
治疗组治疗并发症积分较治疗前减少明显(p＜0.05),而对照组的治疗并发症积分无明显变化(p＞0.05)。
结论:
1熄风定颤丸可明显改善PD患者的临床症状,有效降低PD患者Webster评分。
2熄风定颤丸具有显著改善PD中医证候的优势,并且随着疗程的延长,疗效增强。其作用与中医治疗重视“辩证论治”,从多靶点、多层次、多途径整体调节机体功能的优势有关。
3熄风定颤丸可显著提高PD患者的生存质量。提示中药治疗具有对生理、心理、情绪等多层次调节的优势,可显著改善抑郁、失眠、健忘、痴呆等非运动症状,从而大大提高PD患者的生存质量。
4熄风定颤丸可明显减少PD治疗并发症的发生。提示中药治疗可减轻西药的毒副作用。
Objective
1 To study the therapeutic effects of Xifeng Dingchan Pill(XDP) on Parkinson's disease (PD) using acknowledged reformative Webster rating scale and Chinese medicine criteria.
2 To study the effects of XDP on the life quality of PD patients using MOS-SF36 evaluative scale.
3 To study the poison-reducing effects of Chinese medicine by observing the effects on PD and its complications.
Methods
The clinical research was followed up in randomized,controlled and opened clinical trial. According to the diagnostic criteria,outpatients and inpatients of medium-term PD patients, from the First Hospital affiliated to Henan University of Traditional Chinese Medicine,have been observed and been randomly divided into treatment and control group at the ratio of 1:1.The treatment group(n=30) were given madopar and XDP,control group(n=30) were only given madopar.It was used to evaluate the Webster score,quantification scores of symptoms in TCM, grip weight index(GWI),quality of life and some other complication in order to study the therapeutic efficacy and poison-reducing effects of XDP and its preponderance on PD.
Results
1 Clinical curative effect of XDP on PD
Clinical treatment effect outcomes were assessed using reformative Webster rating scale. The total rate of effect in the treatment group was 76.67%,whereas it was 53.33%in the control group.The treatment group was better than the control group in total effect rate.
2 Effect of XDP on TCM symptoms
Compared with the control group,the score of TCM symptoms decreased(p＜0.01),but it deteriorated in the control group.The efficacy of the treatment group was superior to that of western medical treatment(p＜0.01).Sustaining therapy leads to greater effect.
3 Effect of XDP on the reformative Webster rating score
According to symptom estimation,Webster score of both the treatment group and the control group was significantly reduced compared with those prior to the treatment(p＜0.01), Webster score at different time points had a trend of durative decrease.The efficacy of the treatment group was superior to that of western medical treatment(p＜0.01).Compared with those prior to the treatment,tremor factor and rigidity factor were all improved significantly in the two groups(p＜0.01,p＜0.05),akinesia factor and gait factor were also improved in the treatment group(p＜0.001).There is little improvement in the control group in terms of akinesia factor and gait factor(p＞0.05).No obvious effect was observed in both groups on postural reflex impairment factor.
4 Effect of XDP on Grip Weight Index(GWI)
In terms of GWI,there was significant difference in the two groups compared with those prior to the treatment(p＜0.01).The efficacy of the treatment group was superior to that of the control group(p＜0.05).
5 Effect of XDP on the life quality
The general health status was improved in the treatment group(p＜0.01).The life quality of the patients has been greatly improved in the treatment group,better than that of patients in western medicine group(p＜0.05).
6 Effect of XDP on the complications
The complications score of the treatment group decreased markedly(p＜0.01) compared with that prior to the treatment,whereas that of the western medicine group increased(p＜0.01).
Conclusion
1 XDP has obvious effects on reducing Webster score and improving clinical symptoms of PD.
2 XDP has significant preponderance on relieving TCM symptoms of PD.Sustaining therapy leads to greater effect,which has some correlation with the multi-target,multi-level and multi-approach regulation based on syndrome differentiation and treatment of TCM.
3 XDP can markedly improve the life quality of PD patients.
4 XDP can significantly reduce complications of PD,which shows Chinese medicine can relieve the toxic or side effects of Western medicines,greatly increase medical compliance of the patients,and help slow down the progress of PD.
引文
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