加味五虎追风散对肾虚血瘀型早期帕金森病中医证候和生活质量的影响

Clinical Effect of Modified Wuhu Zhuifeng Powder on Traditional Chinese Medicine Syndrome and Quality of Life of Early Parkinson’s Disease Patients with Kidney Deficiency and Blood Stasis Syndrome

【目的】观察加味五虎追风散对肾虚血瘀型早期帕金森病(PD)患者中医证候和生活质量的影响。【方法】将80例肾虚血瘀型早期PD患者随机分为观察组和对照组,每组各40例。观察组患者给予加味五虎追风散治疗,对照组患者给予多巴丝肼片治疗,疗程为3个月,并随访3个月。观察2组患者治疗前、治疗后和疗程结束3个月后中医证候积分、帕金森病生活质量量表(PDQ-39)评分的变化情况,评价2组患者的中医证候疗效和安全性。【结果】(1)观察期间,观察组脱落2例,对照组脱落1例,最终观察组38例、对照组39例患者完成试验。(2)治疗后及疗程结束3个月后,观察组的总有效率分别为89.47%(34/38)和78.95%(30/38),对照组分别为30.77%(12/39)和17.95%(7/39),观察组的中医证候疗效均明显优于对照组,差异均有统计学意义(P<0.05)。(3)治疗后,观察组的各项证候积分均较治疗前改善(P<0.05),而对照组仅肢体颤振、肢体拘痉、运动迟缓积分较治疗前改善(P<0.05);组间比较,观察组在改善精神萎靡、善忘性、失眠多梦、腰膝酸软、刺痛及痛有定处、夜尿频多、大便秘结等证候积分方面优于对照组(P<0.05)。疗程结束3个月后,观察组的肢体颤振、肢体拘痉、运动徐缓、腰膝酸软、刺痛及痛有定处、大便秘结等证候积分仍较治疗前改善(P<0.05),而对照组仅肢体拘痉积分较治疗前改善(P<0.05);组间比较,观察组在改善肢体颤振、运动徐缓、精神萎靡、失眠多梦、腰膝酸软、刺痛及痛有定处、大便秘结等证候积分方面优于对照组(P<0.05)。(4)治疗后,2组患者的PDQ-39评分均较治疗前降低(P<0.05),且观察组在降低PDQ-39评分方面优于对照组(P<0.05)。疗程结束3个月后,观察组的PDQ-39评分仍较治疗前降低(P<0.05),而对照组的PDQ-39评分又恢复至治疗前水平(P>0.05);组间比较,观察组在降低PDQ-39评分方面仍优于对照组(P<0.05)。(5)2组患者的不良反应发生率比较,差异无统计学意义(P>0.05)。【结论】加味五虎追风散能明显改善肾虚血瘀型早期PD患者的中医证候,提高患者的生活质量,其疗效优于多巴丝肼片,且作用持久和安全性高。

Objective To observe the effect of modified Wuhu Zhuifeng Powder on the traditional Chinese medicine(TCM)syndrome and quality of life of early Parkinson’s disease(PD)patients with the syndrome type of kidney deficiency and blood stasis. Methods Eighty cases of early PD patients with kidney deficiency and blood stasis syndrome were randomized into observation group and control group, 40 cases in each group. The observation group was treated with modified Wuhu Zhuifeng Powder orally,and the control group was treated with Madopar Tablets orally. The patients in the two groups were treated for 3 months and then were followed up for 3 months.Before and after treatment and 3 months after the completion of treatment course,the scores of TCM syndrome and quality of life in Parkinson’s Disease Questionnaire(PDQ-39)were observed for the evaluation of clinical efficacy on TCM syndrome and the safety of the therapy. Results(1)During the trial,2 cases from the observation group and one case from the control group dropped out,and then at the end of trial,38 cases of the observation group and 39 cases of the control group finished the trial.(2)After treatment and 3 months after the completion of treatment course,the total effective rate of the observation group was 89.47%(34/38)and 78.95%(30/38), and that of the control group was 30.77%(12/39)and 17.95%(7/39)respectively, and the clinical effect on TCM syndrome of the observation group was stronger than that of the control group(P<0.05).(3)After treatment,the scores of various TCM symptoms in the observation group were obviously improved in comparison with those before treatment(P<0.05),and in the control group only the scores of TCM symptoms of limb tremor,limb spasm,and clumsiness were improved(P<0.05). The intergroup comparison showed that the observation group had stronger effect on improving the scores of dispiritedness,amnesia,insomnia and dreaminess,aching loin and limp legs,pricking pain with a fixed location,nocturnal polyuria,and constipation than the control group(P<0.05). Three months after the completion of treatment course, the scores of symptoms of limb tremor, limb spasm, clumsiness, aching loin and limp legs, pricking pain with a fixed location, and constipation in the observation group were still much improved in comparison with those before treatment(P<0.05), and in the control group only the scores of limb spasm were improved(P<0.05). The intergroup comparison showed that the observation group had stronger effect on improving the scores of limb tremor, clumsiness, dispiritedness,insomnia and dreaminess,aching loin and limp legs,pricking pain with a fixed location,and constipation than the control group(P<0.05).(4)After treatment,the scores of quality of life in PDQ-39 in the two groups were decreased in comparison with those before treatment(P<0.05), and the decrease in the observation group was superior to that in the control group(P<0.05). Three months after the completion of treatment course,the scores of PDQ-39 in the observation group were still lower than those before treatment(P<0.05),but the scores of the control group increased to the levels before treatment(P>0.05). The observation group had stronger effect on decreasing PDQ-39 scores than the control group(P<0.05).(5)The difference of the incidence of adverse reactions between the two groups was insignificant(P>0.05). Conclusion Modified Wuhu Zhuifeng Powder is more effective and safer on improving the TCM syndrome and quality of life of early PD patients with the syndrome of kidney deficiency and blood stasis than Madopar,and its effect is persisting.