应用国产神经节苷脂改善帕金森病患者临床症状的时间及效果:多地区、多中心6 344例回顾性分析

Ameliorating the time and effect of ganglioside made in China on the clinical symptoms of patients with Parkinson disease: Retrospective analysis of multi-region and multi-center

目的:观察口服国产神经节苷脂对帕金森病患者临床症状的改善时间及效果。方法:于2001-01/2005-01通过脑病防治健康教育计划小组选取帕金森患者,包括黑龙江、河北、山东、河南、北京、江苏、甘肃、青海、贵州、福建、湖南、山西、湖北、四川、重庆、江西、上海、云南等地区共6344例患者,均符合《实用神经病学》有关帕金森病的诊断及分类标准,纳入口服神经节苷脂≥10mg/d,服用1个月以上且知情同意者。患者口服国产神经节苷脂口服液进行神经功能康复,每支含神经节苷脂(内含单唾液酸四己糖神经节苷脂1(占21%)、二唾液酸四已糖神经节苷脂1a(占40%)、二唾液酸四已糖神经节苷脂1b(占16%)、三唾液酸四已糖神经节苷脂1b(占19%))0.25g/L,每天早上空腹2支,晚上睡前2支或每晚临睡前4支服用。3个月为1个治疗周期,患者服用两三个周期,个别病程时间长者服用4个周期以上。服用过程中进行定期随访,观察帕金森患者在震颤、肌强直、运动迟缓、姿势异常等方面的改善情况。疗效评估:对患者服用国产神经节苷脂口服液后3个月、6个月、9个月、1年的病情改善情况进行观察。显效为震颤和肌强直消失,姿势异常消失,渐停止服用多巴胺制剂等药物;好转为上述症状减轻,多巴胺制剂等药物减少使用;无效为上述症状无改善。结果:符合纳入标准者5937例,全部进入结果分析,无脱落。不同服药时间帕金森病患者临床症状的改善情况:服用国产神经节苷脂1￣3个月有效者669例,服用4￣6个月有效者941例,服用7￣12个月有效者1713例,总有效率为56%。结论:国产神经节苷脂能有效改善帕金森患者震颤、肌强直、运动迟缓、姿势异常等临床症状,长期服用效果更好。

AIM： To probe into the rehabilitative action of ganglioside made in China on patients with Parkinson disease （PD）. METHODS： A total of 6 344 PD patients, treated with oral ganglioside medication between January 2001 and January 2004 were selected from Heilongjiang, Hebei, Shandong, Henan, Beijing, Jiangsu, Gansu, Qinghai, Guizhou, Fujian, Hunan, Shanxi, Hubei, Sichuan, Chongqing, Jiangxi, Shanghai and Yunnan areas. All subjects met the diagnostic and classification criteria of PD recorded in Practical Neurology. Patients, who knew and agreed with the items and orally took more than 10 mg of ganglioside per day for more than one month, were enrolled. Patients orally taken ganglioside for neurofunctional recovery, and each piece contained 0.25 g/L of ganglioside [including monosialoteterahexosyl ganglioside 1 （GM1）, accounted for 21%; GD 1a, accounted for 40%; GD1b, accounted for 16%; GT1b, accounted for 19%] two pieces in the morning and two pieces at night or 4 pieces together before sleep. Three months was taken as one course, and patients undertook 2-3 courses. Some patients with long course of disease undertook more than 4 courses. Regular follow-up was conducted in the treatment, and the ameliorations of tremor, myotonia, bradykinasia and. postural instability in patients were studiad. Effect evaluation： The improvements in patients at 3, 6 and 9 months and 1 year after treatment with ganglioside were studied, Excellence as tremor, myotonia and postural instability disappeared, and patients gradually stopped taking dopamine preparation; Improved as above-mentioned symptoms were ameliorated and releasing of dopamine preparation; Invalid as no amelioration in above-mentioned symptoms. RESULTS： 5 937 enrolled patients were involved in the analysis of results, and no one withdraw from the study. Improvements of clinical symptoms in PD patients treated at different time： It was valid in 669 patients within 1-3 months of taking ganglioside, in 941 patients within 4-6 months and was valid in 1 713 patients withiri 7-12 months with a total effective rate of 56%. CONCLUSION： Ganglioside made in China can effectively ameliorate the symptoms of tremor, myotonia, bradykinesia and postural instability in PD patients, and the effect is better in long-term treatment.