Safety and efficacy of pramipexole hydrochloride extended-release tablets in treatment of idiopathic Parkinson′s disease

doi:10.3877/cma.j.issn.1674-0785.2017.19.003

Abstract

Abstract:

Objective

To explore whether the curative effect of the extended-release form of pramipexole is better than that of the immediate-release form and levodopa in treating idiopathic Parkinson′s disease.

Methods

One hundred and ten Parkinson′s disease patients treated at the Second Hospital of Shanxi Medical University and Shanxi Dayi Hospital from October 2015 to July 2017 were randomly divided into three groups to receive the extended-release form of pramipexole plus levodopa, the immediate-release form plus levodopa, and levodopa alone, respectively. Motor symptoms, levodopa dosage, Hamilton depression rating scale-17 (HAMD-17) score, Parkinson′s disease sleep scale (PDSS) score, and the 36-item short form health survey (SF-36) score were compared between the three groups.

Results

The extended-release form plus levodopa had similar efficacy to the immediate-release form plus levodopa in improving motor symptoms (P>0.05), but was better than levodopa alone. The extended-release form plus levodopa was significantly better than the immediate-release form plus levodopa and levodopa alone in improving depression and sleep (P<0.05). The safety was similar between the three groups (P>0.05).

Conclusion

The extended-release form plus levodopa is similar to the immediate-release form in improving motor symptom in patients with idiopathic Parkinson′s disease, but can significantly better improve depressive and sleep symptoms. The combination treatment with pramipexole and levodopa has better curative effect than levodopa alone. Pramipexole extended-release tablets is safe and reliable in the treatment of patients with idiopathic Parkinson′s disease.

Key words: Pramipexole extended-release tablets, Idiopathic Parkinson′s disease, Clinical efficacy, Safety

Zhixia Li, Yipeng Ma, Weijun Liang, Weimin Hu. Safety and efficacy of pramipexole hydrochloride extended-release tablets in treatment of idiopathic Parkinson′s disease[J]. Chinese Journal of Clinicians(Electronic Edition), 2017, 11(19): 2263-2267.

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References 25

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组别	年龄（岁）	男[例（%）]	病程（年）	Hoehn-Yahr（H&Y）分级	UPDRSⅡ＋Ⅲ（分）	开期时间（h）	左旋多巴（mg）
ER组（36例）	67.6±7.71	19（53）	3.00±2.19	2.17±0.67	40.97±9.59	2.54±0.75	272.57±202.19
IR组（44例）	66.7±5.92	21（47.7）	2.98±2.20	2.09±0.62	40.52±8.18	2.60±0.65	268.24±279.24
左旋多巴组（30例）	66.0±8.30	16（53.3）	3.03±2.42	2.22±0.61	44.07±8.83	2.59±0.49	387.50±184.53
统计值	t=0.396	χ²=0.048	t=0.005	t=0.370	t=1.586	t=0.983	t=0.783
P值	0.674	0.953	0.995	0.692	0.210	0.987	0.066

组别	年龄（岁）	男[例（%）]	病程（年）	Hoehn-Yahr（H&Y）分级	UPDRSⅡ＋Ⅲ（分）	开期时间（h）	左旋多巴（mg）
ER组（36例）	67.6±7.71	19（53）	3.00±2.19	2.17±0.67	40.97±9.59	2.54±0.75	272.57±202.19
IR组（44例）	66.7±5.92	21（47.7）	2.98±2.20	2.09±0.62	40.52±8.18	2.60±0.65	268.24±279.24
左旋多巴组（30例）	66.0±8.30	16（53.3）	3.03±2.42	2.22±0.61	44.07±8.83	2.59±0.49	387.50±184.53
统计值	t=0.396	χ²=0.048	t=0.005	t=0.370	t=1.586	t=0.983	t=0.783
P值	0.674	0.953	0.995	0.692	0.210	0.987	0.066

组别	UPDRSⅡ（分）	UPDRSⅢ（分）	UPDRSⅡ＋Ⅲ（分）	"关"期时间（h）	"开"期时间（h）	左旋多巴（mg）
ER组（36例）	-5.97±2.44	-6.00±3.89	-11.97±6.23	-0.50±0.06	0.51±0.07	-29.51±60.66
IR组（44例）	-4.20±2.61	-6.43±2.51	-10.64±4.16	-0.68±0.20	0.55±0.21	-19.89±92.18
左旋多巴组（30例）	-4.83±1.62	-4.47±1.17	-9.30±2.12	0.05±0.15	0.10±0.18	4.17±15.86
F值	24.500	27.750	34.500	4.173	1.847	2.071
P值	0.000	0.000	0.000	0.018	0.163	0.130

组别	UPDRSⅡ（分）	UPDRSⅢ（分）	UPDRSⅡ＋Ⅲ（分）	"关"期时间（h）	"开"期时间（h）	左旋多巴（mg）
ER组（36例）	-5.97±2.44	-6.00±3.89	-11.97±6.23	-0.50±0.06	0.51±0.07	-29.51±60.66
IR组（44例）	-4.20±2.61	-6.43±2.51	-10.64±4.16	-0.68±0.20	0.55±0.21	-19.89±92.18
左旋多巴组（30例）	-4.83±1.62	-4.47±1.17	-9.30±2.12	0.05±0.15	0.10±0.18	4.17±15.86
F值	24.500	27.750	34.500	4.173	1.847	2.071
P值	0.000	0.000	0.000	0.018	0.163	0.130

组别	HAMD-17	PDSS	SF-36总分	SF-36精神	SF-36生理
ER组（36例）	-6.78±2.58	8.56±5.66	7.75±2.49	7.42±3.48	6.00±3.09
IR组（44例）	-4.95±2.51	7.50±6.17	5.52±3.75	5.11±3.19	3.09±2.65
左旋多巴组（30例）	-1.60±1.67	2.30±3.66	2.97±3.27	2.60±2.33	3.27±2.77
F值	40.77	12.332	17.688	20.001	12.203
P值	<0.001	<0.001	<0.001	<0.001	<0.001

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