复方海蛇胶囊及盐酸多奈哌齐联合治疗血管性痴呆的临床研究

Clinical Study of Combined Treatment with Compound Reinhartdt and Sea Cumber Capsule and Donepezil for Vascular Dementia

目的研究复方海蛇胶囊(Reinhartdt and Sea Cumber Capsule,RSC)及盐酸多奈哌齐联合治疗血管性痴呆(vascular dementia,VD)的临床疗效、安全性及其对VD患者甲状腺功能轴的影响。方法63例患者随机分为RSC治疗组、盐酸多奈哌齐治疗组、联合(RSC加盐酸多奈哌齐)治疗组治疗,以MMSE、ADAS-Cog和ADL分数评定疗效,每组患者分别在治疗前、治疗3个月及6个月用放免法测定甲状腺素水平(TSH,FT3,FT4,TT3,TT4)。结果3组在治疗3、6个月,MMSE评分升高,ADAS-Cog、ADL评分降低,较治疗前有显著性差异(P<0.05,P<0.01);盐酸多奈哌齐组治疗6个月MMSE、ADAS-Cog、ADL评分较同期RSC组有统计学差异(P<0.05);联合治疗组治疗3、6个月MMSE、ADAS-Cog、ADL评分较同期RSC组、盐酸多奈哌齐组有显著性差异(P<0.01);联合治疗组FT3、FT4水平在治疗3个月较治疗前升高,无统计学差异(P>0.05);FT3、FT4水平在治疗6个月,较治疗前有显著性差异(P<0.01);TSH、TT3、TT4水平治疗前后差异无显著性(P>0.05)。盐酸多奈哌齐组FT3、FT4水平在治疗6个月后较治疗前水平升高,但无统计学差异(P>0.05);TSH、TT3、TT4水平治疗前后无显著差异(P>0.05)。RSC组甲状腺素水平治疗前后无显著差异(P>0.05)。3组患者未发现明显不良反应。结论RSC加盐酸多奈哌齐联合治疗VD安全、有效,无明显不良反应,作用优于单一药物组。联合治疗组作用优于单一药物组可能是通过影响VD患者甲状腺激素代谢、调节甲状腺激素水平,从而进一步改善认知功能。

Objective To study the efficacy and safety of the combined treatment with compound Reinhartdt and Sea Cumber Capsule （RSC, a Chinese medicinal preparation consisted mainly of Reinhartdt and Sea Cumber） and Donepezil for vascular dementia （VD）, and its effect on thyroid function axis. Methods Sixty-three patients with VD were treated respectively with RSC, Donepezil and the combined treatment. MMSE, ADAS-Cog and ADL scales were used to evaluate the condition of patients before treatment as well as at 3 months and 6 months after treatment. Meanwhile, levels of thyroid hormones, including （TSH, FT3,FT4,TT3,TT4） were measured with radioimmunoassay. Results As compared with the baseline, MMSE score increased, ADAS-Cog score and ADL score decreased significantly in all the three groups after 3 months and 6 months of treatment （P〈0.05, P〈0.01）, the improvement in the Donepezil group was more significant than that in the RSC group after 6 months of treatment （P 〈 0.05）, but the combined treatment group showed the best efficacy （P〈 0.01）. After 3 months of treament, the levels of FTa and FT4 in the combined treatment group increased, but showed no statistical significance （P 〉0.05）. However, significant changes were found at 6 months after com- bined treatment （P 〈 0.01）. No significant changes were seen at all in levels of TSH, TTa and TT4 （P 〉 0.05）. FTa, FT4 increased without statistical significance after 6 months Donepezil treatment, TSH, TTa and TT4 also showed no significant difference in the Donepezil group and no other significant changes of thyroid hormones was seen in patients treated with RSC （P 〉 0.05）. No obvious adverse reaction occurred in any of the three groups. Conclusion Combined treatment of RSC and Donepezil was effective and safe on VD patient,with the efficacy much better than either of them alone. No significant adverse reaction was observed. The regulation on thyroid hormones may one of the mechanisms of the combined treatment in improving cognitive function.