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[摘要]
目的 观察血脂胶囊治疗高脂血症的临床疗效和安全性。方法 入选的224例高脂血症患者随机分为治疗组(114例)、对照组(110例)。治疗组口服血脂胶囊4粒/次,3次/d,血脂胶囊模拟剂1粒/次,3次/d。对照组口服脂脉康胶囊5粒/次,3次/d。一个疗程为6周。服药前及服药6周后,观察两组的疗效及不良反应。结果 用药6周末,治疗组和对照组中医证候疗效的总有效率分别为87.72%、79.09%,两组间比较差异有统计学意义(P<0.05)。两组对头晕单项症状的总有效率分别为75.44%、57.27%,对健忘单项症状的总有效率分别为62.28%、49.09%,差异有统计学意义(P<0.05),两组的血脂综合疗效的总有效率分别为84.21%、75.46%,差异有统计学意义(P<0.05)。试验中未见相关的肝肾功能损害及其他与临床药物有关的不良反应。结论 血脂胶囊能明显改善血脂紊乱的肾虚血瘀型证候、调节血脂系列指标,尤其是对头晕、健忘症状有显著疗效,且临床使用安全。
[Key word]
[Abstract]
Objective To observe the clinical efficacy and safety of Xuezhi Capsule in the treatment of hyperlipidemia. Methods The patients (224 cases) with hyperlipidemia were randomly divided into treatment (114 cases) and control (110 cases) groups. The patients in the treatment group were po administered with Xuezhi Capsule, 4 capsules once, three times daily, and at the same time, they were po administered with Xuezhi Capsule simulated agent, 1 capsule once, three times daily. The patients in the control group were po administered with Zhimaikang Capsule, 5 capsules once, three times daily. The course of the treatment was 6 weeks. The clinical efficacy and safety of the two groups were observed before treatment and 6 weeks after treatment. Results Six weeks after treatment, the efficiency on syndromes in traditional Chinese medicine for the patients in both groups were 87.72% and 79.09%, with significant difference (P < 0.05). The total effective rates of dizziness in two groups were 75.44% and 57.27%, respectively; The total effective rates of amnesia in two groups were 62.28% and 49.09%, with significant difference (P < 0.05). The comprehensive efficiency on blood lipid between two groups were 84.21% and 75.46%, with significant difference (P < 0.05). There was no relative impairment of hepatic and renal function and other adverse effects related with clinical drug observed in the trial. Conclusion Xuezhi Capsule can obviously improve the symptom of kidney energy deficiency and blood stasis of dyslipidemia, and regulate series of blood lipid indicators, with obvious curative effect on dizziness and amnesia in special, and it is safe for clinical use.
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