目的 觀察血脂膠囊治療高脂血癥的臨床療效和安全性。方法 入選的224例高脂血癥患者隨機分為治療組（114例）、對照組（110例）。治療組口服血脂膠囊4粒/次，3次/d，血脂膠囊模擬劑1粒/次，3次/d。對照組口服脂脈康膠囊5粒/次，3次/d。一個療程為6周。服藥前及服藥6周后，觀察兩組的療效及不良反應。結果 用藥6周末，治療組和對照組中醫(yī)證候療效的總有效率分別為87.72%、79.09%，兩組間比較差異有統(tǒng)計學意義（P<0.05）。兩組對頭暈單項癥狀的總有效率分別為75.44%、57.27%，對健忘單項癥狀的總有效率分別為62.28%、49.09%，差異有統(tǒng)計學意義（P<0.05），兩組的血脂綜合療效的總有效率分別為84.21%、75.46%，差異有統(tǒng)計學意義（P<0.05）。試驗中未見相關的肝腎功能損害及其他與臨床藥物有關的不良反應。結論 血脂膠囊能明顯改善血脂紊亂的腎虛血瘀型證候、調(diào)節(jié)血脂系列指標，尤其是對頭暈、健忘癥狀有顯著療效，且臨床使用安全。

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.