脂必妥胶囊治疗高脂血症多中心临床试验

目的：验证脂必妥胶囊治疗高脂血症的疗效和安全性。方法：采用随机、对照、多中心研究方法。脂必妥胶囊治疗组３００ 例，男性１５６ 例，女性１４４例，年龄５８ ａ±ｓ８ ａ； 血脂康对照组１５０ 例；男性７１例，女性７９ 例，年龄５７ ａ ±８ ａ 。脂必妥胶囊：１ 粒，ｐｏ，ｂｉｄ； 血脂康胶囊：２ 粒，ｐｏ，ｂｉｄ。疗程均为８ｗｋ 。结果：脂必妥组临床控制１１６ 例，显效１１３ 例，有效４１ 例，显效率为７６ ．３ ％ ， 总有效率为９０ ．０ ％ ；血脂康组临床控制４５ 例，显效６６ 例，有效１７ 例，显效率７４ ．０ ％ ，总有效率８５ ．３ ％ （ Ｐ＜ ０ ．０５） 。未发现明显不良反应。结论：脂必妥胶囊对高脂血症安全有效。

Zhibituo Capsules in treatment of hyperlipidemia: a multicenter clinical trial

AIM: To evaluate the efficacy and safety of Zhibituo in treating hyperlipidemia. METHODS: In randomized, comparative and multicenter studies, Zhibituo therapy group of 300 patients (M 156, F 144, age 58 a±s 8 a) received Zhibituo 1 capsule, po, each time in the morning and evening for 8 wk; Xuezhikang control group of 150 patients (M 71, F 79, age 57 a±8 a) received Xuezhikang 2 capsules, po, each time in the morning and evening for 8 wk. RESULTE: Zhibituo group total effective rates were 90.0%. Xuezhikang group total effective rates were 85.3% (P<0.05). There were no severe adverse reactions. CONCLUSION: Zhibituo is a safe and effective antihyperlipidemia drug. among three groups,but there was no significant differences between mixed gas groups and air group.Airway reactivity to histamine was remarkably increased after inhaling mixed gas.Percentage of neutrophil in BAL increased.Conclusion:Airway hyperresponsiveness can be induced by short time inhaling SO 2 and NO 2 mixed gas in Guinea pigs. Key words:Sulfur Dioxide; Nitrogen Dioxide; Airway responsiveness; Guinea pig