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腸胃舒膠囊30例臨床試驗觀察
發布日期:2017-02-27  來源:本站原創  作者:優克  瀏覽次數:1301

昆明醫學院第一附屬醫院中醫科(國家藥品臨床試驗基地)
      李喜枝(主治醫師)、羅珊(主治醫師)、諸貴保(主治醫師)、
      狄群英(主治醫師)、李麗華(主治醫師)、陳曉麗(主治醫師)等

一、實驗目的:

觀察腸胃舒膠囊對痞滿證所表現的胃脘飽脹、脹痛不適、食少納呆、大便溏或排便不爽、赤痢、大腸下血等癥狀的療效,并考察其安全性。

二、試驗方法:

本實驗按GCP的規定執行,采用隨機單盲法進行試驗。

實驗藥品:腸胃舒膠囊     云南優克制藥公司生產

對照藥品:香果健消片     云南省個舊市藥業責任有限公司生產

三、實驗小結

1、經統計,腸胃舒膠囊治療時不受性別,年齡,病程的限制。

2、總療效觀察:試驗組(腸胃舒膠囊組)總有效率為98%,對照組總有效率為94.7%。

3、癥狀療效觀察:實驗組(腸胃舒膠囊組)對脘腹飽脹,食少納呆,暖氣,大便溏或大便不爽等7組癥狀,療效明顯。

4、攝像、脈象療效觀察:兩組舌象、脈象對比觀察,經統計學處理P>0.05,無顯著差異,提示兩組療效基本一致。

5、大便常規療效觀察:對實驗組30例患者進行了治療前后的大便常規對比觀察,經統計學處理平P<0.01,有顯著差異,提示試驗藥物對改善大便常規有明顯療效。

6、肝、腎功能檢查:實驗組30例中做了18例肝腎功能治療前后對比觀察,發現均在正常范圍內,經統計學處理P>0.05,無顯著差異,提示試驗藥物對肝腎功能影響沒有變化。

7、毒副作用觀察:30例試驗患者,在服藥期間均未見任何毒副反應發生。

四、結論

腸胃舒膠囊是云南優克制藥公司生產的老藥,本品來自于彝族驗方,主要由草果、木香、蜘蛛香、紫地榆、草血竭等藥組成,具有健胃消食、理氣止痛、止痢止血之功效,主要用于治療痞滿證所表現的胃脘飽脹,脹痛不適,食少納呆,大便溏或不爽,赤痢,大腸下血等癥,經我院臨床試驗觀察,認為本品療效確切,無毒副作用,且服用方便,是治療痞滿證的良藥。



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