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十二指腸潰瘍Doxepin和Cimetidine療效比較研究

Doxepin in the Treatment of Duodenal Ulcer: An Open Clinical and Endoscopic Study Comparing Doxepin and Cimetidine

摘要


消化性潰瘍疾病是國人常見的慢性內科疾病之一,男遠較女為多。目前較流行的藥物治療是屬於組織胺第二型接受體阻斷劑的cimetidine和ranitidine,然而兩者價格昂貴是其缺點。作者們於1984年7月1日至12月31日止,對於經內視鏡檢查證實為十二脂腸潰瘍並且符合「入選條件」的病人,進行開放式比較性藥物治療試用,徵求病人自願參加並且完成簽署文件,共有doxepin組16位及cimetidine組22位完成八星期的治療試用計畫,在第四及第八週施作內視鏡檢查,來判別十二指腸潰瘍是否已有痊癒的情形。Doxepin組病人每天睡前服用50 mg,cimetidine組病人每天總量為1,000 mg,共服8星期。結果發現痊癒率在第四週時doxepin組有43.7%,cimetidine組有54.5%,而在第八週時痊癒率兩組各為56.3%及72.2%,兩組病人的痊癒率在第四及第八週時都沒有顯著的差異。服用doxepin的主要副作用有昏沉、倦怠感及暈眩等,多在第一週後即自行消失。兩組病人的臨床症狀改善情形很相似,若從比較藥物療效、副作用及費用負擔等因素而言,doxepin用於十二指腸潰瘍的治療是有加以推薦的實用性。

並列摘要


Peptic ulcer disease (PUD) is one of the chronic diseases commonly seen in Taiwan, with the incidence higher in males than in females. Nowadays, the most popularly and extensively prescribed agents to treat PUDs are histamine H2-receptor blockades such as cimetidine and ranitidine, both are very expensive. The authors conducted an open clinical and endoscopic study comparing doxepin and cimetidine in treating patients with duodenal ulcer verified by endoscopic examination at the Taichung Veterans General Hospital from July 1 to December 31, 1984. Patients must meet both inclusion and exclusion criteria before entering this study. Informed consents were obtained from each patient who agreed to attend the 8-week open clinical study voluntarily. All patients were assigned into either the doxepin or the cimetidine group by a random method. Sixteen patients receiving doxepin and 22 patients receiving cimetidine completed the trial. Each patient received two occasions of endoscopic examination to verify healing of ulceration at the 4th and 8th weeks in the treatment program. Patients in the doxepin group took 50 mg of doxepin before sleep while patients in the cimetidine group took 200 mg of cimetidine three times a day postprandially and 400 mg of cimetidine before sleep. The healing rate at the 4th week of treatment was 43.7% for doxepin and 54.5% for cimetidine; that at the 8th week of treatment was 56.3% for doxepin and 72.7% for cimetidine. The differences in healing rate between the two groups were not statistically significant. The main side-effects of doxepin are lethargy, tiredness, dizziness or giddiness, and dryness of mouth which disappeared quickly within the first week. The improvements of clinical manifestations of duodenal ulcer were quite similar in the two groups. Considering both clinical therapeutic efficacies and costs of drugs based on this study, we suggest that doxepin can replace cimetidine in treating duodenal ulcer disease.

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