Imipramine與Desmopressin對原發性尿床之療效比較

Comparison between Imipramine and Desmopressin for Primary Nocturnal Enuresis

凃乃瑜(Nai –Yu Tu)

指導教授 ： 周明勇

中山醫學大學/醫學院/醫學研究所/碩士(2005年)

摘要

研究目的：
夜間遺尿（Nocturnal enuresis）是指睡眠時不自覺的排尿現象。而夜間遺尿的現象從未間斷超過六個月以上，則稱為原發性尿床（Primary nocturnal enuresis , PNE）。這個問題容易造成兒童的心理障礙及精神負擔，阻礙人際關係，甚至人格發展不良。在處理原發性尿床的藥物治療方面， Imipramine與 Desmopressin都有相當的成效。但現在仍缺乏直接醫學證據顯示口服Desmopressin 與Imipramine 之間對尿床療效的比較，希望藉由本研究探討病患接受Desmopressin治療是否比接受Imipramine治療有效，提供既有療效又能節省醫療資源的臨床藥物治療選擇。
研究設計及方法：
本研究為隨機臨床試驗（Randomized control trial），遵守治療意願分析法（Intention-to-treat analysis），從2004 年3 月1 日至2004 年9 月30 日止，由某醫學中心同一位醫師診斷選擇符合治療資格之原發性夜間尿床病患，隨機進入Desmopressin組及Imipramine組，整個療程共3個月，停藥後持續追蹤觀察6 個月， Desmopressin使用劑量為每天睡前0.2-0.6 mg，Imipramine使用劑量為每天睡前25-50 mg。評估Desmopressin與Imipramine的療效，並追蹤治癒病童6 個月後的復發率 ( Relapse rate )。療效的定義為治療3個月後每月尿床次數減少50％以下則視為該藥物無效（Stationary response），50％以上則視為該藥物有效（Responsive），50％-90％則視為該藥物部份有效（Partial response），90％以上則視為該藥物完全有效（Full response ）。復發率的定義為在治療療程結束6個月期間內，任何一個月的尿床次數超過治療期間第3個月的尿床次數。

研究結果：
本試驗納入89位病人中Desmopressin組共計45 人，Imipramine組共計44人，完成試驗的受試者共70人 (Desmopressin組共計37 人，Imipramine組共計33人)。本研究結果顯示對該藥物有反應者，Desmopressin組共計34 人 (75.55％)，而Imipramine組共計29人 (65.91％) (relative ratio, 1.046 ; 95% confidence interval, 0.892 - 1.226 )，兩者間之差異不具統計意義。治療結束後再追蹤6個月之復發率，Desmopressin組復發者有13 人 (48.15%)，Imipramine組有7 人 (35%)， (relative ratio, 0.855 ; 95% confidence interval, 0.532 - 1.862 ) ，兩者間之差異不具統計意義。對於藥物不良反應報告，Desmopressin組無特別報告，Imipramine組則有2人（4.5％）有不良反應事件發生。
綜觀本研究之結果顯示原發性尿床病患接受12 星期治療之後，Desmopressin療效與Imipramine的療效與復發率，無統計上之差異，不良反應發生率則Desmopressin比Imipramine低。

關鍵字

原發性尿床 ； Imipramine ； Desmopressin

並列摘要

Aim:
Nocturnal enuresis indicates involuntary urinary incontinence during sleep. Primary nocturnal enuresis is defined as persistent nocturnal enuresis for more than 6 months. The condition generally comes with emotional stress, psychiatric disturbance, altered social relationship, and even disordered personality development. It is estimated that 15% to 20% of 5 years old children and 2% of adolescent patients are affected by these problems. Medical treatment for childhood nocturnal enuresis had been successful since the introduction of tricyclic antidepressants and desmopressin. However, there is no experiential of these two drugs. The aim of this study is to compare the efficiency between desmopressin and imipramine, with a final goal of finding the most efficacious while and cost-effective treatment for clinical practice.
Method:
The current study is a randomized control trial subjected to intention-to-treat analysis. Children with nocturnal enuresis from a medical center and examined by a single physician, who meet the treatment indications were included for analysis. They are randomly assigned into Desmopressin group and Imipramine group. Desmopressin is given at a dosage of 0.2-0.6 mg daily before sleep, while Imipramine 25-50 mg daily before sleep. All patients are treated for a 3-month course of medications, followed by 6 months of observation. The effectiveness is measured by responsiveness and relapse rate. The reduction of the frequency of enuresis during the third month of treatment of 50% or greater is defined as responsive, greater than 90% as fully responsive, 50% to 90% as partial responsive, while less than 50% classified as non-responsive. A relapse is defined as an increase in the number of enuresis during any single month of the 6-month observation period, comparing to the frequency during the third month of treatment.
Result:
Eighty-nine children (45 in Desmopressin group and 44 in Imipramine) were enrolled in the study. Seventy children (37 in Desmopressin group and 33 in Imipramine group) had completed for analysis. Thirty-four children in Desmopressin were responsive (75.55%) while 29 in Imipramine group were responsive 65.91% with relative ratio 1.046; 95% confidence interval 0.892 to 1.226 (not statistically significant difference). Nineteen children in Desmopressin group (42.22%) and 17 in Imipramine group (38.64%) were fully responsive; 15 children in Desmopressin group (33.33%) and 12 in Imipramine group (27.27%) were partial responsive. 3 children in Desmopressin group (6.66%) and 4 in Imipramine (9.09%) were non-responsive. Eight children in Desmopressin group and 11 in Imipramine group did not complete the treatment course. Thirteen children in Desmopressin group (48.15%) and 7 in Imipramine group (35.0%) had relapse during the 6-month post-treatment follow up. (relative ratio 0.855; 95% confidence interval 0.532 to 1.862). Two children in Imipramine group (4.5%) had adverse reaction to treatment while no adverse reaction was reported in Desmopressin group.
In summary, after 12-week treatment, there is no significant difference in responsiveness and relapse rate between desmopressin and imipramine. However, there is a significant difference in the rate of adverse drug reaction.

並列關鍵字

primary nocturnal enuresis ； Imipramine ； Desmopressin

參考文獻

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