中华消化杂志
中華消化雜誌
중화소화잡지
Chinese Journal of Digestion
2010年
4期
263-266
,共4页
林英勇%秦湘红%袁耀宗%谭志刚%胡海棠
林英勇%秦湘紅%袁耀宗%譚誌剛%鬍海棠
림영용%진상홍%원요종%담지강%호해당
溃疡性结肠炎%5-氨基水杨酸锌结肠溶胶囊%临床研究%疗效%安全性
潰瘍性結腸炎%5-氨基水楊痠鋅結腸溶膠囊%臨床研究%療效%安全性
궤양성결장염%5-안기수양산자결장용효낭%림상연구%료효%안전성
Ulcerative colitis%5-aminosalicylic acid zinc enteric-coated capsule%Clinical trial%Efficacy%Safety
目的 探索5-氨基水杨酸锌结肠溶胶囊治疗溃疡性结肠炎(活动期)的疗效、安全性及合适剂量.方法 采用多中心、随机、双盲双模拟、剂量反应和阳性对照设计,将2004年3月至9月上海瑞金医院等6家医院108例活动性溃疡性结肠炎患者随机分为5-氨基水杨酸锌高剂量组和低剂量组(每天给予5-氨基水杨酸锌结肠溶胶囊2次,每次分别为1 g和0.5 g)以及对照组(每天3次给予奥沙拉秦钠胶囊,每次1 g),每组36例,疗程均为8周.随访记录评估三组患者的临床症状和肠镜检查情况,并记录治疗过程中的不良反应.结果 5-氨基水杨酸锌高剂量组和低剂量组临床疗效有效率分别为68.97%和45.45%,对照组为62.86%,组间差异无统计学意义(P>0.05).肠镜检查5-氨基水杨酸锌高剂量组和低剂量组痊愈率分别为51.72%和21.21%,有效率分别为82.76%和69.70%,高剂量组优于低剂量组(P=0.023),但与对照组(分别为34.29%和88.57%)相比差异无统计学意义(P>0.05).不良反应主要是腹泻,5-氨基水杨酸锌高剂量组为2.8%(1/36),低剂量组未发生不良反应,对照组为2.8%(1/36).结论 5-氨基水杨酸锌高剂量组能有效治疗活动期溃疡性结肠炎,疗效与对照组相当,安全性相似,但试验药有减少用药次数的优点.
目的 探索5-氨基水楊痠鋅結腸溶膠囊治療潰瘍性結腸炎(活動期)的療效、安全性及閤適劑量.方法 採用多中心、隨機、雙盲雙模擬、劑量反應和暘性對照設計,將2004年3月至9月上海瑞金醫院等6傢醫院108例活動性潰瘍性結腸炎患者隨機分為5-氨基水楊痠鋅高劑量組和低劑量組(每天給予5-氨基水楊痠鋅結腸溶膠囊2次,每次分彆為1 g和0.5 g)以及對照組(每天3次給予奧沙拉秦鈉膠囊,每次1 g),每組36例,療程均為8週.隨訪記錄評估三組患者的臨床癥狀和腸鏡檢查情況,併記錄治療過程中的不良反應.結果 5-氨基水楊痠鋅高劑量組和低劑量組臨床療效有效率分彆為68.97%和45.45%,對照組為62.86%,組間差異無統計學意義(P>0.05).腸鏡檢查5-氨基水楊痠鋅高劑量組和低劑量組痊愈率分彆為51.72%和21.21%,有效率分彆為82.76%和69.70%,高劑量組優于低劑量組(P=0.023),但與對照組(分彆為34.29%和88.57%)相比差異無統計學意義(P>0.05).不良反應主要是腹瀉,5-氨基水楊痠鋅高劑量組為2.8%(1/36),低劑量組未髮生不良反應,對照組為2.8%(1/36).結論 5-氨基水楊痠鋅高劑量組能有效治療活動期潰瘍性結腸炎,療效與對照組相噹,安全性相似,但試驗藥有減少用藥次數的優點.
목적 탐색5-안기수양산자결장용효낭치료궤양성결장염(활동기)적료효、안전성급합괄제량.방법 채용다중심、수궤、쌍맹쌍모의、제량반응화양성대조설계,장2004년3월지9월상해서금의원등6가의원108례활동성궤양성결장염환자수궤분위5-안기수양산자고제량조화저제량조(매천급여5-안기수양산자결장용효낭2차,매차분별위1 g화0.5 g)이급대조조(매천3차급여오사랍진납효낭,매차1 g),매조36례,료정균위8주.수방기록평고삼조환자적림상증상화장경검사정황,병기록치료과정중적불량반응.결과 5-안기수양산자고제량조화저제량조림상료효유효솔분별위68.97%화45.45%,대조조위62.86%,조간차이무통계학의의(P>0.05).장경검사5-안기수양산자고제량조화저제량조전유솔분별위51.72%화21.21%,유효솔분별위82.76%화69.70%,고제량조우우저제량조(P=0.023),단여대조조(분별위34.29%화88.57%)상비차이무통계학의의(P>0.05).불량반응주요시복사,5-안기수양산자고제량조위2.8%(1/36),저제량조미발생불량반응,대조조위2.8%(1/36).결론 5-안기수양산자고제량조능유효치료활동기궤양성결장염,료효여대조조상당,안전성상사,단시험약유감소용약차수적우점.
Objective To evaluate the efficacy and safety of two kinds of dosage of 5-aminosalicylic acid zinc enteric-coated capsule in treatment of active ulcerative colitis (UC). Methods The muhicentre, double blind, dosage reaction and contrast trial was conducted in six hospitals during March 2004 to Sep. 2004. One hundred and eight patients with UC were randomly allocated into the high dosage (n= 36, 1 g, bid) and the low dosage (n = 36, 0.5 g, bid) of 5-aminosalicylic acid zinc enteric-coated capsule groups, and the Olsalazine sodium group (n = 36, 1 g, tid) with a 8-week treatment. The efficacy and adverse events of 5-aminosalicylic acid zinc enteric-coated capsule were evaluated based on the clinical presentations and endoscopic findings. Results The clinical efficacy was 68.97% in high dosage group, 45. 45% in low dosage group and 62.86% in Olsalazine sodium group with no significant difference (P>0. 05). The endoscopic examination showed that the healing rate of UC in high dosage group and low dosage group was 51.72% and 21.21%, respectively, whereas the efficacy rate was 82.76% and 69.70% respectively. The results showed that high dosage was more effective than low dosage (P=0.023), but was similar to Olsalazine sodium (healing rate of 34.29% and effective rate of 88.57% ,P>0. 05). Diarrhea was main adverse event, which was accounted for 2.8% (1/36) in high dosage group and 2.8% (1/36) in the Olsalazine sodium group. There was no adverse event in low dosage group. Conclusions 5-aminosalicylic acid zinc enteric-coated capsule is an effective agent in treatment of UC, especially in high dosage. It is similar to Olsalazine sodium in treatment of UC, and has advantages in reducing medication times.
