中华胃肠外科杂志
中華胃腸外科雜誌
중화위장외과잡지
CHINESE JOURNAL OF GASTROINTESTINAL SURGERY
2013年
7期
654-657
,共4页
彭慧%汪建平%杨新庆%郑毅%丁义江%丁曙晴%李国栋%景建中%赵宝明
彭慧%汪建平%楊新慶%鄭毅%丁義江%丁曙晴%李國棟%景建中%趙寶明
팽혜%왕건평%양신경%정의%정의강%정서청%리국동%경건중%조보명
慢性肛裂%硝酸甘油软膏%随机对照试验%治疗效果
慢性肛裂%硝痠甘油軟膏%隨機對照試驗%治療效果
만성항렬%초산감유연고%수궤대조시험%치료효과
Chronic anal fissure%Glyceryl trinitrate ointment%Randomized controlled trial%Treatment outcomes
目的 评价硝酸甘油软膏治疗肛裂的临床疗效和安全性.方法 采用多中心、随机、双盲、安慰剂平行对照的临床试验方法,从7个临床中心入组240例慢性肛裂患者,按随机数字表法随机分为试验组(硝酸甘油软膏,120例)和对照组(凡士林软膏,120例),疗程为8周.比较两组肛裂愈合率、肛裂疼痛强度VAS评分、肛管静息压的变化及不良反应事件发生率.结果 共有221例(92.1％)完成了试验,其中试验组114例,对照组107例.治疗终点(56 d),试验组和对照组肛裂愈合率分别为78.9％(90/114)和29.0％(31/107),排粪后肛裂疼痛VAS评分下降率分别为(94.8±15.7)％和(61.2±35.7)％,差异均有统计学意义(均P＜0.01).试验组和对照组分别有12例和6例患者接受了肛门直肠测压,首次用药前后肛管静息压下降值试验组为(20.2±18.5) mm Hg,对照组为(7.1±14.7) mm Hg,但两组差异并无统计学意义(P=0.152).试验组不良反应事件发生率明显高于对照组[42.1％(48/114)比9.3％(10/107),P＜0.05],但不良反应事件主要为轻度的头痛、头胀,可自行缓解.结论 硝酸甘油软膏可有效缓解肛裂疼痛,促进肛裂愈合,且使用安全、耐受性好.
目的 評價硝痠甘油軟膏治療肛裂的臨床療效和安全性.方法 採用多中心、隨機、雙盲、安慰劑平行對照的臨床試驗方法,從7箇臨床中心入組240例慢性肛裂患者,按隨機數字錶法隨機分為試驗組(硝痠甘油軟膏,120例)和對照組(凡士林軟膏,120例),療程為8週.比較兩組肛裂愈閤率、肛裂疼痛彊度VAS評分、肛管靜息壓的變化及不良反應事件髮生率.結果 共有221例(92.1％)完成瞭試驗,其中試驗組114例,對照組107例.治療終點(56 d),試驗組和對照組肛裂愈閤率分彆為78.9％(90/114)和29.0％(31/107),排糞後肛裂疼痛VAS評分下降率分彆為(94.8±15.7)％和(61.2±35.7)％,差異均有統計學意義(均P＜0.01).試驗組和對照組分彆有12例和6例患者接受瞭肛門直腸測壓,首次用藥前後肛管靜息壓下降值試驗組為(20.2±18.5) mm Hg,對照組為(7.1±14.7) mm Hg,但兩組差異併無統計學意義(P=0.152).試驗組不良反應事件髮生率明顯高于對照組[42.1％(48/114)比9.3％(10/107),P＜0.05],但不良反應事件主要為輕度的頭痛、頭脹,可自行緩解.結論 硝痠甘油軟膏可有效緩解肛裂疼痛,促進肛裂愈閤,且使用安全、耐受性好.
목적 평개초산감유연고치료항렬적림상료효화안전성.방법 채용다중심、수궤、쌍맹、안위제평행대조적림상시험방법,종7개림상중심입조240례만성항렬환자,안수궤수자표법수궤분위시험조(초산감유연고,120례)화대조조(범사림연고,120례),료정위8주.비교량조항렬유합솔、항렬동통강도VAS평분、항관정식압적변화급불량반응사건발생솔.결과 공유221례(92.1％)완성료시험,기중시험조114례,대조조107례.치료종점(56 d),시험조화대조조항렬유합솔분별위78.9％(90/114)화29.0％(31/107),배분후항렬동통VAS평분하강솔분별위(94.8±15.7)％화(61.2±35.7)％,차이균유통계학의의(균P＜0.01).시험조화대조조분별유12례화6례환자접수료항문직장측압,수차용약전후항관정식압하강치시험조위(20.2±18.5) mm Hg,대조조위(7.1±14.7) mm Hg,단량조차이병무통계학의의(P=0.152).시험조불량반응사건발생솔명현고우대조조[42.1％(48/114)비9.3％(10/107),P＜0.05],단불량반응사건주요위경도적두통、두창,가자행완해.결론 초산감유연고가유효완해항렬동통,촉진항렬유합,차사용안전、내수성호.
Objective To evaluate the clinical efficacy and safety of glyceryl trinitrate (GTN) ointment in the treatment of anal fissure.Methods In this multi-center,randomized,double-blind and placebo-controlled trial,240 chronic anal fissure patients from 7 clinical centers were randomized to receive eight-week treatment with GTN ointment (treatment group) or vaseline ointment (control group) respectively.Healing rate,visual analogue score (VAS),maximum anal resting pressure (MARP) and adverse reactions were recorded and compared.Results A total of 221 patients (92.1％) finished the trial,including 114 patients in treatment group (95.0％,114/120) and 107 in control group (89.2％,107/120).At the endpoint of treatment (56 d),90 patients in treatment group (78.9％,90/114) healed completely compared to 31 patients in control group(29.0％,31/107),and decrease rates of VAS in the two groups were (94.8±15.7)％ and (61.2±35.7)％ respectively,both differences were statistically significant (P＜0.01).MARP after first administration was (20.2± 18.5) mm Hg in treatment group (n=12)and (7.1 ± 14.7) mm Hg in control group (n=6),which was not significantly different (P=0.152).Adverse reaction incidence was higher in treatment group (42.1％ vs.9.3％,P＜0.05),while these adverse reactions were mainly headache and fullness in head,which were self-limiting.Conclusion GTN ointment can effectively promote healing and relieve pain in anal fissure with safety and tolerance.
