CAJ | 학술논문

目的：评价地佐辛注射液用于镇痛的有效性和安全性。方法用多中心、随机、双盲、平行对照的方法，单次给药以度冷丁注射液为对照药，7d给药以硫酸吗啡注射液为对照药，试验药均为地佐辛。140例手术后中、重度疼痛患者，试验组70例，单次肌注地佐辛2支（5 mg· mL-1）；对照组70例，肌注度冷丁和安慰剂各1支。56例癌性疼痛患者，试验组（31例）肌注地佐辛，每次2支；对照组（25例）肌注硫酸吗啡和硫酸吗啡模拟药，各1支，均每日4次，连续给药均7d。以疼痛强度差（PID）作为镇痛效果主要疗效判定指标。结果地佐辛和度冷丁用于手术后疼痛以及地佐辛和吗啡用于慢性癌性疼痛，试验组与对照组PID值的差异无统计学意义。不良反应主要有恶心、呕吐、头晕等。结论地佐辛可治疗各种手术后引起的急性中、重度疼痛和慢性癌性疼痛，临床镇痛效果和不良反应与吗啡相似。
목적：평개지좌신주사액용우진통적유효성화안전성。방법용다중심、수궤、쌍맹、평행대조적방법，단차급약이도랭정주사액위대조약，7d급약이류산마배주사액위대조약，시험약균위지좌신。140례수술후중、중도동통환자，시험조70례，단차기주지좌신2지（5 mg· mL-1）；대조조70례，기주도랭정화안위제각1지。56례암성동통환자，시험조（31례）기주지좌신，매차2지；대조조（25례）기주류산마배화류산마배모의약，각1지，균매일4차，련속급약균7d。이동통강도차（PID）작위진통효과주요료효판정지표。결과지좌신화도랭정용우수술후동통이급지좌신화마배용우만성암성동통，시험조여대조조PID치적차이무통계학의의。불량반응주요유악심、구토、두훈등。결론지좌신가치료각충수술후인기적급성중、중도동통화만성암성동통，림상진통효과화불량반응여마배상사。
Objective To evaluate the efficacy and safety of dezocine injection for analgesia.Methods A multicenter , randomized , double blind, parallel group controlled study was performed with dezocine as the test drug , and pethidine injection and morphine injection as positive con-trol for the single treatment and 7 days treatment of moderate and severe pain , respectively.The test drug was dezocine injection.One hundred of forty patients with postoperative moderate and severe pain received single treatment with dezocine ( single injection of dezocine , n=70 ) or pethi-dine ( single injection of pethidine and placebo , n =70 ).Fifty -six cancer pain patients received 7 days treatment with dezocine or morphine as follows:the test group was intramuscularly injected two dezocines each time ( n=31 ) , and the control group was injected morphine and moe-phine simulation respectively ( n=25 , four times a day ) .Pain intensity difference ( PID) was evaluated as the primary analgesic effect criteria.Results There was no significant difference in PID between the test group and the control one both in the controlled trail of postoperative pain and that of chronic cancer pain.The most common adverse reactions of dezocine were nausea , vomiting and dizziness , et al.Conclusion The analgesic effect and adverse effects of dezocine were similar to those of morphine , which indicats dezocine is an effective and safe analgesic for postoperative pain and chronic cancer pain that are moderate and severe.