盐酸丁丙诺啡舌下含片用于乳腺癌改良根治术后镇痛

Analgesia of sublingual buprenorphine following modified radical operation for breast cancer

目的以安慰剂和吗啡为对照,观察丁丙诺啡舌下含片用于乳腺癌改良根治术后镇痛的有效性及安全性。方法120例乳腺癌改良根治术病人随机分为4组(每组30例),当术后出现中等程度疼痛(VSA≥4分)时,分别给予安慰剂、丁丙诺啡0.2,0.4mg舌下含片或吗啡片剂10mg。给药后8h内,记录各观察点的疼痛程度差值、疼痛缓解程度及药物不良反应。结果8例病人因未按计划用药被剔除,共有112例完成临床观察并进行分析。丁丙诺啡各组与吗啡组总的疼痛缓解程度均明显优于安慰剂组(P<0.05,P<0.01),各观测点的疼痛程度差值和疼痛缓解程度也优于安慰剂组(P<0.05)。丁丙诺啡与吗啡组的恶心及呕吐发生率高于安慰剂组,但仅丁丙诺啡0.4mg组与安慰剂组有显著性差别(P<0.05)。结论丁丙诺啡舌下含片用于术后镇痛的效应及药物不良反应发生率与吗啡接近,可作为术后镇痛的一种选择。

Objective To observe the analgesic effect and safety of sublingualbuprenorphine in patients after modified radical operation for breast cancercompared with placebo and morphine. Methods One hundred twenty patientsundergoing modified radical operation for breast cancer were randomly dividedinto one of four groups (30 cases each group). The patients with moderate pain willbe received one of placebo,0.2,0.4mg sublingual buprenorphine or 10mgmorphine tablet, respectively. Pain intensity difference (PID) and pain relief (PR) ofthe patients after taking the drugs will be recorded at given time. Results Eightcases were picked out from the study because the observed drugs were notadministered as the protocol. Only 112 cases completed the study and their resultswere analyzed. Total pain relief(TPR)of two buprenorphine groups and morphinegroup were lower than placebo group(P<0.05,or P<0.01), PID and PR of thesegroups at given time were superior to placebo group(P<0.05).The rates of nauseaand vomiting in buprenorphine groups and morphine group were higher thanplacebo group, but the rates of nausea and vomiting in 0.4mg buprenorphine groupwere significantly higher than placebo group(P<0.05). Conclusion The analgesiceffect and rates of nausea and vomiting produced by sublingual buprenorphinewere similar to these of morphine tablet, and can be used as a choice of analgesicdrug postoperatively.