不同剂量的地佐辛在妇科腹腔镜手术超前镇痛中的有效性和安全性：一项前瞻性、双盲、随机对照临床试验
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Efficacy and safety of different doses of dezocine for preemptive analgesia in gynecological laparoscopic surgeries: A prospective, double blind and randomized controlled clinical trial
背景与目的:我国女性生殖系统肿瘤的发病率呈逐年上升趋势，随着发病年龄的年轻化。腹腔镜手术已得到广大医务人员和患者的认可，但术后疼痛仍然存在。因此，采取有效的镇痛措施以减轻患者术后疼痛并同时提高患者的舒适度和满意度，已成为医务工作者关注的焦点。研究的目的是观察不同剂量地佐辛超前镇痛的安全性及对妇科腹腔镜手术患者术后疼痛的影响，以找到地佐辛用于妇科腹腔镜手术术后镇痛的最佳剂量。
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方法：纳入了符合标准的妇科腹腔镜手术患者（n＝390）并采用随机双盲对照研究随机分为三组（A、B、C组），0.1mg/kg、0.15mg/kg及0.2mg/kg剂量的地佐辛于术前15min静脉注射以用于超前镇痛。通过VAS评分、拉姆齐评分、MMSE评分评估超前镇痛和镇静的有效性和安全性，同时观察辅助镇痛药物的使用情况和不良反应的发生率。
结果：0.15mg / kg和0.2mg / kg剂量的地佐辛组在术后2h，4h，6h，8h，12h和24h的VAS评分均显著低于0.1mg / kg组，差异有统计学意义（p <0.05）。 而在0.15mg / kg和0.2mg / kg组之间差异没有统计学意义（p> 0.05），除了12h的时间点。 三组术后12h MMSE评分与术前12h比较，差异无统计学意义（p> 0.05），且患者认知功能障碍的发生率未见增加。 0.1mg / kg组镇痛药使用率明显高于0.15mg / kg和0.2mg / kg组，差异有统计学意义（p <0.05）。 三组不良事件的发生率差异无统计学意义（P> 0.05）。
结论：地佐辛的镇痛镇静作用随使用剂量的增加而增强，这表明地佐辛的作用呈剂量依赖性。 妇科腹腔镜手术术前15分钟静脉注射0.15mg / kg剂量的地佐辛，其镇痛和镇静作用较好，且不良反应较少，应作为妇科腹腔镜手术超前镇痛的最佳剂量。
Zhou M1, Wang L1, Wu C1, Yan L1, Wang R1, Sun B1, Wang J2. Efficacy and safety of different doses of dezocine for preemptive analgesia in gynecological laparoscopic surgeries: A prospective, double blind and randomized controlled clinical trial Int J Surg. Oct 30 ,2017,pii: S1743-9191(17)31401-2. doi: 10.1016/j.ijsu.2017.09.079. [Epub ahead of print]
Background: The incidence of reproductive system tumors in Chinese females is increasing year by year, with the trend of younger onset ages. Laparoscopic surgery has been recognized by the majority of medical staff and patients, but the postoperative pain still exists. Therefore, it has become the focus of attention of medical workers to take effective analgesia measures to alleviate postoperative pain as well as to improve the degree of comfort and satisfaction for the patients.The research objective was to study the effect of different doses of dezocine preemptive analgesia on the safety and the pain post laparoscopic surgeries, in order to explore the best dose of dezocine for postoperative analgesia in gynecological laparoscopic surgeries.
Methods: Gynecological laparoscopic surgery patients conformed to the criteria (n=390) were randomly divided into three groups (group A, B and C) by the methods of randomized, double-blind studies. 0.1mg/kg, 0.15 mg/kg or 0.2 mg/kg dezocine was intravenously injected 15 min before surgeries for preemptive analgesia. VAS score, Ramsay score and MMSE score were used to evaluate the efficacy and safety of dezocine in preemptive analgesia and sedation, and the use of adjuvant analgesic drugs and the incidence of adverse reactions were also observed.
Results:The VAS scores of the 0.15mg/kg and 0.2mg/kg dezocine groups were significantly lower than that of the 0.1mg/kg group at 2h, 4h, 6h, 8h, 12h and 24h post-surgery, and the difference was statistically significant (p<0.05). There was no statistically significant difference between the 0.15mg/kg and 0.2mg/kg groups (p>0.05) except for the 12h time point. The MMSE scores 12h post-surgery of the three groups were compared with those 12h prior-to-surgery, and the differences were not statistically significant (p>0.05) and no increase in the incidence of cognitive impairment was observed. The use rate of analgesic drugs in the 0.1mg/kg group wassignificantly higher than those in the 0.15mg/kg and 0.2mg/kg groups, and the difference was statistically significant (p<0.05). There were no significant differences in the incidence of adverseevents between the three groups (P>0.05).
Conclusion:The analgesia and sedation effects of dezocine were enhanced with the increase of usage dose, which suggested that the effects of dezocine were dose-dependent. Intravenous injection of 0.15mg/kg dezocine 15 min before gynecological laparoscopic surgery showed better analgesic and sedative effects as well as less adverse reactions, and should be the appropriate dose to be used in the preemptive analgesia in gynecological laparoscopic surgeries.
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