骨架扩散型芬太尼透皮贴剂对中重度癌性疼痛的镇痛效果及安全性评价

Analgesic efficacy and safety of skeleton diffusion type fentanyl transdermal patch for the patients with moderate and severe cancer pain

目的探讨骨架扩散型芬太尼透皮贴剂对中重度癌性疼痛的镇痛效果及不良反应发生情况。方法选择我院收治的中重度癌性疼痛的患者为研究对象,随机分为观察组和对照组。观察组应用骨架扩散型芬太尼透皮贴剂进行镇痛,对照组应用储库型芬太尼透皮贴剂进行镇痛。对比分析两组患者的镇痛效果、不良反应发生情况、生活质量改善情况及用药满意度。结果两组患者用药后1个月,VAS评分均较治疗前明显改善,差异有统计学意义(P<0.01),而两组用药后VAS评分比较差异无统计学意义(P>0.05);观察组疼痛完全缓解率及总有效率略高于对照组,但差异均无统计学意义(P>0.05)。观察组患者满意度明显高于对照组,差异有统计学意义(P<0.05)。观察组皮疹、水疱的发生率明显低于对照组,差异有统计学意义(P<0.05),两组其余不良反应的发生率比较差异无统计学意义(P>0.05)。用药1个月后,两组FACT-G总评分均较治疗前明显升高,差异均有统计学意义(P<0.01),两组比较差异无统计学意义(P>0.05)。结论新型的骨架扩散型芬太尼透皮贴剂对中重度癌性疼痛镇痛效果良好,与传统储库型芬太尼透皮贴剂相比,具有起效快,皮肤耐受性、黏合性、舒适度好等优点,更易于患者接受,且具有良好的安全性,值得临床推广应用。

Objective To investigate the analgesic effect, adverse reactions of skeleton diffusion type fentanyl transdermal patch for the patients with moderate and severe cancer pain. Methods The moderate and severe cancer pain patients of our hospital were chosen and randomly divided into observation group and control group. Observation group was given skeleton diffusion type fentanyl transdermal patch for analgesia, control group was given repository type fentanyl transdermal patch. The analgesic effect, adverse reactions, improvement of quality life and patient satisfaction of the two groups were compared. Results After 1 month treatment, the VAS scores of the two groups were all obviously improved（ P 〈 0. 01 ） , and there was no significant difference between the two two groups （ P 〉 0.05 ） ; the complete remission rate and total effective rate of observation group were slightly higher than those of control group with no significant difference（ P 〉 0.05 ）. The patient satisfaction of observation group was obviously higher than that of control group with significant difference（ P 〈 0. 05 ）. The incidences of rashes and blister of observation group were obviously lower than those of control group, there were significant differences between the two groups （ P 〈 0. 05 ）, and no significant difference was found in the incidences of the other adverse reactions between the two groups （ P 〉 0. 05 ）. The total scores of FACT-G in the two groups increased significantly after one month＇s treatment（ P 〈0. 01 ） ,and there was no significant difference between the two groups （ P 〉 0. 05 ）. Conclusion The analgesic efficacy of new-style skeleton diffusion type fentanyl transdermal patch on moderate and severe cancer pain is good, compared with the traditional repository type fentanyl transdermal patch ,it has the advantages of more rapid onset with better skin tolerability, skin adhesiveness and comfort level, it is more easily accepted by patients with higher safety and worthy of clinical popularization and application.