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目的:评价癌痛灵栓剂对中重度癌症疼痛患者生存质量和镇痛作用的影响。方法:本研究采用交叉设计,自身对照的方法,观察60例伴有中重度癌症疼痛的恶性肿瘤患者,按入组顺序随机分为试验组和对照组。试验组用癌痛灵栓剂,1粒,q12h,纳肛;对照组用硫酸吗啡控释片,20mg,q12h,口服,均连续用药2天。观察其疼痛强度差、总疼痛强度差、疼痛缓解度、总疼痛缓解度、中度以上疼痛缓解率、总镇痛分等镇痛评价指标,运用EORTCQLQ量表,观察治疗前后生活质量变化。以t检验、秩和检验和χ2检验进行统计分析。结果:临床研究显示:两组在用药后0.5小时开始疼痛强度差呈逐渐增加趋势,T4、T5时点达到峰值并逐渐开始下降,受试者在D1的T3～T6时点,其疼痛强度差显示试验组优于对照组(P<0.05),在T4～T6时点试验组达到中度以上疼痛缓解度的人数所占比较对照组多,T10时点疼痛未缓解的人数所占比较对照组少(P<0.05)。在D2的T0.5时点试验组疼痛强度差比对照组小(P<0.05),而在T3～T6、T8和T10时点,试验组疼痛强度差均大于对照组(P<0.05)。T3～T5时点,两组中达到中度以上疼痛缓解度人数所占比相似,但试验组中3度和4度缓解的人数所占比优于对照组(P<0.05),T6和T8时点,中度以上疼痛缓解度的人数所占比较对照组多(P<0.05),在T10时点疼痛未缓解的人数所占比较对照组少(P<0.05)。试验组各天的总疼痛缓解度、总镇痛分高于对照组(P<0.05)。生存质量方面,两组在疼痛、失眠方面均较治疗前有好转(P<0.05),对照组在恶心、呕吐、便秘、食欲等方面有影响(P<0.05)。在长期生活质量观察指标方面两组均无统计学意义的变化。结论:癌痛灵栓剂用于治疗中重度癌症疼痛时,疗效可靠,无明显不良反应,有助于改善癌痛患者生存质量,可作为癌症患者止痛药物应用。
Objective: To evaluate the effect of Jiaotongning suppository on quality of life and analgesia in patients with moderate-severe cancer pain. Methods: In this study, 60 patients with malignant tumors accompanied by moderate and severe cancer pain were observed by crossed design and self-control method. The patients were randomly divided into experimental group and control group according to the sequence of entering group. The experimental group with Jia Tong Ling suppository, a grain, q12h, anal; control group morphine sulfate controlled-release tablets, 20mg, q12h, oral, were continuous medication for 2 days. To observe the pain intensity difference, the total pain intensity difference, the pain relief degree, the total pain relief degree, the middle and above pain relief rate, the total analgesia grading analgesia evaluation index, using the EORTCQLQ scale to observe the quality of life before and after treatment. T test, rank sum test and χ2 test were used for statistical analysis. Results: The clinical study showed that the pain intensity of the two groups began to increase gradually at 0.5 hour after treatment, the peak reached the peak at T4 and T5, and gradually began to decline. The pain intensity was poor at T3 ~ T6 of D1 (P <0.05). Compared with the control group, the number of patients with moderate to severe pain relief in the experimental group at T4 ~ T6 was significantly higher than that in the control group, and the number of patients with no pain relief at T10 was higher than that in the control group Less (P <0.05). The pain intensity difference of the experimental group was smaller than that of the control group at T0.5 of D2 (P <0.05), and the pain intensity difference of the experimental group was greater than that of the control group at T3-T6, T8 and T10 (P <0.05). At T3 ~ T5, the proportion of patients with moderate to severe pain relief was similar in both groups, but the proportion of patients with 3 and 4 degrees of remission in the two groups was better than that in control group (P <0.05). T6 and T8 At the time point, the number of people with moderate to moderate pain relief was higher than that of the control group (P <0.05), and the number of people with no pain relief at T10 was less than that of the control group (P <0.05). Total pain relief and total analgesia scores of the experimental group were higher than those of the control group (P <0.05). In terms of quality of life, both groups had better pain and insomnia than before treatment (P <0.05), while the control group had nausea, vomiting, constipation and appetite (P <0.05). There were no statistically significant changes in long-term quality of life indicators between the two groups. Conclusion: When used in the treatment of moderate to severe cancer pain, Jia Tong Ling Suppository has reliable curative effect and no obvious adverse reactions, which can help improve the quality of life of patients with cancer pain. It can be used as a painkiller in cancer patients.