克痛散外敷缓解中度癌痛的临床研究

发布时间：2018-10-24 18:08

【摘要】：目的:研究克痛散是否能缓解中度癌痛及与阿片类药物联合运用是否有协同抗癌痛的作用,为克痛散缓解癌性疼痛提供切实的临床依据。方法:将符合纳入标准的病例按1:1的比例随机分为试验组和对照组。试验组:外敷克痛散联合口服盐酸羟考酮缓释片,克痛散外敷于疼痛最明显处,1日两次,每次持续两小时;盐酸羟考酮缓释片起始剂量因个体差异给药,12小时1次。对照组:单纯口服盐酸羟考酮缓释片,用法与试验组相同。7天1疗程,连续观察2疗程。结果:1.试验组患者外敷克痛散联合口服盐酸羟考酮缓释片止痛的总有效率为86%、而单纯口服盐酸羟考酮缓释片的对照组患者止痛的总有效率为62%,两者止痛的总有效率有显著差异,试验组止痛效果明显比对照组好。2.治疗前后、治疗后两组组间比较NRS评分均下降并有显著差异,两组药物都能有效减轻患者的疼痛程度,且试验组优于对照组。3.治疗前后、治疗后两组组间比较KPS评分均提高并有显著差异,两组药物都能有提高患者的生活质量,且试验组优于对照组。4.试验组的患者在整个疗程中所服用的盐酸羟考酮缓释片的使用量比对照组少,且克痛散联合盐酸羟考酮缓释片的治疗方法比单纯口服盐酸羟考酮缓释片的治疗方法起效快,止痛的维持时间长,爆发痛的发生机率小。5.不良反应分析,克痛散联合盐酸羟考酮缓释片的治疗方法对比单纯口服盐酸羟考酮缓释片的治疗方法,出现的恶心、呕吐、便秘症状更少。说明克痛散联合盐酸羟考酮缓释片不仅有协同抗癌痛的作用,而且能减少盐酸羟考酮缓释片的使用剂量,从而减轻患者因为口服盐酸羟考酮缓释片所带来的相关不良反应发生率。6、安全性指标分析,在整个疗程中,仅试验组发生不良反应1例(皮肤过敏1例)。两组患者血常规、肝功能、肾功能、心跳、血压、呼吸、脉搏在治疗前后均无统计学差异,说明两组药物均安全。结论:克痛散外敷能有效缓解癌痛,与盐酸羟考酮缓释片联合运用有协同控制癌痛的作用,还能减少盐酸羟考酮缓释片的用量从而降低服用该药所带来的不良反应,并且相比单纯使用盐酸羟考酮缓释片控制癌痛的治疗方法的起效时间更快,止痛维持时间更长,在临床应用中有一定的价值,值得进一步研究。
[Abstract]:Objective: to study whether Ketongsan can relieve moderate cancer pain and whether combined use with opioid drugs has synergistic effect of anticancer pain, and provide practical clinical basis for Ketong Powder to alleviate cancer pain. Methods: the patients who met the inclusion criteria were randomly divided into the trial group and the control group according to the 1:1 ratio. The experimental group: Ketongsan was applied externally in combination with oral hydroxycodone hydrochloride sustained release tablets, Ketongsan was applied in the most obvious place of pain, twice a day for two hours each time, and the initial dose of hydroxycodone hydrochloride sustained release tablet was given once in 12 hours because of individual differences. Control group: only oral hydroxycodone hydrochloride sustained release tablets, the same as the test group. 7 days a course of treatment, continuous observation of 2 courses. The result is 1: 1. The total effective rate of external application of Ketongsan and oral hydroxycodone sustained release tablets was 86%, while that of control group was 62.The total effective rate of pain relief was significantly different between the two groups. The analgesic effect of the test group was better than that of the control group. 2. Before and after treatment, the NRS scores of the two groups decreased and there were significant differences between the two groups. Both drugs in the two groups could effectively alleviate the pain of the patients, and the experimental group was better than the control group. Before and after treatment, the KPS scores of the two groups were improved and there were significant differences. Both drugs could improve the quality of life of the patients, and the test group was better than the control group. 4. In the trial group, the dosage of hydroxycodone hydrochloride sustained release tablets was less than that of the control group during the whole course of treatment, and the treatment of Ketongsan combined with hydroxycodone hydrochloride sustained release tablets was more effective than that of oral hydroxycodone sustained release tablets alone. The maintenance time of pain relief is long, and the incidence of pain outbreak is small. 5. 5. Side effect analysis, Ketongsan combined with hydroxycodone hydrochloride sustained release tablets treatment method than oral hydroxycodone sustained release tablets alone, there are less nausea, vomiting, constipation symptoms. The results showed that Ketongsan combined with hydroxycodone hydrochloride sustained-release tablets not only had synergistic effect of anticancer pain, but also could reduce the dosage of hydroxycodone hydrochloride sustained-release tablets. In order to reduce the incidence of related adverse reactions caused by oral hydroxycodone sustained release tablets. 6. Safety index analysis, in the whole course of treatment, only one case of adverse reactions (1 case of skin allergy) occurred in the trial group. Blood routine, liver function, renal function, heartbeat, blood pressure, respiration and pulse were not significantly different between the two groups before and after treatment, indicating that the two groups were safe. Conclusion: the external application of Ketongsan can effectively relieve cancer pain, which can be used in combination with hydroxycodone hydrochloride sustained release tablets to control cancer pain synergistically, and can also reduce the dosage of hydroxycodone hydrochloride sustained release tablets and thus reduce the adverse reactions caused by taking this drug. Compared with the control of cancer pain treated with hydroxycodone hydrochloride sustained-release tablets alone, the effective time is faster and the pain relief time is longer. It has certain value in clinical application and is worthy of further study.
【学位授予单位】：云南中医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R273

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