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克痛散外敷緩解中度癌痛的臨床研究

發(fā)布時(shí)間:2018-10-24 18:08
【摘要】:目的:研究克痛散是否能緩解中度癌痛及與阿片類藥物聯(lián)合運(yùn)用是否有協(xié)同抗癌痛的作用,為克痛散緩解癌性疼痛提供切實(shí)的臨床依據(jù)。方法:將符合納入標(biāo)準(zhǔn)的病例按1:1的比例隨機(jī)分為試驗(yàn)組和對(duì)照組。試驗(yàn)組:外敷克痛散聯(lián)合口服鹽酸羥考酮緩釋片,克痛散外敷于疼痛最明顯處,1日兩次,每次持續(xù)兩小時(shí);鹽酸羥考酮緩釋片起始劑量因個(gè)體差異給藥,12小時(shí)1次。對(duì)照組:單純口服鹽酸羥考酮緩釋片,用法與試驗(yàn)組相同。7天1療程,連續(xù)觀察2療程。結(jié)果:1.試驗(yàn)組患者外敷克痛散聯(lián)合口服鹽酸羥考酮緩釋片止痛的總有效率為86%、而單純口服鹽酸羥考酮緩釋片的對(duì)照組患者止痛的總有效率為62%,兩者止痛的總有效率有顯著差異,試驗(yàn)組止痛效果明顯比對(duì)照組好。2.治療前后、治療后兩組組間比較NRS評(píng)分均下降并有顯著差異,兩組藥物都能有效減輕患者的疼痛程度,且試驗(yàn)組優(yōu)于對(duì)照組。3.治療前后、治療后兩組組間比較KPS評(píng)分均提高并有顯著差異,兩組藥物都能有提高患者的生活質(zhì)量,且試驗(yàn)組優(yōu)于對(duì)照組。4.試驗(yàn)組的患者在整個(gè)療程中所服用的鹽酸羥考酮緩釋片的使用量比對(duì)照組少,且克痛散聯(lián)合鹽酸羥考酮緩釋片的治療方法比單純口服鹽酸羥考酮緩釋片的治療方法起效快,止痛的維持時(shí)間長,爆發(fā)痛的發(fā)生機(jī)率小。5.不良反應(yīng)分析,克痛散聯(lián)合鹽酸羥考酮緩釋片的治療方法對(duì)比單純口服鹽酸羥考酮緩釋片的治療方法,出現(xiàn)的惡心、嘔吐、便秘癥狀更少。說明克痛散聯(lián)合鹽酸羥考酮緩釋片不僅有協(xié)同抗癌痛的作用,而且能減少鹽酸羥考酮緩釋片的使用劑量,從而減輕患者因?yàn)榭诜}酸羥考酮緩釋片所帶來的相關(guān)不良反應(yīng)發(fā)生率。6、安全性指標(biāo)分析,在整個(gè)療程中,僅試驗(yàn)組發(fā)生不良反應(yīng)1例(皮膚過敏1例)。兩組患者血常規(guī)、肝功能、腎功能、心跳、血壓、呼吸、脈搏在治療前后均無統(tǒng)計(jì)學(xué)差異,說明兩組藥物均安全。結(jié)論:克痛散外敷能有效緩解癌痛,與鹽酸羥考酮緩釋片聯(lián)合運(yùn)用有協(xié)同控制癌痛的作用,還能減少鹽酸羥考酮緩釋片的用量從而降低服用該藥所帶來的不良反應(yīng),并且相比單純使用鹽酸羥考酮緩釋片控制癌痛的治療方法的起效時(shí)間更快,止痛維持時(shí)間更長,在臨床應(yīng)用中有一定的價(jià)值,值得進(jìn)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.
【學(xué)位授予單位】:云南中醫(yī)學(xué)院
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2017
【分類號(hào)】:R273

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