“丁香止痛方”穴位貼敷治療癌性腹部脹痛的臨床研究
發(fā)布時間：2018-07-31 16:48
【摘要】：研究目的:1.明確"丁香止痛方"穴位貼敷治療癌性腹部脹痛的臨床療效;2.評價"丁香止痛方"穴位貼敷治療癌性腹部脹痛安全性。研究方法:本課題采用前瞻性、隨機(jī)、雙盲、安慰劑平行對照的臨床試驗(yàn)設(shè)計(jì)方法。將50例符合本研究納入排除標(biāo)準(zhǔn)的受試者隨機(jī)為試驗(yàn)組和安慰劑組,每組各25例。試驗(yàn)組采用基礎(chǔ)治療+ "丁香止痛方"穴位貼敷的治療方案,安慰劑組采用基礎(chǔ)治療+ "丁香止痛方"安慰劑穴位貼敷的治療方案,療程為1周,治療結(jié)束后停藥觀察3天。研究過程中受試者出現(xiàn)爆發(fā)痛則予嗎啡注射液皮下注射治療,并在研究過程根據(jù)受試者的疼痛強(qiáng)度及時調(diào)整緩釋阿片類藥物的口服劑量。在特定的觀察時間,記錄NRS評分、腹脹評分、24小時發(fā)生爆發(fā)痛發(fā)生次數(shù)、UBA疼痛行為評分、24小時嗎啡使用總量、KPS評分、以及主管醫(yī)生和受試者對穴位貼敷治療滿意度。研究結(jié)果:本研究納入50例受試者,按照隨機(jī)對照試驗(yàn)結(jié)果統(tǒng)計(jì)的意向性處理分析原則,本研究結(jié)果以在全數(shù)據(jù)分析集(50例)中進(jìn)行統(tǒng)計(jì)分析的結(jié)果為最終結(jié)果。1.臨床有效率:①腹痛緩解率:7天治療結(jié)束后試驗(yàn)組的疼痛緩解率(84.0%)高于安慰劑組的疼痛緩解率(52.0%),兩組的疼痛緩解人數(shù)比較差異(P=0.015),貼敷治療結(jié)束3天后,兩組的疼痛緩解人數(shù)比較仍有差異(P=0.004)。對于兩組中僅用穴位貼敷進(jìn)行治療的受試者腹痛緩解率進(jìn)行比較:試驗(yàn)組受試者的腹痛緩解率(88.8%)高于安慰劑組受試者的腹痛緩解率(40%),并且在治療結(jié)束3天后試驗(yàn)組的腹痛緩解率仍高于安慰劑組。②腹脹緩解率:7天治療結(jié)束后試驗(yàn)組的腹脹緩解率(80.0%)高于安慰劑組的腹脹緩解率(44.0%),兩組的腹脹緩解人數(shù)比較有差異(P=0.009),貼敷治療結(jié)束3天后,兩組的腹脹緩解人數(shù)比較仍有差異(P=0.009)。對兩組中僅使用穴位貼敷治療癌性腹部脹痛的試驗(yàn)組受試者腹痛緩解率(88.8%)高于安慰劑組受試者腹痛緩解率(40%),并且在治療結(jié)束3天后試驗(yàn)組的腹痛緩解率仍高于安慰劑組。對于兩組中僅用穴位貼敷進(jìn)行治療的受試者腹脹緩解率進(jìn)行比較:試驗(yàn)組腹脹緩解率為88.9%,對照組腹脹緩解率為53.5%,并且在治療結(jié)束3天后試驗(yàn)組緩解率仍高于對照組。2.疼痛行為評分:試驗(yàn)組受試者7天治療后的疼痛行為評分為(1.95± 1.22)分,而安慰劑組為(2.90± 1.62)分,兩組比較有統(tǒng)計(jì)學(xué)差異(P=0.044)。3.24小時爆發(fā)痛發(fā)作次數(shù):兩組受試者在入組的D1、D4、D7、D10這4個觀察日的24小時爆發(fā)痛發(fā)作次數(shù)比較均無統(tǒng)計(jì)學(xué)差異。4.24小時嗎啡使用總量:兩組在入組的第D1、D4、D7、D10這2個觀察日的24小時嗎啡使用總量比較無統(tǒng)計(jì)學(xué)差異。5.KPS評分:入組后兩組在D7、D10的KPS評分比較均無統(tǒng)計(jì)學(xué)差異。6.滿意度和滿意率方面:兩組受試者、受試者主管醫(yī)生在入組治療后(D7)對穴位貼敷治療的滿意評分比較均無統(tǒng)計(jì)學(xué)差異。安慰劑組受試者的主管醫(yī)生對穴位貼敷治療的滿意率為96%,試驗(yàn)組受試者的主管醫(yī)生對穴位貼敷治療的滿意率為92%。安慰劑組受試者對治療的滿意率92%,試驗(yàn)組受試者對治療的滿意率為88%。7.安全性評估:使用"丁香止痛方"治療癌性腹部脹痛的受試者時皮膚過敏反應(yīng)發(fā)生率為4.2%,與安慰劑組相比無統(tǒng)計(jì)學(xué)差異(P=1.000)。"丁香止痛方"穴位貼敷治療癌性腹部脹痛與安慰劑組相比,不增加患者血常規(guī)、尿常規(guī)、便常規(guī)+潛血、肝功能、腎功能、電解質(zhì)和心電圖檢查結(jié)果的惡化風(fēng)險。研究結(jié)論:1.輕中度癌性腹部脹痛患者,在應(yīng)用阿片類藥物止痛的基礎(chǔ)上加用"丁香止痛方"穴位貼敷治療,可進(jìn)一步患者減輕腹部脹痛癥狀,減輕腹脹的有效率為86.0%,減輕腹痛的有效率是80.0%。2.輕度癌性腹部脹痛者單純使用"丁香止痛方"穴位貼敷治療,能夠有效緩解患者的腹部脹痛癥狀,提示其能夠替代三階梯止痛藥物治療輕度癌性腹部脹痛。3."丁香止痛方"穴位貼敷治療癌性腹部脹痛能降低患者的疼痛行為評分,但不能減少患者使用阿片類藥物的劑量。4.臨床醫(yī)生和患者對"丁香止痛方"穴位貼敷治療癌性腹部脹痛的滿意程度高。5."丁香止痛方"穴位貼敷治療癌性腹部脹痛可能導(dǎo)致患者出現(xiàn)局部皮膚過敏反應(yīng),但無全身毒副作用,臨床使用安全有效。
[Abstract]:Objective: 1. to clarify the clinical effect of Acupoint Application of "clove Zhitong prescription" in the treatment of cancer abdominal distention and pain; 2. to evaluate the safety of cancer abdominal distention by Acupoint Application of "clove analgesic prescription". Research methods: this subject adopts a prospective, randomized, double blind, placebo parallel control clinical trial design method. 50 cases are in accordance with this study. The standard subjects were randomized to the experimental group and the placebo group, with 25 cases in each group. The experimental group was treated with basic therapy plus the "clove analgesic prescription" acupoint application. The placebo group was treated with a basic therapy plus a "clove analgesic prescription" on a placebo acupoint application. The treatment course was 1 weeks. After the treatment, the drug was observed for 3 days. The subjects during the study were subjects. The onset pain was given subcutaneous injection of morphine injection, and the oral dose of sustained release opioids was adjusted in time according to the pain intensity of the subjects. NRS score, abdominal distention score, 24 hours of burst pain occurred, UBA pain behavior score, 24 hours morphine total use, KPS evaluation at a specific time of observation. Results: the results of this study were included in the intent handling analysis of 50 subjects, according to the results of randomized controlled trials. The results of this study were statistically analyzed in the total data analysis set (50 cases) for the final result of.1. clinical efficiency: (1) abdominal pain After 7 days of treatment, the rate of pain relief in the experimental group (84%) was higher than that of the placebo group (52%), the number of pain relief in the two groups was different (P=0.015). The number of pain relief in the two groups was still different (P=0.004) after the end of the application of the treatment (P=0.015). The abdominal pain in the two groups only treated with acupoint application was the abdominal pain of the subjects. The rate of remission was compared: the rate of abdominal pain relief in the experimental group (88.8%) was higher than that of the placebo group (40%), and the remission rate of abdominal pain in the test group was still higher than that of the placebo group at the end of the treatment. The remission rate of abdominal distension was higher than that of the placebo group (80%) after 7 days of treatment (80%) was higher than that of the placebo group. Rate (44%), there was a difference in the number of abdominal distention in the two groups (P=0.009), and there were still differences in the number of abdominal distention in the two groups (P=0.009) for 3 days after the end of the application. The rate of abdominal pain relief (88.8%) was higher than that of the placebo group (40%), and the rate of abdominal pain relief (40%) was higher in the two group. The remission rate of abdominal pain in the experimental group was still higher than that in the placebo group at the end of the 3 day treatment. The remission rate of abdominal distention in the two groups was compared with that of the acupoint application only: the remission rate of abdominal distention was 88.9%, the remission rate of abdominal distention in the control group was 53.5%, and the remission rate of the experimental group was still higher than the control group.2. pain after 3 days of treatment. Score: the score of pain behavior after 7 days of treatment in the experimental group was (1.95 + 1.22), while the placebo group was (2.90 + 1.62), the two groups had a statistically significant difference (P=0.044).3.24 hour burst times: the two groups were in the group of D1, D4, D7, D10, the 24 hours of 4 observation days were not statistically significant. The total amount of morphine use difference.4.24 hours: two groups in the group of D1, D4, D7, D10, the total amount of morphine used in the 2 observation days was not statistically significant difference.5.KPS score: the KPS scores of the group in D7, D10's KPS scores were not statistically different.6. satisfaction and satisfaction rate: two groups of subjects, subjects in charge of the doctor in the group treatment There was no statistical difference in the satisfaction score of acupoint application treatment after D7. The satisfactory rate of acupoint application was 96% in the placebo group. The satisfaction rate of the acupoint application was 92% in the placebo group in the test group and 92% in the placebo group, and the subjects in the experimental group were full of the treatment. 88%.7. safety assessment: the incidence of skin allergy in patients with cancer abdominal distention was 4.2%, with no statistically significant difference compared with placebo group (P=1.000). The risk of the deterioration of the results of occult blood, liver function, renal function, electrolytes and electrocardiogram. Conclusion: 1. patients with mild and moderate abdominal distention and pain, combined with Acupoint Application of "clove analgesic prescription" on the basis of opioid analgesics, can further alleviate abdominal distention and pain, reduce abdominal distension and relieve abdominal pain, reduce abdominal pain, and relieve abdominal pain. The effective rate is 80.0%.2. mild cancer abdominal distention and pain only use "clove analgesic prescription" point sticking treatment, can effectively alleviate the patient's abdominal distention and pain symptoms, suggesting that it can replace the three ladder analgesic drug treatment mild cancer abdominal distention and pain.3. "clove analgesic prescription" point sticking treatment of cancer abdominal distention can reduce the pain of patients In order to score, but can not reduce the dosage of opioid drugs in patients with.4. clinicians and patients with "clove analgesic prescription" acupoint application treatment of cancer abdominal distention and pain satisfaction high.5. "clove analgesic prescription" point sticking treatment of cancer abdominal distention may lead to patients with local skin allergy, but no systemic side effects, clinical causes It is safe and effective.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R730.5
本文編號：2156199
[Abstract]:Objective: 1. to clarify the clinical effect of Acupoint Application of "clove Zhitong prescription" in the treatment of cancer abdominal distention and pain; 2. to evaluate the safety of cancer abdominal distention by Acupoint Application of "clove analgesic prescription". Research methods: this subject adopts a prospective, randomized, double blind, placebo parallel control clinical trial design method. 50 cases are in accordance with this study. The standard subjects were randomized to the experimental group and the placebo group, with 25 cases in each group. The experimental group was treated with basic therapy plus the "clove analgesic prescription" acupoint application. The placebo group was treated with a basic therapy plus a "clove analgesic prescription" on a placebo acupoint application. The treatment course was 1 weeks. After the treatment, the drug was observed for 3 days. The subjects during the study were subjects. The onset pain was given subcutaneous injection of morphine injection, and the oral dose of sustained release opioids was adjusted in time according to the pain intensity of the subjects. NRS score, abdominal distention score, 24 hours of burst pain occurred, UBA pain behavior score, 24 hours morphine total use, KPS evaluation at a specific time of observation. Results: the results of this study were included in the intent handling analysis of 50 subjects, according to the results of randomized controlled trials. The results of this study were statistically analyzed in the total data analysis set (50 cases) for the final result of.1. clinical efficiency: (1) abdominal pain After 7 days of treatment, the rate of pain relief in the experimental group (84%) was higher than that of the placebo group (52%), the number of pain relief in the two groups was different (P=0.015). The number of pain relief in the two groups was still different (P=0.004) after the end of the application of the treatment (P=0.015). The abdominal pain in the two groups only treated with acupoint application was the abdominal pain of the subjects. The rate of remission was compared: the rate of abdominal pain relief in the experimental group (88.8%) was higher than that of the placebo group (40%), and the remission rate of abdominal pain in the test group was still higher than that of the placebo group at the end of the treatment. The remission rate of abdominal distension was higher than that of the placebo group (80%) after 7 days of treatment (80%) was higher than that of the placebo group. Rate (44%), there was a difference in the number of abdominal distention in the two groups (P=0.009), and there were still differences in the number of abdominal distention in the two groups (P=0.009) for 3 days after the end of the application. The rate of abdominal pain relief (88.8%) was higher than that of the placebo group (40%), and the rate of abdominal pain relief (40%) was higher in the two group. The remission rate of abdominal pain in the experimental group was still higher than that in the placebo group at the end of the 3 day treatment. The remission rate of abdominal distention in the two groups was compared with that of the acupoint application only: the remission rate of abdominal distention was 88.9%, the remission rate of abdominal distention in the control group was 53.5%, and the remission rate of the experimental group was still higher than the control group.2. pain after 3 days of treatment. Score: the score of pain behavior after 7 days of treatment in the experimental group was (1.95 + 1.22), while the placebo group was (2.90 + 1.62), the two groups had a statistically significant difference (P=0.044).3.24 hour burst times: the two groups were in the group of D1, D4, D7, D10, the 24 hours of 4 observation days were not statistically significant. The total amount of morphine use difference.4.24 hours: two groups in the group of D1, D4, D7, D10, the total amount of morphine used in the 2 observation days was not statistically significant difference.5.KPS score: the KPS scores of the group in D7, D10's KPS scores were not statistically different.6. satisfaction and satisfaction rate: two groups of subjects, subjects in charge of the doctor in the group treatment There was no statistical difference in the satisfaction score of acupoint application treatment after D7. The satisfactory rate of acupoint application was 96% in the placebo group. The satisfaction rate of the acupoint application was 92% in the placebo group in the test group and 92% in the placebo group, and the subjects in the experimental group were full of the treatment. 88%.7. safety assessment: the incidence of skin allergy in patients with cancer abdominal distention was 4.2%, with no statistically significant difference compared with placebo group (P=1.000). The risk of the deterioration of the results of occult blood, liver function, renal function, electrolytes and electrocardiogram. Conclusion: 1. patients with mild and moderate abdominal distention and pain, combined with Acupoint Application of "clove analgesic prescription" on the basis of opioid analgesics, can further alleviate abdominal distention and pain, reduce abdominal distension and relieve abdominal pain, reduce abdominal pain, and relieve abdominal pain. The effective rate is 80.0%.2. mild cancer abdominal distention and pain only use "clove analgesic prescription" point sticking treatment, can effectively alleviate the patient's abdominal distention and pain symptoms, suggesting that it can replace the three ladder analgesic drug treatment mild cancer abdominal distention and pain.3. "clove analgesic prescription" point sticking treatment of cancer abdominal distention can reduce the pain of patients In order to score, but can not reduce the dosage of opioid drugs in patients with.4. clinicians and patients with "clove analgesic prescription" acupoint application treatment of cancer abdominal distention and pain satisfaction high.5. "clove analgesic prescription" point sticking treatment of cancer abdominal distention may lead to patients with local skin allergy, but no systemic side effects, clinical causes It is safe and effective.
【學(xué)位授予單位】：北京中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R730.5
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