“丁香止痛方”穴位贴敷治疗癌性腹部胀痛的临床研究
发布时间：2018-07-31 16:48
【摘要】：研究目的:1.明确"丁香止痛方"穴位贴敷治疗癌性腹部胀痛的临床疗效;2.评价"丁香止痛方"穴位贴敷治疗癌性腹部胀痛安全性。研究方法:本课题采用前瞻性、随机、双盲、安慰剂平行对照的临床试验设计方法。将50例符合本研究纳入排除标准的受试者随机为试验组和安慰剂组,每组各25例。试验组采用基础治疗+ "丁香止痛方"穴位贴敷的治疗方案,安慰剂组采用基础治疗+ "丁香止痛方"安慰剂穴位贴敷的治疗方案,疗程为1周,治疗结束后停药观察3天。研究过程中受试者出现爆发痛则予吗啡注射液皮下注射治疗,并在研究过程根据受试者的疼痛强度及时调整缓释阿片类药物的口服剂量。在特定的观察时间,记录NRS评分、腹胀评分、24小时发生爆发痛发生次数、UBA疼痛行为评分、24小时吗啡使用总量、KPS评分、以及主管医生和受试者对穴位贴敷治疗满意度。研究结果:本研究纳入50例受试者,按照随机对照试验结果统计的意向性处理分析原则,本研究结果以在全数据分析集(50例)中进行统计分析的结果为最终结果。1.临床有效率:①腹痛缓解率:7天治疗结束后试验组的疼痛缓解率(84.0%)高于安慰剂组的疼痛缓解率(52.0%),两组的疼痛缓解人数比较差异(P=0.015),贴敷治疗结束3天后,两组的疼痛缓解人数比较仍有差异(P=0.004)。对于两组中仅用穴位贴敷进行治疗的受试者腹痛缓解率进行比较:试验组受试者的腹痛缓解率(88.8%)高于安慰剂组受试者的腹痛缓解率(40%),并且在治疗结束3天后试验组的腹痛缓解率仍高于安慰剂组。②腹胀缓解率:7天治疗结束后试验组的腹胀缓解率(80.0%)高于安慰剂组的腹胀缓解率(44.0%),两组的腹胀缓解人数比较有差异(P=0.009),贴敷治疗结束3天后,两组的腹胀缓解人数比较仍有差异(P=0.009)。对两组中仅使用穴位贴敷治疗癌性腹部胀痛的试验组受试者腹痛缓解率(88.8%)高于安慰剂组受试者腹痛缓解率(40%),并且在治疗结束3天后试验组的腹痛缓解率仍高于安慰剂组。对于两组中仅用穴位贴敷进行治疗的受试者腹胀缓解率进行比较:试验组腹胀缓解率为88.9%,对照组腹胀缓解率为53.5%,并且在治疗结束3天后试验组缓解率仍高于对照组。2.疼痛行为评分:试验组受试者7天治疗后的疼痛行为评分为(1.95± 1.22)分,而安慰剂组为(2.90± 1.62)分,两组比较有统计学差异(P=0.044)。3.24小时爆发痛发作次数:两组受试者在入组的D1、D4、D7、D10这4个观察日的24小时爆发痛发作次数比较均无统计学差异。4.24小时吗啡使用总量:两组在入组的第D1、D4、D7、D10这2个观察日的24小时吗啡使用总量比较无统计学差异。5.KPS评分:入组后两组在D7、D10的KPS评分比较均无统计学差异。6.满意度和满意率方面:两组受试者、受试者主管医生在入组治疗后(D7)对穴位贴敷治疗的满意评分比较均无统计学差异。安慰剂组受试者的主管医生对穴位贴敷治疗的满意率为96%,试验组受试者的主管医生对穴位贴敷治疗的满意率为92%。安慰剂组受试者对治疗的满意率92%,试验组受试者对治疗的满意率为88%。7.安全性评估:使用"丁香止痛方"治疗癌性腹部胀痛的受试者时皮肤过敏反应发生率为4.2%,与安慰剂组相比无统计学差异(P=1.000)。"丁香止痛方"穴位贴敷治疗癌性腹部胀痛与安慰剂组相比,不增加患者血常规、尿常规、便常规+潜血、肝功能、肾功能、电解质和心电图检查结果的恶化风险。研究结论:1.轻中度癌性腹部胀痛患者,在应用阿片类药物止痛的基础上加用"丁香止痛方"穴位贴敷治疗,可进一步患者减轻腹部胀痛症状,减轻腹胀的有效率为86.0%,减轻腹痛的有效率是80.0%。2.轻度癌性腹部胀痛者单纯使用"丁香止痛方"穴位贴敷治疗,能够有效缓解患者的腹部胀痛症状,提示其能够替代三阶梯止痛药物治疗轻度癌性腹部胀痛。3."丁香止痛方"穴位贴敷治疗癌性腹部胀痛能降低患者的疼痛行为评分,但不能减少患者使用阿片类药物的剂量。4.临床医生和患者对"丁香止痛方"穴位贴敷治疗癌性腹部胀痛的满意程度高。5."丁香止痛方"穴位贴敷治疗癌性腹部胀痛可能导致患者出现局部皮肤过敏反应,但无全身毒副作用,临床使用安全有效。
[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.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R730.5
本文编号：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.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R730.5
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