痛块消乳膏外治癌性躯体痛的临床研究
详细信息    本馆镜像全文|  推荐本文 |  |   获取CNKI官网全文
摘要
本论文包括文献综述和临床研究两个部分。
     文献综述:
     癌性疼痛是癌症患者最常见且最恐慌的症状之一,常为慢性疼痛,约3/4晚期肿瘤患者合并疼痛,如果得不到有效控制,将极大地影响到患者的生活质量。全面的癌痛评估对确定恰当的疼痛治疗方案至关重要。NCCN成人癌痛指南推荐数字评分量表来评估疼痛。目前慢性癌痛的治疗主要有药物治疗、非药物治疗以及中医中药的治疗。药物治疗主要是以WHO三阶梯止痛原则和NCCN成人癌痛指南为指导的,以阿片类镇痛药为主,配合辅助药物的综合治疗方案。非药物治疗主要有放射治疗、放射性核素治疗、神经毁损疗法、自控镇痛技术及心理干预疗法等。中医中药毒副作用小、治疗手段丰富,在镇痛的同时能够改善患者的主观症状,提高患者的生活质量,与止痛药配合可增强止痛药的疗效,减少其用量,减轻其副作用,是癌性疼痛综合治疗中的安全、有效的方法。但仍缺乏大规模临床试验验证其便于临床推广的有效治疗方案。
     临床研究:
     目的:评价中医外治药物痛块消乳膏配合阿片类镇痛药治疗中重度癌性躯体痛的有效性与安全性。
     方法:采用随机、双盲、安慰剂对照临床试验设计,共纳入124例中重度癌性躯体痛患者,随机分为治疗组(N=63)和对照组(N=61),分别给予痛块消乳膏或安慰剂外用,同时按NCCN成人癌痛指南进行口服吗啡片剂量滴定,24小时后转换为缓释阿片制剂,出现爆发痛给予即释吗啡处理,共观察5天。
     结果:用药前和用药5天后疼痛程度(NRS评分)比较,治疗组分别为6.44±1.43VS3.22±2.17,对照组分别为6.20±1.45VS3.48±2.34,两组用药前后差异有统计学意义(P<0.0001),组间差异无统计学意义(P>0.05);止痛起效时间(h)治疗组与对照组分别为3.16±2.18VS3.72±2.43,组间差异无统计学意义(P>0.05),疼痛缓解持续时间(h)两组分别为24.42±25.53VS12.02±11.25,组间差异有统计学意义(P<0.05);首日吗啡用量(mg)治疗组与对照组分别为38.97±41.43VS60.44±50.46,组间差异有统计学意义(P<0.05),全程吗啡用量(mg)分别为167.02±143.87VS216.96±192.16,组间差异无统计学意义(P>0.05);用药前和用药5天后疼痛影响评估总评分比较,治疗组分别为46.97±12.85VS24.06±16.75,对照组分别为47.48±11.67VS26.05±16.99,两组用药前后差异有统计学意义(P<0.0001),组间差异无统计学意义(P>0.05);总有效率治疗组为95.24%,对照组为93.44%,组间差异无统计学意义(P>0.05)。研究过程中无明显不良反应。
     结论:痛块消乳膏外用配合阿片类镇痛药治疗中重度癌性躯体痛(阴寒内阻证)安全、有效,值得临床推广应用。
Objective To evaluate the efficacy and safety of Tongkuaixiao Ointment(TKXO) combining with opioid analgesics in the treatment of Moderate-to-Severe somatic cancer pain.
     Methods In a prospective,randomized,placebo-controlled,double-blind clinical trial,124patients with Moderate-to-Severe somatic cancer pain were randomly divided into the TKXO group(Treatment group,N=63)and the placebo group(Control group,N=61),who were externally treated with Tongkuaixiao Ointment or the placebo and took opioid analgesics orally at the same time.The treatment was administered for5days.
     Results The NRS decreased obviously after5days'treatment in both two groups(TKXO group:6.44±1.43VS3.22±2.17,Placebo group:6.20±1.45VS3.48±2.34),but the difference between these two groups wasn't statistically significant(P>0.05).The onset time of the two groups was3.16±2.18VS3.72±2.43(P>0.05),the duration was24.42±25.53VS12.02±11.25(P<0.05). Morphine dose of the first day of the two groups was38.97±41.43VS60.44±50.46(P<0.05),total dose was167.02±143.87VS216.96±192.16(P>0.05).The grade in impact of pain measurement decreased after5days'treatment(TKXO group:46.97±12.85VS24.06±16.75, Placebo group:47.48±11.67VS26.05±16.99), the difference between these two groups wasn't statistically significant(P>0.05). The overall improvement rates of the two groups were95.24%VS93.44%, the difference between these two groups wasn't statistically significant (P>0.05).No obvious adverse effects were found in the TKXO group.
     Conclusion It was demonstrated that Tongkuaixiao Ointment combining with opioid analgesics is effective and safe in the treatment of Moderate-to-Severe somatic cancer pain.
引文
[1]NCCN Clinical Practice Guidelines in Oncology Adult Cancer Pain V.2.2011.
    [2]付晖,王芳,陈建国.癌性疼痛的药物控制及治疗新观念[J].中国药师,2010,13(7):945-949.
    [3]WHO.Medical need for opioid analgesics.In:WHO,ed.Achieving balance in national opioids control policy:Guidelines for assessment[M].Geneva:WHO,2000:324.
    [4]张丽莹.缓控释强阿片类药物在老年癌痛患者中的应用分析[J].实用老年医学,2011,25(4):301-303.
    [5]De Scheppor HU,Cremonini F,Park Ml,et al.Opioids and the gut:pharmacology and current clinical experience[J].Neurogastroenterol Motil,2004,16(4):383-394.
    [6]Eisenach JC,Carpenter R,Curry R.Analgesia from a peripherally active kappa-opioid receptor agonist in patients with chronic pancreatitis[J].Pain,2003,101(1-2):89-95.
    [7]Kamp EH,Jones RC W,Tillman SR,et al.Quantitative assessment and characterization of visceral nociception and hyperalgesia in mice[J].Am J Physiol Gastrointest.Liver Physiol,2003,284(3):G434-G444.
    [8]于慧,梁立双,王建峰,等.盐酸羟考酮和硫酸吗啡控释片治疗癌性内脏痛的疗效比较[J].中国现代普通外科进展,2009,12(9):769-811.
    [9]黄琼,刘庆春.盐酸羟考酮控释片口服与直肠给药控制癌性疼痛的效果比较[J].实用医药杂志,2011,28(01):41-42.
    [10]Markenson JA, Croft J, Zhang PG et al. Treatment of persistent pain associated with osteoarthritis with controlled-release oxycodone tablets in a randomized controlled clinical trial.Clin J Pain,2005,21(6):524-535.
    [11]史进,赵林,车红军.氨酚羟考酮对晚期肺癌患者的镇痛效果[J].实用医药杂志,2006,23(10):1188-1189.
    [12]薛鹏,蔡讯,王理伟.氨酚羟考酮片与硫酸吗啡控释片治疗晚期中度或中重度癌痛患者的疗效与药物经济学分析[J].中国新药杂志,2008,17(22):1967-1969.
    [13]夏小玉.氨酚羟考酮片与硫酸吗啡控释片治疗晚期中重度癌症疼痛的成本-效果分析[J].中外医疗,2010,26:111-112.
    [14]Catherinem,Maloneykm,Kaykesner RN,et al.The rectal administration of Ms Contin in the advanced cancer[J].The American Journal of Hospital Care,2003,6(4):34.
    [15]徐瀚峰,郑勤,张全安,等.盐酸羟考酮控释片不同给药方式治疗中重度癌性疼痛的疗效比较.实用癌症杂志,2010,,25(5):533-534.
    [16]马存梅.硫酸吗啡不同给药方式对癌痛控制的效果[J].中外医疗,2010,33:110.
    [17]孔凡君,蔡玮,王华灵,等.硫酸吗啡控释片直肠给药治疗癌性疼痛临床观察[J].实用医药杂志,2011,28(6):497-498.
    [18]孙燕,顾蔚萍.癌症三阶梯止痛指导原则[M]第二版.北京:北京医科大学出版社,2002,63-64.
    [19]王莉娜,刘杰,李道睿,等.阿片类药物所致便秘的中医治疗现状[J].中国中西医结合外科学杂志,2010,16(1):116-119.
    [20]林国棣,杨贵美,刘珍值.阿片类止痛剂常见副作用的处理[J].工企医刊,2005,18(3):46.
    [21]王欣,薛朝霞.加巴喷丁的药理学及其在疼痛临床的应用进展[J].实用疼痛学杂志,2010,6(2):129-133.
    [22]罗琼,黄华.单用吗啡与联合用药治疗转移性骨肿瘤疼痛疗效比较[J].重庆医科大学学报,2005,30(6):892-894.
    [23]顾悦超,张勇.双氯芬酸钠联合吗啡控释片治疗转移性骨肿瘤疼痛[J].中国癌症杂志,2004,14(1):78-79.
    [24]王新林,苏金虎,王湘辉.注射用双氯芬酸钠利多卡因联合硫酸吗啡控释片治疗晚期癌症疼痛[J].西北国防医学杂志,2010,31(3):213-214.
    [25]章必成,姚国庆,刘健,等.氟比洛芬联合吗啡治疗难治性转移性骨痛[J].中国疼痛医学杂志,2011,17(8):506-507.
    [26]程少会,付占昭,王蕴,等.癌症疼痛患者焦虑状态分析[J].山东医药,2010,50(48):14.
    [27]高文斌,韩金娣,杜敏,等.抗精神抑郁(焦虑)药物在恶性肿瘤癌痛治疗中的应用[J].现代预防医学,2007,34(5):998-1000.
    [28]任洁.盐酸多塞平辅助吗啡控释片治疗晚期癌痛的临床观察[J].辽宁医学杂志,2008,22(1):40-41.
    [29]冯洁,李丽,耿立成.加巴喷丁治疗神经病理性疼痛的研究进展[J].医学综述,2011,17(14):2167-2169.
    [30]Bennett MI,Simpson KH.Gabapentin in the treatment of neuropathic pain[J].Palliat Med,2004,18(1):5-11.
    [31]刘国凯,黄宇先,罗爱俭,等.加巴喷丁用于神经病理性疼痛治疗的研究进展[J].中国临床药理学与治疗学,2003,8(3):241-244.
    [32]冯善武,吴智方,杨建军,等.加巴喷丁联合吗啡治疗大鼠神经病理性疼痛的疗效[J1].临床麻醉学杂志,2009,25(8):707-709.
    [33]Caraceni A,Zecca E,Martini C,et al.Gabapentin as an adjuvant to opioid analgensia for neuropathic cancer pain[J].J Pain Symptom Manage,1999,17(6):441-445.
    [34]梁锐,吴裕超,黄冰,等.加巴喷丁联合吗啡应用于癌痛的临床研究[J].临床肿瘤学杂志,,2010,15(1):34-38.
    [35]朱小勇,陈百松.硫酸吗啡控释片联合加巴喷丁治疗癌性神经痛的临床观察[J].中国疼痛医学杂志,2011,17(8):487-490.
    [36]Augusto,Ernesto,et al. Gabapentin for neuropathic cancer pain:A randomized controlled trial from the gabapentin cancer pain study group[J].J Clin Oncol,2004,22(15):2909-2917.
    [37]Theriault RL, Lipton A, Hortobagyi GN, et al. Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions:A randomized,placebo-controlled trial. Protocol 18 Aredia Breast Cancer Study Group.J Clin Oncol,1999,17:846.
    [38]Hortobagyi GN, Theriault RL, Lipton A, et al. Longterm prevention of skeletal complications of metastatic breast cancer with pamidronate.J Clin Oncol,1998,16:2038.
    [39]Conte PF, Latreille J, Mauriac L, et al. Delay in progression of bone metastases in breast cancer patients treated with intravenous pamidronate:Results from a multinational randomized controlled trial.J Clin Oncol,1996,14:2552.
    [40]付全宝,年卫国,何永明.帕米膦酸二钠治疗恶性肿瘤骨转移疼痛的临床研究[J].基层医学论坛,2005,9(6):499-500.
    [41]赵彤,刘淑芹.帕米磷酸二钠治疗恶性肿瘤转移性骨痛的近期疗效观察[J].吉林医学,2002,23(4):253.
    [42]王燕,苏卫.唑来磷酸治疗恶性肿瘤骨转移疼痛的临床疗效观察[J].中国实用医药,2011,6(7):138-139.
    [43]李宇清,何雁冰,杜志强.羟考酮控释片联合双膦酸盐治疗骨转移癌69例[J].中国组织工程研究与临床康复,2010,14(25):4673-4676.
    [44]李真真,来松涛.唑来磷酸治疗癌症患者骨转移性疼痛[J].中国癌症杂志,2008,18(6):479-480.
    [45]李永强,胡晓桦.唑来膦酸治疗癌性骨痛临床分析[J].广西医学,2005,27(9):1353-1355.
    [46]文西年,陈兵,阿不都外力·吾守尔.奥曲肽在胃肠道肿瘤所致恶性肠梗阻治疗中的应[J].中国微创外科杂志,2011,11(5):409-420.
    [47]章旭灿.奥曲肽治疗恶性肠梗阻29例临床分析[J].医学信息,2011,24(4):2043.
    [48]徐娟.奥曲肽治疗肠梗阻疗效观察[J].医学信息,2011,24(6):3765-3766.
    [49]Aaron A D. The management of cancer metastatic to bone[J] JAMA,1994.272:1206.
    [50]万恒,高启容,谢明瑛.放射治疗骨转移癌痛72例临床分析[J].西部医学.2005,17(5):459-461.
    [51]Palliative Radiotherapy For Bone Metastases:An ASTRO Evidence-Based Guideline 2011, Int. J. Radiation Oncology Biol. Phys., Vol.79, No.4, pp.965-976.
    [52]杨立,成志.放疗和帕米磷酸二钠治疗骨转移癌疼痛的疗效观察[J].肿瘤防治研究,2004,31(5):307-308.
    [53]汪志求.放疗联合帕米膦酸二钠治疗多发骨转移癌的疗效观察[J].河北医学,2011,17(7): 865-868.
    [54]宁忠华,裴红蕾,黄谨,等.放疗联合唑来磷酸治疗转移性骨痛的临床研究[J].现代肿瘤医学,2007,15(12):1843-1846.
    [55]王爱芬,王亚娟.帕米磷酸二钠联合局部放疗治疗多发性骨转移癌性疼痛的临床观察[J].浙江医学,2006,28(5):405-406.
    [56]杨艾,李小妹.89氯化锶临床治疗恶性肿瘤骨转移疼痛13例[J],中国医疗前沿,2009,4(16):37.
    [57]庞雁,何景华,朱殿清,等.放射性核素89Sr治疗前列腺癌骨转移[J].放射免疫学杂志,2011,24(1):8-10.
    [58]方毅,龙亚红,成为彬153Sm-EDTMP治疗多发骨转移癌骨痛的临床观察[J].中华临床医师杂志,2011,5(6):1811-1813.
    [59]赵志国,刘兴国,庄岚,等153Sm-EDTMP治疗多发性骨转移癌[J].临床军医杂志,2008,36(6):969.
    [60]路宇,杨志杰153Sm-EDTMP、89SrCl2治疗前列腺癌、乳腺癌骨转移瘤的对比研究.哈尔滨医科大学学报,2007,41:630-631.
    [61]Baczyk M,Czepczynski R,Milecki P,et al.89Sr versus 153Sm-EDTMP:comparison of treatment efficacy of painful bone metastases in prostate and breast carcinoma.Nucl Med Commun,2007,28:245-250.
    [62]Green CR,Hart-Johnson T.A longitudinal examination of cancer pain:severity,quality and impact on quality of life. Abstracts of the 12th World Congress on Pain,2008,286-287.
    [63]Ferreira KA,Kimura M,Nobrega JM,et al.Cancer pain and its correlation with interleukin-6,iI-8,iI-1 and tnf.Abstracts of the 12th World Congress on Pain,2008.69-70.
    [64]辛浩琳,郑宝森.癌性疼痛与多模式治疗[J].实用疼痛学杂志,2008,4(6):462-465.
    [65]Aouizerat BE,PauJ SM,Cooper B,et al.Pain and ethnicity predict the trajectories of sleep disturbance in patients undergoing radiation therapy(rt) for prostate cancer. Abstracts of the 12th World Congress on Pain,2008,76-77.
    [66]李喜庆PCIA治疗晚期癌性疼痛的临床观察[J].医学信息,2011,24(6):3867.
    [67]庞庆贵,刘辉,刘艳芳,等.芬太尼静脉自控镇痛用于顽固性癌痛[J].中国临床康复,2002,6(14):2113.
    [68]吴永伟,王建伟,屈瀚,等.静脉自控镇痛在晚期癌痛治疗中的应用[J].中国煤炭工业医学杂志,2004,7(7):682.
    [69]梅菊香,汪英,周泉华,等.晚期癌痛病人静脉自控镇痛PCIA疗效观察[J].右江医学,2009,37(4):427-428.
    [70]李宇虹.静脉自控镇痛用于晚期癌痛治疗[J].中国煤炭工业医学杂志,2002,5(5):483-484.
    [71]汪立,杨青川,陈迪,等.经皮椎体成形术对脊柱转移癌患者生活质量的影响[J].重庆医学,2011,40(24):2434-2435.
    [72]Bhatnagar S,Mishra S,Gupta D,et al.Bedside ultrasound-guided celiac plexus block can be an effective first line pain management technique in advanced upper abdominal cancer pain.Abstracts of the 12th World Congress on Pain,2008.57-58.
    [73]Nolte T.Prolonged-release oxycodone/naloxone is effective and safe in cancer pain.Abstracts of the 12th World Congress on Pain,2008.66-67.
    [74]李庆萍,马熙天,杨萌.对肿瘤疼痛患者进行心理干预的临床疗效分析[J].国际护理学杂志,2008,27(6):638-640.
    [75]杨宝林,石雪松,王爽,等.镇痛药物结合心理干预治疗癌性疼痛的临床分析[J].中国基层医药,2010,17(5):677-678.
    [76]韦燕,陈彦凡,赵善琳,等.疼痛知识教育对癌痛患者自身障碍因素的影响[J].西部医学,2011,23(6):1050-1052.
    [77]黄丽,姜乾鑫,任蔚红.应对方式、社会支持与癌症病人心身症状的相关性研究[J].中国心理卫生杂志,1996,10(4):160.
    [78]王艳玲,张霄峰.中药复方治疗癌性疼痛用药规律分析[J].辽宁中医杂志,2006,33(3):352-354.
    [79]程海波,吴勉华.癌性疼痛的中医理论探讨[J].中华中医药杂志,2008,23(1):50-52.
    [80]秦善文.中医药辨证治疗癌性疼痛的临床观察[J].光明中医,2008,23(9):1328-1329.
    [81]李景梅,王晓婷.癌痛散治疗癌性疼痛90例临床观察[J].中医药信息,2004,21(2):41-41.
    [82]刘明霞.芍药甘草汤加味治疗中晚期癌症疼痛42例[J].国医论坛,2005,20(5):5-6.
    [83]郑少翰,卓建腾.益气化瘀解毒方防治癌性疼痛32例[J].福建中医药,2005,36(6):10-11.
    [84]魏强,陈树泉,王兆香,等.酸味三君子方治疗癌性疼痛临床观察[J].河南中医,2005,25(12):34-34.
    [85]张红,丑天舒.身痛逐瘀汤加味联合氨酚羟考酮片治疗骨转移癌痛疗效分析[J].中国中医药信息杂志,2010,17(9):74-75.
    [86]徐曜灵.中西医结合治疗癌性疼痛40例临床观察[J].江苏中医药,2010,42(10):46-47.
    [87]赵景芳,尤建良,林苏,等.消癥止痛膏治疗癌痛临床研究[J].中医药研究.2000,13(2):18-191.
    [88]陈孟溪,黄立中.复方蟾酥散外敷治疗癌痛60例临床研究[J].湖南中医学院学报,2004,24(3):37-39.
    [89]郭军,时秀华,邱鹏,等.中药解痛酊治疗癌性疼痛的疗效研究[J].中国中医基础医学杂志,2005,11(11):870-871.
    [90]杨晨光.癌症止痛贴治疗癌性疼痛30例[J].陕西中医,2007,28(5):521-522.
    [91]万冬桂,李佩文.痛块消巴布剂治疗癌症疼痛的临床研究[J].中国中医药信息杂 志,2005,12(10):68-69.
    [92]陈仲杰,郭宇鹏,吴中朝.以痛为腧针刺治疗癌性疼痛疗效观察[J].中国针灸,2008,28(4):251-253.
    [93]杨莉,冀东英,王素枝,等.穴位药物注射治疗癌性疼痛72例疗效观察[J].山东医药,2005,29(1):69-70.
    [94]陈大燕.穴位注射小剂量氯胺酮治疗癌性疼痛[J].中国临床康复,2009,17(8):230-231.
    [95]万冬桂,李佩文,董秀荣,等.穴位离子导人治疗癌性疼痛18例[J].中国中西医结合杂志,1994,14(9):562-563.
    [1]NCCN Clinical Practice Guidelines in Oncology Adult Cancer Pain V.2.2011.
    [2]王艳玲,张霄峰.中药复方治疗癌性疼痛用药规律分析[J].辽宁中医杂志,2006,33(3):352-354.
    [3]高学敏主编.中药学[M].中国中医药出版社,2002,365-366.
    [4]高学敏主编.中药学[M].中国中医药出版社,2002,391-392.
    [5]张显彬,林洪生,花宝金,等.中医外治癌性疼痛的文献质量评价与证治方药规律研究[J].中国中医药信息杂志,2009,16(8):96-97.

© 2004-2018 中国地质图书馆版权所有 京ICP备05064691号 京公网安备11010802017129号

地址:北京市海淀区学院路29号 邮编:100083

电话:办公室:(+86 10)66554848;文献借阅、咨询服务、科技查新:66554700