痛块消乳膏外治癌性躯体痛的临床研究

【作者】 范青；

【导师】 贾立群；

【作者基本信息】 北京中医药大学 ， 中西医结合临床， 2012， 硕士

【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。更多还原

【Abstract】 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.更多还原