【作者】 苏婷；

【导师】 叶小卫；

【作者基本信息】 广州中医药大学 ， 中西医结合临床， 2012， 硕士

【摘要】 目的通过加味双柏散(简称双柏散)局部外敷联合吗啡对肝癌中重度疼痛的临床疗效及生存质量的观察,为肝癌患者寻求一种有效、安全、经济、耐受性好的癌痛辅助治疗药物。方法通过随机、双盲、对照、多中心的临床研究,将34例原发性肝癌合并肝区中重度疼痛的患者作为研究对象,随机分为治疗组17例,对照组17例,分别予双柏散或安慰剂局部外敷疼痛处,连续治疗7天,并指导患者进行NRS评分及生存质量评分(《QLQ-C30生存质量》)。通过比较患者治疗前后NRS及生存质量评分,以观察双柏散联合吗啡治疗肝癌中重度疼痛的临床疗效及生存质量的影响。结果在NRS评分方面,经治疗后,治疗组NRS评分下降幅度较显著,与对照组相应时点的评分进行比较,差别具有统计学意义(P<0.05)。在开始敷药后3小时内疗效最佳,另随着治疗时间的推移,治疗组下降的趋势与对照组不一致。提示双柏散不仅有较好的止痛效果,同时有疗效维持的趋势,符合中药外敷疗效持久的特点。在止痛药使用方面,治疗组使用的美施康定人均用量低于对照组。在治疗过程中,在爆发性疼痛的次数方面,治疗组和对照组无明显差异,具有统计学意义(P<0.05)。提示双柏散外敷联合吗啡可以减少止痛药物的用量。在生存质量评分方面,经过治疗后,治疗组与对照组在恶心与呕吐、腹泻、便秘、食欲丧失、疲倦、疼痛等均有显著性差异(P<0.05),治疗组在评价生存质量的上述领域方面优于对照组,提示双柏散可减轻患者的消化道反应。在KPS评分方面,随着治疗时间的推移,两组间KPS变化趋势不一致,具有统计学意义(P<0.05)。提示经治疗,治疗组的KPS高于对照组。安全性方面,治疗后,两组患者在血分析、肝肾功能无统计学意义(P>0.05),提示双柏散外敷肝区痛处对造血系统及肝肾功能无不良作用。一般体检项目未见异常。部分患者在外敷药物时出现痉痒、水疱等不适,两组在不良反应方面无统计学差异(P>0.05),所有出现不适的患者症状均较轻,未见不良反应而退出实验者。结论双柏散局部外敷联合吗啡治疗肝癌中重度癌痛起到较好的止痛效果。通过降低止痛药的用量,在一定程度减少吗啡药物引起的恶心呕吐、纳差、便秘、疲倦等消化道症状,提高肝癌患者的生存质量,起到增效减毒的作用。其副作用小,简单易行。双柏散联合吗啡是治疗肝癌中重度癌痛一种有效、安全、经济的治疗手段。更多还原

【Abstract】 ObjectiveThe objective of this study was to observe the clinical therapeutic efficacy and the quality of Life using shuang Baisan on relieving Pain and improving the quality of life of the primary liver cancer patients with the moderate and severe pain. to observe an effective, safe, economical and assistant medication in treating the cancer Pain.Methods34eligible Patients, having the moderate and severe pain of liver or upper abdominal, were divided into the treatment group (17patients) and and control group(17patients) in a double-blind, randomized, controlled,multi-center study. All patients were received7days treatment of ShuangBaisan(in treatment group)or placebo (in control group) by external application. Guided the patients to fill the NRS score and 《quality of life instruments QLQ-C30V3.0》, made an analysis of the score changes of NRS and quality of life after the treatment, then evaluated the effect of Shuang Baisan on relieving pain and improving the quality of life of the patients with primary liver cancerResultsAfter therapy, The NRS scores in the treated had showed a significant decreasing trend compared with those in control group in the corresponding (P<0.05), prompting the clinical effect in the treatment group were superior to that in the control group, and the best effect was the three hours after the start of the treatmen.Over time both of the downward trend was inconsistent which suggested that Shuang Baisan had a persistent effect in relieving pain. During the course of therapy, research group using average morphine was well bejow the corntoJ. Break pain of the both group patients had no significant diiference (P>0.05),which suggested that Shuang Baisa combined with morphine can reduce the amount of morphine.After therapy, the result in the quality of life showed that Patients in the treatment group had a better living quality in nausea and vomiting, constipation, diarrhea, appetite loss, languor etc than in the control group (P＜0.05), which suggested that Shuang Baisa can alleviate digestive tract reaction.in terms of KPS, Over time t he KPS in the treated had showed a signi ficant upwards trend compared with those in control group. The difference we staiistically significant(P<0.05).At the safety aspect, from data analysis of change for complete blood count and hepatic/renal function, None of these had adverse reactionsConclusionShuang Baisan had better effeet. on relieving pain combined with morphine in the primary liver cancer patients with the moderate and severe pain.lt could alleviate digestive tract reaction.of nausea and vomiting, constipation, diarrhea, appetile loss, languor etc due to reduce the dosage of morphine, it could improve the quality of life of the Patients, possessed the effect of improving the efficiency and depressing the toxicity. It had less side effeet and simple.These suggested shuang Baisan had better effeet on relieving pain combined with morphine. It would be an effective, safe and economical assistant medication for liver cancer pain.更多还原