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复方苦参注射液治疗轻中度癌性疼痛的临床研究
Effect of Compound Sophora Injection(CSI) in treatment of mild or moderate cancer pain
【Author】 Chen Yan-zhi, Li Yuan-qing, Wang Wei, Zhang Yan, Li Ping-ping﹟ Key laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Integration of Traditional Chinese and Western Medicine, Peking University School of Oncology, Beijing Cancer Hospital & Institute, Beijing (100142), China
【机构】 北京大学临床肿瘤学院; 北京肿瘤医院; 北京市肿瘤防治研究所中西医结合科,恶性肿瘤发病机制及转化研究教育部重点实验室;
【摘要】 目的探讨复方苦参注射液对于轻中度癌性疼痛的疗效和不良反应。方法采用随机对照的研究方法,将50例轻度的癌痛患者分为两组,即治疗组(复方苦参组)和对照组(意施丁组);将54例中度的癌痛患者分为两组,即治疗组(复方苦参组)和对照组(奇曼丁组)。给药方法为:复方苦参注射液12-15mL加入250mL生理盐水静脉滴注,每日1次,连用10天。意施丁每次25mg,一日两次,进食后整片吞服,连用10天。奇曼丁每次100mg,一日2次,连用10天。观察两组的镇痛效果,药物的起效时间、最佳缓解时间和持续时间,以及不良反应。结果复方苦参注射液对于轻度癌性疼痛的总有效率为84.6%,与对照组(意施丁组)比较,无统计学差异(P>0.05)。但是在疼痛缓解率方面,复方苦参注射液逊于意施丁;而在微效率方面,复方苦参注射液则优于意施丁,且具有统计学意义(P﹤0.05)。复方苦参注射液对于中度癌性疼痛的总有效率为75.0%,与对照组(奇曼丁组)比较,无统计学差异(P>0.05)。但是在疼痛缓解率方面,复方苦参注射液逊于奇曼丁;而在微效率方面,复方苦参注射液则优于奇曼丁,且具有统计学意义(P﹤0.05)。复方苦参注射液的中位起效时间、最佳缓解时间以及持续时间分别为3、3和4天,而相应的西药中位作用时间则分别为1、2、6小时。复方苦参注射液的不良反应轻微。结论复方苦参注射液对于轻度和中度的癌性疼痛具有较好的疗效,虽然在疼痛缓解率方面,复方苦参注射液不及对应的西药,但是在微效率方面,则优于对应的西药。复方苦参注射液的止痛起效时间缓慢,但是,止痛的缓解时间长,并且不良反应轻微。
【Abstract】 Objective To evaluate the effects and side-effects of Compound Sophora Injection(CSI) in treatment of mild or moderate cancer pain.Methods 50 patients with mild cancer pain were randomly divided into 2 groups,the treatment group(CSI) and the control group(Indometacin Sustained-release Tablets).54 patients with moderate cancer pain were randomly divided into 2 groups,the treatment group(CSI) and the control group(Tramadol Hydrochloride).CSI added into 250ml normal saline for continuous intravenous dripping,one time per day for 10 days.Indometacin Sustained-release Tablets were given 25mg every time,twice per day for 10 days.Tramadol Hydrochloride were given 100mg every time,twice per day for 10 days.The changes of the analgesia effect,the initial median time of relieve pain,median remission duration,relieving pain duration and the side effects of 2 groups were observed.Results The tota1 remission rate of CSI in treating mild cancer pain were 84.6%.there is no significant difference(P>0.05),compared with the control group.However,CSI was inferior to the control group in pain relief rate(RR),was superior to the control group in minor remission rate(P﹤0.05).The tota1 remission rate of CSI in treating moderate cancer pain were 75.0%,there is no significant difference(P>0.05),compared with the control group.But,CSI was inferior to the control group in RR,was superior to the control group in minor remission rate(P﹤0.05).The initial median time of relieve pain,median remission duration and relieving pain duration of CSI were the third day,3,4 days respectively,however,the control group of the western medicine were the first hour,2,6 hours respectively.The side-effects of CSI were slight.Conclusion CSI had a better therapeutic effect in treatment of mild or moderate cancer pain.Although CSI was inferior to the control group in RR,was superior to the control group in minor remission rate(P﹤0.05).The initial median time of relieve pain of CSI was slowly,but,the median remission duration and relieving pain duration of CSI were longer than the control group.The side-effects of CSI were slight.
【Key words】 Compound Sophora Injection(CSI); mild cancer pain; moderate cancer pain; The tota1 remission rate; pain relief rate(RR); minor remission rate; side-effects;
- 【会议录名称】 第七届全国癌症康复与姑息医学大会大会论文集和专题讲座
- 【会议名称】第七届全国癌症康复与姑息医学大会
- 【会议时间】2011-11-01
- 【会议地点】中国福建福州
- 【分类号】R730.5
- 【主办单位】中国抗癌协会癌症康复与姑息治疗专业委员会