中药艾迪注射液足三里穴位注射防治含顺铂方案患者化疗相关恶心呕吐的临床效果
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中国中医科学院院级课题自由探索项目重点资助(ZZ0708089);望京医院院级课题(WJYY2014-YY-057);国自然青年基金项目(81603598)


Clinical Study on Aidi Injection in Zusanli (ST 36) in Treating Chemotherapy Induced Nausea and Vomiting Suffered from Chemotherapy with Cisplatin
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    摘要:

    目的:观察中药艾迪注射液穴位注射防治含顺铂化疗方案相关恶心呕吐的临床疗效和安全性。方法:采用前瞻性、多中心、随机、对照临床研究方法,选取90例患者,随机分为对照组,生理盐水组、中药艾迪注射液组,各30例;后2组分别给予生理盐水、中药艾迪注射液双侧足三里穴位注射治疗,于化疗后第1、2、3、7天观察消化道毒性反应、止呕药疗效、生命质量及安全性。结果:3组CINV缓解比较,自化疗第1天开始3组差异有统计学意义(P<005),由程度级别可知中药组化疗后消化道毒性反应最低,其次是生理盐水组,而对照组消化道毒性最重;3组止呕药疗效比较,自化疗第1天开始3组差异有统计学意义(P<005),由疗效级别可知中药组止呕药疗效最好,其次是生理盐水组,而对照组最差;3组患者KPS评分比较,中药组从化疗第3天开始、生理盐水组与对照组从第2天开始差异有统计学意义(P<005),基本呈下降趋势;3组患者KPS评分改善程度自化疗第7天差异有统计学意义(P<005)。结论:中药艾迪注射液双侧足三里穴位注射能够有效缓解含顺铂化疗方案患者化疗后相关恶心呕吐;能够改善含顺铂化疗方案患者KPS评分,改善患者生命质量,并具有良好的安全性。

    Abstract:

    To verify the efficacy and safety of the Aidi injection in Zusanli (ST 36) in the prevention and treatment in patients suffered from chemotherapy induced nausea and vomiting (chemotherapy induced nausea and vomiting, CINV) by the standardization of clinical research. Methods:A prospective, multicenter, randomized control clinical studies were carried out. A total of 90 patients were randomly divided into three groups of control group, normal saline group and Aidi injection group, with 30 cases in each group. The last two groups were given normal saline and Aidi injection in Zusanli (ST 36). The gastrointestinal toxicity reaction, anti-vomiting drug efficacy, life quality and safety were observed at day 1, 2, 3, 7 after chemotherapy. Results:The comparison of CINV among three groups from day 1 were statistically significant (P<005). From the degree level, it can be seen that Aidi injection group had lowest toxicity of digestive tract, followed by normal saline group. And the control group had the highest. The comparison of anti-vomiting drug efficacy among three groups from day 1 were statistically significant (P<005). According to the level of curative effect, the Aidi injection group had best curative effect, followed by normal saline group and control group. Compared with KPS score in the three groups, there was a statistically significant difference in Aidi injection group from day 3, and normal saline group and control group from day 2 (P<005), with a decreasing tendency. The improvement of KPS score in the three groups was statistically significant (P<005) from day 7 after chemotherapy. Conclusion:Aidi injection in Zusanli (ST 36) of both sides can effectively alleviate CINV, and can improve KPS scores, the quality of life of patients after chemotherapy, and with good safety.

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芦殿荣,柏大鹏,何生奇,王芳,高音,王宁军,江正龙,芦殿香.中药艾迪注射液足三里穴位注射防治含顺铂方案患者化疗相关恶心呕吐的临床效果[J].世界中医药,2018,(03).

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  • 收稿日期:2016-10-20
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  • 在线发布日期: 2018-04-04
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