论文部分内容阅读
目的观察中药艾迪注射液穴位注射对含顺铂化疗方案痰瘀互阻证型患者中医证候和血液系统安全性的影响。方法采用前瞻性、多中心、随机、对照临床研究方法,共纳入90例患者,随机分为对照组、生理盐水组、中药组各30例。对照组单纯给予西药盐酸格拉司琼,于顺铂化疗前后30 min常规静脉滴注。中药组和生理盐水组分别在对照组治疗基础上加用中药艾迪注射液和生理盐水组进行双侧足三里穴位注射治疗。于化疗第1、2、3、7天观察中医证候积分、卡诺夫斯基评分(KPS)及血液学安全性指标。结果 3组患者中医证候总积分与治疗前比较,自化疗第1天开始各组差异均有统计学意义(P<0.05),并且痰瘀互阻积分呈逐渐下降趋势;3组患者中医证候积分差值组间比较发现,化疗第7天中药组、生理盐水组、对照组比较,差异有统计学意义(P<0.01),而且中药组优于生理盐水组(P<0.01)。KPS积分改善程度比较发现,3组于化疗第7天比较有统计学意义(P<0.05),即化疗第7天时中药组可较其余两组更好的改善患者生活质量。血液学安全性分析发现3组治疗前后血红蛋白、白细胞组内前后比较,差异无统计学意义(P>0.05),而中药组血红蛋白具有升高的趋势(P<0.05)。结论中药艾迪注射液双侧足三里穴位注射能够缓解含顺铂化疗患者中医证候积分、改善患者KPS评分,具有良好的血液学、肝肾功能安全性,并且中药艾迪穴位注射具有升高血红蛋白的趋势,值得临床推广。
Objective To observe the effects of traditional Chinese medicine Aidi injection on TCM syndromes and blood system safety in patients with phlegm and blood stasis syndrome containing cisplatin chemotherapy. Methods A prospective, multicenter, randomized, controlled clinical study was conducted. A total of 90 patients were included and randomly divided into control group, saline group and TCM group. The control group was given granisetron hydrochloride alone and was given routine intravenous infusion 30 minutes before and after cisplatin chemotherapy. The traditional Chinese medicine group and the saline group were treated with Aizhi injection and saline group on the basis of the control group, respectively. On the 1st, 2nd, 3rd and seventh days of chemotherapy, TCM syndrome score, Karnofsky score (KPS) and hematological safety indexes were observed. Results The total score of TCM syndromes in the three groups was statistically significant (P <0.05), and the scores of phlegm and blood stasis resistance decreased gradually from the first day after chemotherapy. The TCM syndromes of the three groups The differences between the two groups were statistically significant (P <0.01), and the Chinese medicine group was superior to the saline group (P <0.01). The improvement of KPS score showed that the three groups were statistically significant on the 7th day after chemotherapy (P <0.05), that is, on the 7th day of chemotherapy, the Chinese medicine group better than the other two groups to improve the quality of life. Hematology safety analysis found that before and after treatment, hemoglobin, leukocyte group before and after comparison, the difference was not statistically significant (P> 0.05), while the traditional Chinese medicine group hemoglobin increased (P <0.05). Conclusion Injection of Aizi injection on both sides of Zusanli can relieve the TCM syndrome score, improve KPS score of patients with cisplatin chemotherapy, and have good hematological, liver and renal functional safety. Hemoglobin trend, it is worth clinical promotion.