消癌平注射液对恶性肿瘤化疗患者外周血象影响的回顾性临床研究

【作者】 雷勇；

【导师】 孙霈；

【作者基本信息】 北京中医药大学 ， 中西医结合临床， 2014， 博士

【摘要】 恶性肿瘤已成为世界上对人类健康与生命危害最大的疾病,世界癌症发病率以年均3-5%的速度递增,其发病率和死亡率在许多国家急剧增长。化疗是恶性肿瘤常用的治疗方法之一,不论是对于恶性肿瘤手术和非手术患者。临床实践证明：化疗在消除肿瘤术后残留、减轻肿瘤负荷、缓解病情、控制肿瘤并发症、提高生活质量等方面确能给患者带来临床受益。但化疗可引起骨髓抑制、肝肾功能损害、胃肠道不良反应、周围神经病变等毒副反应。其中,化疗引起的外周血象下降(骨髓抑制)是临床最常见,也是影响化疗能否顺利进行的最常见的并发症。从临床角度分析,几乎所有的化疗药物都会有很强的血液学毒性。因不同的化疗药物对外周血象产生的影响不同,且无法准确预测骨髓抑制的发生时间,故临床治疗中不能针对化疗相关性的骨髓抑制预防性用药,需待到骨髓抑制出现后才能采取相应治疗。西医针对骨髓抑制的治疗,一方面会增加患者医疗负担和身体负担,而且这些治疗措施有其相应的缺点,另一方面会影响化疗药物剂量和推迟化疗时间而影响肿瘤治疗效果。抗肿瘤中药注射剂联合化疗是目前中国治疗恶性肿瘤的常用治疗方法。在临床实践中,我们发现消癌平注射液可以减轻化疗引起的血小板下降。目的第一部分：通过回顾性临床研究,观察消癌平注射液对恶性肿瘤化疗患者外周血象的影响,评价消癌平注射液对恶性肿瘤化疗患者外周血象的保护作用。第二部分：通过回顾性临床研究,观察消癌平注射液对非小细胞肺癌化疗患者外周血象、气血两亏证及生活质量的影响,评价消癌平注射液对非小细胞肺癌化疗患者外周血象的保护作用、气虚两亏证的疗效、生活质量的改善情况。方法第一部分：以东直门医院肿瘤血液科恶性肿瘤化疗的住院患者为研究对象,按照患者临床实际治疗情况,分为治疗组(消癌平注射液+化疗组)和对照组(单纯化疗组),以外周血象为观察指标,观察消癌平注射液对化疗患者外周血象的影响。第二部分：以东直门医院肿瘤血液科非小细胞肺癌化疗的住院患者为研究对象,按照患者临床实际治疗情况,分为治疗组(消癌平注射液+化疗组)和对照组(单纯化疗组),以外周血象、中医气血两亏证证候积分及生活质量等为观察指标,评价消癌平注射液对NSCLC化疗患者外周血象的影响、气血两亏证的疗效、生活质量改善的情况。结果第一部分：纳入统计分析的病例共88例次,治疗组与对照组各为44例次。化疗周期第8天,治疗组的血小板为(175.52±61.12)×109/L,对照组为(167.15±42.83)×109/L,两组比较具有统计学差异(p<0.05)；治疗组血小板平均体积(8.30±1.46)f1,对照组为(10.18±1.46)f1,两组比较具有统计学差异(p<0.05)。治疗组与对照组患者的白细胞、中性粒细胞、血红蛋白在两组间的比较中经统计学分析均无显著差异(P>0.05)。第二部分：纳入统计分析的病例共64例次,其中治疗组31例次,对照组33例次。化疗周期第8天,治疗组与对照组血小板分别为：(223.71±95.31)x109/L、(173.48±52.51)×109/L,平均血小板体积分别为(8.22±1.18)f1、(10.45±1.55)f1,经统计学分析,PLT、MPV在两组间比较均有统计学差异(p<0.05)；治疗组与对照组患者的白细胞、中性粒细胞、血红蛋白在两组间的比较中经统计学分析均无显著差异(P>0.05)。化疗周期第8天治疗组气血两亏证疗效判定：显效0例次、有效0例次、进步11例次、无效20例次,对照组为：显效0例次、有效0例次、进步6例次、无效27例次,两组比较经统计学分析无显著差异(P>0.05)。化疗周期第8天治疗组KPS评分疗效判定：改善3例次、稳定12例次、下降16例次,对照组为：改善4例次、稳定6例次、下降23例次,两组比较差异有统计学意义(P<0.05)。结论①消癌平注射液可以减轻恶性肿瘤化疗患者的血小板下降。②消癌平注射液可以减轻NSCLC化疗患者的血小板下降。③消癌平注射液可以改善NSCLC化疗患者的生活质量。更多还原

【Abstract】 Malignant cancer has become the disease that threatens the human health and life the most in the world. And its morbidity has been increased by3to5percent throughout the world with a sharp raise of morbidity and mortality in many countries. For curing it, chemotherapy is one of the most common methods for both patients whose tumors have or have not been surgically removed. Clinical practice has proven that chemotherapy contributes a lot in removing tumors left after operations, lightening tumor load, alleviating the problem, preventing complications and improving patient’s quality of life. However, it can lead to numerous toxic and side effects, such asmyelosuppression, hepatorenal function damage, adverse reactions of gastrointestinal tract, and peripheral neuropathy. Among these side effects, myelosuppression, characterized by peripheral hemogram decrease, is the most common complication that greatly affects the completion of chemotherapy in clinical practice in that almost all chemotherapy drugs have strong clinical hematologic toxicity. Even seriously, this complication cannot be prevented with certain medication until it occurs. It is because that the effects of different chemotherapy drugs on peripheral hemogram vary greatly and that their occurrence time cannot be accurately predicted. What is more, western medicine treatment of myelosuppression has shown many disadvantages. For one thing, it adds burdens upon both medical expenses and patients’ bodies. For another, it influences the therapeutic effects of chemotherapy drugs through limiting drugs to lower dose and proponing chemotherapy. Alternatively, chemotherapy combined with Traditional Chinese medicine injection is currently the most common therapy for treating malignant cancer in China. And in clinical practice, we found that Xiaoaiping Injection alleviated chemotherapy-induced blood platelet decrease.Objectives:Part I:The aim of this study is to observe and evaluate the protective effect of Xiaoaiping Injection on peripheral hemogram of patients who received chemotherapy for malignant cancer through a retrospective clinical study.Part Ⅱ:The aim of this part is to observe and assess the effect of Xiaoaiping Injection on protecting peripheral hemogram, treating qi and blood deficiency pattern and improving quality of life of patients who underwent chemotherapy for non-small cell lung cancer (NSCLC) through retrospective clinical study.Methods:Part I:Subjects were included from malignant cancer in-patients who were treated with chemotherapy in Department of Oncology and Hematology, Dongzhimen Hospital. According to the therapy they received,these patients were divided into two groups:treatment group (chemotherapy combined with Xiaoaiping Injection) and control group (chemotherapy only). Then, peripheral hemogram was detected and the effect of Xiaoaiping Injection on peripheral hemogram of patients who underwent chemotherapy was observed. Part Ⅱ:Subjects were included from NSCLC in-patients who underwent chemotherapy in Department of Oncology and Hematology, Dongzhimen Hospital. These patients were divided into two groups according to the therapy they received:treatment group (chemotherapy combined with Xiaoaiping Injection) and control group (chemotherapy only). Then, their peripheral hemogram, score of qi and blood deficiency pattern and quality of life were detected. The effects of Xiaoaiping Injection on protecting peripheral hemogram, treating qi and blood deficiency pattern and improving quality of life of patients who received chemotherapy treatment for NSCLC were also assessed.Resualts:Part Ⅰ:Eighty-eight patients were included in this study with44patients in each group. On Day8of chemotherapy, average blood platelet (PLT) in treatment group was (175.52±61.12)×109/L while that in control group was (167.15±42.83)×109/L, which showed a statically significant difference (p<0.05) between this two groups. The difference in mean platelet volume (MPV)of this two groups was also statically significant (p<0.05) with (8.30±1.46)fl and (10.18±1.46)fl in treatment group and control group respectively. However, there is no significant difference (P>0.05)between the two groups on regards of white blood cell, neutrophile granulocyte or hemoglobin.Part Ⅱ:Sixty-four patients were included in this study with31in treatment group and33in control group. On Day8of chemotherapy, average PLT in treatment group and control group were (223.71±95.31)×109/L and (173.48±52.51)×109/L respectively. And the MPV in treatment group and control group were (8.22±1.18) fl and (10.45±.55) fl respectively. Both PLT and MPV of this two groups were statistically significantly different (p<0.05). On the contrary, there is no significant difference between the two groups in white blood cell, neutrophile granulocyte or hemoglobin (P>0.05).The therapeutic effects for treating qi and blood deficiency pattern on Day8of chemotherapy:in treatment group,0case was markedly effective,0case was effective,11cases were slightly effective and20patients were ineffective; and in control group,0case was markedly effective,0case was effective,6cases were slightly effective and27patients were ineffective. By comparison,there was no significant difference(P>0.05) in the two groups on treating qi and blood deficiency pattern.The curative effects of two groups on KPS on Day8of chemotherapy showed a significant difference(P<0.05) with3cases improved,12cases stabilized and16cases declined in treatment group and4cases improved,6cases stabilized and23cases declined in control group.Conclusion:1. Xiaoaiping Injection can alleviate the chemotherapy-induced blood platelet decrease in malignant cancer patients.2. Xiaoaiping Injection can alleviate the chemotherapy-induced blood platelet decrease in NSCLC patients.3. Xiaoaiping Injection can improve the quality of life of NSCLC patients during and after chemotherapy.更多还原