健脾益气摄血方治疗脾气虚型免疫性血小板减少症的临床研究
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摘要
目的：通过规范化临床试验,验证以不同干预方法(健脾益气摄血、健脾益气摄血联合强的松、强的松)改善脾气虚型免疫性血小板减少症患者临床症状(证候)与止血疗效,观察临床应用的安全性,探索从脾论治免疫性血小板减少症的疗效机制,比较从脾论治的疗效优势与特色,为临床推广应用提供支撑。
方法：采用中央随机对照、多中心临床试验的方法。各临床试验单位的研究者将符合入选病例标准的ITP患者,通过中央随机方法分组,分别给予健脾益气摄血配方颗粒、健脾益气摄血配方颗粒联合强的松、强的松治疗。健脾益气摄血配方颗粒(组成：黄芪、党参、茯苓、白术、阿胶、茜草、炙甘草),每次1袋,每日2次；强的松首次剂量按1-1.5mg／(kg·d),早8点顿服,治疗期间有效减量；健脾益气摄血联合强的松组用法用量同前。各组疗程均为21天。治疗开始后每周对受试者进行访视,采集可供有效性、安全性评估以及机制探讨的各种试验数据,包括：临床症状(证候)、出血症状、外周血象、5-羟色胺、13-内啡肽、血管活性肠肽、外周血T细胞及其亚群及安全性监测指标,并记录在CRF表上。
结果：主要观察指标：①中医证候疗效,三组中医证候疗效比较有显著性差异,三组不全相同,P<0.05。其中强的松组与联合组,组间有显著性差异,P=-0.017；健脾益气摄血组与强的松组、联合组比较均无显著性差异,P>0.05。②各时间点三组中医证候总积分与治疗前行配对t检验,结果1周时健脾益气摄血组、联合组与疗前比有显著性差异,P<0.05,强的松组与疗前比无显著性差异,P>0.05。2、3周时三组与疗前比均有显著性差异,P<0.05。③单项症状疗效比较,体倦乏力、神疲懒言、食欲不振、食后腹胀各组均有效。其中对体倦乏力的疗效三组间比较有显著性差异,P<0.05；三组间两两进行秩和检验,取a=0.025,其中强的松组与联合组、健脾益气摄血组与强的松组组间有显著性差异,P<0.025,健脾益气摄血组与联合组无显著性差异,P>0.025。而对神疲懒言、食欲不振、食后腹胀,三组均有效,但疗效无显著性差异,P>0.05。④三组在止血方面,均有疗效。三组止血疗效比较有显著性差异,P<0.05；三组间两两进行秩和检验,取α=0.025,结果强的松组、联合组与健脾益气摄血组比较,组间均有显著性差异,P<0.025,强的松组与联合组无显著性差异,P>0.025。⑤三组在提升血小板方面,均有疗效。三组间血小板疗效比较无显著性差异,P>0.05。⑥各时间点三组血小板与疗前变化行配对t检验,结果显示：强的松组各时点与疗前比有显著性差异,P<0.05,健脾益气摄血组与联合组各时点与疗前比无显著性差异,P>0.05。
次要观察指标：三组外周血白细胞、红细胞、血红蛋白治疗前后比较,经配对t检验,联合组血红蛋白疗后与疗前比有显著性差异,P<0.05,健脾益气摄血组、强的松组与疗前比无显著性差异,P>0.05,三组白细胞、红细胞在治疗前后比较无显著性差异,P>0.05。
探索性指标：①三组T细胞亚群各指标,疗前与疗后比较均无显著性差异,P>0.05。②三组5-羟色胺、β-内啡肽疗前疗后比较无显著性差异,P>0.05。③健脾益气摄血组与联合组血管活性肠肽疗前疗后比较有显著性差异,P<0.05。
结论：根据目前临床研究的结果,可得到以下结论：①健脾益气摄血方,能够有效改善患者临床症状,改善出血情况；②健脾益气摄血方对脾气虚型ITP患者的治疗机制,可能与其改善患者免疫功能状态、升高肽类神经递质——血管活性肠肽有关。
Objective:Through standardized clinical trials to test different interventions(the methods of JianpiYiqi,JianpiYiqi combined with prednisone,prednisone) in improving clinical symptoms(syndromes) and hemostatic efficacy in patients with immune thrombocytopenia of spleen qi deficiency,observe the security in clinical application,explore immune thrombocytopenia's efficacy mechanism of treatment from the spleen, compare the efficacy advantages and characteristics in order to provide support for the clinical application.
Methods:Apply the method of center randomized controlled, multi-center clinical trials.By using central randomization,investigators of each clinical trial unit selected ITP patients who met the case criteria, then respectively assigned them to the group of JianpiYiqi Granules,JianpiYiqi Granules combined with prednisolone or prednisolone only therapy.JianpiYiqi Granules (Components:Astragalus,Codonopsis,Poria,Atractylodes,gelatin,madder,licorice),one bag each time, two times a day;The initial dose of prednisone is1-1.5mg/(kg-d),as early as8:00Dayton clothing;dosage reduced if effect shows during the treatment;the group of JianpiYiqi combined with prednisone use the same amount.The treatment lasted21days in each group.The investigators visit patients weekly after the start of the treatment.They collected various test data available for the efficacy, safety assessment and mechanism, including:clinical symptoms(syndromes),bleeding symptoms,peripheral blood,5-hydroxytryptamine,P-endorphin,vasoactive intestinal peptide.peripheral blood T cells and their subsets and safety monitoring indicators, and record them on the CRF.
Results:Main outcome measures:①Efficacy of TCM syndromes:There are significant differences among the three groups; three groups are not completely same,P<0.05. There are significant differences between the prednisone group and the combination group,P=0.017;There are no significant differences when the JianpiYiqi group is compared with the prednisone group and the combination group,P>0.05.②The three groups are tested by using the TCM syndromes total score and comparing with the data before each time point by paired t test.The results show that at first week,the JianpiYiqi group and the combination group have significant differences compared with before treatment,P<0.05;the prednisone group has no significant differences compared with before treatment, P>0.05.In the second and third week,three groups have significant differences compared with before treatment, P<0.05.③The comparison of the individual symptoms efficacy,including body tired and fatigue,tired of shen and words,loss of appetite, abdominal distention after eating,the three group are all valid.There are significant differences in efficacy of body tired and fatigue among the three groups, P<0.05; using rank test to test the two of the three groups, taking a=0.025,there are significant differences between the prednisone group and the combination group, and between the JianpiYiqi group and the prednisone group,P<0.025.There are no significant differences between the JianpiYiqi group and the combination group, P>0.025.The three groups are all effective about tired of shen and words,loss of appetite, abdominal distention after eating,but there are no significant differences in efficacy, P>0.05.④At hemostasis aspect,three groups are all effective,and there are significant differences among the three groups in hemostatic efficacy,P<0.05,using rank test to test the two of the three groups, takeing a=0.025,there are significant differences between the the prednisone group and JianpiYiqi group, and between the combination group and JianpiYiqi group,P<0.025;There are no significant differences between the prednisone group and the combination group,P>0.025.⑤In terms of enhancing platelets,the three groups are all effective.There are no significant differences in platelet effect among the three groups, P>0.05.⑥The three group are tested for the platelet count by comparing with before treatment at each time point using paired t test.The results show that the prednisone group has significant differences compared with before treatment at each time point,P<0.05; the JianpiYiqi group and the combination group have no significant differences compared with before treatment at each time point,P>0.05.
Secondary outcomes:After the treatment,the three groups are tested for peripheral blood leukocytes, erythrocytes, hemoglobin compared with before treatment using paired t test. The results show that the combination group has significant differences in hemoglobin,P<0.05,but the JianpiYiqi group and the prednisone group show no significant differences,P>0.05;the three groups have no significant differences in leukocytes,erythrocytes,.P>0.05.
Exploratory indicators:①Before treatment and after treatment,each index of T cell subsets shows no significant differences in the three groups,P>0.05.②Before treatment and after treatment,5-HT and (3-endorphin show no significant differences in the three groups,P>0.05.③Before treatment and after treatment,the JianpiYiqi group and the combination group have significant differences in vasoactive intestinal peptide,P<0.05.
Conclusion:According to the results of the current clinical study, we can get the following conclusions:①JianpiYiqi can effectively improve the clinical symptoms and relieve bleeding;②The efficacy mechanism of JianpiYiqi treatment for the ITP patients with type of spleen deficiency may be related to the improvement of immune function and elevation of peptide neurotransmitters——vasoactive intestinal peptide.
方法：采用中央随机对照、多中心临床试验的方法。各临床试验单位的研究者将符合入选病例标准的ITP患者,通过中央随机方法分组,分别给予健脾益气摄血配方颗粒、健脾益气摄血配方颗粒联合强的松、强的松治疗。健脾益气摄血配方颗粒(组成：黄芪、党参、茯苓、白术、阿胶、茜草、炙甘草),每次1袋,每日2次；强的松首次剂量按1-1.5mg／(kg·d),早8点顿服,治疗期间有效减量；健脾益气摄血联合强的松组用法用量同前。各组疗程均为21天。治疗开始后每周对受试者进行访视,采集可供有效性、安全性评估以及机制探讨的各种试验数据,包括：临床症状(证候)、出血症状、外周血象、5-羟色胺、13-内啡肽、血管活性肠肽、外周血T细胞及其亚群及安全性监测指标,并记录在CRF表上。
结果：主要观察指标：①中医证候疗效,三组中医证候疗效比较有显著性差异,三组不全相同,P<0.05。其中强的松组与联合组,组间有显著性差异,P=-0.017；健脾益气摄血组与强的松组、联合组比较均无显著性差异,P>0.05。②各时间点三组中医证候总积分与治疗前行配对t检验,结果1周时健脾益气摄血组、联合组与疗前比有显著性差异,P<0.05,强的松组与疗前比无显著性差异,P>0.05。2、3周时三组与疗前比均有显著性差异,P<0.05。③单项症状疗效比较,体倦乏力、神疲懒言、食欲不振、食后腹胀各组均有效。其中对体倦乏力的疗效三组间比较有显著性差异,P<0.05；三组间两两进行秩和检验,取a=0.025,其中强的松组与联合组、健脾益气摄血组与强的松组组间有显著性差异,P<0.025,健脾益气摄血组与联合组无显著性差异,P>0.025。而对神疲懒言、食欲不振、食后腹胀,三组均有效,但疗效无显著性差异,P>0.05。④三组在止血方面,均有疗效。三组止血疗效比较有显著性差异,P<0.05；三组间两两进行秩和检验,取α=0.025,结果强的松组、联合组与健脾益气摄血组比较,组间均有显著性差异,P<0.025,强的松组与联合组无显著性差异,P>0.025。⑤三组在提升血小板方面,均有疗效。三组间血小板疗效比较无显著性差异,P>0.05。⑥各时间点三组血小板与疗前变化行配对t检验,结果显示：强的松组各时点与疗前比有显著性差异,P<0.05,健脾益气摄血组与联合组各时点与疗前比无显著性差异,P>0.05。
次要观察指标：三组外周血白细胞、红细胞、血红蛋白治疗前后比较,经配对t检验,联合组血红蛋白疗后与疗前比有显著性差异,P<0.05,健脾益气摄血组、强的松组与疗前比无显著性差异,P>0.05,三组白细胞、红细胞在治疗前后比较无显著性差异,P>0.05。
探索性指标：①三组T细胞亚群各指标,疗前与疗后比较均无显著性差异,P>0.05。②三组5-羟色胺、β-内啡肽疗前疗后比较无显著性差异,P>0.05。③健脾益气摄血组与联合组血管活性肠肽疗前疗后比较有显著性差异,P<0.05。
结论：根据目前临床研究的结果,可得到以下结论：①健脾益气摄血方,能够有效改善患者临床症状,改善出血情况；②健脾益气摄血方对脾气虚型ITP患者的治疗机制,可能与其改善患者免疫功能状态、升高肽类神经递质——血管活性肠肽有关。
Objective:Through standardized clinical trials to test different interventions(the methods of JianpiYiqi,JianpiYiqi combined with prednisone,prednisone) in improving clinical symptoms(syndromes) and hemostatic efficacy in patients with immune thrombocytopenia of spleen qi deficiency,observe the security in clinical application,explore immune thrombocytopenia's efficacy mechanism of treatment from the spleen, compare the efficacy advantages and characteristics in order to provide support for the clinical application.
Methods:Apply the method of center randomized controlled, multi-center clinical trials.By using central randomization,investigators of each clinical trial unit selected ITP patients who met the case criteria, then respectively assigned them to the group of JianpiYiqi Granules,JianpiYiqi Granules combined with prednisolone or prednisolone only therapy.JianpiYiqi Granules (Components:Astragalus,Codonopsis,Poria,Atractylodes,gelatin,madder,licorice),one bag each time, two times a day;The initial dose of prednisone is1-1.5mg/(kg-d),as early as8:00Dayton clothing;dosage reduced if effect shows during the treatment;the group of JianpiYiqi combined with prednisone use the same amount.The treatment lasted21days in each group.The investigators visit patients weekly after the start of the treatment.They collected various test data available for the efficacy, safety assessment and mechanism, including:clinical symptoms(syndromes),bleeding symptoms,peripheral blood,5-hydroxytryptamine,P-endorphin,vasoactive intestinal peptide.peripheral blood T cells and their subsets and safety monitoring indicators, and record them on the CRF.
Results:Main outcome measures:①Efficacy of TCM syndromes:There are significant differences among the three groups; three groups are not completely same,P<0.05. There are significant differences between the prednisone group and the combination group,P=0.017;There are no significant differences when the JianpiYiqi group is compared with the prednisone group and the combination group,P>0.05.②The three groups are tested by using the TCM syndromes total score and comparing with the data before each time point by paired t test.The results show that at first week,the JianpiYiqi group and the combination group have significant differences compared with before treatment,P<0.05;the prednisone group has no significant differences compared with before treatment, P>0.05.In the second and third week,three groups have significant differences compared with before treatment, P<0.05.③The comparison of the individual symptoms efficacy,including body tired and fatigue,tired of shen and words,loss of appetite, abdominal distention after eating,the three group are all valid.There are significant differences in efficacy of body tired and fatigue among the three groups, P<0.05; using rank test to test the two of the three groups, taking a=0.025,there are significant differences between the prednisone group and the combination group, and between the JianpiYiqi group and the prednisone group,P<0.025.There are no significant differences between the JianpiYiqi group and the combination group, P>0.025.The three groups are all effective about tired of shen and words,loss of appetite, abdominal distention after eating,but there are no significant differences in efficacy, P>0.05.④At hemostasis aspect,three groups are all effective,and there are significant differences among the three groups in hemostatic efficacy,P<0.05,using rank test to test the two of the three groups, takeing a=0.025,there are significant differences between the the prednisone group and JianpiYiqi group, and between the combination group and JianpiYiqi group,P<0.025;There are no significant differences between the prednisone group and the combination group,P>0.025.⑤In terms of enhancing platelets,the three groups are all effective.There are no significant differences in platelet effect among the three groups, P>0.05.⑥The three group are tested for the platelet count by comparing with before treatment at each time point using paired t test.The results show that the prednisone group has significant differences compared with before treatment at each time point,P<0.05; the JianpiYiqi group and the combination group have no significant differences compared with before treatment at each time point,P>0.05.
Secondary outcomes:After the treatment,the three groups are tested for peripheral blood leukocytes, erythrocytes, hemoglobin compared with before treatment using paired t test. The results show that the combination group has significant differences in hemoglobin,P<0.05,but the JianpiYiqi group and the prednisone group show no significant differences,P>0.05;the three groups have no significant differences in leukocytes,erythrocytes,.P>0.05.
Exploratory indicators:①Before treatment and after treatment,each index of T cell subsets shows no significant differences in the three groups,P>0.05.②Before treatment and after treatment,5-HT and (3-endorphin show no significant differences in the three groups,P>0.05.③Before treatment and after treatment,the JianpiYiqi group and the combination group have significant differences in vasoactive intestinal peptide,P<0.05.
Conclusion:According to the results of the current clinical study, we can get the following conclusions:①JianpiYiqi can effectively improve the clinical symptoms and relieve bleeding;②The efficacy mechanism of JianpiYiqi treatment for the ITP patients with type of spleen deficiency may be related to the improvement of immune function and elevation of peptide neurotransmitters——vasoactive intestinal peptide.
引文
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