加味八珍汤联合小剂量醋酸泼尼松片治疗特发性血小板减少性紫癜临床研究
|
摘要
目的:观察加味八珍汤联合小剂量醋酸泼尼松片治疗特发性血小板减少性紫癜(ITP)的临床疗效。方法:60例符合诊断标准与纳入标准的ITP患者采用区组随机化方法随机分为治疗组(G1)与对照组(G2)。G1组口服中药加味八珍汤与小剂量醋酸泼尼松片;对照组(G2)单纯口服常规剂量醋酸泼尼松片。两组均以6周为1个疗程。连续用药3个疗程后,对比两组间的临床总有效率、血小板计数与中医症状积分的变化情况,并记录G1与G2组不良反应事件的发生状况。结果:1)治疗组的临床总有效率为89.99%,对照组为76.66%,G1、G2组的临床总有效率经组间比较,差异有统计学意义(P<0.05)。2)治疗后,G1组中血小板计数由(39.26±7.32)上升至(112.32±9.28),G2组中血小板计数亦由(40.18±5.36)增加为(95.27±7.45);G1、G2组患者血小板计数经组内、组间比较,差异均具有统计学意义(P<0.05)。3)治疗后,G1组患者的中医症状积分由(34.23±4.52)降至(11.26±2.34),而G2组患者中医症状积分前后变化不明显。G1组患者中医症状积分经组内比较,差异有统计学意义(P<0.05);G2组患者中医症状积分经组内比较,差异无统计学意义(P>0.05)。治疗后,G1与G2组患者中医症状积分经组间比较,差异有统计学意义(P<0.05)。4)G1组中患者出现腹胀2例,不良事件发生率为6.66%;G2组中患者出现肺部感染1例,恶心2例,皮肤瘙痒1例,不良事件发生率为13.33%;两组经组间比较,差异有统计学意义(P<0.05)。结论:加味八珍汤联合小剂量醋酸泼尼松片用于治疗ITP可明显提高患者血小板计数,降低中医症状积分,减少不良反应事件的发生几率,显著提高临床疗效,改善患者的生活质量。
Objective: To observe the clinical efficiency of Jiawei Bazhen prescription and small doses of western medicine Prednisone acetate tablets for treating idiopathic thrombocytopenic purpurar. Method: 60 patients were randomly divided into a treatment group( G1) and a control group( G2). Treatment group( G1) was treated with Jiawei Bazhen prescription and small doses of western medicine Prednisone acetate tablets,while control group( G2) was treated by conventional dose of prednisone acetate tablets. After 3 months of treatment compare the clinical total effective rate between the two groups,the change of platelet count and the Chinese medicine symptom integral,and record the occurrence of adverse events in the G1 and G2 groups. Results: 1) Clinically total effective rate was 89. 99% in the treatment group,and the control group was 76. 66%. The clinically total effective rate of G1,G2 groups by the comparison between groups the difference was statistically significant( P < 0. 05). 2) After treatment,the platelet count in G1 group from( 39. 26 ± 7. 32) to( 112. 32 ± 9.28),platelet count in the G2 group also increased from( 40. 18 ± 5. 36) to( 95. 27 ± 7. 45); G1 and G2 groups were compared between patients with platelet count by the groups,and the differences were statistically significant( P < 0. 05). 3) After treatment,the G1 group of patients with Chinese medicine symptom integral rating was from( 34. 23 ± 4. 52) to( 11. 26 ± 2. 34),while G2 group of patients in TCM symptom score before and after the change was not obvious. G1 group of patients with traditional Chinese medicine symptom integral,comparing within the group,the difference was statistically significant( P < 0. 05); G2 group of patients with traditional Chinese medicine symptom integral,comparing within the group,there was no statistically significant difference( P > 0. 05). After treatment,the G1 and G2 groups of patients with Chinese medicine symptom integral by the comparison between groups,the difference was statistically significant( P < 0. 05). 4)G1 group of patients with abdominal distension had 2 cases,and the incidence of the advers events was 6.66%; G2 group of patients with pulmonary infection had 1 case,with nausea 2 cases and itchy skin 1 case,and the incidence of the adverse event was 13. 33%; comparison between two groups,the difference was statistically significant( P < 0. 05). Conclusion: Jiawei Bazhen prescription and small doses of western medicine Prednisone acetate tablets for the treatment of patients with ITP can obviously increase the platelet count and reduce the TCM symptom integral,reducing the risk of adverse events,significantly improving the clinically curative effect and the patient's quality of life.
Objective: To observe the clinical efficiency of Jiawei Bazhen prescription and small doses of western medicine Prednisone acetate tablets for treating idiopathic thrombocytopenic purpurar. Method: 60 patients were randomly divided into a treatment group( G1) and a control group( G2). Treatment group( G1) was treated with Jiawei Bazhen prescription and small doses of western medicine Prednisone acetate tablets,while control group( G2) was treated by conventional dose of prednisone acetate tablets. After 3 months of treatment compare the clinical total effective rate between the two groups,the change of platelet count and the Chinese medicine symptom integral,and record the occurrence of adverse events in the G1 and G2 groups. Results: 1) Clinically total effective rate was 89. 99% in the treatment group,and the control group was 76. 66%. The clinically total effective rate of G1,G2 groups by the comparison between groups the difference was statistically significant( P < 0. 05). 2) After treatment,the platelet count in G1 group from( 39. 26 ± 7. 32) to( 112. 32 ± 9.28),platelet count in the G2 group also increased from( 40. 18 ± 5. 36) to( 95. 27 ± 7. 45); G1 and G2 groups were compared between patients with platelet count by the groups,and the differences were statistically significant( P < 0. 05). 3) After treatment,the G1 group of patients with Chinese medicine symptom integral rating was from( 34. 23 ± 4. 52) to( 11. 26 ± 2. 34),while G2 group of patients in TCM symptom score before and after the change was not obvious. G1 group of patients with traditional Chinese medicine symptom integral,comparing within the group,the difference was statistically significant( P < 0. 05); G2 group of patients with traditional Chinese medicine symptom integral,comparing within the group,there was no statistically significant difference( P > 0. 05). After treatment,the G1 and G2 groups of patients with Chinese medicine symptom integral by the comparison between groups,the difference was statistically significant( P < 0. 05). 4)G1 group of patients with abdominal distension had 2 cases,and the incidence of the advers events was 6.66%; G2 group of patients with pulmonary infection had 1 case,with nausea 2 cases and itchy skin 1 case,and the incidence of the adverse event was 13. 33%; comparison between two groups,the difference was statistically significant( P < 0. 05). Conclusion: Jiawei Bazhen prescription and small doses of western medicine Prednisone acetate tablets for the treatment of patients with ITP can obviously increase the platelet count and reduce the TCM symptom integral,reducing the risk of adverse events,significantly improving the clinically curative effect and the patient's quality of life.
引文
[1]赵华,刘丽.桑椹三仙胶治疗慢性原发性血小板减少性紫癜30例疗效观察[J].中医药信息,2011,28(5):67-68.
[2]邓稼栋,杨崇礼,杨天楹,等.邓稼栋临床血液学[M].上海:上海科技出版社,2001:279.
[3]Cines DB,Blanchette VS.Immune thrombocytpenic purpura[J].N Mngl J Med,2002,346(13):995-1008.
[4]陆再英,钟南山.内科学[M].北京:人民卫生出版社,2010:650.
[5]翠琴.生血康胶囊治疗慢性血小板减少性紫癜临床研究[D].长春:吉林大学,2004.
[6]张之南.血液病诊断与疗效标准[S].2版,北京:科学出版社,2002:279.
[7]郑筱萸.中药新药临床研究指导原则[S].北京:中国医药科技出版社,2003:182-184.
[8]谭艳飞.不同剂量丙种球蛋白联合激素治疗小儿特发性血小板减少性紫癜疗效对比分析[J].中国医学创新,2013,10(26):60-61.
[9]罗正凯,江利民,孙岸弢,等.孙伟正教授治疗特发性血小板减少性紫癜学术思想研究[J].中医药信息,2012,29(3):49-51.
[10]赵丹,任现志.过敏性紫癜性肾炎疗效评价方法的现状与思考[J].中医药信息,2010,27(6):102-103.
[11]吴萸.益气养阴和血方治疗难治复发性血小板减少性紫癜的疗效观察[D].南京:南京中医药大学,2011.
[12]尹霖,王全,周文彬,等.陈德宁教授从脾胃论治男性亚健康经验[J].中医药信息,2014,30(1):50-52.
[13]杨天仁,刘云平,耿爱春.《脾胃论》益气升阳方剂治法研究[J].中医药信息,2012,29(6):104-106.
[14]张超,南莉莉,孙志,等.八珍汤物质基础及药理学研究进展[J].上海医药,2008,29(6):273-276.
[15]章俏雷,曲志刚,方炳木,等.增血汤联合生血散对特发性血小板减少性紫癜患者外周血CD4+T淋巴细胞表面Fas L和Fas的影响[J].中医药学报,2014,42(1):70-72.
[16]李冬,曲晓波,胡丽娜,等.动物药蛤蚧的整理研究[J].杏林中医药,2009,29(8):707-708.
[2]邓稼栋,杨崇礼,杨天楹,等.邓稼栋临床血液学[M].上海:上海科技出版社,2001:279.
[3]Cines DB,Blanchette VS.Immune thrombocytpenic purpura[J].N Mngl J Med,2002,346(13):995-1008.
[4]陆再英,钟南山.内科学[M].北京:人民卫生出版社,2010:650.
[5]翠琴.生血康胶囊治疗慢性血小板减少性紫癜临床研究[D].长春:吉林大学,2004.
[6]张之南.血液病诊断与疗效标准[S].2版,北京:科学出版社,2002:279.
[7]郑筱萸.中药新药临床研究指导原则[S].北京:中国医药科技出版社,2003:182-184.
[8]谭艳飞.不同剂量丙种球蛋白联合激素治疗小儿特发性血小板减少性紫癜疗效对比分析[J].中国医学创新,2013,10(26):60-61.
[9]罗正凯,江利民,孙岸弢,等.孙伟正教授治疗特发性血小板减少性紫癜学术思想研究[J].中医药信息,2012,29(3):49-51.
[10]赵丹,任现志.过敏性紫癜性肾炎疗效评价方法的现状与思考[J].中医药信息,2010,27(6):102-103.
[11]吴萸.益气养阴和血方治疗难治复发性血小板减少性紫癜的疗效观察[D].南京:南京中医药大学,2011.
[12]尹霖,王全,周文彬,等.陈德宁教授从脾胃论治男性亚健康经验[J].中医药信息,2014,30(1):50-52.
[13]杨天仁,刘云平,耿爱春.《脾胃论》益气升阳方剂治法研究[J].中医药信息,2012,29(6):104-106.
[14]张超,南莉莉,孙志,等.八珍汤物质基础及药理学研究进展[J].上海医药,2008,29(6):273-276.
[15]章俏雷,曲志刚,方炳木,等.增血汤联合生血散对特发性血小板减少性紫癜患者外周血CD4+T淋巴细胞表面Fas L和Fas的影响[J].中医药学报,2014,42(1):70-72.
[16]李冬,曲晓波,胡丽娜,等.动物药蛤蚧的整理研究[J].杏林中医药,2009,29(8):707-708.