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派能达胶囊Ⅰ期人体耐受性临床研究 被引量:1
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作者 邹冲 熊宁宁 +3 位作者 蒋萌 高维敏 邹建东 刘芳 《中成药》 CAS CSCD 北大核心 2015年第11期2383-2386,共4页
目的考察人体对派能达胶囊(人参二醇组皂苷提取物,40 mg/粒)的耐受性和初步安全性,为该药Ⅱ期临床试验提供安全的剂量范围。方法选择健康人为受试对象,顺序开展单次给药耐受性试验和累积性耐受性试验。单次给药耐受性试验42例,7个剂量... 目的考察人体对派能达胶囊(人参二醇组皂苷提取物,40 mg/粒)的耐受性和初步安全性,为该药Ⅱ期临床试验提供安全的剂量范围。方法选择健康人为受试对象,顺序开展单次给药耐受性试验和累积性耐受性试验。单次给药耐受性试验42例,7个剂量组,分别为1、2、4、8、12、16、20粒,每日1次给药。累积性耐受性试验12例,2个剂量组,分别为每次5粒和每次6粒,每日2次给药,连续7 d。观察指标为临床症状、生命体征和安全性指标等,采用SAS 9.13统计软件进行统计学处理。结果 54例受试者其中19人出现28次轻度不良反应。本试验单次给药16粒剂量组6人中出现1例轻度不良反应,单次给药20粒剂量组6例均出现轻度不良反应;多次给药12粒剂量组6人均出现轻度不良反应,10粒剂量组未出现不良反应。不良反应主要表现为牙龈出血、失眠、口干、出汗、体温轻度升高、血清总胆红素升高、血清甘油三酯偏高等。结论单次给药最大耐受量为640 mg(16粒),多次给药安全剂量为400 mg(10粒/d×7 d),推荐Ⅱ期临床试验的安全剂量范围为每日6~10粒,建议在Ⅱ、Ⅲ期临床试验中注意对不良反应的观察。 展开更多
关键词 派能达胶囊 Ⅰ期 临床耐受性研究
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派能达胶囊对慢乙肝肝硬化患者外周血象及症状的影响 被引量:1
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作者 余亚平 叶蕾 高瑞兰 《云南中医学院学报》 2015年第3期55-57,共3页
目的通过观察派能达胶囊对慢乙肝肝硬化患者外周血象及症状的影响,探讨其是否可增强抗病毒治疗疗效,为临床慢乙肝肝硬化的治疗提供帮助。方法 60例患者随机分为2组,每组30例,对照组用抗病毒药(拉米夫定100mg/d+阿德福韦酯10mg/d),治疗... 目的通过观察派能达胶囊对慢乙肝肝硬化患者外周血象及症状的影响,探讨其是否可增强抗病毒治疗疗效,为临床慢乙肝肝硬化的治疗提供帮助。方法 60例患者随机分为2组,每组30例,对照组用抗病毒药(拉米夫定100mg/d+阿德福韦酯10mg/d),治疗组加用派能达胶囊(2粒/次,2次/d);派能达胶囊治疗6个月,治疗结束后所有患者继续服用抗病毒药物并随访。比较两组治疗前后的中医证候积分。对病例中伴白细胞减少(<4*109/L)和(或)血小板减少(<100*109/L)的比较治疗前后血细胞水平。结果 1.治疗后,治疗组患者的WBC计数较治疗前升高(P<0.05),对照组患者的WBC计数较治疗前也升高(P>0.05),治疗后治疗组的WBC计数高于对照组(P<0.05);2.治疗后2组血小板计数较前均有升高,但同组治疗前后比较无统计学差异,两组间比较治疗前后PLT计数也无统计学差异;3.2组治疗后证候积分均下降(P<0.05),且治疗后治疗组积分低于对照组(P<0.05)。结论派能达胶囊联合抗病毒治疗可提高抗病毒疗效,改善慢乙肝肝硬化患者血细胞减少症,改善患者临床症状,提高生活质量。 展开更多
关键词 派能达胶囊 慢性乙型 病毒性肝炎 肝硬化 白细胞 血小板 证候积分
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派能达胶囊对慢乙肝肝硬化患者HBeAg阴转率及IL-2水平的影响 被引量:1
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作者 叶蕾 高瑞兰 余亚平 《云南中医学院学报》 2015年第4期64-66,共3页
目的通过观察派能达胶囊对慢乙肝肝硬化患者HBeAg阴转率及IL-2水平的影响探讨其是否可增强抗病毒治疗疗效,为临床慢乙肝肝硬化的治疗提供帮助。方法对照组用抗病毒药(拉米夫定100mg/d+阿德福韦酯10mg/d),治疗组加用派能达胶囊(2粒/次,2... 目的通过观察派能达胶囊对慢乙肝肝硬化患者HBeAg阴转率及IL-2水平的影响探讨其是否可增强抗病毒治疗疗效,为临床慢乙肝肝硬化的治疗提供帮助。方法对照组用抗病毒药(拉米夫定100mg/d+阿德福韦酯10mg/d),治疗组加用派能达胶囊(2粒/次,2次/d);派能达胶囊治疗6个月,治疗结束后所有患者继续服用抗病毒药物并随访9个月。乙肝三系每3月检测1次;治疗前及治疗结束时检测IL-2水平。结果经派能达胶囊治疗的患者治疗结束后的第6个月及第9个月,HBeAg阴转率高于对照组(P<0.05);治疗后治疗组IL-2水平高于对照组(P<0.05);治疗后治疗组IL-2水平较治疗前显著升高(P<0.05)。结论派能达胶囊可与西药联合应用于慢乙肝肝硬化患者,提高HBeAg阴转率,提高抗病毒疗效,为今后治疗慢乙肝及乙肝肝硬化提供安全有效的新方案。 展开更多
关键词 派能达 慢性乙型病毒性肝炎 肝硬化 HBEAG IL-2
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Research and Development of the Effective Components of Panaxdiol Saponin as New Chinese Patent Medicine for Treating Hemocytopenia 被引量:13
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作者 高瑞兰 CHONG Beng Hock 《Chinese Journal of Integrative Medicine》 SCIE CAS 2012年第12期897-902,共6页
Pancytopenia (hemocytopenia) such as primary immune thrombocytopenia (ITP), aplastic anemia and chronic neutropenia (agnogenic leukocytopenia) were often treated by glucocorticoids, androgen and immunosuppressiv... Pancytopenia (hemocytopenia) such as primary immune thrombocytopenia (ITP), aplastic anemia and chronic neutropenia (agnogenic leukocytopenia) were often treated by glucocorticoids, androgen and immunosuppressive agents at present, but the response to these treatments has not been always satisfactory, and may cause serious adverse events. Our research has identified a biological active component in ginseng extract and the active component, panaxadiol saponins component (PDS-C), was isolated from total saponins of ginsenosides, and formulated into capsules named as Painengda (派能达). We successfully obtained approval from State Food and Drug Administration (SFDA) of China in 2010 to conduct clinical trials of PDS-C as class-five new Chinese patent medicine. Phase Ⅰand phase Ⅱ clinical trials of PDS-C and Painengda Capsule were carried out in the treatment of ITP and agnogenic leukocytopenia. Thecomposition and content of PDS-C have been analyzed and defined by high-performance liquid chromatography mass spectrometry (HPLC-MS) and HPLC using specific monomers of ginsenosides as the reference standards. PDS-C is very efficacious for treating mice and rats with ITP and aplastic anemia, and myelosuppression caused by chemotherapy or radiation. Our animal model studies and cell biology and molecular biology experiments demonstrated that PDS-C possessed dual activities, namely that of promoting proliferation and differentiation of hematopoietic progenitor cells, and that of regulating the immune function. PDS-C and Painengda Capsule as a new Chinese patent medicine have been successfully transferred to industry. We believe that PDS-C is effective and safe in the treatment of refractory hemocytopenia. The advantages are that it is effective in small doses, it is convenient to use because of its oral administration, its lack of adverse events, it could be used alone or in combination with pharmacological agents, which improve the efficacy and decrease adverse events. 展开更多
关键词 Panaxadiol saponins painengda preclinical trial hemocytopenia primary immunethrombocytopenia agnogenic leukocytopenia
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