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机构地区:[1]河南省医学科学研究所,郑州450052 [2]河南省郑州市公路管理局医保办公室,郑州450052
出 处:《中国新药杂志》2005年第9期1192-1195,共4页Chinese Journal of New Drugs
摘 要:目的:评价中药补肺活血胶囊治疗慢性肺原性心脏病的有效性和安全性。方法:采用平行对照试验方法,160例肺心病患者随机分为试验组120例和对照组40例,分别口服补肺活血胶囊和金咳息胶囊,剂量均为1·4g,tid,疗程均为90d。结果:试验组用药后显效率和总有效率分别为45·8%和85·0%,对照组显效率和总有效率分别为20%和57·5%,试验组明显优于对照组(P<0·01)。治疗后试验组症状体征总积分、肺功能指标、血液流变学指标、动脉血气分析、免疫学指标均显著优于对照组(P<0·01或P<0·05)。两组各有1例患者用药期间出现轻度口干,多饮水后缓解。结论:补肺活血胶囊对肺心病的疗效优于金咳息胶囊,未发现明显不良反应。Objective:To evaluate the efficacy and safety of a new herbal capsules for nourishing lung and activating blood circulation (Bufeihuoxue-BFHX) for the treatment of chronic pulmonary cardiac disease (PCD). Methods: 160 patients with PCD recruited in a randomized, parallel arm and comparative control clinical trial were randomized orally to receive the BFHX capsules (1.4 g, n = 120, rid) or the Jinkexi (JKX) capsules (1.4 g, n = 40, tid) for 90 days. Results: The overall efficacy in BFHX group was significantly superior to Jinkexi group (85.0 % vs 57.5 %, P 〈 0.05). The BFHX patients experienced more significant improvements than JKX patients in general physical characters, pulmonary function index, hemodynamic index, arterial blood gas analyses and immunological index ( P 〈 0.05). The adverse event reported in both groups was mild thirsty. Conclusion: The BFHX capsules offer an alternative in the treatment of PCD.
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