益气活血解郁方治疗气虚血瘀肝郁型中风后抑郁症患者的临床观察

目的 探讨益气活血解郁方治疗气虚血瘀,肝郁气滞型的中风后抑郁症(Post-stroke depression, PSD)临床效果。方法 选取2015年3月—2017年2月期间在浙江大学医学院附属第二医院中医门诊、浙江中医药大学附属第二医院中医门诊和神经内科就诊的气虚血瘀、肝郁气滞型PSD患者156例,按照随机数字表法分为西药氟西汀对照组、益气活血解郁方中医治疗组、中西医结合治疗组,每组各52例。治疗1个月后,观察比较3组患者临床总有效率、愈显率、中医证候临床疗效,治疗前后HAMD评分。结果 治疗后3组患者HAMD评分均较治疗前降低,差异有统计学意义(P<0.05);且中西医结合治疗组HAMD评分较对照组、中医治疗组明显降低,差异有统计学意义(P<0.05)。治疗后3组患者总有效率比较,差异无统计学意义(P>0.05)。治疗后对照组、中医治疗组、中西医结合治疗组愈显率(治愈和显效)分别为48.08%(25/52)、51.92%(27/52)、73.08%(38/52),中西医结合治疗组愈显率明显优于对照组、中医治疗组,差异有统计学意义(P<0.05)。治疗后对照组、中医治疗组、中西医结合治疗组中医证候临床疗效总有效率分别为69.23%(36/52)、75.00%(39/52)、86.54%(45/52),中西医结合治疗组总有效率明显优于对照组、中医治疗组,差异有统计学意义(P<0.05)。结论 益气活血解郁方可有效治疗气虚血瘀肝郁型PSD。

冠心病慢性心力衰竭阳虚寒凝、血脉瘀阻证诊断与疗效评定标准(试行)

心力衰竭是各种心血管疾病的严重或终末阶段,多种原因导致心脏结构和/或功能的异常改变,使心室收缩和/或舒张功能发生障碍,从而引起的一组复杂临床综合征。冠心病慢性心力衰竭是临床上常见的疾病,在临床有多种中医证型。项目组经临床中医证型研究,提出阳虚寒凝、血脉瘀阻证是该病常见证型之一。根据临床研究,结合中西医诊断标准、中医症状分级计分法等,建立冠心病慢性心力衰竭阳虚寒凝,血脉瘀阻证诊断标准和疗效评价标准,有助于冠心病慢性心力衰竭的标准化研究。

清解宣透肺卫方药治疗外感热病邪郁肺卫证安全性和有效性的随机双盲、阳性药平行对照、多中心临床研究

目的:评价清解宣透肺卫方——银花平感颗粒治疗外感热病邪郁肺卫证的安全性及有效性。方法:采用随机分组、双盲单模拟、阳性药平行对照、多中心临床试验的设计方法;按临床试验3∶1随机分配至试验组与阳性药对照组,实际共入组病例416例,415例受试者进入FAS人群(试验组312例,阳性药对照组103例),409例受试者进入PPS人群(试验组307例,阳性药对照组102例)。试验组给予银花平感颗粒,对照组给予银翘解毒颗粒,疗程均为3d。结果:两组患者在基线病情等指标均具有可比性;服药依从性良好。在PPS人群中,试验组、对照组中医证候疗效愈显率分别为84.69%、72.55%;中医主要症状疗效愈显率分别为80.78%,70.59%,其差异均有统计学意义(P<0.05)。中医证候总评分和主症总评分在用药第3天,两组组内比较,差异有统计学意义(P<0.01)。试验组体温起效时间和体温解热时间显著优于阳性药对照组(P<0.01)。治疗3d后两组患者发热恶寒、头身疼痛、鼻塞流涕、咯痰、口渴等中医症状消失情况组间比较,差异有统计学意义(P<0.05);除舌质外,两组间其余差异无统计学意义。白细胞计数与分类、呼吸道病毒检测结果显示,该类疾病多属于病毒性感染疾病。结论:清解宣透肺卫方药银花平感颗料治疗外感热病邪郁肺卫证患者可显著提高疗效,具有显著解热、镇痛、止咳化痰等作用。

Efficacy of Yangyin Yiqi Huoxue Granule (养阴益气活血颗粒) in Treatment of Ischemic Stroke Patients with Qi-Yin Deficiency and Blood Stasis Syndrome: A Randomized, Double-Blind, Multicenter, Phase-2 Clinical Trial

Objective To evaluate the efficacy and safety of Yangyin Yiqi Huoxue Granule(养阴益气活血颗粒,YYHG)in the treatment of ischemic stroke(IS)patients with qi-yin deficiency and blood stasis syndrome(QYDBSS),and to explore its effective dosage.Methods The total of 288 patients were randomly assigned to the YYHG high-dose,YYHG low-dose,positive control(administered Xiaoshuantong Granule,XSTG,消栓通颗粒),or placebo control(administered inert granule)groups(72 cases per group)by software-drived competitive block randomization.The trial was conducted for a 28-day period,with a 180-day follow-up period.The primary outcome was the comprehensive curative evaluation,and secondary outcomes were the National Institute of Health Stroke Scale(NIHSS)score,Barthel activities of daily living(ADL)index score,the quality of life index(QLI)score,and the Chinese medicine syndrome(CMS)score.All analyses were done on an intention-to-treat basis.The clinical safety was also assessed.Results The total of 288 participants were recruited between June 1,2008 and September 30,2009,and 287 patients received intervention;the treatment groups were well balanced at baseline.The comprehensive cure rates of YYHG high-dose,low-dose,positive and placebo control groups were 63.38%,31.94%,36.11%and 6.14%,respectively;there was a statistical difference between the two groups(P<0.01),while the high-dose YYHG treatment group was significantly higher than the other 3 groups(P<0.01).The improvement of NIHSS,ADL,QLI and CMS scores of the YYHG high-dose and low-dose groups was significantly better than that of the positive control group and the placebo control group(P<0.05).In terms of improving the classification of the NIHSS scale and the assessment of the ADL scale,the YYHG high-dose group was significantly better than the other three groups(P<0.05),and the YYHG low-dose group was better than the placebo control group(P<0.01).At the same time,except for the QLI score,the high-dose group was better than the low-dose group(P<0.05).In terms of safety,adverse reactions after YYHG treatment were generally mild(3.78%),and no serious adverse reactions have been reported.Conclusion YYHG is safe and effective in the treatment of IS patients with QYDBSS.