PMID- 26380441 OWN - NLM STAT- MEDLINE DCOM- 20160915 LR - 20181202 IS - 1003-5370 (Print) IS - 1003-5370 (Linking) VI - 35 IP - 7 DP - 2015 Jul TI - [Treatment of Chronic Heart Failure Patients with Qi-Yang Deficiency and Blood Stasis Resistance Syndrome by Xnmallong Injection: a Multi-center Randomized Control Study]. PG - 796-800 AB - OBJECTIVE: To evaluate the efficacy and safety of Xinmailong Injection (XI) in treatment of chronic heart failure (CHF) patients with qi-yang deficiency and blood stasis resistance syndrome (QY-DBSRS). METHODS: Totally 238 CHF patients with QYDBSRS were assigned to the treatment group (118 cases) and the control group (120 cases) by randomized, double-blind, placebo parallel controlled method. Patients in the treatment group received routine therapy and XI (100 mg/2 mL, by dripping at 5 mg/kg, twice per day for 5 consecutive days), while those in the control group received routine therapy and XI mimetic agent (100 mg/2 mL, by dripping at 5 mg/kg, twice per day for 5 consecutive days). The heart function classification of New York Heart Association (NYHA), 6-min walking distance, left ventricular ejection fraction (LVEF), scores for Chinese medical symptoms were observed before and after treatment, and safety assessed. RESULTS: Totally 235 patients actually entered full analysis set (FAS), including 120 cases in the control group and 115 cases in the treatment group. The total effective rate of heart function, 6-min walking distance and increased post-pre-treatment distance in the experimental group were superior to those of the control group with statistical difference (all P < 0.05). Compared with the control group, increased value of post-pre-treatment LVEF, the total effective rate of Chinese medical syndrome efficacy, scores for Chinese medical symptoms and decreased post-pre-treatment value of Chinese medical syndrome scores were obviously improved (all P < 0.05). There was no significant difference in the incidence of adverse events between the two groups (P > 0.05). CONCLUSIONS: XI could improve the heart function of CHF patients, improve Chinese medical symptoms, elevate exercise tolerance, and improve LVEF. It had no obvious toxic and side effects. FAU - Xue, Jin-gui AU - Xue JG FAU - Wang, Xiao-long AU - Wang XL FAU - Xu, Yong AU - Xu Y FAU - Li, Feng-chun AU - Li FC FAU - Liu, Li AU - Liu L FAU - Wang, Xing AU - Wang X FAU - Wang, Jian-zhong AU - Wang JZ FAU - Liu, Fan AU - Liu F LA - chi PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - China TA - Zhongguo Zhong Xi Yi Jie He Za Zhi JT - Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine JID - 9211576 RN - 0 (Drugs, Chinese Herbal) SB - IM MH - Chronic Disease MH - Double-Blind Method MH - Drugs, Chinese Herbal/administration & dosage/pharmacology/*therapeutic use MH - Heart Failure/*drug therapy MH - Humans MH - Injections MH - Medicine, Chinese Traditional MH - Phytotherapy MH - *Qi MH - Syndrome MH - *Yang Deficiency EDAT- 2015/09/19 06:00 MHDA- 2016/09/16 06:00 CRDT- 2015/09/19 06:00 PHST- 2015/09/19 06:00 [entrez] PHST- 2015/09/19 06:00 [pubmed] PHST- 2016/09/16 06:00 [medline] PST - ppublish SO - Zhongguo Zhong Xi Yi Jie He Za Zhi. 2015 Jul;35(7):796-800.