重組人B型腦鈉肽治療急性失代償性心衰的臨床研究

摘要： 目的探討重組人B型腦鈉肽用于急性失代償性心衰(ADHF)的療效、安全性、適應(yīng)證及不良反應(yīng)情況。方法對(duì)照組45例給予標(biāo)準(zhǔn)常規(guī)治療,包括擴(kuò)管、利尿、抗感染、病因治療;治療組46例在常規(guī)治療基礎(chǔ)上(但不使用利尿劑)加用重組人B型腦鈉肽,首次負(fù)荷劑量1.5μg/kg,然后以0.0075μg/(kg·min)連續(xù)靜脈滴注72小時(shí)。觀察兩組用藥前后臨床癥狀、體征的變化,同時(shí)記錄兩組血壓、尿量、超聲心動(dòng)圖LVEF、CI變化,并觀察血、尿常規(guī)、肝、腎功能的變化。結(jié)果兩組基線特征差異無(wú)顯著性,經(jīng)治療后,治療組心率、血壓顯著下降,而24小時(shí)尿量顯著增加,LVEF、CI亦較對(duì)照組改善更多,兩組間各項(xiàng)臨床指標(biāo)差異有顯著性;治療組呼吸困難明顯減輕,總有效率91.3%,對(duì)照組為77.8%。結(jié)論重組人B型腦鈉肽可明顯改善患者臨床癥狀和全身狀況,短期臨床療效優(yōu)于對(duì)照組,不良反應(yīng)少,但使用時(shí)應(yīng)嚴(yán)格掌握適應(yīng)證,并按照推薦劑量,以確保患者的用藥安全。
Objective To investigate therapeutic effect,safety,indication and adverse effects in treatment for chinese patients with acute decompensated heart failure (ADHF) with Lyophilized Recombinant Human Brain Natriuretic Peptide (rh-BNP) made in China.Methods Selective patients with ADHF were divided randomly into control group (n=45) and treatment group (n =46):control group received typical conventional therapy,including enlarging blood vessel,diuresis,anti-infection,etilogical treatment,etc;and treatment group received Lyophilized rh-BNP made in China on the basis of conventional therapy (except diuresis) with priming loading dose of 1.5μg/kg iv and following dose of 0.0075μg/(kg·min) for continuous 72 hours by ivgtt.Then the changes of clinical symptoms and physical signs in both groups were observed,and the changes of blood pressure,urinary volume during 24h,left ventricular ejection fraction,cardiac index,blood routine,urine routine,liver function,renal function in both groups before and after treatment were recorded.Results The differences in baseline characteristics between two groups weren't significant.Heart rate and blood pressure was decreased significantly,and urinary volume during 24h,left ventricular ejection fraction,cardiac index increased significantly in treatment group;dyspnea was abated in relieved and total effective rate was 91.3% in treatment group and that was 77.8% in control group.Conclusion Lyophilized rh-BNP made in China could improve clinical symptoms and physical condition of the Chinese patients with ADHF significantly,and have an advantage for conventional therapy on short-term therapeutic effect,and bring about less and slight adverse effects;however,indications and doses of the drug should be grasped exactly during using it in order to ensure safety.