中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2011年
24期
1677-1681
,共5页
汪爱虎%浦介麟%齐小勇%苗文林%侯子山%丛洪良%周建中%刘晓方%李淑梅%韩清华%刘永家%杨新春
汪愛虎%浦介麟%齊小勇%苗文林%侯子山%叢洪良%週建中%劉曉方%李淑梅%韓清華%劉永傢%楊新春
왕애호%포개린%제소용%묘문림%후자산%총홍량%주건중%류효방%리숙매%한청화%류영가%양신춘
心房颤动%参松养心胶囊%普罗帕酮
心房顫動%參鬆養心膠囊%普囉帕酮
심방전동%삼송양심효낭%보라파동
Atrial fibrillation%Shensongyangxin capsules%Propafenone
目的 评价复方中药参松养心胶囊治疗阵发性心房颤动(房颤)的有效性及安全性.方法 自2007年8月至2008年7月,采用随机、双盲、双模拟、平行对照、多中心临床试验方法,在11家临床医院的门诊患者,选择年龄18～75岁,男女不限,阵发性房颤发作频率≥2次/月的受试者,按1:1:1比例随机数字分组分为3组:(1)参松养心组:服用参松养心胶囊4粒+普罗帕酮模拟剂150 mg,1日3次;(2)普罗帕组:服用普罗帕酮片150 mg+参松养心胶囊模拟剂4粒,1日3次;(3)参松养心+普罗帕酮组:服用参松养心胶囊4粒+普罗帕酮片150 mg,1日3次.门诊随访1次/月,疗程为8周.结果 共纳入阵发性房颤患者349例,其中参松养心组和参松养心+普罗帕酮组各117例,普罗帕酮组115例;3组患者的基线房颤发作频率、24 h动态心电图、心脏超声及症状等指标差异均无统计学意义(均P>0.05).经8周治疗,房颤发作频率(由平均6 次/月降至2 次/月,P<0.01)、房颤发作例数[参松养心组从46(43.8%)降至22(20.8%)例,普罗帕酮组从43(43.4%)例降至25(25.3%)例,参松养心+普罗帕酮组从40(40.6%)降至31(29.2%)例,P<0.01]、房颤发作持续时间(参松养心组,普罗帕酮组从4 h 降至0.5 h,参松养心+普罗帕酮组从4.25 h降至0.5 h,P<0.01)均显著下降,房颤总体疗效参松养心组62.3%,普罗帕酮组58.6%,参松养心+普罗帕酮组58.5%.参松养心组发生不良反应2例(1.8%),普罗帕酮组和参松养心+普罗帕酮组分别发生不良反应9例(8.2%)和6例(5.4%).结论 参松养心胶囊与普罗帕酮治疗阵发性房颤疗效相当;参松养心胶囊具有良好的安全性.
目的 評價複方中藥參鬆養心膠囊治療陣髮性心房顫動(房顫)的有效性及安全性.方法 自2007年8月至2008年7月,採用隨機、雙盲、雙模擬、平行對照、多中心臨床試驗方法,在11傢臨床醫院的門診患者,選擇年齡18～75歲,男女不限,陣髮性房顫髮作頻率≥2次/月的受試者,按1:1:1比例隨機數字分組分為3組:(1)參鬆養心組:服用參鬆養心膠囊4粒+普囉帕酮模擬劑150 mg,1日3次;(2)普囉帕組:服用普囉帕酮片150 mg+參鬆養心膠囊模擬劑4粒,1日3次;(3)參鬆養心+普囉帕酮組:服用參鬆養心膠囊4粒+普囉帕酮片150 mg,1日3次.門診隨訪1次/月,療程為8週.結果 共納入陣髮性房顫患者349例,其中參鬆養心組和參鬆養心+普囉帕酮組各117例,普囉帕酮組115例;3組患者的基線房顫髮作頻率、24 h動態心電圖、心髒超聲及癥狀等指標差異均無統計學意義(均P>0.05).經8週治療,房顫髮作頻率(由平均6 次/月降至2 次/月,P<0.01)、房顫髮作例數[參鬆養心組從46(43.8%)降至22(20.8%)例,普囉帕酮組從43(43.4%)例降至25(25.3%)例,參鬆養心+普囉帕酮組從40(40.6%)降至31(29.2%)例,P<0.01]、房顫髮作持續時間(參鬆養心組,普囉帕酮組從4 h 降至0.5 h,參鬆養心+普囉帕酮組從4.25 h降至0.5 h,P<0.01)均顯著下降,房顫總體療效參鬆養心組62.3%,普囉帕酮組58.6%,參鬆養心+普囉帕酮組58.5%.參鬆養心組髮生不良反應2例(1.8%),普囉帕酮組和參鬆養心+普囉帕酮組分彆髮生不良反應9例(8.2%)和6例(5.4%).結論 參鬆養心膠囊與普囉帕酮治療陣髮性房顫療效相噹;參鬆養心膠囊具有良好的安全性.
목적 평개복방중약삼송양심효낭치료진발성심방전동(방전)적유효성급안전성.방법 자2007년8월지2008년7월,채용수궤、쌍맹、쌍모의、평행대조、다중심림상시험방법,재11가림상의원적문진환자,선택년령18～75세,남녀불한,진발성방전발작빈솔≥2차/월적수시자,안1:1:1비례수궤수자분조분위3조:(1)삼송양심조:복용삼송양심효낭4립+보라파동모의제150 mg,1일3차;(2)보라파조:복용보라파동편150 mg+삼송양심효낭모의제4립,1일3차;(3)삼송양심+보라파동조:복용삼송양심효낭4립+보라파동편150 mg,1일3차.문진수방1차/월,료정위8주.결과 공납입진발성방전환자349례,기중삼송양심조화삼송양심+보라파동조각117례,보라파동조115례;3조환자적기선방전발작빈솔、24 h동태심전도、심장초성급증상등지표차이균무통계학의의(균P>0.05).경8주치료,방전발작빈솔(유평균6 차/월강지2 차/월,P<0.01)、방전발작례수[삼송양심조종46(43.8%)강지22(20.8%)례,보라파동조종43(43.4%)례강지25(25.3%)례,삼송양심+보라파동조종40(40.6%)강지31(29.2%)례,P<0.01]、방전발작지속시간(삼송양심조,보라파동조종4 h 강지0.5 h,삼송양심+보라파동조종4.25 h강지0.5 h,P<0.01)균현저하강,방전총체료효삼송양심조62.3%,보라파동조58.6%,삼송양심+보라파동조58.5%.삼송양심조발생불량반응2례(1.8%),보라파동조화삼송양심+보라파동조분별발생불량반응9례(8.2%)화6례(5.4%).결론 삼송양심효낭여보라파동치료진발성방전료효상당;삼송양심효낭구유량호적안전성.
Objective To evaluate the efficacy and safety of Chinese medicinal shensongyangxin capsules in the treatment of paroxysmal atrial fibrillation. Methods From August 2007 to July 2008, Beijing Chaoyang Hospital coducted a multicenter study, select the eleven hospital's outpatient subjects, aged 18 to 75 years old, male or female, paroxysmal atrial fibrillation (at least one electrocardiogram diagnosis) seizure frequency ≥ 2 times / month, groups: a. Shensongyangxin group, taking shensongyangxin capsule 4 + propafenone analogues 150 mg, 3 times a day; b. Propafenone group, taking propafenone tablets 150 mg + 4 shensongyangxin analogues, 3 times a day; shensongyangxin capsule + propafenone group, taking shensongyangxin capsule 4 + propafenone 150 mg, 3 times a day. The treatment course is 8 weeks, with 3 times of follow-up.Results Total of 349 cases of paroxysmal atrial fibrillation, which 117 cases in shensongyangxin group, 115 cases in propafenone group; 117cases in shensongyangxin + propafenone group.The baseline data analysis showed that there were no significantly difference (P>0.05) among the three groups of atrial fibrillation seizure frequency, vital signs, general condition, medical history, 24-hour ambulatory ECG, 12-lead normal electrocardiogram, cardiac ultrasound and symptoms. The comparioson before and after (8 weeks ) treatment showed that the frequency(from 6 times/m to 2 times/m in each group, P<0.01), number of cases [from 46(43.3%) to 22(20.8%), 43(43.4%) to 25(25.3%), and 40(40.6%) to 31(29.2%), respectively P<0.01] and dutaion time of attack of atrial fibrillation (from 4 h to 0.5 h,4 h to 0.5 h, and 4.25 h to 0.5 h, respectively P<0.01) all decreased in three groups.No significant difference among the three groups comparing the overall effect (62.3%,58.6%, and 58.5%, respectively, P>0.05), while the efficiacy of TCM symptoms in shensongyangxin group(80.2%) was better than that of propafenone group(67.7%)( P<0.05). Safety evaluation showed that adverse reaction rate was 1.8% in shensongyangxin group, and 8.2% and 5.4% in propafenone group and shensongyangxin + propafenone group.Conclusion Shensongyangxin capsules and propafenone have comparable efficacies in the treatment of PAF. The efficacy of TCM symptoms is better than propafenone. Shensongyangxin capsules have an excellent profile of safety.
