中国中医药信息杂志
中國中醫藥信息雜誌
중국중의약신식잡지
CHINESE JOURNAL OF INFORMATION ON TRADITIONAL CHINESE MEDICINE
2015年
9期
18-21
,共4页
谷春华%任君霞%杨立波%田野%孙利%高学东%刘桂颖%胡思源%史利卿%王檀%曲妮妮%朱文翔
穀春華%任君霞%楊立波%田野%孫利%高學東%劉桂穎%鬍思源%史利卿%王檀%麯妮妮%硃文翔
곡춘화%임군하%양립파%전야%손리%고학동%류계영%호사원%사리경%왕단%곡니니%주문상
连花急支片%急性气管-支气管炎%中医药疗法%痰热壅肺%随机对照临床试验
連花急支片%急性氣管-支氣管炎%中醫藥療法%痰熱壅肺%隨機對照臨床試驗
련화급지편%급성기관-지기관염%중의약요법%담열옹폐%수궤대조림상시험
Lianhua Jizhi Tablets%acute trachitis and bronchitis%traditional Chinese medicine therapy%phlegm-heat obstructing lung%randomized controlled clinical trial
目的：初步评价连花急支片治疗急性气管-支气管炎痰热壅肺证的有效性和安全性。方法采用随机双盲、安慰剂对照、多中心临床试验的设计方法,将240例患者随机分为试验组和对照组各120例,纳入全分析集237例,试验组服用连花急支片,对照组服用安慰剂,均12片/d,疗程7 d。观察2组对急性气管-支气管炎的疾病疗效、中医证候疗效、咳嗽与咯痰症状积分及曲线下面积(AUC)、咳嗽症状消失疗效,并进行安全性评价。结果疾病疗效的愈显率试验组与对照组分别为66.67%(78/117)和29.17%(35/120),中医证候疗效的愈显率试验组与对照组分别为68.38%(80/117)和27.50%(33/120),咳嗽与咯痰症状积分曲线下面积2组比较差异有统计学意义(P＜0.01),日间咳嗽消失率(痊愈)试验组与对照组分别为52.99%(62/117)和13.33%(16/120),夜间咳嗽消失率(痊愈)试验组与对照组分别为76.52%(88/115)和31.90%(37/116)。试验组未见不良反应。结论连花急支片治疗急性支气管-支气管炎能明显缓解临床症状,具有良好的临床疗效与安全性。
目的：初步評價連花急支片治療急性氣管-支氣管炎痰熱壅肺證的有效性和安全性。方法採用隨機雙盲、安慰劑對照、多中心臨床試驗的設計方法,將240例患者隨機分為試驗組和對照組各120例,納入全分析集237例,試驗組服用連花急支片,對照組服用安慰劑,均12片/d,療程7 d。觀察2組對急性氣管-支氣管炎的疾病療效、中醫證候療效、咳嗽與咯痰癥狀積分及麯線下麵積(AUC)、咳嗽癥狀消失療效,併進行安全性評價。結果疾病療效的愈顯率試驗組與對照組分彆為66.67%(78/117)和29.17%(35/120),中醫證候療效的愈顯率試驗組與對照組分彆為68.38%(80/117)和27.50%(33/120),咳嗽與咯痰癥狀積分麯線下麵積2組比較差異有統計學意義(P＜0.01),日間咳嗽消失率(痊愈)試驗組與對照組分彆為52.99%(62/117)和13.33%(16/120),夜間咳嗽消失率(痊愈)試驗組與對照組分彆為76.52%(88/115)和31.90%(37/116)。試驗組未見不良反應。結論連花急支片治療急性支氣管-支氣管炎能明顯緩解臨床癥狀,具有良好的臨床療效與安全性。
목적：초보평개련화급지편치료급성기관-지기관염담열옹폐증적유효성화안전성。방법채용수궤쌍맹、안위제대조、다중심림상시험적설계방법,장240례환자수궤분위시험조화대조조각120례,납입전분석집237례,시험조복용련화급지편,대조조복용안위제,균12편/d,료정7 d。관찰2조대급성기관-지기관염적질병료효、중의증후료효、해수여각담증상적분급곡선하면적(AUC)、해수증상소실료효,병진행안전성평개。결과질병료효적유현솔시험조여대조조분별위66.67%(78/117)화29.17%(35/120),중의증후료효적유현솔시험조여대조조분별위68.38%(80/117)화27.50%(33/120),해수여각담증상적분곡선하면적2조비교차이유통계학의의(P＜0.01),일간해수소실솔(전유)시험조여대조조분별위52.99%(62/117)화13.33%(16/120),야간해수소실솔(전유)시험조여대조조분별위76.52%(88/115)화31.90%(37/116)。시험조미견불량반응。결론련화급지편치료급성지기관-지기관염능명현완해림상증상,구유량호적림상료효여안전성。
Objective To evaluated the effectiveness and safety ofLianhua Jizhi Tablets for acute trachitis and bronchitis with syndrome of phlegm-heat obstructing.Methods A randomized double-blind, placebo-controlled and multi-center clinical trial design was selected. Totally 240 cases were randomly divided into experimental group and control group, 120 cases in each group, of which 237 cases were included in the analysis of FAS. Experimental group was givenLianhua Jizhi Tablets, while control group was given placebo, 12 tablets/day, 7 days for a course. Curative effect of acute trachitis and bronchitis, TCM syndrome and disappearance of cough, cough and sputum symptom scores and area under the curve (AUC) were observed. The safety was evaluated. Results The cure rates of disease in experimental group and control group were 66.67% (78/117) and 29.17% (35/120), respectively;cure rates of TCM syndrome in experimental group and the control group were 68.38% (80/117) and 27.50% (33/120), respectively;there was statistically significant difference in area under the curve of cough and sputum symptom score between the two groups (P<0.01). Disappearance rates (cure) of daytime cough in experimental group and control group were 52.99% (62/117) and 13.33% (16/120), respectively;disappearance rates (cure) of nocturnal cough in experimental group and control group were 76.52% (88/115) and 31.90% (37/116), respectively;there were no side effects in experimental group.ConclusionLianhua Jizhi Tablets can significantly relieve clinic symptoms in the treatment of acute trachitis and bronchitis, and have good clinical efficacy and safety.
