通过联合使用吸入型异丙托溴铵及硫酸沙丁胺醇控制感染后咳嗽:一项随机、空白对照、双盲临床试验
2014/10/17
摘要
病毒感染后咳嗽是一种由上呼吸道感染引起,且在解决感染问题后持续存在的咳嗽类型。尽管有假设提出支气管扩张剂或可控制病毒感染后咳嗽,但却未有研究明确证实其有效性。因此,本随机、双盲、对照临床试验旨在检验联合使用一种β受体激动剂及一种抗胆碱药物是否能有效减轻病毒感染后咳嗽。试验中,实验组患者将接受10天1.875毫克/0.5毫升硫酸沙丁胺醇及0.375毫克/0.5毫升异丙托溴铵联合雾化吸入治疗,而对照组则吸入安慰剂,治疗结束后随访10天。分别在治疗开始前、治疗10天后、治疗20天后,测试评估白天及夜间咳嗽症状严重程度,并进行肺功能检测。92位患者被随机分为对照组(共46名)及实验组(共46名);其中9名患者(4名空白组,5名实验组)被排出该试验。试验期间,两组患者白天及夜间咳嗽症状的严重程度均明显减轻,但治疗10天后,实验组的咳嗽减轻状况更加显著(白天咳嗽,P=0.003;夜间咳嗽,P=0.061),而在随访的最后一段时期,两组间咳嗽症状的严重程度大致相同。与对照组相比,实验组患者肺功能指数小幅上升,且具有统计学意义,但在随访结束时无明显差异。两组患者不良反应发生率无明显差异。研究结果提示联合使用β受体激动剂和抗胆碱药物可显著减轻病毒感染后咳嗽症状,可作为该类咳嗽的一种有效治疗选择。
(刘国梁 审校)
PulmPharmacolTher.2014Aug8.pii:S1094-5539(14)00089-3.doi:10.1016/j.pupt.2014.07.008. [Epub ahead of print]
A randomized, placebo-controlled, double-blind trial on the management of post-infectivecough by inhaled ipratropium and salbutamol administered in combination.
Zanasi A1, Lecchi M2, Del Forno M3, Fabbri E4, Mastroroberto M5, Mazzolini M6, Pisani L7, Pandolfi P8, Nava S9, Morselli-Labate AM10.
ABSTRACT
Post-viral cough is a type of cough originating from upper respiratory tract infections that persists after the infection is resolved. Although it was hypothesized that bronchodilators might have a role in the management of post-viral cough, a clear demonstration of their efficacy is missing. Therefore, we tested the efficacy of a combination of a β-agonist and an anticholinergic agent in reducing post-viral cough with a randomized, double blind, placebo controlled clinical trial. Patients were treated for 10 days with either a nebulized combination of salbutamol 1.875 mg/0.5 mL and ipratropium bromide 0.375 mg/0.5 mL, or a placebo, and followed up for another 10 days. Daytime and nighttime cough severity and spirometry testing were assessed before starting treatment, after 10 and 20 days. Ninety-two patients were randomized to receive placebo (n = 46) or the active treatment (n = 46); nine of them (4 in the placebo group, 5 in the active treatment group) dropped out from the study. Daytime and nighttime cough severity were significantly reduced in both groups during the study period, but the reduction was more prominent in the active treatment group vs. placebo after 10 days of treatment (P = 0.003 for day cough; P = 0.061 for night cough), whereas at the end of follow-up period cough severity was comparable between the two groups. Small but significant increases in spirometric parameters were observed in the active treatment vs. placebo group, although at the end of follow-up these values returned to be comparable to placebo. The frequency of adverse events was not significantly different between the two groups of patients. We concluded that a combination of a β-agonist and an anticholinergic agent can effectively reduce post-viral cough, and can thus represent a valid option for this type of cough.
PulmPharmacolTher.2014Aug8.pii:S1094-5539(14)00089-3.doi:10.1016/j.pupt.2014.07.008. [Epub ahead of print]
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