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首页> 外文期刊>Arzneimittel-Forschung: =Drug Research >Efficacy and tolerability of ambroxol hydrochloride lozenges in sore throat. Randomised, double-blind, placebo-controlled trials regarding the local anaesthetic properties.
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Efficacy and tolerability of ambroxol hydrochloride lozenges in sore throat. Randomised, double-blind, placebo-controlled trials regarding the local anaesthetic properties.

机译：盐酸氨溴索锭剂在喉咙痛中的功效和耐受性。关于局部麻醉剂性质的随机，双盲，安慰剂对照试验。

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摘要

Two confirmatory clinical trials were performed to investigate the efficacy and tolerability of ambroxol lozenges at doses of 20 mg and 30 mg relative to placebo in relieving the symptoms of sore throat of at least moderately severe intensity in patients suffering from oro-pharyngeal catarrh accompanied by pain on swallowing, feeling of scratchiness, burning and urge to cough. OBJECTIVE: Description and comparison of the efficacy and tolerability of lozenges containing 20 mg or 30 mg ambroxol hydrochloride (trans-4-[(2-amino-3,5-dibrom-benzyl)amino]cyclohexano hydrochloride, CAS 18683-91-5) in relieving acute sore throat, in comparison to placebo. DESIGN: Two similar, multi-centre, prospective, placebo-controlled, randomised, double-blind trials involving three days of treatment with up to 6 lozenges containing 20 or 30 mg ambroxol hydrochloride per day. SUBJECTS: There were enrolled three-hundred-thirty-one (331, study I) and three-hundred-eighty-three (383, study II) outpatients with acute uncomplicated sore throat of at least moderately severe intensity which is not suspected to be due to bacterial pharyngitis. TREATMENTS: Double-blind treatment with up to six lozenges per day containing either 20 mg or 30 mg ambroxol hydrochloride or placebo (a lozenge with a distinct minty flavour). MAIN OUTCOME MEASURES: The time-weighted average pain relief over the first 3 h after the first lozenge as a ratio of the baseline pain intensity of sore throat (SPIDnorm) and the patients' evaluation of efficacy and tolerability at the end of each day of the three days treatment. RESULTS: All treatments led to a reduction of pain intensity; the means (+/- SD) SPIDnorm after the 1st lozenge were 0.53 +/- 0.28 or 0.50 +/- 0.30 or 0.38 +/- 0.28 with 20 mg or 30 mg ambroxol hydrochloride or placebo respectively in study I, and 0.53 +/- 0.30 or 0.60 +/- 0.28 or 0.39 +/- 0.31 in study II; the effect of treatment was statistically significant (p: 0.0002 or p: 0.0033 in study I and p: 0.0005 or p: 0.0001 in study II, respectively, for the comparison of 20 mg or 30 mg ambroxol hydrochloride vs. placebo). The improvement with the active treatments was greater than with placebo (95% confidence interval (CI) estimates of the mean treatment differences vs. placebo were 0.08 to 0.23 or 0.05 to 0.20 for lozenges with 20 mg or 30 mg ambroxol hydrochloride, respectively, in study I, and 0.06 to 0.21 or 0.13 to 0.28 in study II). At the end of each subsequent ambulatory treatment day with up to six lozenges per day, a statistically significantly higher proportion of patients scored a higher level of efficacy for the active treatments with ambroxol hydrochloride compared to placebo. The treatments investigated were equally well tolerated. CONCLUSIONS: Sucking lozenges containing 20 mg or 30 mg ambroxol hydrochloride has a beneficial pain-relieving effect in patients with acute sore throat, superior to that achieved by sucking a placebo lozenge. While both strengths were equally well tolerated, the higher strength of 30 mg ambroxol hydrochloride did not prove more effective. The findings confirm that the previously discovered local anaesthetic properties of ambroxol hydrochloride do have beneficial clinical implications.
机译：进行了两项验证性临床试验，以研究20mg和30mg剂量的氨溴索锭剂相对于安慰剂在缓解咽咽粘膜炎伴痛患者中至少中等强度的咽痛症状方面的功效和耐受性吞咽，抓痒，灼热和咳嗽。目的：描述和比较含20 mg或30 mg盐酸氨溴索（反式-4-[（2-氨基-3,5-二溴-苄基）氨基]环己醇盐酸盐，CAS 18683-91-5）的锭剂的功效和耐受性），与安慰剂相比，可减轻急性喉咙痛。设计：两项类似，多中心，前瞻性，安慰剂对照，随机，双盲试验，涉及三天的治疗，每天服用6片含20或30毫克盐酸氨溴索的锭剂。研究对象：三百三十一（331，研究一）和三百八十三（三，研究二）门诊患者，急性急性并发性咽喉炎的强度至少为中度至重由于细菌性咽炎。处理：每天最多六片含20毫克或30毫克盐酸氨溴索或安慰剂（含明显薄荷味的锭剂）的双盲治疗。主要观察指标：第一次锭剂后3小时内的时间加权平均疼痛缓解率，以喉咙痛的基线疼痛强度（SPIDnorm）与患者每天结束时疗效和耐受性的评估之比三天的治疗。结果：所有治疗均导致疼痛强度降低;在研究I中，第一次锭剂后的SPIDnorm平均值分别为0.53 +/- 0.28或0.50 +/- 0.30或0.38 +/- 0.28和20 mg或30 mg盐酸氨溴索或安慰剂，和0.53 +/- -研究II中的0.30或0.60 +/- 0.28或0.39 +/- 0.31;治疗效果在统计学上具有显着意义（将20 mg或30 mg盐酸氨溴索与安慰剂进行比较，研究I中的p：0.0002或p：0.0033，研究II中的p：0.0005或p：0.0001）。与安慰剂相比，积极治疗的改善更大（95％置信区间（CI）与安慰剂相比，含20毫克或30毫克盐酸氨溴索的锭剂的平均治疗差异估计为0.08至0.23或0.05至0.20。研究I，以及研究II中的0.06至0.21或0.13至0.28）。在随后的每天不超过六个锭剂的非卧床治疗日结束时，与安慰剂相比，统计学上显着更高比例的盐酸氨溴索有效治疗患者的疗效得分更高。研究的治疗方法同样耐受良好。结论：吸入含20 mg或30 mg盐酸氨溴索的锭剂对急性喉咙痛患者具有良好的止痛效果，优于通过吸入安慰剂锭剂获得的效果。尽管两种强度的耐受性均相同，但较高的30 mg盐酸氨溴索的强度并未证明更有效。这些发现证实了先前发现的盐酸氨溴索的局部麻醉特性确实具有有益的临床意义。

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