目的：评估双衣开音颗粒治疗声门闭合不良型声嘶的有效性与安全性。方法随机、开放、对照，总计100位声门闭合不良型声嘶患者参与研究，随机分配服用对照药清喉利咽颗粒或者实验药双衣开音颗粒，实验组80例，对照组20例。安全性研究主要终点为随访第3个月受试者主诉不适为主，辅以实验室、心电图等检查。有效性研究主要终点为随访第3个月受试者嗓音嘶哑评估GRBAS评分变化、受试者主观感受评分变化及最长发声时间（MPT）、基频微扰（jitter）、振幅微扰（shimmer）等客观嗓音学指标变化。结果实验组临床疗效总有效率为58.75%，对照组总有效率15.00%，两组相比较有显著性差异（P<0.001）。实验组经治疗后嗓音评价主客观治疗指标VHI、MPT (P<0.01), G、shimmer、声强（P<0.001）均有改善，jitter、F0差异不明显（P>0.05）。对照组VHI、G、MPT、jitter、shimmer、声强、F0均无明显差异（P>0.05）。本研究过程中除1例患者短暂胃部不适外，其余均无不良主诉。结论双衣开音颗粒治疗声门闭合不良型声嘶疗效显著，安全性良好，值得在临床上推广使用。%Objective To evaluate the efficacy and safety of“Shuang Yi Kai Yin Granule (SYKYG)” on hoarseness induced by glottal incompetence. Methods One hundred patients with hoarseness induced by glottal incompetence were randomly assigned to 2 groups, with 80 patients in treating group (TG) and 20 patients in control group (CG). Cases in TG were given SYKYG orally, while those in CG were treated by orally taken compound Chinese herbal“Qing Hou Li Yan Granule (QHLYG)”. All these cases were followed up for 3 months. When following up period ended, they were asked complaints of discomfort for security research, and examined to test such parameters as GRBAS, voice handicap index (VHI), and maximum phonation time (MPT), jitter, shimmer for voice rehabilitation level evaluated both objectively and subjectively. Results The total effective rate was 58.75% in TG but 15% in CG, and the difference was significant between the two groups (P<0.001). The subjective and objective indicators of voice evaluation such as VHI, MPT (P<0.01), G, shimmer and sound intensity (P<0.001)in TG were significantly different, not the same of jitter and F0 (P>0.05). But none of the difference of these indicators in CG was obvious (P>0.05). Except one case of transient stomach discomfort, the rest had no complaint in the study. Conclusion SYKYG is effective in the treatment of hoarseness induced by glottal incompetence without side effects, which is worthy of promotion in clinical use.
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