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Optimal Dosage of Botulinum Toxin Type A for Treatment of Glabellar Frown Lines: Efficacy and Safety in a Clinical Trial

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机构: [1]Department of Dermatology, General Hospital of PLA, Beijing, China [2]Department of Dermatology, Peking Union Medical College Hospital (PUMCH), Beijing, China [3]Department of Dermatology, The First Affiliated Hospital of Kunming Medical University, Kunming, China [4]Department of Dermatology, Peking University First Hospital, Beijing, China [5]Department of Dermatology, Xiangya Hospital, Central South University, Changsha, China [6]Department of Dermatology, Air Force General Hospital, PLA, Beijing, China [7]Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China [8]Peking University Clinical Research Institute, Beijing, China
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BACKGROUND Various preparations of botulinum toxin type A (BTX-A) are used to reduces glabellar (frown) lines. However, dose-related safety and efficacy of intramuscular injections of a widely used, locally produced BTX-A in China has not been established. OBJECTIVE Assessment of dose-dependent safety and efficacy of Chinese botulinum toxin type A (Hengli BTX-A [HBTX-A]) intramuscular injections on glabellar lines. METHODS Four hundred eighty-eight BTX-A-naive participants were included in the double-blind trial and randomly divided into placebo (n = 122), low-dose (n = 183), and high-dose (n = 183) treatment groups for injection with saline solution, 10 units and 20 units of HBTX-A, respectively, at 4 sites in the corrugator muscle and 1 site in the procerus muscle. Outcomes were recorded before treatment and after 7, 30, 60, and 120 days, including glabellar line severity at maximum contraction and relaxation. RESULTS Significantly greater improvement was observed in both HBTX-A groups in comparison with the placebo group (p <.05). Better efficacy was obtained in the high-dose treatment group. More participants developed adverse events after treatment with HBTX-A doses, than with the placebo (p <.05). CONCLUSION Twenty-unit HBTX-A provided optimal improvement in glabellar lines, and its use might minimize injection frequency while maintaining acceptable safety.

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出版当年[2016]版:
大类 | 3 区 医学
小类 | 3 区 皮肤病学 3 区 外科
最新[2023]版:
大类 | 3 区 医学
小类 | 3 区 皮肤病学 3 区 外科
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出版当年[2015]版:
Q2 SURGERY Q2 DERMATOLOGY
最新[2023]版:
Q1 SURGERY Q2 DERMATOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2015版] 出版当年五年平均 出版前一年[2014版] 出版后一年[2016版]

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第一作者机构: [1]Department of Dermatology, General Hospital of PLA, Beijing, China
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通讯机构: [*1]Department of Dermatology, General Hospital of PLA, Beijing 100853, China
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