PURPOSE: The combination treatment for mix infantile hemangiomas (IHs) using oral propranolol with topical timolol maleate was not well documented in the literature. The aim of this study was to evaluate the therapeutic effects and safety of oral propranolol along with topical timolol maleate or oral propranolol alone for treating mixed IHs in the oral and maxillofacial regions. METHODS:Between March 2013 and June 2014, a total of 31 patients with mixed IHs in the oral and maxillofacial regions were recruited to the study and randomly divided into experimental and control groups. Fourteen patients in the experimental group (A) were treated withoral proranolol in combination with topical timolol maleate, and 17 patients in the control group (B) underwent orally proranolol treatment alone. The maximal treatment duration was planned for 8 months. Ultrasonography and serial photographs based on Visual Analogue Scale (VAS) were used to assess the effects of treatment before and after treatment, as well as adverse effects after medication were evaluated and managed accordingly. RESULTS: All patients completed treatment. Among the most patients, there was obvious fading of color or decrease in size of the IHs when compared with pretreatment. There was significant reduction of color fading in A (mean VAS score: 8.36 ± 1.39) than that in B (7.18 ± 1.71) (P = 0.043) after the end of treatment, whereas the reduction of sizes in A (8.00 ± 1.75) had no significant difference than that in B (7.59 ± 1.80) (P= .51). The treatment duration of A (5.64 ± 1.45) was shorter than that of B (6.71 ± 1.10) (P= .037). No major collateral effects were observed in both the groups throughout the course of treatment. CONCLUSIONS: Oral proranolol combined with topical timolol maleate was well tolerated and effective treatment, mild side effects, and especially gave rise to better clinical response in the treatment of mixed IHs than oral propranolol alone.
RCT Entities:
PURPOSE: The combination treatment for mix infantile hemangiomas (IHs) using oral propranolol with topical timolol maleate was not well documented in the literature. The aim of this study was to evaluate the therapeutic effects and safety of oral propranolol along with topical timolol maleate or oral propranolol alone for treating mixed IHs in the oral and maxillofacial regions. METHODS: Between March 2013 and June 2014, a total of 31 patients with mixed IHs in the oral and maxillofacial regions were recruited to the study and randomly divided into experimental and control groups. Fourteen patients in the experimental group (A) were treated with oral proranolol in combination with topical timolol maleate, and 17 patients in the control group (B) underwent orally proranolol treatment alone. The maximal treatment duration was planned for 8 months. Ultrasonography and serial photographs based on Visual Analogue Scale (VAS) were used to assess the effects of treatment before and after treatment, as well as adverse effects after medication were evaluated and managed accordingly. RESULTS: All patients completed treatment. Among the most patients, there was obvious fading of color or decrease in size of the IHs when compared with pretreatment. There was significant reduction of color fading in A (mean VAS score: 8.36 ± 1.39) than that in B (7.18 ± 1.71) (P = 0.043) after the end of treatment, whereas the reduction of sizes in A (8.00 ± 1.75) had no significant difference than that in B (7.59 ± 1.80) (P= .51). The treatment duration of A (5.64 ± 1.45) was shorter than that of B (6.71 ± 1.10) (P= .037). No major collateral effects were observed in both the groups throughout the course of treatment. CONCLUSIONS: Oral proranolol combined with topical timolol maleate was well tolerated and effective treatment, mild side effects, and especially gave rise to better clinical response in the treatment of mixed IHs than oral propranolol alone.