Intralesional injection of compound betamethasone for the treatment of keloid and hyperplastic scar: a multi-center study

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Author:
ZONG Wen-hai(Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China)
YU Hao()
LOU Dong-hua()
CAO Yuan-hua(Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China)
CHEN Zhi-qiang(Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China)
WANG Bao-xi(Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China)
LI Hong-chun()
GU Jun()
CHEN Jie()
WEN Hai()
GU Ju-lin()
Journal Title:
INTERNATIONAL JOURNAL OF DERMATOLOGY AND VENEREOLOGY
Issue:
Volume 37, Issue 03, 2011
DOI:
10.3760/cma.j.issn.1673-4173.2011.03.001
Key Word:
Keloid;Hyperplasia;Betamethasone;Multicenter studies

Abstract: Objective To compare the safety and efficacy of home - made and imported (diprospan) compound betamethasone injection in the treatment of keloid and hypeiplastic scar. Methods A multi-center, randomized, blind, positive-controlled, parallel-group clinical study was conducted. Patients with keloid or hyperplastic scar were divided into test and control groups to receive intralesional injection of compound betamethasone made in China and Schering-Plough Labo N.V. Belgium, respectively. A lesion without ulceration was selected as the target lesion for the evaluation of symptom and signs of patients at the beginning of the treatment (DO), on day 21 (D21), 42 (D42) and 63 (D63) after the initiation of treatment. Results A total of 144 patients were enrolled, and 133 patients, including 64 in the control group and 69 in the study group, completed the trial. The improvement rate was 61.11% in the control group and 65.28% in the test group (x2 = 0.27, P = 0.6071), and the cure rate was 2.78% in the control group, 0.00% in the test group (P =0.4965), indicating that there was no statistically significant difference in the efficiency between the domestic and imported injection (P> 0.05). There were 3 (4.17%) cases of adverse reaction in the test group, and no statistical difference was noted in the occurrence of side effects between the two groups (P = 0.2448). Conclusion The local injection of domestic compound betamethasone shows a favorable efficacy and safety, which are comparable to those of diprospan, in the treatment of keloid and hyperplastic scar.

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