复方倍他米松注射液局部注射治疗瘢痕疙瘩和增生性瘢痕的多中心研究

目的评价国产复方倍他米松注射液局部注射治疗瘢痕疙瘩和增生性瘢痕的安全性和疗效,并与进口复方倍他米松注射液(得宝松)进行对照.方法本研究采用多中心、随机盲法、阳性药物平行对照的临床研究方法.受试者分别接受国产复方倍他米松注射液和得宝松注射液治疗.在治疗前、治疗3、6,9周,选择一处无破溃皮损作为观察的靶皮损,观察临床症状和体征.结果本临床试验共入组病例144例,完成试验病例133例,其中对照组64例,试验组69例.试验结束时FAS分析临床疗效有效率(对照组为61.11%,试验组为65.28%,x3=0.27,P=0.6071)、痊愈率(对照组为2.78%,试验组为0.00%,P=0.4965)提示试验组和对照组疗效相当,经检验差异均无统计学意义(P>0.05).安全性方面,试验组共有3例不良反应发生,不良反应发生率为4.17%,两组不良反应发生情况比较差异无统计学意义(P=0.2448).结论国产复方倍他米松注射液局部注射治疗瘢痕疙瘩和增生性瘢痕安全有效,与得宝松相当.

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.

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

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.