国产一类抗癌新药盐酸博安霉素Ⅱ期临床研究

Phase Ⅱ Clinical Study of a New Anticancer Drug Boanmycin

目的 对国产一类抗癌新药盐酸博安霉素（ＢＡＭ）治疗中、晚期恶性肿瘤的临床疗效和毒性进行评价。方法 对多中心应用ＢＡＭ 治疗中、晚期恶性肿瘤的效果进行Ⅱ期临床分析。全组３２５例，其中单用ＢＡＭ 治疗者１０５例，与其他药物联合治疗者２２０例。结果 单一用药的总有效率为３５％ ，对恶性淋巴瘤、头颈部癌和乳腺癌的有效率分别为６６７％ 、６５０％ 和３７５％ ；联合用药的总有效率为６４２％ ，对恶性淋巴瘤、乳腺癌、头颈部癌、食道癌和肺癌的有效率分别为８８５％ 、６２５％ 、５００％ 、４７２％ 和４５８％ 。盐酸博安霉素的主要不良反应有发热、寒战、肌肉疼痛、消化道反应、注射局部及皮肤反应，大多为Ⅰ～Ⅱ度。未见有骨髓抑制及肝肾功能损害。肺毒性显著低于博来霉素、培洛霉素及平阳霉素。结论 盐酸博安霉素对恶性淋巴瘤、头颈部癌、乳腺癌。

Objective To evaluate the efficacy of boanmycin (BAM) in patients with advanced cancers. Methods A multicenter phase Ⅱ clinical study on BAM was conducted on 105 cases received BAM as single agent,and 220 cases were treated with combination chemotherapy containing BAM. Results The total response rate was 35 0% for single agent and 64 2% for combination chemotherapy group in advanced cancers.The response rate for single agent in malignant lymphoma,cancer of head and neck and breast cancer was 66 7%,65 0% and 37 5%,respectively;and for combination chemotherapy group in malignant lymphoma,breast cancer,head and neck cancer,esophageal cancer and lung cancer was 88 5%,62 5%,50 0%,47 2% and 45 8%,respectively.The main side effects with mild or moderate fever,chill,myalgia,gastrointestinal reactions,skin pigmentation as well as hardening of skin at injection site. Conclusions BAM therapy was effective in malignant lymphoma,cancer of head and neck and other cancers.