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为进一步评价表阿霉素上市以来的临床疗效和安全性,采用统一的设计方案,多中心临床研究协作组开展了前瞻性研究。共20个单位应用以表阿霉素为主的联合化疗方案,治疗了516例各类肿瘤,其中将表阿霉素代替阿霉素组成CEOP[环磷酰胺(CTX)、表阿霉素(EPI)、长春新碱(VCR)、泼尼松(PND)]方案治疗的恶性淋巴瘤213例中,完全缓解87例,部分缓解99例,有效率为87.3%;应用CEP[CTX、EPI、顺铂(PDD)]方案治疗的非小细胞肺癌161例,完全缓解2例,部分缓解71例,有效率为45.3%;采用EMF[EPI、氨甲喋呤(MTX)、5-氟脲嘧啶(5-FU)]方案治疗乳腺癌70例,完全缓解8例,部分缓解28例,有效率为51.4%。此外,对消化道癌、鼻咽癌也都有较好的效果。不良反应除消化道反应外,限制剂量提高的主要毒性为白细胞减少。以表阿霉素为主的化疗方案对肝功能和心电图影响轻微。结合文献报道,认为表阿霉素和阿霉素疗效相近,而心脏毒性较轻,因此可进一步增加剂量强度,从而达到在一定程度上提高临床疗效的目的。
To further evaluate the clinical efficacy and safety of epirubicin since its launch, a unified design scheme was adopted and a multicenter clinical research collaboration group conducted a prospective study. A total of 20 units were treated with epirubicin-based combination chemotherapy and 516 cases of various types of tumors were treated. Epirubicin instead of doxorubicin was used to compose CEOP [cyclophosphamide (CTX), epirubicin ( In the 213 cases of malignant lymphoma treated with EPI, vincristine (VCR), and prednisone (PND) regimens, 87 cases were completely relieved and 99 cases were partially relieved. The effective rate was 87.3%; CEP [CTX, EPI, cisplatin (PDD) regimen treatment of 161 cases of non-small cell lung cancer, complete remission in 2 cases, partial remission in 71 cases, the effective rate was 45.3%; using EMF [EPI, methotrexate (MTX), 5-fluorourea The pyrimidine (5-FU) regimen was used to treat 70 cases of breast cancer, with 8 cases of complete remission and 28 cases of partial remission, with an effective rate of 51.4%. In addition, it has a good effect on digestive tract cancer and nasopharyngeal cancer. Adverse reactions In addition to the digestive tract reaction, the main toxicity that limits the dose increase is leukopenia. The chemotherapy regimen based on epirubicin has little effect on liver function and electrocardiogram. Combined with reports in the literature, it is considered that epirubicin and adriamycin have similar curative effects, but the cardiotoxicity is lighter, so the dose intensity can be further increased, thereby achieving the purpose of improving the clinical curative effect to some extent.