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1996年7月～1997年6月,对康莱特注射液进行Ⅲ期临床研究。全组34例,按实体瘤疗效评定标准判断疗效,PR8例(23.5％)。治疗前后对比主观症状明显改善,症状缓解率>50％。治疗后生存质量明显提高,KPS记分提高>10分24例(70.6％),对造血系统无损伤,并具有骨髓保护作用,治疗后外周血白细胞、血小板及血红蛋白值较治疗前提高,具有统计学意义。结果表明,康莱特具有确切的抗癌作用,能明显改善主观症状,提高患者生存质量,保护骨髓造血功能,值得临床推广应用,尤其适用于晚期恶性肿瘤患者的治疗。
From July 1996 to June 1997, Phase III clinical study of Kanglaite Injection was conducted. In the whole group of 34 patients, the curative effect was judged according to the evaluation criteria of the curative effect of solid tumors, 8 cases of PR (23.5%). The subjective symptoms were significantly improved before and after treatment, and the symptomatic remission rate was >50%. After the treatment, the quality of life was significantly improved. The KPS score was improved by >10 points and 24 cases (70.6%). There was no damage to the hematopoietic system and bone marrow protection. After treatment, peripheral blood leukocytes, platelets, and hemoglobin values were improved compared with before treatment. significance. The results show that Kanglaite has the exact anti-cancer effect, can significantly improve the subjective symptoms, improve the quality of life of patients, protect bone marrow hematopoietic function, it is worthy of clinical application, especially for the treatment of patients with advanced malignant tumors.