Yura J, Shinagawa N, Ishikawa S, Nakamura A, Yoshimi O, Fukumoto I
Jpn J Antibiot. 1985 Sep;38(9):2622-9.
SM-4300, a newly developed human immunoglobulin preparation for intravenous use, has been evaluated clinically in 11 patients with severe bacterial infections in the combination therapy with antibiotics in the surgery. SM-4300 was administered to the patients, for whom antibiotics alone had not been effective, at a dosage of 2.5 or 5 g/day with continuous use of the same antibiotics. The results obtained were as follows: Clinical effects of SM-4300 were excellent in 1 case, good in 2, fair in 4, poor in 3 and unknown in 2. The efficacy rate was summarized as 30.0%, and the rate including fair response was 70.0%. No subjective and objective clinical side effect was observed. No abnormal laboratory finding was observed. Clinical usefulness of SM-4300 were usefulness in 3 cases, fairly usefulness in 2, useless in 3 and unevaluable in 4. The usefulness rate was 37.5%, and the rate including fairly usefulness was 62.5%. In conclusion, combination therapy with SM-4300 and antibiotics was considered to be safe and effective against severe bacterial infections in the surgery.
SM - 4300是一种新研发的静脉用人免疫球蛋白制剂,已在11例严重细菌感染患者中进行了临床评估,这些患者在外科手术中与抗生素联合使用。对于单独使用抗生素无效的患者,以2.5或5克/天的剂量给他们使用SM - 4300,并持续使用相同的抗生素。获得的结果如下:SM - 4300的临床效果为1例优秀,2例良好,4例中等,3例差,2例未知。有效率总计为30.0%,包括中等反应的比率为70.0%。未观察到主观和客观的临床副作用。未观察到实验室检查异常。SM - 4300的临床实用性为3例有用,2例相当有用,3例无用,4例不可评估。有用率为37.5%,包括相当有用的比率为62.5%。总之,SM - 4300与抗生素联合治疗被认为对外科手术中的严重细菌感染安全有效。