Nakao I, Uchino H, Orita K, Kaido I, Kimura T, Goto Y, Kondo T, Takino T, Taguchi T, Nakajima T, Fujimoto S, Miyazaki T, Miyoshi A, Yachi A, Yoshida K, Ogawa N, Furue H
Gan To Kagaku Ryoho. 1983 Apr;10(4 Pt 2):1146-59.
To clarify the clinical efficacy of SPG, a beta-1, 3 glucan extracted from cultured Schizophyllum commune Fries, a randomized comparative study was performed in combination with mitomycin C+5-fluorouracil (MF protocol) or tegafur (F protocol). A total of 514 cases with inoperable or recurrent gastric cancer were randomly allocated to either the SPG group or the control group, 367 of which were finally assessed for clinical efficacy. SPG was intramuscularly given at a dose of 20 mg twice a week or 40 mg once a week. Significant prolongation of life span was confirmed in the SPG group (MF protocol: p less than 0.01, F protocol: p less than 0.05), although the combination of SPG did not demonstrate a remarkable antitumor effect in both MF and F protocols. Among immune response parameters tested, the positive reactions in the PHA skin test were maintained in the SPG group and decreases in lymphocyte counts were inhibited by SPG in the MF protocol. Side effects associated with SPG therapy were noted in 6 of 258 cases treated with SPG. From these results, it is indicated that the combination of SPG and the chemotherapeutic agents may be useful in treating patients with inoperable or recurrent gastric cancer.
为阐明裂褶菌多糖（SPG，一种从培养的裂褶菌中提取的β-1,3-葡聚糖）的临床疗效，开展了一项随机对照研究，将其与丝裂霉素C + 5-氟尿嘧啶（MF方案）或替加氟（F方案）联合使用。总共514例无法手术或复发的胃癌患者被随机分配至SPG组或对照组，最终对其中367例进行了临床疗效评估。SPG采用肌肉注射给药，剂量为每周两次20mg或每周一次40mg。尽管在MF和F方案中，SPG联合使用均未显示出显著的抗肿瘤效果，但在SPG组中证实了生存期有显著延长（MF方案：p<0.01，F方案：p<0.05）。在检测的免疫反应参数中，SPG组维持了PHA皮肤试验的阳性反应，并且在MF方案中，SPG抑制了淋巴细胞计数的下降。在接受SPG治疗的258例患者中，有6例出现了与SPG治疗相关的副作用。从这些结果表明，SPG与化疗药物联合使用可能对治疗无法手术或复发的胃癌患者有用。
