A群链球菌冻干制剂联合顺铂治疗恶性胸腔积液临床观察

目的　观察A群链球菌冻干制剂 (沙培林 )联合中、小剂量顺铂治疗恶性胸腔积液的临床疗效及毒副反应。方法　选择由组织学和 (或 )细胞学诊断的恶性胸腔积液病人 6 9例 ,随机分为两组 ,采用胸腔穿刺 ,置入中心静脉导管持续闭式引流胸液。治疗组 (35例 ) :以青霉素皮试为阴性 ,取沙培林 10KE ,顺铂 80mg胸腔内注射 ;对照组 (34例 ) :单用顺铂 80mg胸腔内注射。上述治疗每周 1～ 2次 ,最多 3次。 结果　治疗组完全缓解率及总有效率分别为 4 5 7% (16 / 35 )、88 6 % (31/ 35 ) ,明显优于对照组的 17 6 % (6 / 34)、5 8 8% (2 0 / 34) ,差异有显著意义 (P <0 0 5 )。两组毒副反应主要为轻度消化道反应、白细胞降低、发热、胸痛。结论　沙培林和顺铂联合应用治疗恶性胸腔积液能起相互协同作用 ,具有较高的疗效 ,毒副反应轻 ,值得临床广泛应用。

Clinical efficacy of OK-432 and cisplatin in the treatment of malignant pleural effusion

Objective To evaluate therapeutic effects and toxicities of picibanil(OK-432) plus moderate or low dose cisplatin(DDP) in the treatment of malignant pleural effusion.Methods 69 patients with malignant pleural effusion were randomized into two groups,and then,they were placed the center vein catheter into the pleural cavity by pleurocentesis and closed-drainage contiuously.Treatment group:35 cases treated by intrapleural administration of OK-432(10KE) plus DDP(80mg) with negative penicillin skin test.Control group:34 cases,only received DDP 80mg.The treatment was repeated one to three times every week.Results It showed that the complete remission rate(CR) and overall response rate(CR PR) of treatment group were 45.7%(16/35),88.6%(31/35),respectively,versus 17.6%(6/34) and 58.8%(20/34) in control group.There were statistically significant differences between the two groups(P<0.05).The main side-effect of two groups were mild gastrointestinal reaction,leukopenia,fever and chest pain.Conclusion It seems that combination therapy of OK-432 plus DDP can produce synergetic action,which is more effective,well tolerated and worthy to be used extensively in the clinical practice.