红色诺卡菌细胞壁骨架加顺铂胸腔内注射治疗恶性胸腔积液36例

Efficacy and safety of nocardia rubra-cell wall skeleton combined with cisplatin in treatment of pleural effusion

目的:探讨国产红色诺卡菌细胞壁骨架(胞必佳)加顺铂对恶性肿瘤患者胸腔积液的疗效和安全性。方法:68例患者随机分为治疗组36例和对照组32例。治疗组于胸腔积液引流后用胞必佳600μg,顺铂40～60mg,地塞米松10mg,利多卡因10mL,生理氯化钠溶液40mL,胸膜腔内注射,每周1～2次,连续2～6次。对照组除不用胞必佳外外,其他治疗同治疗组。给药后每周查血、尿常规及肝肾、心功能,详细记录胸腔内给药前后的有关症状;给药后3d和2周、4周分别作B超检查。结果:治疗组有效率94.4%,对照组有效率46.9%,治疗组疗效明显优于对照组(P<0.01)。两组药物不良反应均表现为呕吐、胸痛、发热和白细胞减少等,对照组发生率较低,但与治疗组比较无显著差异。结论:胞必佳加顺铂胸腔内注射治疗恶性胸腔积液明显优于单用顺铂组,方法较为简便、安全,适用于临床推广。

Objective: To evaluate the efficacy and safety of nocardic rubra-cell wall skeleton plus cisplatin in the treatment of pleurai effusion for patients with malignant tumor. Methods: 68 patients with malignant tumor were randomized to treatment group (n=36) or control group (n=32). The treatment group was intrapleurally injected with a drug regimen containing nocardia rubra-cell wall skeleton (600μg), cisplatin (40～60mg), dexamethason (10mg), lidocaine (10mL) and normal saline (40mL) after removal of pleural effusion 1 times every week for 2 to 6 weeks. The control group had the same therapeutic regimen as treatment group except no administration of nocardia rubra-cell wall skeleton. The evaluation of efficacy and safety resulted from blood and urine tests, examinations of liver, kidney and cardiac function after the administration of study drug in each group. Ultrasonography was performed in day 3, and weeks 2 and 4 after the therapy. Results: A significant efficacy rate in treatment group was observed compared with the one in control group (94.4 percent versus 46.9 percent, P<0.01). The common adverse events patients experienced in treatment group and control group were vomit (36.1% vs. 31.2%), chest pain (80.5% vs. 65.6%), fever (55.5% vs. 37.5%) and leukopenia (19.4% vs. 18.7). Conclusion: Combination of nocardia rubra-cell wall skeleton with cisplatin was more superior to cisplatin alone in the treatment of pleural effusion due to malignant tumor.