重组人p53腺病毒联合顺铂治疗NSCLC合并胸腔积液临床研究

Clinical research on recombinant human Ad-p53 pleural injection combined with cisplatin in treatment of non-small cell lung cancer with malignant pleural effusion

目的本研究评价重组人p53腺病毒注射液(rAd-p53)联合顺铂治疗肺癌所致胸腔积液的临床疗效和毒副反应。方法将38例非小细胞肺癌(NSCLC)合并胸腔积液患者随机分为治疗组和对照组两组。所有患者均在第1、8 d应用吉西他滨1.0 g/m2静脉点滴,每3周重复1次。在上述治疗基础上,治疗组胸腔内注入rAd-p53 1×1012 VP和顺铂30 mg/m2每次;对照组仅胸腔内注入顺铂30 mg/m2每次,两组均每周重复1次,连用4次后观察疗效。结果治疗组和对照组的有效率分别为80.95%和47.06%(P<0.05);治疗组和对照组的一般状况改善率分别为66.67%和29.41%(P<0.05);两组患者主要不良反应均为发热、胸痛、消化道反应及白细胞减少,治疗组发热的发生率高于对照组(P<0.05),主要为自限性,36 h后一般都能自行恢复。结论重组人p53腺病毒注射液联合顺铂治疗肺癌所致胸腔积液疗效确切,安全,值得临床推广使用。

Objective To evaluate the clinical efficacy and toxicity of recombinant human Ad-p53 pleural injection（rAd-p53）combined with cisplatin in treatment of non-small cell lung cancer with malignant pleural effusion.Methods A total of 38 cases of non-small cell lung cancer with malignant pleural effusion were randomly divided into the treatment group（n=21） and the control group（n=17）.On the basis of systemic treatment（Gemcitabine 1.0 g/m2,Days 1,8,every 3 weeks）,the intrathoracic injection of rAd-p53（1×1012 VP）and cisplatin（30 mg/m2）once a week for 4 weeks were given in the treatment group.The control group were given the intrathoracic injection of cisplatin（30 mg/m2）once a week for 4 weeks only.Results The total effective rate in the treatment group was significant higher then that in the control group（80.95% to 47.06%,P〈0.05）.The improvement rate of patients general state in the treatment group also increasd more then that in the control group（66.67% to 29.41%,P〈0.05）.The main toxicities of patients in the two groups were fever,stethalgia,nausea,vomiting and leukopenia.The fever reaction in treatment group was appeared more then that in the control,but most manifesting self-limited fever（P〈0.05）which disappeared automatically after 36 hours.Conclusions rAd-p53 and cisplatin is safe and effective treatment to non-small cell lung cancer with malignant pleural effusion,which is worthy of application in clinical.