重组人p53腺病毒注射液联合化疗治疗恶性胸腔积液临床观察

目的观察重组人p53腺病毒注射液联合化疗治疗非小细胞所致恶性胸腔积液的疗效及不良反应。方法将60例非小细胞肺癌伴恶性胸腔积液患者随机分为二组。观察组：化疗加重组人p53腺病毒注射液，化疗方案为DP方案：多西他赛75mg／m2，第一天静滴；顺铂40mg／（m2·d），第一、八天胸腔注射，胸膜腔注射重组人p53腺病毒注射液2x10”VP，72h后胸腔注射顺铂。对照组：DP方案化疗，多西他赛75mg／m2；第一天静滴，顺铂40mg／（m2·d），第一、八天胸膜腔注射。二组治疗皆为21d一周期，二个周期评价疗效。结果观察组获得完全缓解（CR）3例，部分缓解（PR）18例，稳定（SD）8例，进展（PD）1例，总有效率70．00％。对照组：CR2例，PR11例，SD14例，PD3例，总有效率43．33％，差异有统计学意义（P〈0．05）；观察组患者整体生活质量改善与对照组相比差异有统计学意义（P〈0．05）。二组患者主要不良反应为发热、细胞减少及消化道反应，观察组发热的发生率高于对照组差异有统计学意义（P〈0．05），主要为自限性发热，36h后自行恢复正常，白细胞减少及消化道反应差异无统计学意义（P〉0．05）。结论重组人p53腺病毒注射液胸腔内注射联合化疗治疗恶性胸腔积液的疗效优于单纯化疗，未见明显不良反应，值得进一步推广。

CLINICAL OBSERVATION OF RECOMBINATIONAL HUMAN p53 ADENOVIRUS INJECTION COMBINED WITH CHEMOTHERAPY IN TREATMENT OF MALIGNANT PLEURAL EFFUSION

Objective To evaluate the clinical efficacy and toxicity of Recombinant human p53 Adv in- jection （rAd-p53）combined with cisplatin in treatment of malignant pleural effusion induced by lung cancer. Methods A total of 60 cases of malignant pleural effusion were randomly divided into the co -mbined group（n = 30） and the single- agent group （n = 30）. On the basis of systemic treatment （Do- eetaxel injection： 75mg/m2 on day 1, every 3 weeks, eisplatin： 40mg/m2, day 1, 8）, the combined group were given intracavitary administration of tad - p53 （2× 1012 VP）, the single - agent group were given the same intracavitary administration as the combined group but without tAd - p53 thera- py. Results The total effective rates in the combined group and the single- agent group were 70.00% and 43.33% （P〈0.05）, respectively. The total modification rates in the combined group were higher than the single- agent group （P〈0. 05）. The toxicities in the two groups were fever, stethalgia, nau- sea/vomiting and leueopenia. The toxic reaction in combined group was mainly self- limited fever （P 〈0. 05）, which disappeared automatically after 36h. Concision rAd - p53 and cisplatin is safe and effective for malignant pleural effusion induced by lung cancer. It is worthy of application in clinical treatment.