洛铂腔内灌注治疗恶性胸腹腔积液的临床观察及安全性研究

目的探讨洛铂（LBP）、顺铂（DDP）腔内分别灌注治疗恶性胸腹腔积液的近期临床疗效及临床安全性。方法对41例恶性胸腹腔积液患者，在尽可能放尽胸腹腔内积液以后，腔内分别注入洛铂50mg／m2，或者顺铂60mg／m2，均为每3周1个周期，1周期后评价近期疗效、生活质量以及毒副反应，并对疗效进行分析。结果41例患者均可进行客观疗效评价及安全性评价，全组患者中完全缓解（CR）5例，病情稳定（SD）27例，疾病进展（PD）9例，疾病控制率（DCR）为78．05％；顺铂一线治疗组疗效：CR2例，SD13例，PD3例，DCR83．33％；洛铂二线治疗组疗效：CR3例，SD11例，PD2例，DCR87．50％；顺铂二线治疗组疗效：CR0例，SD3例，PD4例，DCR42．86％。顺铂一线与洛铂二线治疗间疗效无统计学差异（P〉0．05），但明显优于顺铂二线治疗，统计学差异显著（P〈0．05），并且结果与患者生活质量改变相似。三组患者中，恶心、呕吐等消化道反应不明显，但患者乏力明显直接影响患者的生活质量；三组患者白细胞、血小板减少等骨髓抑制反应相当，以Ⅰ-Ⅱ度反应为主，Ⅲ-Ⅳ度反应不明显，三组间比较无统计学差异（P〉0．05）。结论洛铂和顺铂腔内灌注均可以较好的控制恶性胸腹腔积液，既往应用顺铂治疗的患者采用洛铂治疗也具有较好的有效率；洛铂腔内治疗可显著减轻患者的临床症状，改善患者生活质量，临床安全性较好，未增加化疗药物的不良反应发生率。

A clinical observation and safety study of intracavity lobaplatin therapy for malignant ascites and pleural effusion

Objective To observe and compare the short-term clinical efficacy and safety of intracavity lobaplatin（LBP） and cisplatin （DDP） therapy for malignant ascites and pleural effusion. Methods 41 patients with malignant ascites and pleural effusion were respectively intracavity injected with LBP 50 mg/m2 or DDP 60 mg/m2, three weeks for a cycle, after the effusion was eliminated as far as possible. The short-term efficacy, quality of life and toxicity were evaluated at the end of the first cycle and the therapeutic effect was analyzed by stratified analysis. Results The objective efficacy and safety evaluation were available for all of the 41 patients, of which 5 cases in complete response （CR）, 27 cases in stable disease （SD）, 9 cases in progressive disease（PD） and the disease control rate（DCR） is 78.05%; DDP in the first-line treatment group： 2 cases of CR, 13 cases of SD, 3 cases of PD, and DCR is 85.33% ; LBP in the second line treatment group： 3cases of CR, 11 case of SD, 2 cases of PD and the DCR is 87. 50% ; DDP in the second-line treatment group： 0 case of CR, 3 cases of SD, d cases of PD and the DCR is 42.86%. DDP in the first-line treatment group seems superior to DDP in the second-line treatment group （ P 〈 0.05 ）, while there was no significant statistically difference between DDP in the first-line treatment group and LBP in the second-line treatment group（P 〉 0.05 ）. This result accorded to th.e changes of patients＇ quality of life. Among all the patients of the three groups, nausea, vomiting and other gastrointestinal reactions was not obvious, while patients with fatigue significantly affected the patient＇s quality of life. The bone marrow suppression reactions includes leukopenia, thrombocytopenia were equal to each other, and the majority is I -II degree reaction compared to the m-IV degree reaction, and there seemed to be no significant difference （ P 〉 0. 05 ）. Conclusions Intracavity instillation of LBP and DDP regulates malignant ascites and pleural effusion well, patients used to treating with DDP appear to have a good efficiency in the treatment of LBP. Intracavity LBP therapy can significantly reduce clinical symptoms, improve quality of life; what＇ s more, it does not increase the adverse reactions of chemotherapeutic drugs which results in a better clinical safety.