复方苦参注射液治疗恶性胸腔积液的临床观察

目的:观察纯中药制剂复方苦参注射液胸腔灌注治疗恶性胸腔积液的近期疗效、不良反应和患者的生活质量改善情况。方法:将110例恶性胸腔积液患者随机分为2组,复方苦参注射液胸腔灌注治疗组(观察组)56例,胸腔积液引流彻底后用复方苦参注射液20 mL.m-2胸腔灌注,1周1次,连续3周;单纯顺铂胸腔灌注治疗组(对照组)54例,胸腔积液引流彻底后用顺铂40 mg.m-2胸腔灌注,1周1次,连续3周。观察胸腔积液缓解情况、生活质量变化及不良反应等并进行评价。结果:胸腔积液缓解总有效率为观察组75.0%,对照组68.5%,无显著差异(P=0.05);生活质量(卡氏评分)总改善率为观察组91.1%,对照组64.8%,有显著差异(P<0.05);胃肠道反应发生率为观察组1.8%,对照组90.7%,有显著差异(P<0.01)。结论:复方苦参注射液胸腔灌注与顺铂胸腔灌注治疗恶性胸腔积液疗效相当,但不良反应轻,患者生活质量明显改善。

Efficacy of Compound Matrine Injection for Malignant Pleural Effusion

OBJECTIVE：To evaluate the short-term curative efficacy and side-effects of Compound Matrine injection（a pure Chinese drugs preparation） administered by intrathoracic perfusion in patients with malignant pleural effusion and its impact on the improvement of patients’ quality of life.METHODS：A total of 110 patients with malignant pleural effusion were randomly assigned to receive either Compound Matrine injection at a dosage of 20 mL·m-2（trial group,n=56） or Cisplatin alone at a dosage of 40 mg·m-2（control group,n=54） by intrathoracic perfusion once a week for 3 consecutive weeks following thorough drainage of pleural effusion.The improvement of pleural effusion,patients’ quality of life and side effects etc were followed and evaluated.RESULTS：There were no significant differences between the trial group and the control group in total effective rate regarding the improvement of pleural effusion（75.0% vs.68.5%）（P=0.05）;however,significant differences were noted between the two groups in the total improvement rate of quality of life（Karnofsky scores）（91.1% vs.64.8%）（P〈0.05） and in the incidence of adverse gastrointestinal reactions（1.8% vs.90.7%）（P〈0.01）.CONCLUSION：Compound Matrine injection is as effective as Cisplatin（administered via introthoracic perfusion） but less toxic than Cisplatin in patients with malignant pleural effusion and which results in better improvement in the quality of life of these patients