复方苦参注射液联合唑来膦酸治疗骨转移癌骨痛的临床观察

Efficacy and Safety of Compound Kushen Injection Combined with Zoledronic Acid for Ostealgia in Patients with Malignant Tumor and Osseous Metastases

目的:观察复方苦参注射液联合唑来膦酸治疗恶性肿瘤骨转移癌骨痛的有效性和安全性。方法:2008年6月—2010年12月,入组64例恶性肿瘤骨转移患者,其中35例接受复方苦参注射液联合唑来膦酸治疗(治疗组),29例接受唑来膦酸单药治疗(对照组)。治疗组给予复方苦参注射液30 mL加入0.9%氯化钠注射液250 mL静脉滴注,d1～14,唑来膦酸4 mg加入0.9%氯化钠注射液100 mL,静脉滴注15 min,每4周重复1次;对照组单用唑来膦酸,方法同治疗组。观察8周内骨痛及体力改善情况。结果:治疗组35例患者中有31例骨痛得到了不同程度的缓解,其中14例显效,15例有效,6例无效,有效率为82.9%;对照组29例患者中10例显效,11例有效,8例无效,有效率为82.4%;治疗组有效率高于对照组(P<0.05),差异有统计学意义。结论:复方苦参注射液联合唑来膦酸治对恶性肿瘤骨转移癌引起的骨痛具有良好的治疗作用,不良反应较轻微。

OBJECTIVE： To evaluate the curative efficacy and safety of compound Kushen injection combined with zoledronic acid for treating ostealgia in patients with malignant tumor and osseous metastases.METHODS： Between Jun.2008 and Dec.2010,sixty-four patients with malignant tumor and osseous metastases were enrolled in our study,of whom,35 were assigned to trial group treated with compound Kushen injection（30 mL） that was added to 250 mL 0.9% sodium chloride injection by iv gtt for two weeks combined with zoledronic acid（4 mg） that was added to 100 mL 0.9% sodium chloride injection by iv gtt within 15 min（this therapy was repeated in every 4 weeks） and 29 to receive zoledronic acid alone which was administered at the same dosage and administration as in the trial group（control group）.Ostealgia degree and physical strength improvement were observed within treatment of eight weeks.RESULTS： The overall response rate was 82.9% in the trial group（31 showed improvement,with 14 showing excellent response,15 response and 6 no response） vs.72.4%（10 showed excellent response,11 response and 8 no response） in the control group（P0.05）.CONCLUSION： Compound Kushen injection combined with zoledronic acid showed goof efficacy yet mild toxicity for ostealgia in cancer patients with osseous metastases.