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国产因卡膦酸二钠治疗骨转移癌疼痛的Ⅱ期临床试验 被引量：7

Phase Ⅱ clinical study of incadronate for pain control in metastatic bone cancer
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摘要 目的 :观察评价国产因卡膦酸二钠治疗恶性肿瘤骨转移疼痛的有效性和安全性。方法 :自 2 0 0 1年 1 2月至2 0 0 2年 1 0月 ,收治恶性肿瘤骨转移患者 4 3例 ,随机分配至试验组和对照组 ,分别给予国产因卡膦酸二钠 1 0mg与帕米膦酸二钠 90mg静滴 ,观察其疗效和毒副作用。结果 :试验组 2 3例止痛有效率 5 2 2 % ,生活质量改善有效率为 4 3 5 % ,与对照组 2 0例相比无显著性差异 (P >0 0 5 ) ,但毒副反应少见。结论 :国产因卡膦酸二钠治疗恶性肿瘤骨转移疼痛疗效显著 ,安全可靠 。 Objective:To evaluate the response rate and safety of incadronate made in China treating the pain of metastatic bone cancer.Methods:From Dec. 2001 to Oct.2002, 43 cases of metastatic bone cancer were randomly divided into two groups (test group and control group) which were treated with incadronate made in China 10mg and pamidronate 90mg respectively.Results:There were 23 patients in test group and 20 patients in the control group. The total remission rate of the bone pain was 52 2% and the improving rate of quality of life was 43 5% which were no significant difference as compared with the control group ( P >0 05). The toxicity was mild.Conclusion:Incadronate made in China is effective, safe to metastatic bone cancer and worthy of clinical application.
作者 王琳 秦叔逵 陈映霞 何泽明 钱军 杨宁蓉 廖世兵
机构地区 解放军八一医院全军肿瘤中心内科
出处 《临床肿瘤学杂志》 CAS 2003年第3期204-207,共4页 Chinese Clinical Oncology
关键词 因卡膦酸二钠 治疗 骨转移癌 疼痛 Ⅱ期临床试验 有效性 安全性 Incadronate Metastatic bone cancer Bone pain Phase Ⅱ clinical study
分类号 R738.1 [医药卫生—肿瘤] R441.1 [医药卫生—诊断学]
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参考文献10

  • 1张艳,李卫平,明亮,李京培,徐叔云.重组葡激酶溶栓作用的研究[J].中国药理学通报,2000,16(2):187-189. 被引量：10
  • 2谢敏浩,何拥军,罗世能,邹霈,刘娅灵.因卡膦酸二钠的合成[J].中国现代应用药学,2001,18(6):456-457. 被引量：7
  • 3Ohsawa M, Soda M, Mizunuma H. Drugs in development for the treatment of osteoporosis : Incadronate [ J ]. Nippon Rinsho, 2002,60 ( Suppl 3 ) :538.
  • 4Matsumoto T, Nagata N, Horikoshi N, et al. Pharmacokinetics of incadronate, a new bisphosphonate, in healthy volunteers and patients with malignancy-associated hypercalcemia [ J ]. Int J Clin Pharmacol Ther, 1997, 35:239.
  • 5Oura S, Sakurai T, Yoshimura G, et al. Study on the safety of rapid infusion and the efficacy of incadronate [ J ]. Gan To Kagaku Ryoho, 1999,26( 11 ) :1623.
  • 6Nishikawa M, Yamamoto M, Murakami T, et al. A third generation bisphosphonate, YM175, inhibits osteoclast formation in murine cocultures by inhibiting proliferation of precursor cells via supporting cell-dependent mechanisms[ J]. J Bone Miner Res, 1998,13(6) :986.
  • 7Li J, Mori S, Mashiba T, et al. Preadministration of incadronate disodium can prevent bone loss in rat proximal tibial meraphysis when induced by hindlimb immobilization by bandage [ J ]. Bone,1998. 23:459.
  • 8Oura S, Tanino H, Yoshimasu T, Sakurai T, et al. Bisphosphonate therapy for bone metastases from breast cancer: clinical results and a new therapeutic appoach[ J]. Breast Cancer, 2000, 7(4) :307.
  • 9Fukumoto S, Matsumoto T, Talebek OT, et al. Treatment of malignancy associated hypercalcemia with YM175, a new bisphosphonate:elevated threshold for pharathyroid hormone secretion in hypercalcemic patients[J]. J Clin Endocrinal Metab, 1994, 79:165.
  • 10Matsumoto T, Nagata N, Hotikoshi N, et al. Comparative study of incadronate and elcatonin in patients with malignancy-associated hypercalcaemia[ J]. J Int Med Res, 2002,30(3) :230.

二级参考文献7

  • 1陈修，心血管药理学（第2版），1997年，570页
  • 2叶应妩，临床实验诊断学，1994年，1159页
  • 3中华人民共和国卫生部药政局，新药（西药）临床前研究指导原则汇编，1993年，70页
  • 4陈奇，中药药理研究方法学，1993年，510页
  • 5陈奇，中药药理研究方法学，1993年，570页
  • 6徐叔云，药理实验方法学（第2版），1991年，1124页
  • 7傅毅.双膦酸盐类药物的开发与临床研究[J].国外医药（合成药．生化药．制剂分册）,1998,19(5):284-289. 被引量：6

共引文献15

同被引文献42

  • 1王宏羽,冯奉仪,周美珍,李文举,张永强,宋三泰,刘晓晴,朱允中,史鹤玲,王杰军,高勇,何友谦.英卡膦酸二钠治疗恶性肿瘤骨转移[J].医学研究通讯,2005,34(1):19-22. 被引量：2
  • 2陈颖波,陈凌翔,陈嘉,潘良熹.因卡膦酸二钠治疗恶性肿瘤引起的骨转移疼痛或/和高钙血症Ⅱ期临床试验报告[J].现代肿瘤医学,2006,14(2):207-209. 被引量：6
  • 3Rosen LS, Gordon D, Tchekmedyian S, et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solidtumors: a phase Ⅲ, double-blind, randomized trial-The Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group [J]. J Clin 0ncol,2003,21 (16) :3150.
  • 4Ross JR, Saunders Y, Edmonds PM, et al. A systemic review of the role of bisphosphonates in metastatic disease[J]. Health Technol Assess ,2004,8 (4) : 1.
  • 5Major P, Lortholary A, Hon J, et al. Zoledronic acid is superior to pamidronatc in the treatment of hypercalcemia of malignancy: a pooled analysis of two randomized, controlled clinical trials [ J ]. J Clin Oncol, 2001,19 ( 2 ) : 558.
  • 6Corey E, Brown LG, Quinn JE, et al. Zoledronic acid exhibits inhibitoryeffects on osteoblastic and osteolytic metastases ofprostate cancer[ J]. Clin Cancer Res,2003,9 (1) :295.
  • 7Saad F, Gleason DM, Murray R,et al. Long-term efficacy ofzoledronic acid for the prevention of skeletal complications in patientswith metastatic hormone-refractory prostate cancer [J].J Natl Cancer lnst, 2004, 96(11) : 879.
  • 8Nishikawa M, Yamamoto M, Murakami T, et al. A third generation bisphosphonate, YM175, inhibits osteoclast formation in murine cocultures by inhibiting proliferation of precursor cells via supporting cell-dependent mechanisms [ J ]. J Bone Miner Res , 1998,13 ( 6 ) :986.
  • 9Ohsawa M,Soda M, Mizunuma H. Drugs in development for the treatment of osteoporosis : Incadronate [ J ]. Nippon Rinsho ,2002,60( Suppl 3 ) :538.
  • 10Santini D, Vespasiani Gentilucci U, Vincenzi B,et al. The antineoplastic role of bisphosphonates: from basic research to clinical evidence [J].Ann Oncol, 2003,14 (10) :1468.

引证文献7

二级引证文献17

临床肿瘤学杂志
2003年 第3期

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