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目的评价国产英卡膦酸二钠单次静脉滴注(注射剂)和连续口服(片剂)治疗恶性肿瘤骨转移疼痛的安全性,比较国产英卡膦酸二钠与国产氯屈膦酸二钠(洛屈)治疗骨转移疼痛的疗效和安全性。方法骨转移疼痛:多中心,开放,随机阳性药平行对照临床研究。A 组:英卡膦酸二钠注射液10mg,静注,d 1;英卡膦酸二钠片5mg,Po 3次/日,d 6～21。B组:氯屈膦酸二钠注射液300mg,静注,d 1～5;氯屈膦酸二钠胶囊800mg,Po 3次/日,d 6～21。结果 163例病人入组,其中109例可评价不良反应,100例可评价疗效,用药第6天,英卡膦酸二钠英和氯屈膦酸二钠镇痛的疗效分别为58.70%及55.07%,P=0.6457;第21天,疗效分别为70.09%及69.57%,P=0.3547;用药第6天,英卡膦酸二钠英与氯屈膦酸二钠改善活动能力的疗效分别为31.11%及30.43%,P=0.9271;第21天,疗效分别为41.11%及39.13%,P=0.8007。不良反应发热、骨肌肉一过性疼痛、恶心、呕吐、腹泻、皮疹的发生率,英卡膦酸二钠分别为29.79%、19.15%、8.51%、6.38%、4.26%、4.26%;氯屈膦酸二钠分别为7.25%、5.80%、13.04%、11.59%、2.90%、0%,发热的发生率两组差异有统计学显著意义(P=0.0002),骨肌肉一过性疼痛的发生率两组差异无统计学意义(P=0.0662)。对发热和骨肌肉一过性疼痛进行 Lo-gistic 回归分析,不同的试验组用药是影响发热的最显著因素,P=0.0071;组别并不是影响骨肌肉一过性疼痛的因素,P=0.0776。结论英卡膦酸二钠治疗恶性肿瘤骨转移引起的疼痛具有明显的疗效,并在一定程度上改善活动能力,不良反应易于耐受。
Objective To evaluate the safety of a single intravenous infusion of incapacidate (injection) and continuous oral (tablet) in the treatment of bone metastases of malignant tumors. To compare the efficacy and safety of homemade incatricalinib disodium and domestic clodronate disodium (Luoke Qu) treatment of bone metastases pain efficacy and safety. Methods Bone metastases pain: a multicenter, open, randomized controlled clinical trial of positive control. Group A: Inocarpine disodium injection 10mg, intravenous injection, d 1; icaridonate disodium tablets 5mg, Po 3 times / day, d 6 ~ 21. Group B: clodronate disodium injection 300mg, intravenous injection, d 1 ~ 5; clodronate disodium capsules 800mg, Po 3 times / day, d 6 ~ 21. Results A total of 163 patients were enrolled in this study. Among them, 109 were evaluable as adverse reactions and 100 were evaluable. On the 6th day of treatment, the efficacy of disodium econtar disodium and clodronate disodium was 58.70% and 55.07% respectively, , P = 0.6457. On the 21st day, the therapeutic effects were 70.09% and 69.57%, respectively, P = 0.3547. On the 6th day of treatment, the efficacy of disodium econtarodine and clodronate disodium was 31.11% And 30.43% respectively, P = 0.9271. On the 21st day, the therapeutic effects were 41.11% and 39.13% respectively, P = 0.8007. Adverse reactions, fever, bone muscle pain, nausea, vomiting, diarrhea, rash incidence, icariyl disodium were 29.79%, 19.15%, 8.51%, 6.38%, 4.26%, 4.26% Disodium phosphonate was 7.25%, 5.80%, 13.04%, 11.59%, 2.90%, 0% respectively. The incidence of fever was significantly different between the two groups (P = 0.0002) Rate of difference between the two groups was not statistically significant (P = 0.0662). Lo-gistic regression analysis of fever and bone muscle transient pain showed that the most significant factor affecting fever was the different test group medication, P = 0.0071; the group was not the factor that affected the transient pain of bone muscle, P = 0.0776 . Conclusion Inacardic disodium treatment of malignant bone metastases caused by pain has a significant effect, and to some extent, improve mobility, adverse reactions easily tolerated.