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目的以注射用帕米磷酸二钠为对照,评价注射用唑来磷酸单次静脉滴注,治疗肺癌引起的溶骨性骨转移疼痛的有效性和安全性。方法本实验采用多中心、前瞻性、随机、双盲双模拟、阳性药平行对照研究,105例经X线或CT证实有肿瘤溶骨性骨转移并伴有中度或中度以上疼痛的患者参加本次试验且均签署知情同意书。其中,实验组(A组)52例,对照组(B组)53例,均为单次给药后观察14天。结果共有102例进入ITT分析,A、B两组各51例,平均起效时间分别4.97±3.86天、4.69±3.67天。两组患者治疗14天临床镇痛疗效比较,组间比较差异无统计学意义(P>0.05)。结论 A、B两组骨转移疼痛患者治疗后骨痛评分变化与治疗前比较差异无统计学意义(P>0.05);止痛有效率和活动能力改善,两组患者与治疗前相比差异均有统计学意义(P<0.01),两组间比较差异无统计学意义(P>0.05)。用药后两组不良反应均为轻度,未作特殊处理。两组不良反应发生率比较差异无统计学意义(P>0.05)。
OBJECTIVE To evaluate the effectiveness and safety of single injection of zoledronic acid for the treatment of osteolytic bone metastasis caused by lung cancer by injection of sodium pamidronate as a control. METHODS: A multicenter, prospective, randomized, double-blind, double-dummy, positive-drug parallel control study was performed in this study. Of 105 patients with osteolytic bone metastases with or without osteomyelitis confirmed by X-ray or CT with moderate or moderate pain Participate in this trial and both signed informed consent. Among them, 52 cases in the experimental group (group A) and 53 cases in the control group (group B) were observed for 14 days after single administration. Results A total of 102 patients entered the ITT analysis. There were 51 patients in group A and B, with an average onset time of 4.97 ± 3.86 days and 4.69 ± 3.67 days respectively. The two groups of patients 14 days of clinical analgesia efficacy comparison, there was no significant difference between the two groups (P> 0.05). Conclusion There was no significant difference in pain score between the two groups after treatment (P> 0.05). The effective rate of analgesia and the activity ability were improved. There was significant difference between the two groups Statistical significance (P <0.01), no significant difference between the two groups (P> 0.05). Adverse reactions after the two groups were mild, no special treatment. There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05).