伊班膦酸钠治疗骨转移性疾病及多发性骨髓瘤的系统评价

发布时间：2018-10-22 09:03

【摘要】：目的：评价伊班膦酸钠治疗恶性肿瘤及多发性骨髓瘤引起的骨转移性疾病的有效性和安全性。方法：按照Cochrane Collaboration标准,制定全面的检索策略,搜集包括灰色文献在内的所有伊班膦酸钠治疗骨转移性疾病的随机对照试验。本篇文章的主要观察指标是骨相关事件及骨疼痛评分,次要观察指标是腹痛、腹泻、恶心、肾损害等安全性评价。按照纳入排除标准纳入文献,由两名研究者独立筛选并提取资料,采用Handbook5.0推荐的质量评价标准对纳入研究进行质量评价,提取的数据采用RevMan5.1软件进行统计学处理。结果：本研究共纳入10篇随机对照试验,6篇为安慰剂对照,4篇为唑来膦酸对照,包括了3474位研究对象,单项研究病例数最多1401例,最少53例。Meta分析结果与对照组相比较,发现静脉注射6 mg或口服50mg伊班膦酸钠有效降低了骨相关事件的发生率(RR 0.80,95% CI 0.71 to0.90,P=0.002)。另外,治疗96周后,伊班膦酸治疗组患者的疼痛评分相比对照组都低于基线水平(WMD-0.41,95% CI-0.56 to 0.27, P 0.001)。两组患者在发生腹泻的概率上没有显著差异(RR 2.05,95%CI 0.85 to 4.95, P＝0.11),发生肾脏不良反应事件的概率也没有明显差异(RR1.14,95% CI 0.59-2.21, P= 0.69)o但与对照组相比,伊班膦酸钠治疗组患者出现腹痛的风险比对照组明显增高(RR2.26,95% CI 1.09 to 4.70, P= 0.03; I2= 7%)。在伊班膦酸钠与唑来膦酸钠组对比中,发现二者发生骨相关事件的概率没有明显差异(RR 1.02,95% CI 0.82 to1.26,P=0.87).两组患者发生肥胖、恶心等不良反应的概率上并没有显著差异,但伊班膦酸钠组患者发生肾脏不良反应较唑来膦酸组低(RR O.74,95% CI 0.63 to 0.88,P=0.006；I2=9%).出现发热流感样症状不良反应稍低于唑来膦酸组(RR 0.47.95% CI 0.22 to 1.01,P=0.05；12=80%).结论：本研究表明,伊班膦酸钠膦酸明显地减少了骨转移患者的骨相关事件和骨痛发生率；另外,伊班膦酸钠与唑来膦酸在减少骨相关事件发生的概率上没有明显差异。
[Abstract]:Objective: to evaluate the efficacy and safety of ibandronate in the treatment of bone metastases caused by malignant tumor and multiple myeloma. Methods: according to Cochrane Collaboration criteria, a comprehensive search strategy was established to collect all randomized controlled trials of ibandronate in the treatment of bone metastases, including grey literature. The main indicators of this article are bone related events and bone pain scores, the second is abdominal pain, diarrhea, nausea, kidney damage and other safety evaluation. According to the inclusion and exclusion criteria, the data were independently screened and extracted by two researchers, the quality evaluation criteria recommended by Handbook5.0 were used to evaluate the quality of the inclusion study, and the extracted data were processed statistically by RevMan5.1 software. Results: 10 randomized controlled trials, 6 placebo controls and 4 zoledronic acid controls were included in this study, including 3474 subjects. There were 1401 cases in the single study and 53 cases in the single study. The results of Meta analysis were compared with those of the control group. It was found that intravenous injection of ibandronate for 6 mg or oral administration of 50mg ibandronate significantly reduced the incidence of bone related events (RR 0.80 95% CI 0.71 to0.90,P=0.002). In addition, after 96 weeks of treatment, the pain scores in the ibandronic acid group were lower than those in the control group (WMD-0.41,95% CI-0.56 to 0.27, P 0.001). There was no significant difference in the incidence of diarrhea between the two groups (RR 2.05 卤95CI 0.85 to 4.95, P = 0.11), and there was no significant difference in the incidence of renal adverse events between the two groups (RR1.14,95% CI 0.59-2.21, P = 0.69) o but compared with the control group. The risk of abdominal pain in ibandronate group was significantly higher than that in control group (RR2.26,95% CI 1.09 to 4.70, P = 0.03; I2 = 7%). There was no significant difference in the probability of bone related events between ibandronate sodium and zoledronate sodium group (RR 1.0295% CI 0.82 to1.26,P=0.87). There was no significant difference in the incidence of obesity, nausea and other adverse reactions between the two groups, but the incidence of renal adverse reactions in ibandronate group was lower than that in zoledronic acid group (RR 0. 74%, 95% CI 0. 63 to 0. 8 to 0. 006 I 2 + 9%). The adverse effects of fever and flu-like symptoms were slightly lower than those in zoledronic acid group (RR 0.47.95% CI 0.22 to 1.01 to 0.05%). Conclusion: in this study, ibandronate significantly reduced the incidence of bone related events and bone pain in patients with bone metastasis, and there was no significant difference between ibandronate and zoledronic acid in reducing the incidence of bone related events.
【学位授予单位】：广西医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R614;R738.1

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