伊班膦酸鈉治療骨轉移性疾病及多發(fā)性骨髓瘤的系統評價
發(fā)布時間：2018-10-22 09:03
【摘要】：目的：評價伊班膦酸鈉治療惡性腫瘤及多發(fā)性骨髓瘤引起的骨轉移性疾病的有效性和安全性。方法：按照Cochrane Collaboration標準,制定全面的檢索策略,搜集包括灰色文獻在內的所有伊班膦酸鈉治療骨轉移性疾病的隨機對照試驗。本篇文章的主要觀察指標是骨相關事件及骨疼痛評分,次要觀察指標是腹痛、腹瀉、惡心、腎損害等安全性評價。按照納入排除標準納入文獻,由兩名研究者獨立篩選并提取資料,采用Handbook5.0推薦的質量評價標準對納入研究進行質量評價,提取的數據采用RevMan5.1軟件進行統計學處理。結果：本研究共納入10篇隨機對照試驗,6篇為安慰劑對照,4篇為唑來膦酸對照,包括了3474位研究對象,單項研究病例數最多1401例,最少53例。Meta分析結果與對照組相比較,發(fā)現靜脈注射6 mg或口服50mg伊班膦酸鈉有效降低了骨相關事件的發(fā)生率(RR 0.80,95% CI 0.71 to0.90,P=0.002)。另外,治療96周后,伊班膦酸治療組患者的疼痛評分相比對照組都低于基線水平(WMD-0.41,95% CI-0.56 to 0.27, P 0.001)。兩組患者在發(fā)生腹瀉的概率上沒有顯著差異(RR 2.05,95%CI 0.85 to 4.95, P＝0.11),發(fā)生腎臟不良反應事件的概率也沒有明顯差異(RR1.14,95% CI 0.59-2.21, P= 0.69)o但與對照組相比,伊班膦酸鈉治療組患者出現腹痛的風險比對照組明顯增高(RR2.26,95% CI 1.09 to 4.70, P= 0.03; I2= 7%)。在伊班膦酸鈉與唑來膦酸鈉組對比中,發(fā)現二者發(fā)生骨相關事件的概率沒有明顯差異(RR 1.02,95% CI 0.82 to1.26,P=0.87).兩組患者發(fā)生肥胖、惡心等不良反應的概率上并沒有顯著差異,但伊班膦酸鈉組患者發(fā)生腎臟不良反應較唑來膦酸組低(RR O.74,95% CI 0.63 to 0.88,P=0.006；I2=9%).出現發(fā)熱流感樣癥狀不良反應稍低于唑來膦酸組(RR 0.47.95% CI 0.22 to 1.01,P=0.05；12=80%).結論：本研究表明,伊班膦酸鈉膦酸明顯地減少了骨轉移患者的骨相關事件和骨痛發(fā)生率；另外,伊班膦酸鈉與唑來膦酸在減少骨相關事件發(fā)生的概率上沒有明顯差異。
[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 鹵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.
【學位授予單位】：廣西醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R614;R738.1
本文編號：2286716
[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 鹵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.
【學位授予單位】：廣西醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R614;R738.1
【參考文獻】
相關期刊論文 前1條
1 陳宏遠;譚毅;蔡紹暉;馬偉峰;郭芝剛;杜軍;蔡紹皙;;基質細胞衍生因子-1及其受體CXCR4在腫瘤轉移中的作用[J];生物醫(yī)學工程學雜志;2007年05期
，本文編號：2286716
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