羟苯磺酸钙治疗慢性下肢静脉疾病疗效与安全性Meta分析

Clinical Efficacy and Safety of Calcium Dobesilate in the Treatment of Chronic Venous Diseases of Lower Limbs: a Meta-Analysis

目的系统评价羟苯磺酸钙(CaD)治疗慢性下肢静脉疾病(CVD)的疗效及安全性。方法计算机全面检索The Cochrane Library,PubMed,EMbase,CNKI,VIP等数据库自建库至2016年关于CaD治疗CVD的随机对照试验(RCT),根据文献纳入标准提取结局指标,包括下肢水肿的改善情况、患者主观生活质量评分及不良反应。用Review Manager 5. 2软件进行Meta分析。结果 5个RCT(1 265例患者)纳入研究,其中CaD组627例,空白对照组638例。Meta分析显示,CaD组与空白对照组相比,小腿相对体积显著减小[MD=-1. 51%,95%CI(-2. 69,0. 34),P=0. 01],脚踝部周长无统计学差异[MD=-0. 88 cm,95%CI(-3. 08,1. 31),P=0. 43],CVD功能不全问卷(CIVIQ)总评分无统计学差异[MD=-6. 22分,95%CI(-21. 59,9. 14),P=0. 43],CIVIQ问卷疼痛单项评分明显降低[MD=-0. 1分,95%CI(-0. 12,-0. 08),P <0. 000 01],疼痛视觉模拟评分(VAS)无统计学差异[MD=-3. 46 mm,95%CI(-13. 99,7. 07),P=0. 52]; CaD组与羟基芦丁组相比,小腿部周长显著减小[MD=-0. 80 cm,95%CI(-1. 54,-0. 45),P <0. 000 01],脚踝部周长无统计学差异[MD=-0. 20 cm,95%CI(-0. 54,0. 14),P=0. 25]; CaD组不良反应发生率为6. 54%,均为一般不良反应。结论 CaD可显著缓解CVD患者小腿水肿和疼痛,安全性较好。

Objective To systematically evaluated the clinical efficacy and safety of calcium dobesilate（CaD） in the treatment of chronic venous disease（CVD） of lower limbs. Methods Randomized controlled trials（RCTs） of CaD in the treatment of CVD patients in databases such as The Cochrane Library,PubMed,EMbase, CNKI and VIP from inception of databases to 2016 were searched completely. According to the literature inclusion criteria, outcome indicators including improvement of lower edema, subjective score of quality of-life （QOL） of patients and adverse drug reactions. The Metaanalysis was carried out by Review Manager 5.2 software. Results A total of five RCTs including 1 265 patients were included,with 627 cases in the CaD group and 638 cases in the blank control group. Metaanalysis results showed that compared with the blank control group,the relative volume of calf in CaD group was significantly reduced [ MD = - 1.51% ,95% CI（ - 2. 69,0.34）, P = 0.01 ] ,the perimeter of ankle in CaD group showed no statistical difference[ MD = - 0. 88 cm,95% CI（-3.08,1.31）, P =0.43] ,the total CIVIQ score in CaD group showed no statistical difference[ MD = -6. 22 points,95% CI（- 21.59,9.14）, P = 0. 43] ,the CIVIQ sub- score about pain in CaD group was significantly decreased[ MD = -0. 1 points,95% C1 （-0.12, -0.08）,P 〈 0.000 01],VAS score in CaD group showed no statistical difference[MD= -3.46 mm,95% CI（-0.13.99, 7.07）, P=0.52]. Compared with the oxeruti group,the perimeter of calf in CaD group was significantly decreased[MD= -0.8 cm, 95% CI（-1.54,-0.45）, P 〈 0.000 01],the perimeter of ankle in CaD group showed no statistical difference[MD = -0.2 cm,95% CI （-0.54,0.14）, P =0.25]. The incidence rate of adverse reactions in CaD group was 6.54% ,all of which were general adverse reactions. Conclusion CaD can significantly improve calf edemain and pain in patients with CVD,and it has good safety.