药品评价
藥品評價
약품평개
DRUG REEVALUATION
2014年
2期
33-39
,共7页
糖尿病视网膜病变%芪明颗粒%羟苯磺酸钙%疗效%药物经济学
糖尿病視網膜病變%芪明顆粒%羥苯磺痠鈣%療效%藥物經濟學
당뇨병시망막병변%기명과립%간분광산개%료효%약물경제학
Diabetic Retinopathy%Qiming Granule%Calcium Dobesilate%Clinical Efficacy%Economic Evaluation
目的：对芪明颗粒治疗糖尿病视网膜病变的临床疗效及安全性进行综述，并对其经济性进行初步评价。方法：在CNKI中检索芪明颗粒治疗糖尿病视网膜病变的临床研究文献，采用Meta分析对其临床有效性及安全性进行统计合并。在Meta分析的基础上，对芪明颗粒的经济性进行初步评价。结果：对检索到的7项研究进行Meta分析，结果发现芪明颗粒治疗糖尿病视网膜病变的视力、眼底或中医证候疗效均显著高于羟苯磺酸钙。文献中不良事件报告较少，总体上芪明颗粒不良事件发生率低于羟苯磺酸钙。通过3个月疗程药品价格的比较，进行粗略的模拟药物经济学评价，在芪明颗粒与羟苯磺酸钙组患者其他医疗成本相同的保守假设下，芪明颗粒相对于羟苯磺酸钙的ICER在372.7元~679.9元之间。结论：现有的临床研究文献显示芪明颗粒治疗糖尿病视网膜病变的疗效优于羟苯磺酸钙，不良事件发生率可能更低。在初步短期模拟评价中，芪明颗粒的经济性可能由于优于羟苯磺酸钙，但该结论需要更加严谨的研究设计进一步验证。
目的：對芪明顆粒治療糖尿病視網膜病變的臨床療效及安全性進行綜述，併對其經濟性進行初步評價。方法：在CNKI中檢索芪明顆粒治療糖尿病視網膜病變的臨床研究文獻，採用Meta分析對其臨床有效性及安全性進行統計閤併。在Meta分析的基礎上，對芪明顆粒的經濟性進行初步評價。結果：對檢索到的7項研究進行Meta分析，結果髮現芪明顆粒治療糖尿病視網膜病變的視力、眼底或中醫證候療效均顯著高于羥苯磺痠鈣。文獻中不良事件報告較少，總體上芪明顆粒不良事件髮生率低于羥苯磺痠鈣。通過3箇月療程藥品價格的比較，進行粗略的模擬藥物經濟學評價，在芪明顆粒與羥苯磺痠鈣組患者其他醫療成本相同的保守假設下，芪明顆粒相對于羥苯磺痠鈣的ICER在372.7元~679.9元之間。結論：現有的臨床研究文獻顯示芪明顆粒治療糖尿病視網膜病變的療效優于羥苯磺痠鈣，不良事件髮生率可能更低。在初步短期模擬評價中，芪明顆粒的經濟性可能由于優于羥苯磺痠鈣，但該結論需要更加嚴謹的研究設計進一步驗證。
목적：대기명과립치료당뇨병시망막병변적림상료효급안전성진행종술，병대기경제성진행초보평개。방법：재CNKI중검색기명과립치료당뇨병시망막병변적림상연구문헌，채용Meta분석대기림상유효성급안전성진행통계합병。재Meta분석적기출상，대기명과립적경제성진행초보평개。결과：대검색도적7항연구진행Meta분석，결과발현기명과립치료당뇨병시망막병변적시력、안저혹중의증후료효균현저고우간분광산개。문헌중불량사건보고교소，총체상기명과립불량사건발생솔저우간분광산개。통과3개월료정약품개격적비교，진행조략적모의약물경제학평개，재기명과립여간분광산개조환자기타의료성본상동적보수가설하，기명과립상대우간분광산개적ICER재372.7원~679.9원지간。결론：현유적림상연구문헌현시기명과립치료당뇨병시망막병변적료효우우간분광산개，불량사건발생솔가능경저。재초보단기모의평개중，기명과립적경제성가능유우우우간분광산개，단해결론수요경가엄근적연구설계진일보험증。
Objective:To review the clinical efficacy and safety of Qiming granule for diabetic retinophathy and to conduct an initial economic evaluation. Methods:Clinical studies of Qiming granule for diabetic retinophathy in CNKI were retrieved. Statistical analysis of clinical efficacy and safety data was performed in meta-analyses. Following meta-analysis, an initial cost-effectiveness analysis was conducted. Results:Seven studies were included in meta-analysis. The clinical response rates defined by eyesight, fundus examination and TCM syndromes were significantly higher in Qiming group than calcium dobesilate group. Adverse events were rarely reported in the literature. The reported adverse events were fewer in Qiming group. Based on the assumption that other costs were same for the two groups, we compared the drug costs in three months, and simulated an initial economic evaluation. The ICERs of Qiming granule compared with calcium dobesilate was between 372.7 to 679.9 RMB per patient achieving response. Conclusion:The results in published clinical studies showed that the clinical efficacy of Qiming granule was superior to calcium dobesilate and the safety performance may be better. In the short time simulated economic evaluation, Qiming granule was cost-effective in comparison with calcium dobesilate. However, this result needs to be confirmed in more scientifically designed studies in the future.
