中华医学杂志
中華醫學雜誌
중화의학잡지
National Medical Journal of China
2012年
48期
3398-3402
,共5页
许超%姜先洲%张念昭%赵海峰%徐祗顺
許超%薑先洲%張唸昭%趙海峰%徐祗順
허초%강선주%장념소%조해봉%서지순
膀胱,过度活动性%毒蕈碱拮抗剂%Meta分析%索利那新%托特罗定
膀胱,過度活動性%毒蕈堿拮抗劑%Meta分析%索利那新%託特囉定
방광,과도활동성%독심감길항제%Meta분석%색리나신%탁특라정
Urinary bladder,overactive%Muscarinic antagonists%Meta-analysis%Solifenacin%Tolterodine
目的 系统评价索利那新与托特罗定用于治疗膀胱过度活动症的安全性.方法 通过检索PubMed、Medline、中国期刊全文数据库、中国生物医学文献等数据库收集国内外已发表的相关前瞻性随机对照研究.按预设的标准进行筛选,对纳入研究进行质量评价,提取总体及主要不良反应等数据进行荟萃分析.共3个研究符合纳入标准,总样本量1013例,试验组(索利那新5 mg,1次/d)517例,对照组(托特罗定2 mg,2次/d)496例.结果 试验组总体不良反应、口干、便秘以及视物模糊的发生率分别为26.69％(138/517)、10.64％ (55/517)、5.42％ (28/517)及6.55％(26/397),对照组分别为33.27％(165/496)、16.73％(83/496)、2.22％ (11/496)及4.20％(16/381).两组总体不良反应的差异无统计学意义(RR=0.76,95％ CI:0.52～ 1.12,P =0.170).试验组口干的发生风险较对照组降低了37％(RR=0.63,95％CI:0.46～0.87),而便秘的发生风险则提高了1.38倍(RR=2.38,95％CI:1.21 ～4.66).两组视物模糊不良反应的发生风险差异无统计学意义(RR =1.59,95％CI:0.88 ～2.90,P =0.130).结论 索刹那新(5 mg,1次/d)与托特罗定(2 mg,2次/d)最常见的不良反应为口干,索利那新发生口干的风险较托特罗定低,而便秘的发生风险较高.临床中应综合考虑不良反应的发生风险,尤其对易发生便秘的患者应谨慎评估病情后再行用药.
目的 繫統評價索利那新與託特囉定用于治療膀胱過度活動癥的安全性.方法 通過檢索PubMed、Medline、中國期刊全文數據庫、中國生物醫學文獻等數據庫收集國內外已髮錶的相關前瞻性隨機對照研究.按預設的標準進行篩選,對納入研究進行質量評價,提取總體及主要不良反應等數據進行薈萃分析.共3箇研究符閤納入標準,總樣本量1013例,試驗組(索利那新5 mg,1次/d)517例,對照組(託特囉定2 mg,2次/d)496例.結果 試驗組總體不良反應、口榦、便祕以及視物模糊的髮生率分彆為26.69％(138/517)、10.64％ (55/517)、5.42％ (28/517)及6.55％(26/397),對照組分彆為33.27％(165/496)、16.73％(83/496)、2.22％ (11/496)及4.20％(16/381).兩組總體不良反應的差異無統計學意義(RR=0.76,95％ CI:0.52～ 1.12,P =0.170).試驗組口榦的髮生風險較對照組降低瞭37％(RR=0.63,95％CI:0.46～0.87),而便祕的髮生風險則提高瞭1.38倍(RR=2.38,95％CI:1.21 ～4.66).兩組視物模糊不良反應的髮生風險差異無統計學意義(RR =1.59,95％CI:0.88 ～2.90,P =0.130).結論 索剎那新(5 mg,1次/d)與託特囉定(2 mg,2次/d)最常見的不良反應為口榦,索利那新髮生口榦的風險較託特囉定低,而便祕的髮生風險較高.臨床中應綜閤攷慮不良反應的髮生風險,尤其對易髮生便祕的患者應謹慎評估病情後再行用藥.
목적 계통평개색리나신여탁특라정용우치료방광과도활동증적안전성.방법 통과검색PubMed、Medline、중국기간전문수거고、중국생물의학문헌등수거고수집국내외이발표적상관전첨성수궤대조연구.안예설적표준진행사선,대납입연구진행질량평개,제취총체급주요불량반응등수거진행회췌분석.공3개연구부합납입표준,총양본량1013례,시험조(색리나신5 mg,1차/d)517례,대조조(탁특라정2 mg,2차/d)496례.결과 시험조총체불량반응、구간、편비이급시물모호적발생솔분별위26.69％(138/517)、10.64％ (55/517)、5.42％ (28/517)급6.55％(26/397),대조조분별위33.27％(165/496)、16.73％(83/496)、2.22％ (11/496)급4.20％(16/381).량조총체불량반응적차이무통계학의의(RR=0.76,95％ CI:0.52～ 1.12,P =0.170).시험조구간적발생풍험교대조조강저료37％(RR=0.63,95％CI:0.46～0.87),이편비적발생풍험칙제고료1.38배(RR=2.38,95％CI:1.21 ～4.66).량조시물모호불량반응적발생풍험차이무통계학의의(RR =1.59,95％CI:0.88 ～2.90,P =0.130).결론 색찰나신(5 mg,1차/d)여탁특라정(2 mg,2차/d)최상견적불량반응위구간,색리나신발생구간적풍험교탁특라정저,이편비적발생풍험교고.림상중응종합고필불량반응적발생풍험,우기대역발생편비적환자응근신평고병정후재행용약.
Objective To evaluate the safety of solifenacin and tolterodine in the treatment of overactive bladder (OAB).Methods Studies on the solifenacin,tolterodine and OAB were searched and those fulfilling the inclusion criteria were selected.RevMan 5.0 software was used to perform meta-analysis.Three studies were included with an overall sample size of 1013 cases.The experimental group of solifenacin contained 517 cases while the control group had 496 cases.Results The incidence rates of overall adverse event,dry mouth,constipation and blurred vision of the experimental group (solifenacin 5 mg once per day)was 26.69％ (138/517),10.64％ (55/517),5.42％ (28/517) and 6.55％ (26/397) while those of the control group (toherodine 2 mg twice per day) 33.27％ (165/496),16.73％ (83/496),2.22％(11/496) and 4.20％ (16/381) respectively.There was no statistically significant difference in overall adverse event (RR =0.76,95％ CI:0.52-1.12,P =0.170) and blurred vision (RR =1.59,95 ％ CI:0.88-2.90,P =0.130) between two groups.However,the incidence rate of key antimuscarinic adverse events such as dry mouth (RR =0.63,95 ％ CI:0.46-0.87,P =0.005) and constipation (RR =2.38,95％ CI:1.21-4.66,P =0.010) showed statistically significant difference.Conclusions Dry mouth is the most common adverse event of solifenacin (5 mg once per day) and tolterodine (2 mg twice per day).Solifenacin has a lower incidence rate of dry mouth and a higher rate of constipation than tolterodine.A clinical physician should consider the incidence of adverse events during treating OAB,especially for those patients prone to constipation.
