中國(guó)新藥與臨床雜志Chin J New Drugs Clin Rem),2004年2月第23卷第2期E-mail xyylc@ shyyxx. comhttp :// xyyl. chinajournal. net. cn http :// zgylczz. periodicals. com.cn” 101 "groupsof 24 patients( age( 36土s12 )a,18~55 a)clomipramine.was treated with venlafaine ER 75 ~ 225 mg d-1 ,po ,qd ,for 6 wk , clomipranine group of 25 patients[ REFERENCES ](age( 35土12 ) a, 20~ 55 a) was treated withclomipramine 50 ~ 250 mg d-1 , po ,bid ,for 6 wk.[1]GUNF ,LI HF ,SHU L,et al. Extended release venlafxine in .treatment of majordepression: a double blind , randomized , andHAMA was adopted to evaluate the efficacy. Safetycntolld mulicentre study[J ] Chin J New Drugs Clin Ren( inwas evaluated by TESS , laboratory and physcial ex-Chinese), 2002 ,21( 2 )66-71amination.RESULTS : After 6 wk treatment , the .[2]LIU WB,LINZ ,MA Y ,et al. Venlafaxine us clomipramnine in .effective rate of venlafaxine ER group was59 % , thetreating major depression associated with anxiety[J ] Chin J Newcured rate was 27 %. The effective rate olDrugs Clin Ren( in Chinese), 2001 ,20( 2)114-117. .clomipramine group was 62 % , the cured rate was[ 3]BAI LD ,TAN MG. Venlafxine us fluoxetine in treatment of ma-jor depression with anxious symptom[J ] Chin J New Drugs Clin33 %. There was no significant difference betweenRen( in Chinese),2001 ,20(2):119-121two groups( P> 0.05 ). The adverse reactions of[4 ][ 5]See above.venlafaxine ER groups were less than that of[6]GUO CR ,ZHANG XH. Venlafaxine in tratment of generaliedclomipramine group. CONCLUSION : Venlafaxineanxiety disorder[J ] Chin J New Drugs Clin Rem( in Chinese ),2001 ,20(2 )117-119.ER is effective in treatment of GAD as well as[7 ][ 8 ]See above[文章編號(hào)]1007-7669 2004 )02-0101-03聚乙二醇4000治療老年人慢性功能性便秘虞陽(yáng)于曉峰，鄭松柏顧同進(jìn)，王根生(華東醫(yī)院消化內(nèi)科,上海200040 )[關(guān)鍵詞]聚乙烯二醇類便秘老年人[中圖分類號(hào)] R975.3 ;R574.4[文獻(xiàn)標(biāo)識(shí)碼] A[摘要]目的:評(píng)價(jià)聚乙二醇4000對(duì)老年人慢性功能性便秘的療效和安全性。方法:60例年齡在聚乙二醇( macrogol )4000是-種新型滲透性輕(81土s 5)a的老年功能性便秘病人分為2組共瀉劑其通過(guò)氫鍵作用固定水分子使腸道內(nèi)液體體有59例病人完成治療聚乙二醇組29例給予聚乙積增加而產(chǎn)生通便的作用。國(guó)內(nèi)外多項(xiàng)研究顯示其二醇4000,10gp,bid乳果糖組30例給以乳果對(duì)慢性功能性便秘的療效顯著,本 研究將其與乳果糖15 mL,如,bid療程均為21 do治療后觀察病糖( lactulose對(duì)照,觀察聚乙二醇4000對(duì)我國(guó)老年人大便次數(shù)和大便形狀，并觀察腹脹、食欲不振、大人的慢性功能性便秘的療效及安全性。便困難等癥狀緩解率。結(jié)果:聚乙二醇組經(jīng)治療后對(duì)象和方法排便困難發(fā)生率由86 %下降至34 %較治療前有研究對(duì)象所有 納入研究的病人均需符合下列顯著性下降( P<0.01 ) ,與乳果糖組比較無(wú)統(tǒng)計(jì)學(xué)入選標(biāo)準(zhǔn)( 1 )年齡(81土s 5)a70~95 a ,性別不差異( P>0.05 );沮在有效病人中服藥量小于乳果限。(2 )患功能性便秘至少6mo以上,1 wk內(nèi)自發(fā)糖組但2組相比無(wú)統(tǒng)計(jì)學(xué)差異聚乙二醇組治療便中國(guó)煤化工2次而且至少伴有以秘的顯效率和有效率分別為52%和17%與乳果TYHCNMHG糖組相似( P>0.05 )而不良反應(yīng)發(fā)生率為6.9 % ,[收稿日期] 2003-03-06[接受日期] 2003-07-30與乳果糖組相近( P>0.05)結(jié)論聚乙二醇4000[作者簡(jiǎn)介]虞陽(yáng)1976- )男江蘇溧陽(yáng)人,醫(yī)師學(xué)士,現(xiàn)從事消化內(nèi)科的臨床工作。能安全有效地治療老年人慢性功能性便秘。[聯(lián)系人]虞陽(yáng)。Phn 86-21-6248-3180中國(guó)新藥與臨床雜志Chin J New Drugs Clin Rem),2004年2月第23卷第2期102 .E-mail xyylc@ shyyxx. comhttp :// xyyl. chinajournal. net. cn http :// xgyylczz. periodicals. com. cn下3個(gè)癥狀之- -(硬便、排便困難、排便不暢》(3) 6 不良反應(yīng) 出現(xiàn)的任何不 良反應(yīng)(治療過(guò)程中出便秘病史≤2 a者經(jīng)結(jié)腸鏡或鋇劑灌腸檢查除外現(xiàn)任何與原發(fā)疾病無(wú)關(guān)的不適主訴均詳細(xì)記錄并結(jié)腸器質(zhì)性病變病史>2a者在密切的臨床監(jiān)視按照衛(wèi)生部藥物不良事件有關(guān)標(biāo)準(zhǔn)進(jìn)行評(píng)估。出現(xiàn)下未發(fā)現(xiàn)任何提示有結(jié)腸器質(zhì)性病變的癥狀和體必須終止治療的不良事件在48 h內(nèi)填寫(xiě)觀察表后征。排除標(biāo)準(zhǔn)(1在研究期間有可能服用影響結(jié)腸附藥物不良反應(yīng)報(bào)告并告知博福益普生制藥有限.動(dòng)力的藥物。(2 )有明顯的心、肝、腎功能不全者。公司的監(jiān)視員。本研究共觀察病人60例觀察過(guò)程中因出國(guó)失訪1結(jié)果.例共完成研究59例其中治療組29例對(duì)照組3012組療效比較聚乙二醇組的顯效率和有效率例2組年齡、性別、身高、體重、便秘病史等各項(xiàng)指分別為52%(15/29和17%(5/29)乳果糖組的顯標(biāo)相比無(wú)顯著意義差異P>0.05 ,見(jiàn)表1。效率和有效率分別為47 %( 14/30和30 %( 9/30),2組總有效率分別為69 %( 20/29 )和77 %( 23/表1病人的一般資料Tab 1 The general data of the30)經(jīng)Ridit分析差異無(wú)顯著意義P>0.05見(jiàn)表patients ;2。對(duì)照組治療組項(xiàng)目( n=30)(n=29)表22組療效比較例%)]Tab 2 The comparison年齡/a82+580+5of the clinical effects between two groups性別/男/女28/225/4身高/cm167士4166士61 顯效有效 無(wú)效總有效R體重/kg60土1464土17乳果糖301423x 77) 0. 5聚乙二醇2920( 69 )0.5011"2組一般資料相比經(jīng)x2和t檢驗(yàn):P>0.052組療效比較經(jīng)Ridit 分析:P>0. 052研究方法(1)藥物:聚乙二醇4000博福-益2治療前后療效比較 聚乙二醇組排便困難的發(fā)普生制藥有限公司，每袋10g，批準(zhǔn)文號(hào)生率由86 %( 25/29 )下降至34 %( 10/29),下降了X19990370);乳果糖(蘇威制藥有限公司每袋1552 % ,乳果糖組排便困難發(fā)生率由80 %( 24/30 )mL批準(zhǔn)文號(hào)2309451) (2)分組及用藥方法:根下降至33 %( 10/30),下降了47 %差異均有非常據(jù)年齡、性別、身高、體重、便秘病史分為2組，各30.顯著意義( P<0.01 ) 2組的腹脹和食欲不振發(fā)生例聚乙二醇組用聚乙二醇4000,10g ,p ,bid療率也有一定的下降,但治療前后2組比較均無(wú)明顯程21 d。乳果糖組用乳果糖,15 mL ,p ,bid 療程差異見(jiàn)表3。亦為21 d。如果療程中日排便>2次,停服藥物1d。表32組治療前后不適主訴[例% )] .Tab 3 The3觀察項(xiàng)目uncomfortable of two groups before and after treatment3.1 一般資料 記錄病人的性別、年齡、身高、體癥狀治療前乳果糖治療后聚乙二醇重、主訴病史。排便困難24/30(80) 10/30(33) 25/29 86)10/29 34 )3.2 觀察指標(biāo)( 1 )大便次數(shù):每日由病人記錄。.腹脹14/30(47) 8/30(27) 12/2941)7/29 24)(2)大便形狀:根據(jù)布里斯托(Bristol)大便形狀圖食欲不振10/30(33) 5/30( 17)8/29 28)4/2914)譜每日由病人紀(jì)錄。1 2 3型為不正常A ,5 6型治療后2組排便困難、腹脹和食欲不振發(fā)生率與治療前相比經(jīng)為正常,7 型為過(guò)度。(3 )腹脹、食欲不振、大便困難x2檢驗(yàn)°P>0.05 ;P<0.01等便秘常伴有的癥狀是否改善每在服藥前、服藥后32 組用藥量的比較在治療有 效的便秘病人中d8,1522由醫(yī)生詢問(wèn)紀(jì)錄。2組的藥物服用量有所區(qū)別,但無(wú)統(tǒng)計(jì)學(xué)差異。在4療效評(píng)估 顯效經(jīng)治療后大便次數(shù)和性狀均恢聚乙二醇組的20例有效病人中,11 例(55 % )每日復(fù)正常無(wú)任何不適主訴。有效經(jīng)治療后大便次數(shù)僅服中國(guó)煤化工o00既可保持大便通和性狀兩者之一恢復(fù)正常。無(wú)效:經(jīng)治療后大便次暢9lCNMHG);而乳果糖組中,僅6數(shù)和性狀均無(wú)改善。顯效率+有效率為總有效率。例26%每天服用1袋(15ml乳果糖而保持大便5統(tǒng)計(jì)學(xué)方法計(jì)量資料采用t檢驗(yàn),計(jì)數(shù)資料采通暢,15例每日服用2袋(65 % ),另有2例(9 % )用x2檢驗(yàn)等級(jí)資料用Ridit 分析,以P<0.05為需每日服用3袋乳果糖方可保持大便的通暢。顯著性水平方數(shù)據(jù)4不良反應(yīng) 治療過(guò)程中未發(fā)生嚴(yán)重不良反應(yīng)聚中國(guó)新藥與臨床雜志Chin J New Drugs Clin Rem),2004年2月第23卷第2期E-mail xyylc@ shyyxx. comhttp :// xyyl. chinajournal. net. cn http :// zgylczz. periodicals. com.cn” 103 "乙二醇組在服藥后有1例出現(xiàn)輕度上腹不適,1例a low dose polyethylene glycol electrolyte solution with lactulose for出現(xiàn)輕度.上腹疼痛乳果糖在服藥后有1 例出現(xiàn)輕treatment of chronic constipatior[J ] Gut ,1999 A4( 2) 226230.度腹脹2例出現(xiàn)下腹部疼痛發(fā)生率分別為7%和10 %。2組對(duì)比無(wú)統(tǒng)計(jì)學(xué)差異( P>0.05)病人均Macrogol 4000 in treatment of chronic可耐受并完成試驗(yàn)。functional constipation of aged patients討論慢性功能性便秘是消化系統(tǒng)的常見(jiàn)疾病約占普通人群的20 %在老年人中更多。治療便秘的YU Yang , YU Xiao-feng , ZHENG Song-bai ,藥物主要有刺激性瀉劑、溶積性瀉劑、潤(rùn)滑性瀉劑和GU Tong- jing , WANG Gen- sheng滲透性瀉劑。刺激性瀉劑長(zhǎng)期使用會(huì)引起結(jié)腸黑變病并可能會(huì)損害腸壁的神經(jīng)溶積性瀉劑常有腹脹( Department of Gastroenterology ,Huadong Hospi-的不良反應(yīng)潤(rùn)滑性瀉劑長(zhǎng)時(shí)間使用可引起脂溶性tal , SHANGHAI 200040 , China )維生:素的吸收障礙;而滲透性瀉劑促進(jìn)恢復(fù)生理排便較為安全,正在為更多醫(yī)生選用。聚乙二醇[ KEY WORDS ] polyethylene glycols ; constipa-4000屬于滲透性輕瀉劑,它通過(guò)氫鍵結(jié)合在腸腔內(nèi)tion ; aged游離的水分子從而增加糞便含水量使糞便體積增[ ABSTRACT] AIM : To evaluate the effct and大表面軟化利于排出。聚乙二醇4000分子量較大在消化道內(nèi)不被吸收或代謝不影響脂溶性維生safety of macrogol 4000 for the chronic functional素的吸收和電解質(zhì)的代謝,不影響腸道的運(yùn)動(dòng)功能constipation of aged patients.METHODS : Sixty和腸道的正常菌群1]。國(guó)內(nèi)外的多項(xiàng)臨床試驗(yàn)顯aged patients with chronic functional constipation示其效果顯著。本研究通過(guò)對(duì)70a以上慢性功能were divided into two groups. Fivty-nine patients had性便秘病人的臨床試驗(yàn)發(fā)現(xiàn)服用聚乙二醇4000completed the treatment. Thirty aged patients in后病人的排便困難發(fā)生率顯著下降與乳果糖類macrogol group received macrogol 4000 10 g, po ,似而在有效病人中聚乙二醇4000的服用量小于bid , while 30 aged patients in lactulose group received乳果糖的服用量這不僅降低了醫(yī)療費(fèi)用而且增加lactulose 15 mL，po , bid. The times and shape of老年人應(yīng)用聚乙二醇4000治療便秘的依從性。聚defecate , and the symptom improvable rate of bloat-乙二醇4000治療便秘的顯效率和總有效率和乳果ing , anorexia and defecate-difficulty were observed.RESULTS : After treatment with macrogol 4000 ,糖相似,但 2組顯效率和總有效率均低于國(guó)外文獻(xiàn)報(bào)道2]可能與本研究對(duì)象均為70 a以上的老年病the rate of defecate- difficulty reduced from86 % to人有關(guān)老年病人全身各臟器生理功能衰退導(dǎo)致神34 % with significant statistic difference ( P<經(jīng)體液調(diào)節(jié)失調(diào)，以及肌肉退行性變同時(shí)老年人活0.01 ). The result of the macrogol group was similar動(dòng)少慢性病多均可使結(jié)腸運(yùn)轉(zhuǎn)時(shí)間延長(zhǎng)排便反to that of the lactulose group( P>0. 05 ). The dose of射遲鈍,因此老年人便秘特點(diǎn)為癥狀重治療困難。the medicine used in macrogol group was lower than在本次試驗(yàn)中聚乙二醇4000治療組的不良事件發(fā)that of the lactulose group , but with no significantdifferences. The remarkable effective rate and effec-生率與乳果糖組相近病人均能耐受?？傊?聚乙二醇4000又為治療老年人慢性功tive rate of macrogol group was52 % and 17 % ,that能性便秘的有效的藥物不良反應(yīng)少而輕適合老年was similiar to that of lactulose group. And the ad-verse reaction of macrogol group was 6. 9 % , closed病人應(yīng)用。to that of lactulose group.CONCLUSION :Macro-gol中國(guó)煤化工e in the treatment of[參考文獻(xiàn)]chrolMYHCNMHGofagedpatients.[1 ]CLEVELAND MV , FLAVIN DP ,RUBEN RA, et al. New[ REFERENCES ]polyethylene glyool laxative for treatment of constipation in adults :a randomized , double blind，placebo controlled study[ J ] SouthMed J引號(hào)最輻) 478-481.[ 1 ][2]See above[2]ATTAR A,LEMANN M , FERGUSON A ,et al. Comparison of