Vulva-vaginal atrophy (VVA) yana ɗaya daga cikin abubuwan da ke haifar da ƙarancin isrogen, musamman bayan menopause.Yawancin karatu sun kimanta sakamakon hyaluronic acid (HA) akan alamun jiki da jima'i da ke hade da VVA kuma sun sami sakamako mai ban sha'awa.Duk da haka, yawancin waɗannan karatun sun mayar da hankali kan kimantawa na ainihi game da amsawar bayyanar cututtuka ga abubuwan da aka tsara.Duk da haka, HA kwayoyin halitta ne na endogenous, kuma yana da ma'ana cewa yana aiki mafi kyau idan an yi masa allura a cikin epithelium na sama.Desirial® shine farkon hyaluronic acid mai haɗe-haɗe da ake gudanarwa ta hanyar allurar mucosal na farji.Manufar wannan binciken shine don bincika tasirin allurar intramucosal na intravaginal da yawa na ƙayyadaddun hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) akan sakamako na asibiti da yawa da aka ba da rahoton haƙuri.
Nazarin matukin jirgi mai cibiya biyu.Sakamakon da aka zaɓa ya haɗa da canje-canje a cikin kauri na mucosal na farji, ƙwayoyin halitta na collagen, flora na farji, pH na farji, alamar lafiyar farji, bayyanar cututtuka na atrophy na vulvovaginal da aikin jima'i 8 makonni bayan allurar Desirial®.An kuma yi amfani da ma'aunin haɓakawa gabaɗaya na majiyyaci (PGI-I) don tantance gamsuwar haƙuri.
An dauki nauyin mahalarta 20 daga ranar 19/06/2017 zuwa 05/07/2018.A ƙarshen binciken, babu wani bambanci a cikin matsakaicin jimlar ƙwayar mucosa na farji ko procollagen I, III, ko Ki67 fluorescence.Duk da haka, COL1A1 da COL3A1 maganganu sun karu sosai a kididdiga (p = 0.0002 da p = 0.0010, bi da bi).An sami raguwar bayyanar cututtuka na dyspareunia, bushewar farji, itching, da zubar da jini a cikin farji, kuma duk ma'aunin aikin jima'i na mata ya inganta sosai.Dangane da PGI-I, marasa lafiya na 19 (95%) sun ba da rahoton nau'o'in haɓaka daban-daban, wanda 4 (20%) ya ji daɗi kaɗan;7 (35%) ya fi kyau, kuma 8 (40%) ya fi kyau.
Allurar intravaginal da yawa na Desirial® (haɗe-haɗe-haɗe HA) yana da alaƙa da mahimmanci tare da furcin CoL1A1 da CoL3A1, yana nuna cewa haɓakar collagen ya sami kuzari.Bugu da ƙari, alamun VVA sun ragu sosai, kuma gamsuwar haƙuri da ƙimar aikin jima'i sun inganta sosai.Duk da haka, jimlar kauri na mucosa na farji bai canza sosai ba.
Vulva-vaginal atrophy (VVA) yana ɗaya daga cikin sakamakon gama gari na ƙarancin isrogen, musamman bayan menopause [1,2,3,4].Yawancin cututtuka na asibiti suna hade da VVA, ciki har da bushewa, haushi, itching, dyspareunia, da kuma cututtuka na urinary fili, wanda zai iya haifar da mummunar tasiri ga rayuwar mata [5].Duk da haka, farawar waɗannan alamun na iya zama da hankali kuma a hankali, kuma su fara bayyana bayan wasu bayyanar cututtuka na menopause sun ragu.A cewar rahotanni, har zuwa 55%, 41%, da 15% na matan da suka shude suna fama da bushewar farji, dyspareunia, da kuma cututtukan urinary fili, bi da bi [6,7,8,9].Duk da haka, wasu mutane sun yi imanin cewa ainihin yaduwar waɗannan matsalolin ya fi girma, amma yawancin mata ba sa neman taimakon likita saboda alamu [6].
Babban abun ciki na gudanarwa na VVA shine maganin bayyanar cututtuka, ciki har da canje-canjen salon rayuwa, marasa hormonal (kamar man shafawa na farji ko masu moisturizers da maganin laser) da shirye-shiryen maganin hormone.Ana amfani da man shafawa na farji galibi don kawar da bushewar farji yayin jima'i, don haka ba za su iya samar da ingantaccen bayani ga ci gaba da rikitarwa na alamun VVA ba.Akasin haka, an bayar da rahoton cewa moisturizer na farji wani nau'in samfurin "bioadhesive" ne wanda zai iya inganta riƙewar ruwa, kuma amfani da yau da kullum zai iya inganta ciwon farji da dyspareunia [10].Duk da haka, wannan ba shi da alaƙa da haɓakar cikakkiyar ma'aunin balaga na epithelial na farji [11].A cikin 'yan shekarun nan, akwai da'awar da yawa don amfani da mitar rediyo da laser don magance alamun menopause na farji [12,13,14,15].Duk da haka, FDA ta ba da gargadi ga marasa lafiya, tare da jaddada cewa yin amfani da irin waɗannan hanyoyin na iya haifar da mummunan al'amura, kuma har yanzu ba ta ƙayyade aminci da tasiri na na'urori masu amfani da makamashi ba a maganin waɗannan cututtuka [16].Shaida daga nazarin meta-bincike na binciken da bazuwar da yawa na goyan bayan tasirin tasirin maganin hormone na tsarin jiki a cikin rage alamun cututtukan da ke da alaƙa da VVA [17,18,19].Koyaya, ƙayyadaddun adadin karatu sun kimanta tasirin irin waɗannan jiyya bayan watanni 6 na jiyya.Bugu da ƙari, contraindications da zaɓi na sirri sune iyakance dalilai don yaɗuwar amfani da dogon lokaci na waɗannan zaɓuɓɓukan magani.Sabili da haka, har yanzu akwai buƙatar amintaccen bayani mai inganci don sarrafa alamun da ke da alaƙa da VVA.
Hyaluronic acid (HA) shine maɓalli mai mahimmanci na matrix extracellular, wanda ke samuwa a cikin kyallen takarda daban-daban ciki har da mucosa na farji.Yana da polysaccharide daga dangin glycosaminoglycan, wanda ke taka muhimmiyar rawa wajen kiyaye daidaiton ruwa da daidaita kumburi, amsawar rigakafi, samuwar tabo da angiogenesis [20, 21].Ana ba da shirye-shiryen roba na HA a cikin nau'in gels na sama kuma suna da matsayi na "na'urorin likitanci".Yawancin karatu sun kimanta tasirin HA akan alamun jiki da jima'i da ke hade da VVA kuma sun sami sakamako mai ban sha'awa [22,23,24,25].Duk da haka, yawancin waɗannan karatun sun mayar da hankali kan kimantawa na ainihi game da amsawar bayyanar cututtuka ga abubuwan da aka tsara.Duk da haka, HA kwayoyin halitta ne na endogenous, kuma yana da ma'ana cewa yana aiki mafi kyau idan an yi masa allura a cikin epithelium na sama.Desirial® shine farkon hyaluronic acid mai haɗe-haɗe da ake gudanarwa ta hanyar allurar mucosal na farji.
Makasudin wannan binciken matukin jirgi mai nisa-biyu shine don bincika tasirin allurar intramucosal na intravaginal da yawa na takamaiman hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) akan ainihin sakamakon rahotannin asibiti da na haƙuri da yawa, da kuma kimantawa. yuwuwar kimanta kimanta Jima'i waɗannan sakamakon.Cikakkun sakamakon da aka zaɓa don wannan binciken sun haɗa da canje-canje a cikin kauri na mucosal na farji, alamomin biomarkers na farfadowa na nama, flora na farji, pH na farji da ma'aunin lafiyar farji 8 makonni bayan allurar Desirial®.Mun auna sakamakon da aka ruwaito daga marasa lafiya da yawa, ciki har da canje-canje a cikin aikin jima'i da kuma yawan rahotanni na bayyanar cututtuka na VVA a lokaci guda.A ƙarshen binciken, an yi amfani da ma'aunin haɓakawa na gaba ɗaya (PGI-I) don tantance gamsuwar haƙuri.
Yawan binciken ya ƙunshi matan da suka shude (2 zuwa 10 shekaru bayan menopause) waɗanda aka tura su zuwa asibitin menopause tare da alamun rashin jin daɗi na farji da / ko dyspareunia na biyu zuwa bushewar farji.Mata dole ne su kasance ≥ 18 shekaru da <70 shekaru kuma suna da BMI <35.Mahalarta taron sun fito ne daga ɗaya daga cikin ƙungiyoyin shiga guda 2 (Cibiyar Asibitin Regional Universitaire, Nîmes (CHRU), Faransa da Karis Medical Center (KMC), Perpignan, Faransa).Ana ganin mata sun cancanci idan sun kasance ɓangare na shirin inshorar lafiya ko kuma sun amfana daga tsarin inshorar lafiya, kuma sun san cewa za su iya shiga cikin makonni 8 da aka tsara lokacin bibiya.Matan da ke shiga wasu karatun a lokacin ba su cancanci a ɗauka ba.≥ Stage 2 apical pelvic organ prolapse, stress urinary incontinence, vaginismus, vulvovaginal or urinary tract infection, hemorrhagic or neoplastic genital lesions, hormone-dogaran ciwace-ciwacen daji, zubar da jini na al'aurar da ba a sani ba, maimaituwa batsa, rashin kula da farfadiya, cututtukan zuciya, cututtukan zuciya, cututtukan zuciya , rheumatic zazzabi, baya vulvovaginal ko urogynecological tiyata, hemostatic cuta, da kuma hali na samar da hypertrophic scars an dauke a matsayin ware ma'auni.Mata masu shan magungunan rage hawan jini, steroidal da wadanda ba steroidal anti-kumburi kwayoyi, anticoagulants, manyan antidepressants ko aspirin, da kuma sanannun magungunan kashe qwari da ke da alaƙa da HA, mannitol, betadine, lidocaine, amide ko Matan da ke fama da rashin lafiyar duk wani abin da ke cikin wannan maganin. ana ganin ba za su cancanci wannan binciken ba.
A asali, an tambayi mata don kammala Ma'anar Ayyukan Jima'i na Mata (FSFI) [26] kuma suyi amfani da ma'aunin analog na gani na 0-10 (VAS) don tattara bayanan da suka danganci alamun VA (dyspareunia, bushewar farji, abrasions na farji, da itching na al'aura). ) bayani.Ƙimar kafin shiga tsakani ya haɗa da duba pH na farji, ta yin amfani da Bachmann Vaginal Health Index (VHI) [27] don kimantawa na asibiti na farji, Pap smear don tantance furen farji, da biopsy na mucosal na farji.Auna pH na farji kusa da wurin da aka shirya allura da kuma a cikin farji na farji.Don furen farji, maki Nugent [28, 29] yana ba da kayan aiki don ƙididdige yanayin yanayin farji, inda maki 0-3, 4-6 da 7-10 ke wakiltar flora na al'ada, flora na tsaka-tsaki da vaginosis, bi da bi.Ana yin duk kimantawar furen farji a cikin Sashen Bacteriology na CHRU a Nimes.Yi amfani da daidaitattun matakai don biopsy na mucosal na farji.Yi biopsy na 6-8 mm na naushi daga yankin da aka shirya allurar.Dangane da kauri na basal Layer, tsakiyar Layer da na sama, an kimanta biopsy mucosal ta hanyar tarihi.Hakanan ana amfani da biopsy don auna COL1A1 da COL3A1 mRNA, ta yin amfani da RT-PCR da procollagen I da III immunotissue fluorescence azaman abin maye don maganganun collagen, da haske na alamar yaduwa Ki67 a matsayin mai maye gurbin aikin mitotic na mucosal.Ana yin gwajin kwayoyin halitta ta dakin gwaje-gwaje na BioAlternatives, 1bis rue des Plantes, 86160 GENCAY, Faransa (ana samun yarjejeniya akan buƙata).
Da zarar an kammala samfurori na asali da ma'auni, haɗin haɗin HA (Desirial®) yana allurar da ɗaya daga cikin ƙwararrun ƙwararrun 2 bisa ga ƙa'idar ƙa'idar.Desirial® [NaHa (sodium hyaluronate) IPN mai haɗe-haɗe-Kamar 19 mg/g + mannitol (antioxidant)] shine gel injectable HA gel wanda ba asalin dabba ba, don amfani guda ɗaya kuma an shirya shi a cikin sirinji da aka riga aka shirya (2 × 1 ml). ).Na'urar lafiya ce ta Class III (CE 0499), ana amfani da ita don allurar intramucosal a cikin mata, ana amfani da ita don biostimulation da rehydration na saman mucosal na yankin al'aura (Laboratoires Vivacy, 252 rue Douglas Engelbart-Archamps Technopole, 74160 Archamps, Faransa).Kimanin allura 10, kowane 70-100 µl (0.5-1 ml a duka), ana yin su akan layin kwance 3-4 a cikin yanki mai triangular na bangon farji na baya, tushen wanda yake a matakin farji na baya. bango, da koli a 2 cm a sama (siffa na 1).
An tsara kimanta ƙarshen karatu na makonni 8 bayan rajista.Ma'aunin kimantawa na mata iri ɗaya ne da waɗanda suke a asali.Bugu da ƙari, ana kuma buƙatar marasa lafiya don kammala Ƙaddamar Ƙarfafa Ƙwararrun Ƙwararru (PGI-I) Scale [30].
Dangane da rashin bayanan da aka rigaya da kuma yanayin matukin jirgi na bincike, ba shi yiwuwa a gudanar da ƙididdige ƙididdiga na farko na samfurin.Sabili da haka, an zaɓi samfurin da ya dace na jimlar marasa lafiya 20 bisa ga iyawar raka'a biyu masu shiga kuma ya isa ya sami ma'auni mai ma'ana na ka'idojin sakamakon da aka tsara.An yi nazarin ƙididdiga ta amfani da software na SAS (9.4; SAS Inc., Cary NC), kuma an saita matakin mahimmanci a 5%.An yi amfani da gwajin matsayi na Wilcoxon don ci gaba da masu canji kuma an yi amfani da gwajin McNemar don nau'ikan masu canji don gwada canje-canje a makonni 8.
An amince da binciken ta Comité d'ethique du CHU Carémeau de Nimes (ID-RCB: 2016-A00124-47, code protocol: LOCAL/2016/PM-001).Duk mahalarta binciken sun rattaba hannu kan takardar izini mai inganci.Don ziyarar binciken 2 da biopsies 2, marasa lafiya na iya karɓar diyya har zuwa Yuro 200.
An dauki nauyin mahalarta 20 daga 19/06/2017 zuwa 05/07/2018 (majiyyata 8 daga CHRU da marasa lafiya 12 daga KMC).Babu wata yarjejeniya da ta keta ka'idojin haɗa / keɓance fifiko.Dukkan hanyoyin allura sun kasance lafiya kuma an gama su cikin mintuna 20.An nuna alamun alƙaluma da asali na mahalarta binciken a cikin Table 1. A asali, 12 daga cikin 20 mata (60%) sun yi amfani da magani don alamun su (6 hormonal da 6 wadanda ba na hormonal ba), yayin da a cikin mako 8 kawai 2 marasa lafiya. (10%) har yanzu ana bi da su kamar wannan (p = 0.002).
Ana nuna sakamakon sakamakon rahoton asibiti da na haƙuri a cikin Table 2 da Table 3. Ɗaya daga cikin marasa lafiya ya ƙi W8 biopsy na farji;dayan majiyyacin ya ki yarda da kwayar cutar W8 ta farji.Sabili da haka, mahalarta 19/20 zasu iya samun cikakkun bayanan bincike na tarihi da kwayoyin halitta.Idan aka kwatanta da D0, babu wani bambanci a cikin matsakaicin matsakaicin kauri na mucosa na farji a mako na 8. Duk da haka, kauri na basal Layer ya karu daga 70.28 zuwa 83.25 microns, amma wannan karuwa ba ta da mahimmanci (p = 0.8596).Babu wani bambance-bambancen ƙididdiga a cikin kyalli na procollagen I, III ko Ki67 kafin da bayan jiyya.Duk da haka, COL1A1 da COL3A1 maganganu sun karu sosai a kididdiga (p = 0.0002 da p = 0.0010, bi da bi).Babu wani canji mai mahimmanci na ƙididdiga, amma ya taimaka wajen inganta yanayin flora na farji bayan allurar Desirial® (n = 11, p = 0.1250).Hakazalika, kusa da wurin allurar (n = 17) da farji na farji (n = 19), ƙimar pH ta farji kuma tana son raguwa, amma wannan bambancin bai kasance mai mahimmanci ba (p = p = 0.0574 da 0.0955) (Table 2). .
Duk mahalarta binciken suna da damar yin amfani da sakamakon da aka ba da rahoton haƙuri.A cewar PGI-I, daya daga cikin mahalarta (5%) ya ba da rahoton wani canji bayan allura, yayin da sauran marasa lafiya na 19 (95%) sun ruwaito nau'i-nau'i daban-daban na ingantawa, wanda 4 (20%) ya ji dadi kadan;7 (35%) ya fi kyau, 8 (40%) ya fi kyau.An ba da rahoton dyspareunia, bushewar farji, itching na al'aura, abrasions na farji, da FSFI jimlar ƙididdigewa da sha'awar su, lubrication, gamsuwa, da girman jin zafi kuma an rage su sosai (Table 3).
Hasashen da ke goyan bayan wannan binciken shine cewa alluran Desirial® da yawa akan bangon baya na farji za su yi kauri ga mucosa na farji, ƙananan pH na farji, inganta flora na farji, haifar da samuwar collagen da inganta alamun VA.Mun sami damar nuna cewa duk marasa lafiya sun ba da rahoton ci gaba mai mahimmanci, ciki har da dyspareunia, bushewar farji, lalatawar farji, da itching.VHI da FSFI kuma an inganta su sosai, kuma an rage yawan matan da ke buƙatar madadin hanyoyin magance alamun su.Hakazalika, yana yiwuwa a tattara bayanai game da duk sakamakon da aka ƙaddara a farkon kuma ya iya ba da gudummawa ga duk mahalarta binciken.Bugu da ƙari, 75% na mahalarta binciken sun ruwaito cewa alamun su sun inganta ko sun fi kyau a ƙarshen binciken.
Duk da haka, duk da ƙaramar karuwa a cikin matsakaicin kauri na basal Layer, ba za mu iya tabbatar da tasiri mai mahimmanci a kan jimlar kauri na mucosa na farji ba.Kodayake bincikenmu ya kasa kimanta tasirin Desirial® don inganta kauri na mucosal na farji, mun yi imanin cewa sakamakon ya dace saboda maganganun CoL1A1 da CoL3A1 alamomi sun karu sosai a W8 idan aka kwatanta da D0.Yana nufin haɓakar collagen.Duk da haka, akwai wasu batutuwa da za a yi la'akari kafin yin la'akari da amfani da su a cikin bincike na gaba.Na farko, shin lokacin bin makonni 8 yayi gajere don tabbatar da ci gaba a cikin jimlar kauri na mucosal?Idan lokacin biyo baya ya fi tsayi, canje-canjen da aka gano a cikin tushe na ƙila an aiwatar da su a wasu yadudduka.Na biyu, shin kauri na tarihin mucosal Layer yana nuna farfadowar nama?Ƙididdigar tarihi na kauri na mucosal na farji ba dole ba ne la'akari da basal Layer, wanda ya haɗa da nama da aka sabunta a cikin hulɗa tare da nama mai haɗin gwiwa.
Mun fahimci cewa ƙananan adadin mahalarta da kuma rashin girman samfurin farko shine iyakokin binciken mu;duk da haka, duka biyu daidaitattun sifofin binciken matukin jirgi ne.Don haka ne muke guje wa faɗaɗa bincikenmu zuwa da'awar ingancin asibiti ko rashin inganci.Koyaya, ɗayan manyan fa'idodin aikinmu shine yana ba mu damar samar da bayanai don sakamako da yawa, wanda zai taimaka mana ƙididdige girman samfurin ƙima don bincike na ƙayyadaddun lokaci na gaba.Bugu da kari, matukin jirgi yana ba mu damar gwada dabarun daukar ma'aikata, ƙimar churn, yuwuwar tattara samfuri da nazarin sakamako, wanda zai ba da bayani ga duk wani aiki mai alaƙa.A ƙarshe, jerin sakamakon da muka ƙididdige, gami da haƙiƙanin sakamakon asibiti, alamomin halittu, da sakamakon rahoton marasa lafiya da aka kimanta ta amfani da ingantattun matakan, sune manyan ƙarfin bincikenmu.
Desirial® shine farkon hyaluronic acid mai haɗe-haɗe da ake gudanarwa ta hanyar allurar mucosal na farji.Domin isar da samfurin ta wannan hanyar, samfurin dole ne ya sami isasshen ruwa ta yadda za'a iya shigar dashi cikin sauƙi cikin ƙwararrun kayan haɗin haɗin gwiwa tare da kiyaye tsaftar sa.Ana samun wannan ta hanyar haɓaka girman ƙwayoyin gel da kuma matakin haɗin giciye na gel don tabbatar da haɓakar gel mai girma yayin da yake riƙe da ƙananan danko da elasticity.
Yawancin karatu sun kimanta tasirin amfani da HA, mafi yawan su RCTs ba na ƙasƙanci ba ne, kwatanta HA tare da sauran nau'ikan jiyya (mafi yawan hormones) [22,23,24,25].HA a cikin waɗannan karatun an gudanar da shi a gida.HA wani kwayoyin halitta ne wanda ke da matukar mahimmancin ikon gyarawa da jigilar ruwa.Tare da shekaru, adadin endogenous hyaluronic acid a cikin farji mucosa yana raguwa sosai, kuma kauri da vascularization suma suna raguwa, don haka rage fitar da jini da lubrication.A cikin wannan binciken, mun nuna cewa allurar Desirial® tana da alaƙa da haɓaka mai mahimmanci a cikin duk alamun da ke da alaƙa da VVA.Wadannan binciken sun yi daidai da binciken da Berni et al ya yi a baya.A matsayin wani ɓangare na amincewar tsari na Desirial® (bayanan da ba a bayyana ba) (Ƙarin Fayil 1).Ko da yake kawai hasashe, yana da kyau cewa wannan haɓakawa shine na biyu zuwa yiwuwar maido da canja wurin plasma zuwa saman epithelial na farji.
Hakanan an nuna alamar HA gel mai haɗin haɗin gwiwa don ƙara haɓaka nau'in nau'in collagen na I da elastin, don haka ƙara kauri na kyallen da ke kewaye [31, 32].A cikin bincikenmu, ba mu tabbatar da cewa kyalli na procollagen I da III ya bambanta sosai bayan jiyya ba.Duk da haka, COL1A1 da COL3A1 maganganu sun karu sosai a kididdigar.Sabili da haka, Desirial® na iya samun tasiri mai ban sha'awa akan samuwar collagen a cikin farji, amma ana buƙatar ƙarin bincike tare da tsawon lokaci don tabbatarwa ko karyata wannan yiwuwar.
Wannan binciken yana ba da bayanan asali da kuma tasirin tasirin tasiri don sakamako da yawa, wanda zai taimaka ƙididdiga girman samfurin nan gaba.Bugu da kari, binciken ya tabbatar da yuwuwar tattara sakamako daban-daban.Duk da haka, ya kuma bayyana batutuwa da dama da ya kamata a yi la'akari da su a hankali yayin tsara bincike na gaba a wannan fanni.Kodayake Desirial® yana da alama yana inganta alamun VVA da aikin jima'i, ba a san tsarin aikinsa ba.Kamar yadda ake iya gani daga mahimmin bayanin CoL1A1 da CoL3A1, da alama akwai shaidar farko cewa tana motsa samuwar collagen.Duk da haka, procollagen 1, procollagen 3 da Ki67 ba su sami irin wannan tasirin ba.Don haka, dole ne a bincika ƙarin alamomin tarihi da na halitta a cikin bincike na gaba.
Multi-point intravaginal allurar Desirial® (haɗe-haɗe-haɗe HA) yana da alaƙa da mahimmanci tare da maganganun CoL1A1 da CoL3A1, yana nuna cewa yana ƙarfafa haɓakar collagen, yana rage yawan alamun VVA, kuma yana amfani da madadin jiyya.Bugu da ƙari, dangane da ƙimar PGI-I da FSFI, gamsuwar haƙuri da aikin jima'i sun inganta sosai.Duk da haka, jimlar kauri na mucosa na farji bai canza sosai ba.
Za'a iya samun saitin bayanan da aka yi amfani da shi da/ko aka bincika yayin binciken na yanzu daga mawallafin da ya dace bisa buƙatun da ya dace.
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