Uphononongo olutsha kwi-Non-Opioid Treatment of Post-Operative Pain

A BAMBA isiKhululo sasimahla 6 | eTurboNews | eTN
IAvatar kaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

I-Cali Biosciences Co., Ltd. ibhengeze iziphumo eziyimpumelelo kwiSigaba se-IIb sophononongo lwemveliso ye-analgesic esebenza ixesha elide ye-CPL-01, inguqulelo etofwayo eyandisiweyo yeNaropin® (ropivacaine hydrochloride), ephuhliswe yiCali Biosciences ukunyanga i-post-operative. iintlungu zotyando kunye nokunciphisa imfuno ye-opioids.

Olu vavanyo lwezonyango lweSigaba se-IIb lwenzelwe ukuphanda ngakumbi iingenelo zeklinikhi ze-CPL-01 kunye nokuthelekisa kunye namachiza akhoyo okulawula iintlungu kwiimarike. Ulingo lubonise idosi-impendulo ebalaseleyo ekusebenzeni kakuhle. Kwidosi ecetywayo ngoku njengethamo eliza kuthengiswa, abantu abali-14 abafumene i-CPL-01 babonise i-AUC ephakathi kwiiyure ezingama-72 ze-wWOCF ehlengahlengisiweyo kwi-NRS-A (isiphelo sokuqala) se-286.8, ebonisa umkhwa wokubaluleka ngokuchasene nezifundo ezili-13. abafumene i-placebo (p=0.08) kwaye ingcono kakhulu kunezifundo ezingama-40 ezifumene iNaropin®. Intsingiselo yeklinikhi ibonakaliswe ngokubonisa umahluko ongaphezulu kwenqaku le-AUC enye ngeyure. 

Ukongezelela, ukusetyenziswa kwe-opioid kwiiyure ze-72 zezifundo ze-CPL-01 ezifumene i-dose eziza kuthengiswa zinqunywe kwisiqingatha xa kuthelekiswa nokuba iqela le-placebo okanye iqela le-Naropin® (lithetha i-7.9 mg, ngokuchasene ne-15 mg ye-placebo kunye I-16 mg yeNaropin®). Enyanisweni, malunga ne-2/3 yezifundo ze-CPL-01 (9/14) ayifuni i-opioids kwaphela emva kweeyure zokuqala ezingama-72 emva kotyando, xa kuthelekiswa malunga nesiqingatha sezifundo zeNaropin® kunye ne-30% ye-placebo.

Bekungekho zinto zifunyanisiweyo zokhuseleko zinentsingiselo; Ukuphela konyango oluvela kwiziganeko ezimbi eziye zenzeka ngaphezu kwesinye isifundo se-CPL-01 kuwo onke amaqela ngaphakathi kovavanyo (n = 40) kwakukho isicaphucaphu, ukugabha, ukuqhina, i-headache parasthesia, kunye nesiyezi - zonke iziganeko ezenzeka emva kokuhlinzwa kwaye zinokuthi zenzeke. emva kokusetyenziswa kwe-opioid; akukho nanye kwezi ekucingelwa ukuba inxulumene ne-CPL-01. 

I-pharmacokinetics yechiza ixhasa ngakumbi ukhuseleko lwalo - esona sizathu siphambili sokuba kuphuhliswe i-ropivacaine esebenza ixesha elide, kunye neenzuzo ezinokuthi zibe kho ngaphezu kwe-bupivacaine esebenza ixesha elide ekhoyo ngoku. I-Cmax ephakathi kwe-ropivacaine kwizifundo ezifumene i-600 mg dose yi-978 ng / mL, iphantsi kakhulu kunomda apho i-cardiac toxicity ingabonwa (4000 ng / mL). I-CPL-01 ifikelele ekugxininiseni kwayo okuphezulu malunga neeyure ze-18 emva kokulawulwa, ngokuchasene neNaropin® (efikelela kuyo kwiyure yokuqala emva kokulawulwa).

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IAvatar kaLinda Hohnholz

Linda Hohnholz

Umhleli oyintloko we eTurboNews esekwe kwi-eTN HQ.

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