Zunthlum i vei a nih chuan i mit hriselna i ngaihtuah a rinawm. I doctor chuan zunthlum hian i mit a nghawng tih a hrilh che a ni mai thei a, chu chu Diabetic Macular Edema (DME) tih a ni. Chuvangin, he natna enkawl dan tur a nih chuan ‘clinical trial’ tih hi i hre tawh em? He hming hriat hi a hlauhawm deuh thei. I ngaihtuah mai thei, “Ka test mek em?” Mahse, hlauh tur a ni lo. Vawiin hian eng nge a nih tak tak, eng hlawkna nge a thlen theih che tih te, i tan a tha em tih te i sawi dawn nia.
A awlsam zawngin, clinical trial chu eng nge ni?
Damdawi dawr atanga damdawi i lei apiang kha han ngaihtuah teh. Khawsik leh khuh damdawi atanga i zunthlum leh thisen sang damdawi thlengin, engkim hi i kut a thlen hmain uluk taka test a ni. Chu testing chu `Clinical Trial` kan tih chu a ni.
A awlsam zawngin, hei hi damdawi thar mi hnena pek hmaa test a, a thawk tak tak (effective) em tih leh hman a him em (safe) em tih enfiah dan a ni. Hei hi ruahmanna fel tak neia tih a ni a, doctor leh zirchiangtute enkawlna khauh tak hnuaiah tih a ni. Chumi atan chuan damlo pawl pakhat, he enkawlna thar pek tura inpete leh an dinhmun hi uluk takin an enfiah thin. Chuvangin hei hi "guinea pig" nih ang a ni lo tak zet a ni. Hei hi dan mumal tak, ethical tak hnuaia tih a ni a, damlo himna chu ngaih pawimawh ber a ni.
Hetiang test hlawhtling taka an pass hnuah chauh Sri Lanka-a National Medicines Regulatory Authority (NMRA) ang institution-te chuan he damdawi hi ram chhunga hman phalna an pe ṭhin.
DME vei tan clinical trial neih hian eng hlawkna nge a neih?
I ngaihtuah mai thei, "Awle, chu chu a ni, mahse engvangin nge he thilah hian ka inrawlh? Ka tan eng hlawkna nge?" A nihna takah chuan hlawkna engemaw zat a awm. Anni hi han thlir ila.
| Chhawr tangkai | Hei hian a awmzia chu... |
|---|---|
| Cutting-edge treatment hmuh theihna | Mainstream market-a la hit lo treatment thar i enchhin theihna hun i nei ang. I doctor-in a pek theih loh damdawi a ni thei. |
| Results tha zawk hmuh theihna | A châng chuan heng enkawlna tharte hi enkawlna awmsa aiin a hlawk zawk thei a, chu chu i mit a ṭha thei emaw, i dinhmun chu a thunun rang zawk thei tihna a ni. |
| Damdawi lam enkawlna hnai tak a ni | Clinic i kal huna i hmuh dan pangngai aia ngaihven leh enkawlna i dawng tam zawk ang. I test fo ang a, doctor-te pawhin i dinhmun an enfiah reng ang. |
| Nakin hun tur tanpui | I inrawlh hian DME chungchanga scientific hriatthiamna tihpunna kawngah leh nakin lawkah he natna vei midangte tan enkawlna tha zawk pekna kawngah i thawhhlawk hle a ni. |
Zirchiangtute thil tum chu eng nge ni?
Tuna DME chungchanga zirchianna hian thil tum lian tak tak engemaw zat a nei a.
- Clinic tlawh tlem: Mit injection lak nan damdawi inah hetiang taka kal a ngai lo a nih chuan eng ang nge a awlsam zawk ang tih han ngaihtuah teh. Zirchiangtute chuan damdawi rei zawk daih tur zawngin an bei mek a ni.
- Injection ai chuan pills: Mi thenkhat chuan mit chhunga injection luh harsa an ti thin. He natna hi nitin ei thin pill hmanga control theih ni ta se engtin nge ni ang? Hei hi zirchianna lian tak dang a ni.
- Enkawlna thatna tihpun: Tum dang chu damdawi awmsa aiin damdawi tha zawk leh tha zawk zawn chhuah hi a ni.
Engtin nge clinical trial hian hna a thawh?
Heng trial te hi chi hnih ah then theih a ni. Mahse a chi hman tlanglawn ber chungchang hi han sawi ila. `Interventional Trial` tih a ni.
Hei hian zirchiangtute’n damdawi (damdawi emaw injection emaw ang chi) an pek a, a nghawng dan an zirchiang a ni. Hei hi kawng hrang hrangin tih theih a ni.
Mahse a tam zawkah chuan ‘Randomized Controlled Trial’ tih method an hmang thin. A hming hi a buaithlak deuh a, mahse a concept erawh a awlsam hle.
He test atan hian mi 100 vel an inpe tih han ngaihtuah teh.
1. Pawl hrang hranga inthen:Heng mi 100 te hi randomly group hnih ah then an ni a, mi 50 ve ve an awm a, thlan tur an awm lo.
2. Enkawlna pek: 1.1.
- Group hmasa ber (mi 50): enkawl thar chu pek an ni ang.
- Pawl hnihna (mi dang 50): tuna DME tana hman mek, standard treatment tha ber chu an dawng chhunzawm zel dawn a ni. He pawl hi `Control Group` an ti a.
3. Inthlauhna: Hun engemaw chen hnuah group pahnih result chu tehkhin a ni. Enkawlna hlui aiin enkawlna thar hi engtiang chiahin nge a tha zawk? Side effect a nei tlem zawk em? A him em? Hei hmang hian engkim hi dik taka teh theih a ni.
Hetianga control group nena khaikhin loh chuan damdawi thar hi eng ang taka tangkai nge a nih tak tak tih chu scientifically-in finfiah theih a ni lo. Chuvang chuan he method hi a pawimawh em em a ni.
Engtin nge hetiang thilah hian ka inrawlh theih ang?
Hei hi zawhna pawimawh ber a ni. Hei hi i ngaihven a nih chuan i tih tur hmasa ber leh pawimawh ber chu i mit surgeon emaw, i enkawltu zunthlum doctor emaw nena inbiakna neih hi a ni.
- I doctor hian i damdawi lam dinhmun leh i hriselna chanchin a hre chiang ber a, chuvangin chutiang test-a tel chu i tan a dik leh dik loh chungchangah thurawn tha ber ber a pe thei che a ni.
- Hetiang zirchianna hi Sri Lanka rama sorkar damdawi in lianah te, a bik takin medical faculty nena inzawm damdawi inah te neih fo a ni. I doctor chuan tunah hian i tana tha tur test neih mek a awm leh awm loh a hre thei ang a, chu chu a refer thei ang che.
- Doctor rawn hmasa lovin hetiang thutlukna hi nangmah chauhin siam ngai suh.
I tel hmain zirchianna enkawltu team chuan engkim (eng nge tih tur, a hlauhawm theih dan, a hlawkna tur) an hrilhfiah vek ang che. Zawhna i zawh hnuah leh i lungawi kim hnuah chauh ziaka remtihna i dawng ang. Tin, zirlai i neih chhunga engtik lai pawha nuam lo i tih chuan chu chu inhnukdawk theihna dikna famkim i nei bawk.
Take-Home Thuchah a ni
- Clinical trial chu damdawi thar mi hnena pek a nih hmaa a him leh him loh finfiah nan formal study neih a ni.
- Hetiang trial-a i tel hian nang, DME nei te hian tuna enkawl theih loh enkawlna thar ber berte dawng theihna hun remchang i nei a, damdawi lam enkawlna tha zawk i dawng thei bawk.
- Hei hi nangmah leh nakin lawka he natna vei thei tur midangte tanpuina ropui tak a ni.
- Hei hi i ngaihven a nih chuan a hmasa berah chuan i doctor nen inbia la, a thurawn la rawh.











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