Clinical research of Pranoprofen capsule on middle and severe xerophthalmia of chronic graft versus host disease after hematopoietic stem cell transplantation

Abstract

Objective To investigate therapeutic efficiency of Pranoprofen capsule on middle and severe xerophthalmia of chronic graft versus host disease (cGVHD) after hematopoietic stem cell transplantation (HSCT).Methods A prospective random controlled study.Totally sixteen patients diagnosed middle and severe xerophthalmia of cGVHD after HSCT from March,01 2007 to July,01 2012 were divided into two groups:Pranoprofen capsule group (group A) and control group (Vitamin C capsule,group B),eight cases in each group.All groups had been added with Forte eye drops and Fluorometholone eye drops.All patients had been detected and evaluated by subjective symptoms of xerophthalmia.The symptom of ocular surface,Ocular Surface Disease Index (OSDI) and tear film function tests were performed at pre-therapy and 3,7,28 d of post-therapy.Results There were no significant difference for the symptom of ocular surface,OSDI and tear film function were found between two groups pre-therapy [F =0.92 (visual tiredness),0.98 (dry and unsmooth sensation),1.12 (foreign body sensation),1.62 (burning sensation),0.86 (photophobia),0.46 (pain),1.06 (red eye),0.868 (vision),0.924 (OSDI),0.532 (BUT),0.619 (Tear meniscus high),0.584 (SIT),0.882 (FL); P ＞0.05)]; The subjective symptoms,Tear meniscus high,FI,BUT and SIT of middle and severe xerophthalmia of Pranoprofen capsule group had been improved at 28 d after therapy compared with those of pre-therapy:SMD=l.24 (dry and unsmooth sensation),1.82 (foreign body sensation),1.32 (burning sensation),1.53 (pain),1.54 (red eye) [F1=13.2 (dry and unsmooth sensation),15.6 (foreign body sensation),20.4 (burning sensation),19.6 (pain),11.20 (red eye); 9.65 (vision),12.26 (OSDI),10.86(FL); P ＜0.05]; The control group hadn't significantly been improved at 28 d after therapy:SMD=0.62 (visual tiredness),0.48 (dry and unsmooth sensation),0.62 (foreign body sensation),0.48 (burning sensation),0.92 (photophobia),0.49 (red eye),2.98 (OSDI),1.06 (BUT),2.02 (SIT),1.64 (Tear meniscus high),1.58 (FL); P ＞0.05) [F1=2.58 (visual tiredness),1.58 (dry and unsmooth sensation),1.62 (foreign body sensation),2.32 (burning sensation),3.32 (photophobia),2.64 (red eye),P ＞0.05].There were statistically significance for OSDI and fluorescein staining (FL) at the postoperative 1 month in both groups (FOSDI=18.245,FFL=-12.138,P ＜0.05).Conclusions Pranoprofen capsule can significantly mitigation the sings and symptoms of middle and severe xerophthalmia in cGVHD after HSCT. Key words: Pranoprofen; Xerophthalmia; Treatment; cGVHD; HSCT