Patient characteristics
Between 4 December 2018 and 13 August 2020, a total of 218 women were
enrolled and 195 women were finally analyzed in this study (Figure 1).
The trial ended when the sample
size requirement was reached. 18 women withdrew from the study based on
their own willingness, and 5 women with vaginal lesions were not
included in the final statistical analysis. 97 women underwent
fluorescence colposcope guided biopsy with NIR fluorescent dye
TMTP1-PEG4-ICG, and another 98 underwent
conventional
colposcope directed biopsies with
acetic acid and Lugol’s iodine
solution. As shown in Table 1, the average age of the fluorescence group
and the conventional group was 41.7 and 39.9, respectively. In the
fluorescence group, 35 patients had an abnormal Thinprep cytologic test
(TCT) and 91 had a positive HPV test. For the conventional group, there
were 27 and 94 patients with abnormal TCT and HPV positive,
respectively.
Comparison of imaging characteristics betweenfluorescencecolposcope and
conventional colposcopy
Typical images captured with the colposcope were shown in
Figure 2.
Fluorescence colposcope could show
specific fluorescence signals at cervical lesions in patients with CIN 3
(from patient of No.15), and the
patient with normal pathological result (from patient of No.68) had no
obvious fluorescence signal at the cervix. Representative visible light
pictures, fluorescent pictures and combined pictures were displayed
in
Figure 2A. As for conventional
colposcopy, acetic acid stained the cervical lesions of CIN 2-3 patient
(from patient of No.16) white,
while Lugol’s iodine didn’t stain the lesion. And patient with benign
cervix (from patient of No.38) had no acetic acid white reaction and
normal iodine intake. The representative original pictures, acetic acid
staining pictures and iodine staining pictures of the conventional
colposcopy group were displayed in Figure 2B. Both groups of patients
had no obvious local irritation during cervical staining and colposcopy.