Results
Two hundred seventeen patients were recruited in the study including 57
LSIL(VaIN1) and 160 HSIL(VaIN2,3) patients. The general information of
the patients is shown in Table 1. There was no significant difference in
age, menopause status, gravidity, parity, abortion, condemn use status,
cervical contact bleeding or cytologic results before laser between the
LSIL(VaIN1) and HSIL(VaIN2,3) groups. There was a significant difference
in HR-HPV test results before laser ablation between the two groups, and
the HSIL(VaIN2,3) group showed a higher HR-HPV infection rate than the
LSIL(VaIN1) group (89.4% vs 78.9%, p =0.047).
Information about concomitant or previous diseases of CIN or cervical
cancer (CC) and the corresponding previous treatments are listed in
Table 2. Of all the patients, 61.9% had the illness of CIN/CC.
The characteristics of VaIN lesions are listed in Table 3. The average
area of VaIN lesions was 1.17cm2. Areas of 63.1% of
lesions were less than 1cm2. The areas of lesions in
the HSIL(VaIN2,3) group were larger than that in the LSIL(VaIN1) group
with a significant difference (1.31cm2 vs
0.79cm2, p =0.055). A history of CIN/VIN in the
LSIL(VaIN1) group was more common than that in the HSIL(VaIN2,3) group
with a significant difference (75.4% vs 58.1%, p =0.020).
The average laser number for all the patients was 2.94. The average
number of therapeutic laser ablation was 2.32 and that of strengthened
laser ablation was 0.62 (Fig. 1). There was a significant difference in
the total number, therapeutic number and strengthened number of laser
ablation between the HSIL(VaIN2,3) and LSIL(VaIN1) groups (3.15 vs 2.35,p =0.000; 2.47 vs 1.91, p =0.002; 0.68 vs 0.44, p=0.060; respectively).
Seventeen patients lost follow-up for the assessment of pathological
cure and 22 patients lost for the assessment of HPV clearance. The
pathological cure rate increased along with increasing laser times in
all the patients (Fig. S1). The cumulative pathological cure rate was
93.0% (186/200) and the cumulative HR-HPV negative rate was 76.9%
(150/195). Multivariate logistic regression analysis showed that larger
areas of VaIN lesions (p =0.048) and history of hysterectomy
(p =0.017) were independent risk factors for the pathological
persistence (Table S1), and that menopause (p =0.042) and non-use
of condemns (p =0.068) were independent risk factors for
persistent HR-HPV infection (Table S2).
In the HSIL(VaIN2,3) group, the cumulative pathological cure rate was
92.0% (138/150) and the cumulative HR-HPV negative rate was 77.5%
(110/142). Three to five times of laser ablation could obtain a
relatively high pathological cure rate (90.4~92.0%) and
HR-HPV negative rate (68.5~77.5%) (Fig. S2).
Multivariate logistic regression analysis showed that larger areas of
VaIN lesions (p =0.083) and history of hysterectomy (p=0.037) were independent risk factors for pathological persistence, and
that menopause (p =0.006) and immunosuppression (p =0.095)
were risk factors for persistent HR-HPV infection (Table S3 and Table
S4).
In the LSIL(VaIN1) group, the cumulative pathological cure rate was
96.0% (48/50) and the cumulative HR-HPV negative rate was 75.5%
(40/53). Two to three times of laser ablation could obtain a relatively
high pathological cure rate (92.0~93.5%) and HR-HPV
negative rate (65.5~73.6%) (Fig. S3). Multivariate
logistic regression analysis showed there was no risk factor for
pathological persistence, and that condemn use (p =0.002) was a
protective factor against HR-HPV infection (Table S5 and Table S6).
The main complication of laser ablation for VaIN was the vaginal
adhesions (21/217, 9.68%). There was another case of surgical site
bleeding. The complication incidence was significantly higher in the
HSIL group than that in the LSIL group (13.13% vs 1.75%, p=0.014). Bivariate correlation analysis (Table S7) showed that
complication incidence was related to vaginitis (p =0.004), VaIN
grade (p =0.014) and laser times (p =0.046). Multivariate
logistic regression analysis showed that the upper three factors were
independent risk factors for complication incidence (p =0.015,p =0.029 and p =0.046, respectively).
There were 455 published studies searched out in the meta-analysis and
21 eligible articles [14, 18~37] were chosen for analysis. The
overall combined effect was 0.78 (95%CI 0.72~0.84, P<0.05)
for the assessment of pathological cure of laser ablation for VaIN (Fig.
S4). The combined effect was 0.84 (95%CI 0.75~0.92,
P<0.05) of laser ablation for both the HSIL(VaIN2,3) and
LSIL(VaIN1) patients.