A prospective multicentre controlled study of Gaoweikang (Chinese multiherb extract-based tincture) used in high-risk HPV infections.

OBJECTIVE: The aim of the study was to investigate the safety and antiviral efficacy of a Chinese multiherb extract-based tincture (GWK) on a population of patients with high-risk human papilloma (hrHPV) infections and hrHPV-caused cervical low-grade squamous intraepithelial lesions (LSILs). PATIENTS AND METHODS: Patients with persistent hrHPV infection were enrolled in Group A, including A1 subjects, who received the intervention, and A2 subjects, who received the control. Patients with hrHPV infection causing cervical LSIL were enrolled in Group B, which included B1 subjects, who received the intervention, and B2 subjects, who served as the control. For Groups A1 and B1, hrHPV was tested at 3 months (M3) and 6 months (M6) after the intervention. The side effects were also analyzed. RESULTS: At baseline (D0), a total of 99 patients were enrolled in Group A, with 50 subjects in Group A1 and 49 subjects in Group A2. A total of 91 patients were enrolled in Group B, with 45 subjects in Group B1 and 46 subjects in Group B2. There was no significant difference in the characteristics, including average age, age stratification, and HPV genotype. At M6, both Group A1 and Group B1 had a higher hrHPV clearance rate than the control group (A1/A2: 80.0% vs. 20.4%; B1/B2: 64.4% vs. 15.2%, p<0.001). At M6, the effective rates of Group A1 and Group B1 were 84% (42/50) and 68.9% (31/45), respectively. The side effect rates of Groups A1 and B1 were 11.5% (6/52) and 11.1% (5/45), respectively. Most adverse reactions involved local discomfort, including vulvar erythema, vulvar itch, increased vaginal discharge, cervical bleeding, and mild pain in the lower abdomen. Univariate logistic regression analysis showed that the intervention had an OR of 12 (95% CI 4.431-32.50) for clearing persistent HPV infection (p<0.001). For cervical LSIL, the intervention had an OR of 10.1 for clearing persistent HPV infection (95% CI 3.68-27.7) (p<0.001). CONCLUSIONS: The results of this study suggest that the Chinese multiherb extract-based tincture GWK is safe and well tolerated. Furthermore, this preliminary study showed that this Chinese multiherb extract-based tincture is helpful for promoting HPV clearance in cases of persistent HPV and HPV-induced LSIL.

[Characteristics and associated factors of early refractive parameters in premature infants].

Objective: To investigate the characteristics and associated factors of early refractive parameters in premature infants. Methods: Case-control study. Premature infants who underwent the first fundus screening in the ophthalmic clinic of Xiamen children's Hospital from May 2018 to February 2019 were collected. The screening time was 4 to 6 weeks after birth or corrected gestational age from 31 to 32 weeks. The premature infants who were diagnosed with mild retinopathy of prematurity (ROP) in one eye or both eyes but did not receive any treatment were divided into ROP group and divided into zone Ⅱ subgroup and zone Ⅲ subgroup according to the region of ROP; the premature infants without ROP were divided into non-ROP group. The gestational age, birth weight, spherical equivalent, anterior chamber depth, vitreous depth, axial length, lens thickness and corneal refractive power were recorded and compared. Independent sample t-test, multiple linear regression analysis and Pearson correlation analysis were used. Results: A total of 180 premature infants, 101 males and 79 females, with gestational age of (30.82±3.10) weeks, corrected gestational age of (37.21±1.44) weeks and birth weight of (1 577.85±572.12) g were included in this study. Ninety premature infants were included in the ROP group (162 eyes, of which 85 right eyes were included in the analysis) and 90 in the non-ROP group (90 right eyes). There was no significant difference in the distribution of gestational age, birth weight and corrected gestational age between the ROP group and non-ROP group (all P>0.05), but there was significant difference in the spherical equivalent between the two groups [(1.90±1.39) D vs. (3.04±1.88) D, t=-4.653, P<0.01], and ROP group was relatively smaller. In the ROP group, the anterior chamber depth was (1.82±0.23) mm, the lens thickness was (4.54±0.18) mm, and the corneal refractive power was (43.99±0.99) D. In the non-ROP group, the anterior chamber depth was (1.91±0.94) mm, the lens thickness was (4.23±0.50) mm, and the corneal refractive power was (43.72±0.92) D. The difference between the two groups was statistically significant (all P<0.01). In ROP group, the anterior chamber depth was shallower, the lens was thicker, and the corneal refractive power was higher. In ROP group, the corneal refractive power of 48 right eyes in zone Ⅱ subgroup and 37 right eyes in Zone Ⅲ subgroup were (43.92±0.78) D and (43.39±1.05) D respectively, and the spherical equivalent were (2.08±0.95) D and (2.52±1.12) D respectively. The corneal refractive power of zone Ⅱ subgroup was higher and the spherical equivalent was smaller, and the differences were statistically significant (all P<0.05). Multiple regression analysis showed that birth weight, gestational age and corneal refractive power were the influencing factors of spherical equivalent (P<0.01). The results of Pearson correlation analysis showed that the gestational age (r=0.182), birth weight (r=0.223) and corneal refractive power (r=-0.125) of premature infants were closely related to the spherical equivalent (all P<0.05). Conclusions: In premature infants, the larger spherical equivalent is related to greater gestational age and heavier birth weight. The refractive parameters of mild ROP are characterized by shallow anterior chamber, thick lens, high corneal refractive power and small spherical equivalent. The spherical equivalent is closely related to the development of ROP. (Chin J Ophthalmol, 2021, 57: 353-357).