[Multicenter randomized, double-blind, placebo-controlled trial of prostaglandin E1 cream for female sexual arousal disorder].

OBJECTIVE: To investigate the efficacy and safety of alprostadil cream in management of female sexual arouse disorder (FSAD), and its appropriate dose for clinical prescription. METHODS: The volunteers were assigned randomly to four groups which received alprostadil cream in different dosage (500 µg, 700 µg and 900 µg) or placebo cream, respectively. The cream was applied to the clitoris and G-spot before coitus. The efficacy was assessed by comparing the satisfactory rate of sexual arousal, the score of female sexual function index (FSFI) and female sex disorder scale (FSDS) and the general appraised question (GAQ) before and after the treatment. The safety was evaluated by the adverse effects that appeared including symptoms, physical and biochemical examination. RESULTS: Totally, 400 women enrolled in this study with 374 assigned to the group for efficacy evaluation and 387 cases to the group for safety analysis. No significant difference was found among the four groups in the demographic characters and sexual baseline. The increase of satisfactory percentage of sexual arousal in the four groups (placebo, 500 µg, 700 µg and 900 µg) was 22.63%, 36.67%, 34.01%, and 44.29%, respectively (P<0.05), and the increase was statistically higher in the 900 µg group than in the placebo group (P<0.0167). The elevated FSFI score above the baseline in the treatment groups (900 µg 22.89, 700 µg 21.69, and 500 µg 20.71) were higher than that in the placebo group (14.68, P<0.05), while the reduced FSDS score below the baseline (900 µg 25.97, 700 µg 21.98, and 500 µg 20.27) were higher than that of the placebo (17.60, P<0.05). No significant difference was found in the four groups in GAQ (P=0.054). The main common adverse effect was topical stimulation. No adverse effect was reported in physical and biochemical examination, electrocardiogram (ECG) or Thinprep cytologic test (TCT). CONCLUSION: Alprostadil cream can treat female sexual arousal disorder effectively with the maximum effect at the dose of 900 µg and without significant adverse effect except for mild topical stimulation.

[Experimental study of repairing fat defect with human hair keratin material].

OBJECTIVE: To investigate the feasibility of adipogenesis from human hair keratin (HHK) material, so as to provide a new method for fat defect and depression deformity. METHODS: 3 Tibet mini-pigs were used. 8 fat defects (1.5 cm in diameter) were made bilaterally on the back. The ball-shaped HHK material was implanted to repair the defects at one side. The defects at contralateral side were as controls. The absorption of the HHK material and adipogenesis were studied histologically. RESULTS: 2 weeks after implantation, connective tissue and capillary grew into the porous HHK material. 4 weeks after implantation, HHK material was almost totally absorbed, leaving some material debris and foreign body granuloma. Around them, there were clusters of adipocyte. 6 weeks after implantation, the HHK material was totally degraded and the granuloma was disappeared, and then de novo adipose tissue was observed. Its volume was close to the volume of peripheral HHK material that was planted originally. 10 weeks later, the new-formed fat tissue had less fibres and was very similar to the normal fat. CONCLUSIONS: New adipose tissue can be formed after HKK material implantation. It can also be remodeled to be similar to normal fat.

[Use of high-risk human papillomavirus DNA testing to deal with atypical squamous cells undetermined significance and low squamous intraepithelial lesion].

OBJECTIVE: To explore the role of high-risk human papillomavirus (HPV) DNA testing in improvement of recognition of cervical intraepithelial lesions (CIN) 2, 3 or cervical cancer confirmed by biopsy in women with abnormal cervical cytology including atypical squamous cells undetermined significance (ASC-US) and low squamous intraepithelial lesion (LSIL). METHODS: Total 940 patients with abnormal cervical liquid-based cytology including ASC-US and LSIL were included in this study. Hybrid capture II assay was applied in the high-risk HPV detection. The cervical pathologic diagnoses were obtained under colposcopy guided biopsy. RESULTS: Of the 940 cases, 497 were ASC-US, and 443 LSIL. With pathological diagnosis of cervical biopsy, 417 cases were chronic inflammation, 315 condyloma, 124 CIN 1, 65 CIN 2, 19 CIN 3 or cervical cancer. The positive rate of high-risk HPV DNA in groups of ASC-US and LSIL were 59.6% and 84.9%, respectively. In each group of abnormal cytology, detection rates of CIN 2, 3 or cervical cancer in patients with positive HPV DNA were 8.8% and 14.1%, respectively, which were higher than those with negative HPV DNA (0.2% and 6.0%, P < 0.05). In group of ASC-US, high-risk HPV DNA test had a negative predictive value of 99.5%; detection rates of CIN 2, 3 or cervical cancer in patients with HPV DNA virus load 1-9.99 and > or = 10 was 1.6% and 10.7%, respectively. CONCLUSION: High-risk HPV DNA test were helpful to improve the detection rates of CIN 2, 3 or cervical cancer in patients with ASC-US.