1.Real-world patient satisfaction with hyaluronic acid filler HYC-24/HYC-24+ for the treatment of moderate to severe nasolabial folds in China
Ling CAO ; Weimin SONG ; Shiliang XU ; Zhifu SUI ; Maglambayan JOY ; Patel VAISHALI
Chinese Journal of Plastic Surgery 2024;40(4):436-443
Objective:To assess the real-world patient satisfaction with the outcomes in Chinese patients who received HYC-24/HYC-24+ for the treatment of moderate to severe nasolabial folds (NLF).Methods:This study was a prospective, observational, multicenter, real-world cohort study in which patients accepted treatment with HYC-24/HYC-24+ in China during a period from August 2018 to August 2020 at Beijing Lidu Medical Beauty Hospital, Hangzhou Yanshu Yuerong Medical Aesthetic Clinic, and Guangzhou Yuexiu Plastic Surgery Hospital and were followed up for up to 1 year. Patients were adults aged 18 to 65 years with moderate to severe NLF who had not received cosmetic treatment for NLF within 6 months prior to study enrollment. Post-treatment study visits were conducted at Months 1, 6, 9, and 12, but only Months 6 and 9 were required visits. The primary patient-reported outcomes endpoints included the FACE-Q satisfaction with outcome total score (a score from 0 to 100: a higher score indicates better outcomes and higher patient satisfaction), FACE-Q appraisal of lines - NLFs total questionnaire score mean change from baseline (a score from 0 to 100: a higher score indicates the patient was less troubled by NLF in the past week), and proportion of patients who reported that they looked younger than the actual age on the FACE-Q patient perceived age visual analog scale (VAS). Investigator-assessed endpoints included the proportion of patients with a global aesthetic improvement scale (GAIS) score of ≥ 1 point and the proportion of patients with an improvement in NLF severity of ≥ 1 point using the nasolabial fold severity scale (NLFSS). Statistical analyses were performed with SAS software, version 9.4. Measurement data were expressed as Mean±SD, and count data were expressed using cases(%). For both measurement and count data, P values were calculated on the difference between score values at different time points versus baseline using the Wilcoxon signed rank test. Results:A total of 52 subjects were enrolled and treated. Among these subjects, 7 were not included in the 6-month effectiveness analysis data set because the visit time exceeded the visit assessment window, and only 9 patients completed the 12-month visit. All patients were Chinese women, aged 26 to 62 years old, with a mean age of 40.7 years. The FACE-Q satisfaction with outcome total score was (68.76 ± 21.03) points (38-100) at Month 6, and (65.44±18.24) points (24-100) at Month 9, indicating high patient satisfaction with the treatment. The FACE-Q appraisal of lines-NLFs total score was (42.4±15.1) points (10-69) at baseline, (76.9±20.6) points (36-100) at Month 6, and (74.2±16.7) points (36-100) at Month 9, both significantly higher than the baseline scores (both P<0.01). The mean change from baseline in the FACE-Q appraisal of lines-NLFs total scores at Month 6 and Month 9 were 34.9 and 31.8 points, respectively, indicating the disturbance caused by NLF was relatively mild after treatment. The proportion of patients who believed they looked younger than their actual age on the FACE-Q patient perceived age VAS increased from 28.9% (15/52) at baseline to 77.8% (35/45) at Month 6, and 73.1% (38/52 ) at Month 9. The differences were all statistically significant compared to baseline ( P <0.01). At each post-baseline visit, all patients had ≥ 1-point improvement on the GAIS scale, indicating an improvement in patient NLF appearance in the investigators’ opinion. In terms of the NLFSS assessment, 97.8% (44/45) and 82.7% (43/52) of patients achieved a ≥ 1-point improvement on the NLFSS at Months 6 and 9, respectively. No adverse events were reported during the study. Conclusion:In a real-world setting, after the administration of HYC-24/HYC-24+ to Chinese patients, the patients were satisfied with the outcomes based on validated questionnaires. The patients also reported looking younger than their actual age and being less disturbed by NLF. Clinician-reported outcomes were consistent with patient-reported outcomes, indicating improvement in NLF.
2.Real-world patient satisfaction with hyaluronic acid filler HYC-24/HYC-24+ for the treatment of moderate to severe nasolabial folds in China
Ling CAO ; Weimin SONG ; Shiliang XU ; Zhifu SUI ; Maglambayan JOY ; Patel VAISHALI
Chinese Journal of Plastic Surgery 2024;40(4):436-443
Objective:To assess the real-world patient satisfaction with the outcomes in Chinese patients who received HYC-24/HYC-24+ for the treatment of moderate to severe nasolabial folds (NLF).Methods:This study was a prospective, observational, multicenter, real-world cohort study in which patients accepted treatment with HYC-24/HYC-24+ in China during a period from August 2018 to August 2020 at Beijing Lidu Medical Beauty Hospital, Hangzhou Yanshu Yuerong Medical Aesthetic Clinic, and Guangzhou Yuexiu Plastic Surgery Hospital and were followed up for up to 1 year. Patients were adults aged 18 to 65 years with moderate to severe NLF who had not received cosmetic treatment for NLF within 6 months prior to study enrollment. Post-treatment study visits were conducted at Months 1, 6, 9, and 12, but only Months 6 and 9 were required visits. The primary patient-reported outcomes endpoints included the FACE-Q satisfaction with outcome total score (a score from 0 to 100: a higher score indicates better outcomes and higher patient satisfaction), FACE-Q appraisal of lines - NLFs total questionnaire score mean change from baseline (a score from 0 to 100: a higher score indicates the patient was less troubled by NLF in the past week), and proportion of patients who reported that they looked younger than the actual age on the FACE-Q patient perceived age visual analog scale (VAS). Investigator-assessed endpoints included the proportion of patients with a global aesthetic improvement scale (GAIS) score of ≥ 1 point and the proportion of patients with an improvement in NLF severity of ≥ 1 point using the nasolabial fold severity scale (NLFSS). Statistical analyses were performed with SAS software, version 9.4. Measurement data were expressed as Mean±SD, and count data were expressed using cases(%). For both measurement and count data, P values were calculated on the difference between score values at different time points versus baseline using the Wilcoxon signed rank test. Results:A total of 52 subjects were enrolled and treated. Among these subjects, 7 were not included in the 6-month effectiveness analysis data set because the visit time exceeded the visit assessment window, and only 9 patients completed the 12-month visit. All patients were Chinese women, aged 26 to 62 years old, with a mean age of 40.7 years. The FACE-Q satisfaction with outcome total score was (68.76 ± 21.03) points (38-100) at Month 6, and (65.44±18.24) points (24-100) at Month 9, indicating high patient satisfaction with the treatment. The FACE-Q appraisal of lines-NLFs total score was (42.4±15.1) points (10-69) at baseline, (76.9±20.6) points (36-100) at Month 6, and (74.2±16.7) points (36-100) at Month 9, both significantly higher than the baseline scores (both P<0.01). The mean change from baseline in the FACE-Q appraisal of lines-NLFs total scores at Month 6 and Month 9 were 34.9 and 31.8 points, respectively, indicating the disturbance caused by NLF was relatively mild after treatment. The proportion of patients who believed they looked younger than their actual age on the FACE-Q patient perceived age VAS increased from 28.9% (15/52) at baseline to 77.8% (35/45) at Month 6, and 73.1% (38/52 ) at Month 9. The differences were all statistically significant compared to baseline ( P <0.01). At each post-baseline visit, all patients had ≥ 1-point improvement on the GAIS scale, indicating an improvement in patient NLF appearance in the investigators’ opinion. In terms of the NLFSS assessment, 97.8% (44/45) and 82.7% (43/52) of patients achieved a ≥ 1-point improvement on the NLFSS at Months 6 and 9, respectively. No adverse events were reported during the study. Conclusion:In a real-world setting, after the administration of HYC-24/HYC-24+ to Chinese patients, the patients were satisfied with the outcomes based on validated questionnaires. The patients also reported looking younger than their actual age and being less disturbed by NLF. Clinician-reported outcomes were consistent with patient-reported outcomes, indicating improvement in NLF.
3.Whole brain dynamic volume CT angiography and CT perfusion imaging in middle cerebral artery occlusion animal models
Juan YE ; Zhifu QIU ; Hailin SHEN ; Hailong SHANG ; Hongdi DU ; Lelin YU ; Fanghui ZHENG ; Ying CAO ; Fanghong ZHAO ; Ying WANG
Chinese Journal of Neuromedicine 2022;21(2):119-125
Objective:To investigate the evaluation value of one-stop whole-brain dynamic volume CT angiography and CT perfusion imaging (CTA-CTP) in the cynomolgus monkeys models of middle cerebral artery occlusion (MCAO).Methods:Ten adult cynomolgus monkeys were selected and examined by head and neck CTA-CTP and craniocerebral MRI to rule out craniocerebral space-occupying lesions or cerebrovascular malformation. Under guidance of digital substraction angiography (DSA), the right femoral artery was dissected and monkey autologous thrombosis was injected into the right middle cerebral artery (MCA) through microcatheter to prepare MCAO models. Whole brain DSA was performed intraoperatively to observe whether the model was successfully prepared, and head and neck CTA-CTP was performed 24 h and 7 d after modeling to determine the locations and brain blood flow changes of ischemic lesions. The monkeys were sacrificed 8 d after modeling, and the brain tissues were stained with 2,3,5-triphenyltetrazolium chloride (TTC).Results:Among the 10 cynomolgus monkeys, one was excluded because of preoperative cerebrovascular malformation, and one died of cerebral hernia caused by cerebral hemorrhage during the experiment. The remaining 8 MCAO models were successfully prepared. Intraoperative DSA orthography showed unclear M1 segment and distal branch of MCA. Brain CT scan 24 h and 7 d after modeling showed obvious cerebral ischemic lesions in the right MCA blood supply area, and the infarct extent 7 d after surgery was more obvious than that 24 h after surgery. CTA examination showed obvious blood flow interruption imaging in the in M1 segment of MCA on the right side, the distal vessels were not clearly displayed and the distal branches of the infarct side 7 d after surgery were obvious decreased as compared with those 24 h after surgery. CTP scan showed that the cerebral blood volume of the right cerebrum was obviously reduced as compared with that of the left cerebrum, which was consistent with the blood supply area of MCA; and the infarct cores and penumbra areas 7 d after surgery were obvious increased as compared with those 24 h after surgery. TTC staining showed that the ischemic lesions of the brain tissue on the slices were gray and involved multiple layers, and the range was roughly consistent with the infarction sites shown by DSA and CT imaging.Conclusion:One-stop whole brain dynamic volume CTA-CTP has good evaluation value in imaging findings in MCAO animal models.
4.Study on Improvement of the Quality Standard for Bidouyan Granule
Hong ZHOU ; Zhifu YANG ; Xiaopeng SHI ; Aidong WEN ; Jinyi CAO
China Pharmacist 2018;21(1):162-164
Objective:To establish the quality standard for Bidouyan granule .Methods: Scutellariae radix and Magnoloae flos were identified by TLC.The content of baicalin was determined by HPLC with a Kromasi 1 C18 column (250 mm ×4.6 mm,5 μm). The mobile phase consisted of methanol-water-phosphoric acid (45:55:0.2) at a flow rate of 1.0 ml· min-1, and the injection volume was 10μl.The detection wavelength was 280 nm and the column temperature was 30℃.Results:The spots in TLC were clear without any interference.The linear range of baicalin was 10.06 μg· ml-1-100.60 μg· ml-1 (r =1.0000).The average recovery was 96.3%,and RSD was 0.7%(n=6).Conclusion:The method is simple and specific with good repeatability , which can be used for the quality control of Bidouyan granule .
5.Improvement of Quality Standard forAidi B Capsules
Chao ZHAO ; Yan LI ; Xiaodan BAI ; Zhifu YANG ; Aidong WEN ; Jinyi CAO
China Pharmacist 2018;21(2):351-353
Objective:To establish the quality standard for Aidi B capsules.Methods:Astragalus membranaceus,Fallopia multi-flora and Gastrodiae elata were identified by TLC qualitatively.The content of gastrodin was determined by HPLC.The chromatographic separation was carried out on an Eclipse Plus C18column (250 mm ×4.6 mm,5 μm). The mobile phase consisted of acetonitrile-0.05% phosphoric acid solution (2:98) at a flow rate of 1.0 ml·min-1.The detection wavelength and the column temperature was 220 nm and 25℃,respectively.Results:The spots in TLC were clear without any interference.The linear range of gastrodin was 8.532-208.8 μg·ml-1(r=1.000 0),and the average recovery was 100.30%(RSD=0.37%,n=6).Conclusion:The method is simple with good repeatability,which can be used for the quality control of Aidi B capsules.
6.Quality Standard Improvement for Shenzhi Xiaoping Capsules
Wei ZHANG ; Ruili LI ; Jinyi CAO ; Qun DU ; Yan ZHANG ; Zhifu YANG ; Aidong WEN ; Minna YAO
China Pharmacist 2018;21(10):1888-1891
Objective: To establish the quality standard for Shenzhi Xiaoping capsules. Methods: The characteristics of Astragali Radix were identified by microscopy. TLC was adopted to identify Astragali Radix, Fructus Aurantii and Glycyrrhiza uralensis. The con-tent of ginsenoside Rb1in Panax ginseng was determined by HPLC. Results: The microscopic characteristics were obvious. The TLC spots were clear with highly specific identification and good separation. The linear range of ginsenoside Rb1was 47. 06-376. 5 μg· ml-1(r=0. 999 9), and the average recovery was 102. 7% with the RSD of 1. 1% (n=6). Conclusion: The method is simple and specific, which can be used for the quality control of Shenzhi Xiaoping capsules.
7.Improvement of the Quality Standard for Shule Capsules
Shanbo MA ; Jinyi CAO ; Qun DU ; Ruifan ZHAO ; Benxiang HU ; Zhifu YANG ; Aidong WEN ; Xiaopeng SHI
China Pharmacist 2017;20(3):446-448,452
Objective:To establish the quality standard for Shule capsules. Methods: The microscopic characteristic identifica-tion of Figwort and Radix bupleuri was performed under a microscope. The qualitative identification of fritillary, andrographispaniculata and polygonumbistorta was studied by TLC. The content of salvianolic acid B in Salvia miltiorrhiza was determined by HPLC. The chro-matographic separation was carried out by using a phenomenex synergi 4 hydro-RP 80A (250 mm × 4. 6 mm) column. The mobile phase consisted of acetonitrile-methanol-formic acid-water(10 :30 :59 :1)with gradient elution at a flow rate of 1. 0 ml·min-1, and the injection volume was 10 μl . The detection wavelength and the column temperature was 286 nm and 20 ℃, respectively. Results:The microscopic characteristics were obvious. The spots in TLC were clear without any interference. The linear range was 10. 001-100. 007 μg·ml-1(r=1. 0000). The average recovery was 99. 3% with RSD of 1. 8% (n=6). Conclusion:The method is simple with high specificity and good repeatability, which can be used as the quality control method for Shule capsules.
8.Improvement of the Quality Standard for Jinhuanglian Oral Liquid
Long LI ; 第四军医大学西京医院药剂科 ; Shanbo MA ; Jin WANG ; Juan BAI ; Ying CHEN ; Xiaopeng SHI ; Zhifu YANG ; Aidong WEN ; Jinyi CAO
China Pharmacist 2017;20(10):1876-1878
Objective:To improve the quality standard for Jinhuanglian oral liquid. Methods:The three herbs in the preparation, Honeysuckle, Scutellaria Baicalensis Georgir and St John's Wort, were identified by TLC qualitatively. The content of chlorogenic acid in Lonicerae Japonicae Flos was determined by HPLC. The chromatographic separation was carried out on a Promosil C18 (250 mm × 4. 6 mm,5 μm) column at 25℃. The mobile phase consisted of acetonitrile-0. 4% phosphoric acid (10 :90) with gradient elution at a flow rate of 1. 0 ml·min -1 , and the injection volume was 10μl. The detection wavelength was 327 nm. Results:The spots in TLC were clear without any interference. The linear range of chlorogenic acid was 5.325-170.400 μg·ml-1(r=0.9998). The average recovery was 97. 95% and the RSD was 2. 04%(n=6). Conclusion:The method is reliable and easy to operate,which can be used as the quality control method for Jinhuanglian oral liquid.
9.Improvement of the Quality Standard for Jinhuanglian Oral Liquid
Long LI ; 第四军医大学西京医院药剂科 ; Shanbo MA ; Jin WANG ; Juan BAI ; Ying CHEN ; Xiaopeng SHI ; Zhifu YANG ; Aidong WEN ; Jinyi CAO
China Pharmacist 2017;20(10):1876-1878
Objective:To improve the quality standard for Jinhuanglian oral liquid. Methods:The three herbs in the preparation, Honeysuckle, Scutellaria Baicalensis Georgir and St John's Wort, were identified by TLC qualitatively. The content of chlorogenic acid in Lonicerae Japonicae Flos was determined by HPLC. The chromatographic separation was carried out on a Promosil C18 (250 mm × 4. 6 mm,5 μm) column at 25℃. The mobile phase consisted of acetonitrile-0. 4% phosphoric acid (10 :90) with gradient elution at a flow rate of 1. 0 ml·min -1 , and the injection volume was 10μl. The detection wavelength was 327 nm. Results:The spots in TLC were clear without any interference. The linear range of chlorogenic acid was 5.325-170.400 μg·ml-1(r=0.9998). The average recovery was 97. 95% and the RSD was 2. 04%(n=6). Conclusion:The method is reliable and easy to operate,which can be used as the quality control method for Jinhuanglian oral liquid.
10.Improvement of Quality Standard for Shenyan Ⅱ Granules
Shanbo MA ; Jinyi CAO ; Ruifan ZHAO ; Jing WANG ; Xiaopeng SHI ; Zhifu YANG ; Aidong WEN ; Benxiang HU
China Pharmacist 2016;19(5):1008-1010,1011
Objective:To establish the quality standard for Shenyan Ⅱ granules. Methods:The characteristics of Folium Pyrrosiae were identified by microscopy. The three herbs in the preparation,rehmannia,madder and thistle were identified by TLC qualitatively. The content of ginsenoside in American ginseng was determined by HPLC. Chromatographic separation was carried out by using a WONDER CRACT ODS-2(150 mm × 46 mm,5 μm)column. The mobile phase consisted of acetonitrile-0. 1% phosphoric acid(28 ∶72)with gradient elution at a flow rate of 1. 0 ml·min -1 ,and the injection volume was 10 μl. The detection wavelength and the column temperature was 203 nm and 40 ℃,respectively. Results:The spots in TLC were clear without any interference. The linear range of ginsenoside was 38. 9- 194. 5 μg·ml -1(r = 0. 999 3). The average recovery was 98. 3% and RSD was 1. 9%(n = 6). Conclusion:The method is simple and highly specific with good repeatability,which can be used as the quality control method for Shenyan Ⅱ granules.

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