1.A cross-sectional study on the pain caused by hyaluronic acid cosmetic injections
Lishuai SHI ; Lili QI ; Jun ZHANG ; Tao WANG ; Guobao WANG ; Feng ZHOU ; Lunli GONG ; Qiuni GAO ; Xiaoqing YAN ; Meng FAN ; Haiyan CUI
Chinese Journal of Plastic Surgery 2024;40(1):326-333
Objective:To learn about physicians’ concepts and commonly employed method in hyaluronic acid injection and provide reference data for the standardization of pain management.Methods:This study was a cross-sectional study. Convenient sampling method was used to distribute questionnaires to cosmetic injectors and patients experienced with hyaluronic acid injections to collect data on their views of pain associated with hyaluronic acid injections. The physician portion was collected offline from June 15 to July 20, 2022, and the patient portion was collected from November 14, 2022, to December 6, 2022, via the Questionnaire Star platform. The physician questionnaire consisted of 17 questions, question types included single choice, multiple choice and essay questions. The patient questionnaire consisted of 6 questions, question types included single choice and multiple choice. Relevant data were analyzed using SPSS 22.0 software for descriptive statistics, and data were presented in the form of cases and percentages (%).Results:Sixty-two physician questionnaires and 123 patient questionnaires were collected. 42 (67.74%) physicians observed from their daily practice that more than 50% of their patients were very concerned about pain during injection; 101 (82.11%) patients scored ≥5 out of 10 for concern about impending pain prior to hyaluronic acid filler injection. At the time of treatment, 48 (77.42%) physicians advised patients to choose a lidocaine-containing hyaluronic acid filler for reasons including a significant reduction in injection pain (53 cases, 85.48%) and patient comfort with the treatment experience (59 cases, 95.16%). 60 (48.78%) patients were willing to choose an anesthesia-containing product at the time of injection, but the price of the anesthesia-containing product influenced the patient’ s choice (55 cases 44.72%) .Conclusions:Pain from cosmetic injectable treatments is an important issue to both physicians and patients. Lidocaine-containing hyaluronic acid is recognized by physicians and patients for its analgesic effect and high safety profile. There is no perfect solution for pain in cosmetic injection treatment, and multidisciplinary collaboration may be needed to solve the problem.
2.A cross-sectional study on the pain caused by hyaluronic acid cosmetic injections
Lishuai SHI ; Lili QI ; Jun ZHANG ; Tao WANG ; Guobao WANG ; Feng ZHOU ; Lunli GONG ; Qiuni GAO ; Xiaoqing YAN ; Meng FAN ; Haiyan CUI
Chinese Journal of Plastic Surgery 2024;40(4):428-435
Objective:To learn about physicians’ concepts and commonly employed method in hyaluronic acid injection and provide reference data for the standardization of pain management.Methods:This study was a cross-sectional study. Convenient sampling method was used to distribute questionnaires to cosmetic injectors from plastic surgery department of public hospitals or medical beauty institutions and patients experienced with hyaluronic acid injections to collect data on their views of pain associated with hyaluronic acid injections. The physician portion was collected offline from June 15 to July 20, 2022, and the patient portion was collected from November 14 to December 6, 2022, via the Questionnaire Star platform. The physician questionnaire consisted of 17 questions, question types included single choice, multiple choice and essay questions. The patient questionnaire consisted of 6 questions, question types included single choice and multiple choice. Relevant data were analyzed using SPSS 22.0 software for descriptive statistics, and data were presented in the form of cases(%).Results:Sixty-two physician questionnaires and 123 patient questionnaires were collected. 42 (67.74%) physicians observed from their daily practice that more than 50% of their patients were very concerned about pain during injection; 101 (82.11%) patients scored ≥5 out of 10 for concern about impending pain prior to hyaluronic acid filler injection. At the time of treatment, 48 (77.42%) physicians advised patients to choose a lidocaine-containing hyaluronic acid filler for reasons including a significant reduction in injection pain (53 cases, 85.48%) and patient comfort with the treatment experience (59 cases, 95.16%). 60 (48.78%) patients were willing to choose an anesthesia-containing product at the time of injection, but the price of the anesthesia-containing product influenced the patient’s choice (55 cases, 44.72%).Conclusion:Pain from cosmetic injectable treatments is an important issue to both physicians and patients. Lidocaine-containing hyaluronic acid is recognized by physicians and patients for its analgesic effect and high safety profile. There is no perfect solution for pain in cosmetic injection treatment, and multidisciplinary collaboration may be needed to solve the problem.
3.A cross-sectional study on the pain caused by hyaluronic acid cosmetic injections
Lishuai SHI ; Lili QI ; Jun ZHANG ; Tao WANG ; Guobao WANG ; Feng ZHOU ; Lunli GONG ; Qiuni GAO ; Xiaoqing YAN ; Meng FAN ; Haiyan CUI
Chinese Journal of Plastic Surgery 2024;40(1):326-333
Objective:To learn about physicians’ concepts and commonly employed method in hyaluronic acid injection and provide reference data for the standardization of pain management.Methods:This study was a cross-sectional study. Convenient sampling method was used to distribute questionnaires to cosmetic injectors and patients experienced with hyaluronic acid injections to collect data on their views of pain associated with hyaluronic acid injections. The physician portion was collected offline from June 15 to July 20, 2022, and the patient portion was collected from November 14, 2022, to December 6, 2022, via the Questionnaire Star platform. The physician questionnaire consisted of 17 questions, question types included single choice, multiple choice and essay questions. The patient questionnaire consisted of 6 questions, question types included single choice and multiple choice. Relevant data were analyzed using SPSS 22.0 software for descriptive statistics, and data were presented in the form of cases and percentages (%).Results:Sixty-two physician questionnaires and 123 patient questionnaires were collected. 42 (67.74%) physicians observed from their daily practice that more than 50% of their patients were very concerned about pain during injection; 101 (82.11%) patients scored ≥5 out of 10 for concern about impending pain prior to hyaluronic acid filler injection. At the time of treatment, 48 (77.42%) physicians advised patients to choose a lidocaine-containing hyaluronic acid filler for reasons including a significant reduction in injection pain (53 cases, 85.48%) and patient comfort with the treatment experience (59 cases, 95.16%). 60 (48.78%) patients were willing to choose an anesthesia-containing product at the time of injection, but the price of the anesthesia-containing product influenced the patient’ s choice (55 cases 44.72%) .Conclusions:Pain from cosmetic injectable treatments is an important issue to both physicians and patients. Lidocaine-containing hyaluronic acid is recognized by physicians and patients for its analgesic effect and high safety profile. There is no perfect solution for pain in cosmetic injection treatment, and multidisciplinary collaboration may be needed to solve the problem.
4.A cross-sectional study on the pain caused by hyaluronic acid cosmetic injections
Lishuai SHI ; Lili QI ; Jun ZHANG ; Tao WANG ; Guobao WANG ; Feng ZHOU ; Lunli GONG ; Qiuni GAO ; Xiaoqing YAN ; Meng FAN ; Haiyan CUI
Chinese Journal of Plastic Surgery 2024;40(4):428-435
Objective:To learn about physicians’ concepts and commonly employed method in hyaluronic acid injection and provide reference data for the standardization of pain management.Methods:This study was a cross-sectional study. Convenient sampling method was used to distribute questionnaires to cosmetic injectors from plastic surgery department of public hospitals or medical beauty institutions and patients experienced with hyaluronic acid injections to collect data on their views of pain associated with hyaluronic acid injections. The physician portion was collected offline from June 15 to July 20, 2022, and the patient portion was collected from November 14 to December 6, 2022, via the Questionnaire Star platform. The physician questionnaire consisted of 17 questions, question types included single choice, multiple choice and essay questions. The patient questionnaire consisted of 6 questions, question types included single choice and multiple choice. Relevant data were analyzed using SPSS 22.0 software for descriptive statistics, and data were presented in the form of cases(%).Results:Sixty-two physician questionnaires and 123 patient questionnaires were collected. 42 (67.74%) physicians observed from their daily practice that more than 50% of their patients were very concerned about pain during injection; 101 (82.11%) patients scored ≥5 out of 10 for concern about impending pain prior to hyaluronic acid filler injection. At the time of treatment, 48 (77.42%) physicians advised patients to choose a lidocaine-containing hyaluronic acid filler for reasons including a significant reduction in injection pain (53 cases, 85.48%) and patient comfort with the treatment experience (59 cases, 95.16%). 60 (48.78%) patients were willing to choose an anesthesia-containing product at the time of injection, but the price of the anesthesia-containing product influenced the patient’s choice (55 cases, 44.72%).Conclusion:Pain from cosmetic injectable treatments is an important issue to both physicians and patients. Lidocaine-containing hyaluronic acid is recognized by physicians and patients for its analgesic effect and high safety profile. There is no perfect solution for pain in cosmetic injection treatment, and multidisciplinary collaboration may be needed to solve the problem.
5.Efficacy and safety of yimitasvir phospha combined with sofosbuvir in patients with chronic hepatitis C virus infection
Bifen LUO ; Jinglan JIN ; Huiying RAO ; Qin NING ; Jinlin HOU ; Lang BAI ; Yongfeng YANG ; Sujun ZHENG ; Xiaorong MAO ; Jun10 QUAN ; Dongliang YANG ; Lunli ZHANG ; Caiyan ZHAO ; Zhansheng JIA ; Fuchun ZHANG ; Zuojiong GONG ; Feng LIN ; Guiqiang WANG ; Lin LUO ; Li DENG ; Hongming XIE ; Jing LI ; Yingjun ZHANG ; Lai WEI
Chinese Journal of Infectious Diseases 2019;37(7):420-429
Objective To assess the efficacy and safety of 100 mg or 200 mg yimitasvir phosphate combined with sofosbuvir in patients with non-cirrhotic chronic hepatitis C virus ( HCV) genotype 1 infection who were treatment-na?ve or had a virologic failure to prior interferon-based treatment.Methods A multicenter, randomized, open-label, phase 2 clinical trial was conducted.The patients were randomly assigned to yimitasvir phosphate 100 mg+sofosbuvir 400 mg group (Group 100 mg) and yimitasvir phosphate 200 mg+sofosbuvir 400 mg group ( Group 200 mg) in a 1∶1 ratio with the stratified factors of " treatment-naive" or"treatment-experienced" for 12 weeks and followed up for 24 weeks after the end of treatment.During the clinical trial, HCV RNA was tested in all patients.Resistance of virus in patients who didn′t achieved sustained virological response (SVR) was monitored.Safety and tolerability were assessed by monitoring adverse events , physical examination , laboratory examination, electrocardiogram, and vital signs during the study.The primary end point was SVR12 after the end of therapy.Descriptive statistics were used for categorical variables and eight descriptive statistics were used for continuous variables.Descriptive statistics were used and summarized according to HCV genotypes and treatment groups.Safety data were presented using descriptive statistics and summarized according to treatment groups.Results A total of 174 subjects were screened from July 31, 2017 to September 26, 2018.One hundred and twenty-nine patients were successfully enrolled and received treatment , and 127 completed the study.There were 64 patients and 65 patients assigned to Group 100 mg and Group 200 mg, respectively.Among the 129 patients who underwent randomization and were treated , 18.6% were treatment-experienced and: 100%were HCV genotype 1b infection.The total SVR rate was 98.4%(127/129), with 98.4%(63/64, 95%confidence interval [CI]: 91.60%-99.96%) in the Group 100 mg, and 98.50%(64/65, 95%CI: 91.72%-99.96%) in the Group 200 mg.There was no significant difference between the two groups (χ2 =0.000 2, P=0.989 2).The SVR rates in treatment-naive group and treatment-experienced group were 98.10%(95%CI: 93.29%-99.77%) and 100.00%(24/24, 95%CI: 85.75%-100.00%), respectively.Virological failure during treatment ( including breakthrough , rebound and poor efficacy) and relapse after treatment did not occur during the trial.By Sanger sequencing , 11.6%(15/129) patients had baseline NS5A Y93H/Y or Y93H resistance-associated substitutions ( RAS), 1.6%( 2/129) patients had baseline NS5A L31M RAS.No mutation was observed in NS5B S282 at baseline.There was no S282 mutation in HCV NS5B.A total of 100 (77.5%) subjects had adverse events.No adverse events ≥Grade 3 or severe adverse events related to the study treatment.No patient prematurely discontinued study treatment owing to an adverse event.No life-threatening adverse event was reported.Conclusion Twelve weeks of yimitasvir phosphate 100 mg or 200 mg combined with sofosbuvir 400 mg daily is a highly effective and safe regimen for patients without cirrhosis with HCV genotype 1b infection who had not been treated previously or had a virologic failure to prior interferon-based treatment.
6. Efficacy and safety of pegylated interferon α-2b injection (Y shape, 40 kD) in treatment of patients with genotype 1/6 chronic hepatitis C
Bo FENG ; Jia SHANG ; Shuhuan WU ; Hong CHEN ; Ying HAN ; Yueqi LI ; Dazhi ZHANG ; Longfeng ZHAO ; Shaofeng WEI ; Qing MAO ; Zhibiao YIN ; Tao HAN ; Maorong WANG ; Shijun CHEN ; Jun LI ; Qing XIE ; Zhen ZHEN ; Zhiliang GAO ; Yuexin ZHANG ; Guozhong GONG ; Dongliang YANG ; Chen PAN ; Jifang SHENG ; Hong TANG ; Qin NING ; Guangfeng SHI ; Junqi NIU ; Guanghan LUO ; Yongtao SUN ; Hong YOU ; Guiqiang WANG ; Lunli ZHANG ; Jie PENG ; Qin ZHANG ; Jiajun LIU ; Chengwei CHEN ; Xinyue CHEN ; Wei ZHAO ; Runhua WANG ; Li SUN ; Lai WEI
Chinese Journal of Hepatology 2017;25(3):187-194
Objective:
To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control.
Methods:
A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed.
Results:
A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95%
7. Clinical effect and safety of pegylated interferon-α-2b injection (Y shape, 40 kD) in treatment of HBeAg-positive chronic hepatitis B patients
Fengqin HOU ; Yalin YIN ; Lingying ZENG ; Jia SHANG ; Guozhong GONG ; Chen PAN ; Mingxiang ZHANG ; Chibiao YIN ; Qing XIE ; Yanzhong PENG ; Shijun CHEN ; Qing MAO ; Yongping CHEN ; Qianguo MAO ; Dazhi ZHANG ; Tao HAN ; Maorong WANG ; Wei ZHAO ; Jiajun LIU ; Ying HAN ; Longfeng ZHAO ; Guanghan LUO ; Jiming ZHANG ; Jie PENG ; Deming TAN ; Zhiwei LI ; Hong TANG ; Hao WANG ; Yuexin ZHANG ; Jun LI ; Lunli ZHANG ; Liang CHEN ; Jidong JIA ; Chengwei CHEN ; Zhen ZHEN ; Baosen LI ; Junqi NIU ; Qinghua MENG ; Hong YUAN ; Yongtao SUN ; Shuchen LI ; Jifang SHENG ; Jun CHENG ; Li SUN ; Guiqiang WANG
Chinese Journal of Hepatology 2017;25(8):589-596
Objective:
To investigate the clinical effect and safety of long-acting pegylated interferon-α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 μg/week) in the treatment of HBeAg-positive chronic hepatitis B (CHB) patients, with standard-dose Peg-IFN-α-2a as positive control.
Methods:
This study was a multicenter, randomized, open-label, and positive-controlled phase III clinical trial. Eligible HBeAg-positive CHB patients were screened out and randomized to Peg-IFN-α-2b (Y shape, 40 kD) trial group and Peg-IFN-α-2a control group at a ratio of 2:1. The course of treatment was 48 weeks and the patients were followed up for 24 weeks after drug withdrawal. Plasma samples were collected at screening, baseline, and 12, 24, 36, 48, 60, and 72 weeks for centralized detection. COBAS® Ampliprep/COBAS® TaqMan® HBV Test was used to measure HBV DNA level by quantitative real-time PCR. Electrochemiluminescence immunoassay with Elecsys kit was used to measure HBV markers (HBsAg, anti-HBs, HBeAg, anti-HBe). Adverse events were recorded in detail. The primary outcome measure was HBeAg seroconversion rate after the 24-week follow-up, and non-inferiority was also tested. The difference in HBeAg seroconversion rate after treatment between the trial group and the control group and two-sided confidence interval (