1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2. Effects of SIRT1 on morphine-induced conditioned place preference in rats through CREB/BDNF pathway
Ben LIU ; Wan-Yu TU ; Teng-Teng ZHANG ; Shan-Yong YI ; Guo-Sheng LUO ; Wen-Ge JIA ; Chen-Chen LI ; Bin ZHAO ; Lai WEI ; Zhi-Jun YAO ; Ying ZHAO
Chinese Pharmacological Bulletin 2023;39(7):1263-1270
Aim To investigate the effect of microinjection of EX527, a selective SIRT1 antagonist, into the ventrolateral orbital cortex (VLO) on morphine-induced conditioned place preference (CPP), and to explore the role of CREB/BDNF in it. Methods The cannulas were implanted bilaterally in the VLO of rats by brain stereotaxis surgery, and the model of morphine-induced CPP was established. The behavioral experiment consisted of four stages:habituation (d 1), pre-test (d 2-4), conditioning training (d 5-14) and test (d 15). At the stage of conditioning training, EX527 (1 μL, 5 g·L
3.Determination of insulin lispro in rat plasma by LC-MS/MS and its application in a pharmacokinetics study
Xiao-chu SUN ; Fei-fei LIN ; Mi-mi WAN ; Yue TONG ; Lu CHANG ; Meng YUAN ; Ying-ying FENG ; Guo-sheng TENG ; Jia LIU
Acta Pharmaceutica Sinica 2021;56(9):2383-2388
Compared with human insulin, insulin lispro shows a faster hypoglycemic effect and a higher peak plasma concentration, which can better control postprandial hyperglycemia. In this study, we used a solid phase extraction pretreatment method and liquid chromatography-tandem mass spectrometry (LC-MS/MS) to quantify insulin lispro in rat plasma. Bovine insulin was used as an internal standard. Plasma samples were separated on an ACQUITY UPLC Peptide CSH C18 column (2.1 mm × 50 mm, 1.7 μm) after solid phase extraction. Positive electrospray ionization was performed using multiple reaction monitoring (MRM) with transitions of
4.Recent advances of MDM2-p53 inhibitors
Ji-chao WANG ; Cai-bin YANG ; Yi-lin ZHUO ; Chong LIANG ; Jun-gang WANG ; Sheng DONG ; Bo-teng LI ; Shu-hua ZHANG ; Guo-gang ZHANG
Acta Pharmaceutica Sinica 2021;56(4):983-995
Protein-protein interactions (PPI) are involved in a variety of biological processes, including cell-to-cell interactions, metabolism and development control. The misregulation, post-translational modification and interference of PPI are related to a variety of human diseases, making the regulation of these interactions a very attractive field of drug discovery. In recent years, the interaction between MDM2 and p53 has become a research hotspot, which plays an important role in the treatment of tumors. But unfortunately there are no such inhibitors approved all over the world. In this view, recent advances of MDM2-p53 inhibitors were briefly described and its inhibitors with potential therapeutic activities in clinical studies were introduced.
5.Questionnaire investigation of radiation rectal injury with anxiety, depression and somatic disorder.
Bo LIAN ; Xin Ping CAO ; Hai Jun DENG ; Jun JIANG ; Ke Wei JIANG ; Xin Xiang LI ; You Sheng LI ; Guo Le LIN ; Ji Hong LIU ; Shou Min BAI ; Feng WANG ; Zi Qiang WANG ; Ai Wen WU ; Yi XIAO ; Hong Wei YAO ; Wei Tang YUAN ; Wei ZHANG ; Zhen ZHANG ; Yan Bing ZHOU ; Teng Hui MA ; Qing Chuan ZHAO
Chinese Journal of Gastrointestinal Surgery 2021;24(11):984-990
Objective: To observe the incidence and treatment of radiation rectal injury complicated with anxiety, depression and somatic symptom disorder. Methods: A cross-sectional survey research method was carried out. Patients with radiation rectal injury managed by members of the editorial board of Chinese Journal of Gastrointestinal Surgery were the subjects of investigation. The inclusion criteria of the survey subjects: (1) patients suffered from pelvic tumors and received pelvic radiotherapy; (2) colonoscopy showed inflammatory reaction or ulcer in the rectum. Exclusion criteria: (1) patient had a history of psycho-somatic disease before radiotherapy; (2) patient was unable to use a smart phone, unable to read and understand the questions in the questionnaire displayed on the phone; (3) patient refused to sign an informed consent form. According to the SOMA self-rating scale, PHQ-15 self-rating scale, GAD-7 and PHQ-9 self-rating scale, the electronic questionnaire of "Psychological Survey of Radiation Proctitis" was designed. The questionnaire was sent to patients with radiation rectal injury managed by the committee through the WeChat group. Observational indicators: (1) radiation rectal injury symptom assessment: using SOMA self-rating scale, radiation rectal injury symptom classification: mild group (≤3 points), moderate group (4-6 points) and severe group (> 6 points); (2) incidence of anxiety, depression and physical disorder: using GAD-7, PHQ-9 and PHQ-15 self-rating scales respectively for assessment; (3) correlation of radiation rectal injury symptom grading with anxiety, depression, and somatic symptom disorder. Results: Seventy-one qualified questionnaires were collected, of which 41 (56.9%) were from Guangzhou. Among the 71 patients, 6 were males and 65 were females; the mean age was (55.7±9.3) years old and 48 patients (67.6%) were less than 60 years old; the median confirmed duration of radiation rectal injury was 2.0 (1.0, 5.0) years. (1) Evaluation of symptoms of radiation rectal injury: 18 cases of mild (25.4%), 27 cases of moderate (38.0%), and 26 cases of severe (36.6%). (2) Incidence of anxiety, depression and somatic disorder: 12 patients (16.9%) without comorbidities; 59 patients (83.1%) with anxiety, depression, or somatic disorder, of whom 2 patients only had anxiety, 1 patient only had depression, 9 only had somatic disorder, 2 had anxiety plus depression, 4 had anxiety plus somatic disorder, 2 had depression plus somatic disorder, and 40 had all three symptoms. (3) correlation of radiation rectal injury grading with anxiety, depression, and somatic symptom disorder: as compared to patients in mild group and moderate group, those in severe group had higher severity of anxiety and somatic symptom disorder (Z=-2.143, P=0.032; Z=-2.045, P=0.041), while there was no statistically significant difference of depression between mild group and moderate group (Z=-1.176, P=0.240). Pearson correlation analysis revealed that radiation rectal injury symptom score was positively correlated with anxiety (r=0.300, P=0.013), depression (r=0.287, P=0.015) and somatic symptom disorder (r=0.344, P=0.003). Conclusions: The incidence of anxiety, depression, and somatic symptom disorder in patients with radiation rectal injury is extremely high. It is necessary to strengthen the diagnosis and treatment of somatic symptom disorder, so as to alleviate the symptoms of patients with pelvic perineum pain and improve the quality of life.
Aged
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Anxiety
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Cross-Sectional Studies
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Depression
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Female
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Humans
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Male
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Middle Aged
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Quality of Life
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Rectum
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Surveys and Questionnaires
6.Clinical analysis of 554 patients with colorectal diverticulosis.
Jun Ling ZHANG ; Gui Gen TENG ; Tao WU ; Guo Wei CHEN ; Peng Yuan WANG ; Yong JIANG ; Ying Chao WU ; Lie SUN ; Tao LIU ; Shuai ZUO ; Yi Sheng PAN ; Xin WANG
Chinese Journal of Gastrointestinal Surgery 2021;24(11):1008-1014
Objective: Most patients with asymptomatic colorectal diverticulosis are easily overlooked. However, some of diverticulosis become diverticulitis, bleeding and even perforation, which cause extensive harm to patients. The purpose of this study is to analyze the incidence, clinical features, diagnosis and treatment of colorectal diverticulosis in order to improve the clinical understanding of diverticulosis and its related complications. Methods: A descriptive cohort study was carried out. Clinical data of 554 patients with colorectal diverticulosis confirmed by CT, colonoscopy, digestive tract radiography or operation in Peking University First Hospital from January 2009 to June 2019 were retrospectively analyzed. Patients with malignant tumors, autoimmune diseases, long term use of immunosuppressive drugs, chronic liver diseases and renal diseases, and mental disorders were excluded. The analysis parameters included gender, onset age, clinical symptoms, location of diverticulitis, treatment and prognosis. According to the criteria established by the World Society of Emergency Surgery (WSES), acute diverticulitis was divided into 5 stages based on the extension of the infectious process. Stage 0 was simple diverticulitis and stage 1-4 was complicated diverticulitis. Results: Among the 554 patients with colorectal diverticulosis, 358 (64.6%) were males, the median onset age was 63 years; 191 patients (34.5%) had various digestive symptoms, of whom 113 (20.4%) had chronic constipation and abdominal distension, 78 (14.1%) had chronic diarrhea and abdominal pain; the other 363 patients had no obvious abdominal symptoms. Four hundred and six patients were found by colonoscopy and 465 patients were found by CT. Twenty-five patients were diagnosed by lower gastrointestinal tract radiography and 3 were confirmed during operation. There were 339 patients with multiple diverticula (61.2%) and 215 patients with single diverticulum (38.8%). 76.5% (424/554) of diverticula were located in colon, 37.0% (205/554) in ascending colon, 21.3% (118/554) in multiple sites, and 2.2% (12/554) in rectum. The median diameter of diverticulum was 7 mm, and 78 cases (14.1%) was ≥30 mm. Forty-nine patients (8.8%) developed acute diverticulitis, including 13 patients with simple diverticulitis and 36 patients with complicated diverticulitis. Among 36 patients with complicated diverticulitis, 29 (80.6%) were males, 27 (75.0%) had recurrent abdominal pain and fever before onset; diverticula of 25 cases were located in sigmoid colon; 11 cases in ascending colon. Nine cases developed sigmoid colon perforation and 8 cases developed vesicocolonic fistula, and these 17 patients underwent surgical treatment. The other 19 cases with complicated diverticulitis developed gastrointestinal bleeding, of whom 18 cases were male, 11 cases were located in ascending colon; 13 cases were healed after conservative treatment, 4 cases received endoscopic hemostatic intervention, and 2 cases underwent surgery. Conclusions: Colorectal diverticulosis is more common in male patients, and CT and colonoscopy are main diagnostic methods. The symptoms of complicated colonic diverticulitis are related to the location of diverticulum. In addition to symptomatic treatment, surgical procedures are the most important treatments.
Cohort Studies
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Colorectal Neoplasms
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Diverticulitis, Colonic
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Diverticulum
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Humans
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Male
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Middle Aged
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Retrospective Studies
7.Historical Evolution and Modern Research on Shaoyao Gancaotang
Yuan-zhang QU ; Sheng-jun MA ; Guang-wei ZHU ; Lin-chun WAN ; Bo SUN ; Ya-jing LI ; Jie GUO ; Teng-teng XU ; A-qian CHANG ; Gang LI ; Lin-yong YANG ; Bao-guo LI
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(6):216-225
Shaoyao Gancaotang, first seen in
8.Association of Overlapped and Un-overlapped Comorbidities with COVID-19 Severity and Treatment Outcomes: A Retrospective Cohort Study from Nine Provinces in China.
Yan MA ; Dong Shan ZHU ; Ren Bo CHEN ; Nan Nan SHI ; Si Hong LIU ; Yi Pin FAN ; Gui Hui WU ; Pu Ye YANG ; Jiang Feng BAI ; Hong CHEN ; Li Ying CHEN ; Qiao FENG ; Tuan Mao GUO ; Yong HOU ; Gui Fen HU ; Xiao Mei HU ; Yun Hong HU ; Jin HUANG ; Qiu Hua HUANG ; Shao Zhen HUANG ; Liang JI ; Hai Hao JIN ; Xiao LEI ; Chun Yan LI ; Min Qing LI ; Qun Tang LI ; Xian Yong LI ; Hong De LIU ; Jin Ping LIU ; Zhang LIU ; Yu Ting MA ; Ya MAO ; Liu Fen MO ; Hui NA ; Jing Wei WANG ; Fang Li SONG ; Sheng SUN ; Dong Ting WANG ; Ming Xuan WANG ; Xiao Yan WANG ; Yin Zhen WANG ; Yu Dong WANG ; Wei WU ; Lan Ping WU ; Yan Hua XIAO ; Hai Jun XIE ; Hong Ming XU ; Shou Fang XU ; Rui Xia XUE ; Chun YANG ; Kai Jun YANG ; Sheng Li YUAN ; Gong Qi ZHANG ; Jin Bo ZHANG ; Lin Song ZHANG ; Shu Sen ZHAO ; Wan Ying ZHAO ; Kai ZHENG ; Ying Chun ZHOU ; Jun Teng ZHU ; Tian Qing ZHU ; Hua Min ZHANG ; Yan Ping WANG ; Yong Yan WANG
Biomedical and Environmental Sciences 2020;33(12):893-905
Objective:
Several COVID-19 patients have overlapping comorbidities. The independent role of each component contributing to the risk of COVID-19 is unknown, and how some non-cardiometabolic comorbidities affect the risk of COVID-19 remains unclear.
Methods:
A retrospective follow-up design was adopted. A total of 1,160 laboratory-confirmed patients were enrolled from nine provinces in China. Data on comorbidities were obtained from the patients' medical records. Multivariable logistic regression models were used to estimate the odds ratio (
Results:
Overall, 158 (13.6%) patients were diagnosed with severe illness and 32 (2.7%) had unfavorable outcomes. Hypertension (2.87, 1.30-6.32), type 2 diabetes (T2DM) (3.57, 2.32-5.49), cardiovascular disease (CVD) (3.78, 1.81-7.89), fatty liver disease (7.53, 1.96-28.96), hyperlipidemia (2.15, 1.26-3.67), other lung diseases (6.00, 3.01-11.96), and electrolyte imbalance (10.40, 3.00-26.10) were independently linked to increased odds of being severely ill. T2DM (6.07, 2.89-12.75), CVD (8.47, 6.03-11.89), and electrolyte imbalance (19.44, 11.47-32.96) were also strong predictors of unfavorable outcomes. Women with comorbidities were more likely to have severe disease on admission (5.46, 3.25-9.19), while men with comorbidities were more likely to have unfavorable treatment outcomes (6.58, 1.46-29.64) within two weeks.
Conclusion
Besides hypertension, diabetes, and CVD, fatty liver disease, hyperlipidemia, other lung diseases, and electrolyte imbalance were independent risk factors for COVID-19 severity and poor treatment outcome. Women with comorbidities were more likely to have severe disease, while men with comorbidities were more likely to have unfavorable treatment outcomes.
Adult
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Aged
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COVID-19/virology*
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China/epidemiology*
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Comorbidity
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Female
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Humans
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Male
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Middle Aged
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Retrospective Studies
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Severity of Illness Index
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Treatment Outcome
9.Clinical analysis on arthroscopic incomplete removal of calcifications of supraspinatus tendinitis
Xu-Teng ZHANG ; Song-Bo LIU ; Xin-Wei LIU ; Wen-Feng HAN ; Jing-Dong ZHANG ; Chao GUO ; Bai-Sheng WANG ; Hai-Li LIU
Journal of Regional Anatomy and Operative Surgery 2018;27(1):53-55
Objective To evaluate the treatment effect of the arthroscopic incomplete removal of calcifications of the supraspinatus tendinitis without acromioplasty.Methods The clinical data of 20 patients of calcified supraspinatus tendinitis with Ellman Ⅰ or Ⅱ in general hospital of Shenyang military area command from January 2014 to February 2016 were retrospectively analyzed.Of the 20 patients,4 males and 16 females,the age ranged from 45 to 62 years old,with average age (50.2 ± 6.3) years old.All the patients received removal incomplete of calcification without acromioplasty.Pre-and postoperative 3,6,9 months general situation were evaluated by the VAS score,Constant-Murley score,University of California Los Angeles (UCLA) score,X-Radiographs and CT.Results The shoulder function was evidently improved in all 20 patients.The average VAS pain score was (8.2 ± 1.4) preoperatively and (0.8 ± 0.6) at the 6 months follow-up.The average Constant-Murley score was (44.6 ± 7.4) preoperatively and (95.4± 3.4) at the 6 months follow-up.The average UCLA score was (12.2 ± 3.6) preoperatively and (33.1 ± 1.4) at the 6 months follow-up.Conclusion The arthroscopic incomplete removal of calcifications of the supraspinatus tendon without acromioplasty can lead to good results with less iatrogenic injury.
10.Localization of tibial attachment of the posterior cruciate ligament and its gender differences: an MRI analysis
Laiwei GUO ; Ning DING ; Yuanjun TENG ; Xiaoyun SHENG ; Tianen XU ; Huiqiang MENG ; Meng WU ; Yayi XIA
Chinese Journal of Orthopaedic Trauma 2017;19(5):387-392
Objective To localize the tibial attachment of the posterior cruciate ligament (PCL) on the magnetic resonance imaging (MRI) and provide parameters for clinical PCL reconstruction.Methods We retrospectively analyzed 524 patients with intact tibial PCL attachment who had undergone knee MRI from January 2010 to January 2016.They were 286 men and 238 women with an average age of 35 years (from 20 to 50 years).The size and positions of the tibial PCL attachment were measured on the sagittal and coronal MRI slices.The differences were analyzed between different genders.Results On the sagittal slices,the mean distance from the central tibial PCL attachment to the posterior edge of the tibial plateau was 17.9 ± 3.0 mm and the mean anteroposterior diameter of the tibial PCL attachment was 9.7 ± 2.4 mm,with those for males significantly larger than for females (P < 0.05).The above mean values when expressed as a percentage of the posterior tibial slop were 79.9% ±4.5% and 43.7% ± 9.6%,respectively,showing no significant differences between males and females (P > 0.05).On the coronal slices,the distances from the central tibial PCL attachment to the medial and lateral edges of the tibial plateau were 33.5 ± 3.1 mm and 37.4 ±4.1 mm,respectively,and the mediolateral diameter of the tibial PCL attachment was 12.0 ± 1.6 mm,with those for males significantly larger than for females (P < 0.05).The above mean values when expressed as a percentage of the mediolateral diameter of the tibial PCL attachment were 47.4% ± 3.2%,52.7% ±3.1% and 16.9% ± 1.7%,respectively,showing no significant differences between males and females (P > 0.05).Conclusions On knee MRI images,the distance from the central tibial PCL attachment to the posterior edge of the tibial plateau is about 17.9 mm,the anteroposterior diameter of the tibial PCL attachment around 9.7 mm,and the mediolateral diameter of the tibial PCL attachment roughly 12.0 mm.These measurements for males are larger than for females.

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