1.Clinical trial of long-acting and short-acting recombinant human growth hormone in the treatment of children with idiopathic short stature
De-Hui ZHANG ; Wen-Xu CHENG ; Lun-Min ZHANG ; Zhi-Ying ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(15):2178-2181
Objective To observe clinical curative effect of long-acting recombinant human growth hormone(rhGH)and short-acting rhGH,and their influences on growth and development indexes,serum thyroid function indexes and insulin in children with idiopathic short stature(ISS).Methods The children with ISS were randomly divided into long-acting group[subcutaneous injection of polyethylene glycol recombinant human growth hormone(0.2 mg·kg-1·w-1,qw)]and short-acting group[subcutaneous injection of recombinant human growth hormone(0.15 U·kg-1·d-1)at 30 min before sleep every night].All children were treated for 12 months.The growth and development[growth velocity(GV),height standard deviation of points(Ht SDS)],thyroid function,fasting insulin(FINS)and insulin-like growth factor-1(IGF-1)were compared between the two groups.The occurrence of adverse reactions was recorded.Results In the 68 children,there were 4 cases with loss to follow-up and shedding due to personal reasons.Finally,there were 33 cases in long-acting group and 31 cases in short-acting group for statistical analysis.After 6 months of treatment,GV in long-acting group and short-acting group were(4.53±0.56)and(3.97±0.48)cm·year-1,Ht SDS were-2.45±0.23 and-2.66±0.21,IGF-1 levels were(551.62±41.48)and(524.36±37.84)mg·mL-1,respectively.After 12 months of treatment,GV in long-acting group and the short-acting group were(9.44±0.82)and(8.46±0.77)cm·year-1,Ht SDS were-1.68±0.19 and-1.91±0.20,IGF-1 levels were(642.46±36.49)and(593.14±40.12)mg·mL-1,differences were statistically significant(all P<0.05).There were no significant differences in FT3,FT4,TSH and FINS between the two groups after treatment(all P>0.05).There was no significant difference in the total incidences of adverse drug reactions between long-acting group and short-acting group[6.06%(2 cases/33 cases)vs 12.90%(4 cases/31 cases),P>0.05].Conclusion Compared with short-acting rhGH,promotion effect of long-acting rhGH is better on short-term growth and development in ISS children,which can increase level of serum IGF-1 and has no obvious effects on thyroid function,with good safety.
2.Evaluation of Renal Impairment in Patients with Diabetic Kidney Disease by Integrated Chinese and Western Medicine.
Yi-Lun QU ; Zhe-Yi DONG ; Hai-Mei CHENG ; Qian LIU ; Qian WANG ; Hong-Tao YANG ; Yong-Hui MAO ; Ji-Jun LI ; Hong-Fang LIU ; Yan-Qiu GENG ; Wen HUANG ; Wen-Hu LIU ; Hui-di XIE ; Fei PENG ; Shuang LI ; Shuang-Shuang JIANG ; Wei-Zhen LI ; Shu-Wei DUAN ; Zhe FENG ; Wei-Guang ZHANG ; Yu-Ning LIU ; Jin-Zhou TIAN ; Xiang-Mei CHEN
Chinese journal of integrative medicine 2023;29(4):308-315
OBJECTIVE:
To investigate the factors related to renal impairment in patients with diabetic kidney disease (DKD) from the perspective of integrated Chinese and Western medicine.
METHODS:
Totally 492 patients with DKD in 8 Chinese hospitals from October 2017 to July 2019 were included. According to Kidney Disease Improving Global Outcomes (KDIGO) staging guidelines, patients were divided into a chronic kidney disease (CKD) 1-3 group and a CKD 4-5 group. Clinical data were collected, and logistic regression was used to analyze the factors related to different CKD stages in DKD patients.
RESULTS:
Demographically, male was a factor related to increased CKD staging in patients with DKD (OR=3.100, P=0.002). In clinical characteristics, course of diabetes >60 months (OR=3.562, P=0.010), anemia (OR=4.176, P<0.001), hyperuricemia (OR=3.352, P<0.001), massive albuminuria (OR=4.058, P=0.002), atherosclerosis (OR=2.153, P=0.007) and blood deficiency syndrome (OR=1.945, P=0.020) were factors related to increased CKD staging in patients with DKD.
CONCLUSIONS
Male, course of diabetes >60 months, anemia, hyperuricemia, massive proteinuria, atherosclerosis, and blood deficiency syndrome might indicate more severe degree of renal function damage in patients with DKD. (Registration No. NCT03865914).
Humans
;
Male
;
Diabetes Mellitus, Type 2
;
Diabetic Nephropathies
;
Hyperuricemia
;
Kidney
;
Proteinuria
;
Renal Insufficiency, Chronic/complications*
3.Oral Presentation – Clinical and Translational Research
Choon Hoong Chung ; Yee Lynn Soh ; Thinaesh Manoharan ; Arwind Raj ; Dulmini Perera ; Htoo Htoo Kyaw Soe ; Nan Nitra Than ; Lilija Bancevica ; Žanna Kovalova ; Dzintars Ozols ; Ksenija Soldatenkova ; Lim Pyae Ying ; Tay Siow Phing ; Wong Jin Shyan ; Andrew Steven Sinsoon ; Nursabrina Alya Ricky Ramsis ; Nina Azwina Kimri ; Henry Rantai Gudum ; Man Le Ng ; Sze Er Lim ; Hui Yu Kim ; Yee Wan Lee ; Soo Kun Lim ; Sharven Raj ; Mohd Nasir Mohd Desa ; Nurul Syazrah Anuar ; Nurshahira Sulaiman ; Hui Chin Ting ; Zhi Ling Loo ; Choey Yee Lew ; Alfand Marl F Dy Closas ; Tzi Shin Toh ; Jia Wei Hor ; Yi Wen Tay ; Jia Lun Lim ; Lu Yian Tan ; Jie Ping Schee ; Lei Cheng Lit ; Ai Huey Tan ; Shen Yang Lim ; Zhu Shi Wong ; Nur Raziana binti Rozi ; Soo Kun Lim
International e-Journal of Science, Medicine and Education 2022;16(Suppl1):7-14
4.Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study.
Bin SU ; Cheng YAO ; Qing-Xia ZHAO ; Wei-Ping CAI ; Min WANG ; Hong-Zhou LU ; Yuan-Yuan CHEN ; Li LIU ; Hui WANG ; Yun HE ; Yu-Huang ZHENG ; Ling-Hua LI ; Jin-Feng CHEN ; Jian-Hua YU ; Biao ZHU ; Min ZHAO ; Yong-Tao SUN ; Wen-Hui LUN ; Wei XIA ; Li-Jun SUN ; Li-Li DAI ; Tai-Yi JIANG ; Mei-Xia WANG ; Qing-Shan ZHENG ; Hai-Yan PENG ; Yao WANG ; Rong-Jian LU ; Jian-Hua HU ; Hui XING ; Yi-Ming SHAO ; Dong XIE ; Tong ZHANG ; Fu-Jie ZHANG ; Hao WU
Chinese Medical Journal 2020;133(24):2919-2927
BACKGROUND:
Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.
METHODS:
We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.
RESULTS:
At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.
CONCLUSIONS:
The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.
Adult
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Anti-HIV Agents/adverse effects*
;
Antiretroviral Therapy, Highly Active
;
China
;
Drug Therapy, Combination
;
HIV Infections/drug therapy*
;
HIV-1
;
Humans
;
Maleimides
;
Peptides
;
Ritonavir/therapeutic use*
;
Treatment Outcome
;
Viral Load
5.Bilateral Peripheral Facial Paralysis Combined with HIV Meningitis During Acute HIV-1 Infection: A Case Report.
Yan WU ; Ge SONG ; Chun-Bo WEI ; Wen-Hui LUN
Chinese Medical Sciences Journal 2019;34(1):55-59
Here we reported a Chinese case of bilateral peripheral facial paralysis (PFP) in human immunodeficiency virusc (HIV) infected population. A 38-year-old homosexual male patient was referred to our hospital for bilateral facial paralysis. 21 days prior to admission he had developed high fever, chills, headache, fatigue, general malaise, nausea and vomiting. Neurological examination revealed bilateral ptosis of lower lip and cheeks, as well as failure of bilateral eyes closure. Analysis of cerebrospinal fluid (CSF) revealed pleocytosis, a marked rise of micro total protein and a marked rise of intrathecal lgG synthesis. The result of HIV-1 serology was positive by ELISA and that was confirmed by western blot. His CD4 cell count was 180 cells/mm . HIV-1 viral load in CSF was almost 10 times higher than that in plasma. The patient's condition improved steadily and experienced complete resolution of bilateral PFP after 2 months.
Adult
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Facial Paralysis
;
blood
;
pathology
;
physiopathology
;
HIV Infections
;
blood
;
pathology
;
physiopathology
;
HIV-1
;
Humans
;
Male
;
Meningitis
;
blood
;
pathology
;
physiopathology
6.Consensus by Chinese Expert Panel on-Resistant and-Persistent Infection.
Man-Li QI ; Yuan-Li GUO ; Qian-Qiu WANG ; Xiang-Sheng CHEN ; Jian-De HAN ; Xiao-Hong SU ; Wen-Hui LUN ; Hao CHENG ; Jin-Hua XU ; Hong-Qing TIAN ; Li CHEN ; Zhi-Yuan YAO ; Wen-Li FENG ; Juan JIANG ; Ping-Yu ZHOU ; Xian-Biao ZOU ; Hong-Hui XU ; Wei-Min SHI ; Jun LIU ; Lin ZHU ; Quan-Zhong LIU
Chinese Medical Journal 2017;130(23):2852-2856
7.Study on quality of life of asymptomatic HIV infected persons with traditional Chinese medicine.
Li-Ran XU ; Xiao-Ping YANG ; Hui-Jun GUO ; Jin-Wen TU ; Xin DENG ; Cui-E LIU ; Wen-Hui LUN ; Jun-Wen WANG ; Jiang-Rong WANG ; Xing-Hua TAN ; Lu FANG
China Journal of Chinese Materia Medica 2013;38(15):2480-2483
OBJECTIVEStudy on quality of life of asymptomatic HIV infected persons with traditional Chinese medical, which can provide the clinical basis for improving the quality of life.
METHODThis study applied a randomized, double-blind, and placeb-parallel control designed method to select 1 200 persons in the asymptomatic period of HIV infection as the subjects. The subjects were randomly divided into the treatment group and the control group at the ratio of about 2:1. According to the results of monthly differential diagnosis of TCM, the test group and the control group were given homologue Chinese drugs preparations and model Chinese drugs. The total study period was 18 months. Using PRO scale and the world health organization AIDS determination of quality of life short scale form (WHOQOL-HIV-BREF) to investigate asymptomatic HIV infected persons, according to different times, we calculated the total score and each domain score of quality of life of the treatment group and control group, we did statistical analysis.
RESULTForm the PRO scale,we can see that the treatment group showed a trend of stability, compared with the control group with significant statistical difference (P < 0.05) after 6 months; from the WHOQOL-HIV scale analysis, we can see that compared with before treatment, the quality of life of the treatment group was increased, the difference was significant (P < 0.05), but the quality of life of the control quality of life was decreased, the differences was significant (P < 0.05).
CONCLUSIONDialectical therapy of Chinese medicine can significantly improve the patient's quality of life, which can provide the basis for the prevention and control policy formulation and implementation with asymptomatic HIV infected persons.
Asymptomatic Diseases ; Follow-Up Studies ; HIV Infections ; therapy ; Humans ; Medicine, Chinese Traditional ; Quality of Life ; Treatment Outcome
8.Stereotactic surgery combined with intra-operative electrocorticography and neurophysiologic monitoring for epilepsy secondary to subcortex small tumors in the functional areas
Xiao-Dong GUO ; Ben-Hant WANG ; Chang-Yuan ZHANG ; Jia-Rui XIONG ; Jing-Lun LI ; Wei-Feng LU ; Yan-Zhi WU ; Ming-Hui LIU ; Wen-Ming HAO ; Lai-Jun SONG
Chinese Journal of Neuromedicine 2012;11(6):552-555
Objective To investigate the efficiency and complications of stereotactic surgery combined with intra-operative electrocorticography (ECoG) and intra-operative neurophysiologic monitoring (IOM) in treating epilepsy secondary to subcortex small tumors in the functional areas.Methods Fifteen patients with epilepsy secondary to subcortex small tumors in the functional areas,admitted to our hospital from June 2006 to June 2011, were chosen in our study. Resection was performed to these tumors. Guiding with stereotaxic apparatus, epileptogenic foci and boundary localizing by intra-operative ECoG monitoring,functional areas and neuronal structures in the epileptic region judging by IOM,the epileptogenic foci were resected or performed multiple subpial wansaction (MST) and/or cortices lower output powers thermocoagulation.The treatment efficacy was concluded.Results Total resection was achieved in 13 patients and subtotal resection in 2.Epileptogenic foei were ablated in 4 patients,and peri-lesioned cortex of epileptogenic foci in other 11 patients were performed lower output powers thermocoagulation or/and MST. ECoG monitoring found epileptiform discharge disappearance in 6 patients,residual of a few spikes in 6,residual of a lot of spikes as well as having mild to moderate abnormal basilic rhythms in EEG in 3.No permanent and severe complications were noted.All patients were followed up for 1 to 3 y; tumor recurrence was noted in 2; according to Engel's classification standards,Engel I was noted in 10,Engel Ⅱin 3 and Engel Ⅲ in 2,and the effective rate was 100%. Conclusion Stereotactic surgery combined with intra-operative ECoG and IOM is a safe,effective and microinvasive management for epilepsy secondary to subcortex small tumor in the functional areas; it can accuratly locate and totally resect the tumors,treating the epileptogenic foci and avoiding functional defects.


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