1. A multi-center clinical trial: Evaluation on effectiveness and safety of different dosages of Pudilan Xiaoyan Oral Liquid in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome
Chinese Traditional and Herbal Drugs 2017;48(4):753-759
Objective: To evaluate the efficacy and safety of different dosages of Pudilan Xiaoyan Oral Liquid (PXOL) in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome. Methods: A randomized controlled, double-blind, positive drug parallel controlled, and multi-center clinical trial was conducted. Totally 324 children from seven research centers were included, 108 cases in experimental high dose group (A Group), 108 cases in experimental low dose group (B Group), 54 cases in positive medicine group (Xiaoer yanbian Granula, C Group), and 54 cases in placebo group (D Group), with the ratios of 2:2:1:1.5 in a course. Results: (1) Totally 317 cases were in full analysis set (FAS), 284 cases in per-protocol set (PPS) and 324 cases in Safety Set (SS). (2) Evaluation on effectiveness: There was significant difference (P<0.001) between each two groups in the total effective rate of pharyngalgia and pharyngeal swelling. A Group and B Group were both superior to D Group, and were non-inferior to C Group. B Group was non-inferior to A Group. There was significant difference (P<0.001) between each two groups in total effective rate of syndrome of traditional Chinese medicine. There was significant difference (P<0.05) between each two groups in the median time of improving pharyngalgia syndrome. There was significant difference (P<0.001) between each two groups in the median time of pharyngalgia syndrome disappearing. There were significant differences (P<0.05) between each two groups in total effective rate of halitosis, cough, thirst, deep-colored urine, and dry stool. The analysis on PPS agrees with that of FAS. (3) Evaluation on safety: No adverse reactions in clinical significant laboratory examination were found during the trial. Conclusion: High and low dosages of PXOL show advantages over placebo and are non-inferior to the positive medicine Xiaoer Yanbian Granula. High dose group does not show advantage comparing with low dose group. No adverse reactions are found during the trial. Low dose therapy is recommended.
2.Evaluation of combined treatment of gonadotropin-releasing hormone analog with recombinant human growth hormone in girls with central precocious puberty
Hua-Mei MA ; Min-Lian DU ; Yan-Hong LI ; Zhe SU ; Hong-Shan CHEN ;
Chinese Journal of Endocrinology and Metabolism 1986;0(03):-
Objective To evaluate the effect of combined treatment with gonadotropin-releasing hormone analog(GnRHa)and recombinant human growth hormone(rhGH)on predicted adult height(PAH)in girls with central precocious puberty(CPP).Methods Fifteen girls with CPP,whose growth velocity during GnRHa treatment had been less than 4 cm/year,were given additional rhGH treatment at a dose of 1 U?kg~(-1)?w~(-1),sc, for 4-13 months.Comparisons of growth velocity,height SDS for bone age(HtSDS_(BA))and PAH were performed before and after the combined treatment.Results During rhGH combined with GnRHa therapy,growth velocity increased significantly[(7.4?1.7)cm/year vs (3.2?0.7)cm/year baseline,P<0.01].In 7 girls treated with rhGH and GnRHa for more than 9 months,growth velocity in the second 6 months[(6.5?1.0)cm/year]was slightly lower than that in the first 6 months[(8.8?1.1)cm/year],being both faster than that of baseline [(3.2?0.8)cm/year].There was a significant increase in rhGH-duration corrected change of HtSDS_(BA) [(0.35?0.15)/6 month vs (0.12?0.18 )/6 month baseline,P<0.01]and PAH[(3.2_+1.4)cm/ 6 month vs (1.4?1.1)cm/6 month baseline,P<0.01].Conclusion In girls with CPP showing a marked decrease in growth velocity during GnRHa treatment,the combined rhGH and GnRHa treatment remarkably improves growth velocity and PAH.
3.Clinical observation on treatment of children's mild continuous asthma by Fangchuan Mixture combined with flixotide.
Chinese Journal of Integrated Traditional and Western Medicine 2007;27(11):993-995
OBJECTIVETo investigate the efficacy and mechanism of Fangchuan Mixture (FCM) in treating children with mild continuous asthma.
METHODSOne hundred and seventy-five patients in the three groups were treated with FCM (A), Flixotide (B), and the combination of FCM and Flixotide (C), respectively for 12 weeks. Their condition of asthma and TCM syndrome were observed, peak expiratory flow (PEF) and serum levels of immunoglobulin (Ig), interleukin-4 (IL-4) and interferon-gamma (IFN-gamma) were determined.
RESULTSAll the indexes determined were improved significantly in the three groups after treatment (P <0.05). Paired comparison among groups showed that the improvements in non-asthma time, time required beta-receptor activator, expectoration, complexion, appetite, and increasing serum IFN-gamma after treatment were superior in Group C than in Group A and B (P <0.05); the improvements in hidrosis, faint pulse and decreasing serum IL-4 level in Group A and C were better than those in Group B (P <0.05), and the effect for alleviating symptoms of rhinitis such as nasal obstruction and nasal discharge in Group C was more significant than that in Group B (P <0.05).
CONCLUSIONFCM could attenuate the allergic inflammation of bronchi to improve its hypersensitive state in children with asthma, and shows a cooperative action with Flixotide.
Adolescent ; Androstadienes ; therapeutic use ; Asthma ; drug therapy ; Bronchodilator Agents ; therapeutic use ; Child ; Child, Preschool ; Drug Therapy, Combination ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Fluticasone ; Humans ; Male ; Phytotherapy ; Treatment Outcome
4.Correlative analysis of growth velocity in girls with central precocious puberty during gonadotropinreleasing hormone analog therapy
Hua-Mei MA ; Min-Lian DU ; Yan-Hong LI ; Zhe SU ; Hong-Shan CHEN ; Yu-Fen GU ;
Chinese Journal of Endocrinology and Metabolism 2001;0(05):-
Objective To analyse the relative factors of the linear growth velocity(GV)in girls with central precocious puberty(CPP)during gonadotropin-releasing hormone analog(GnRHa)therapy,and to investigate the factors affecting the height gain during two-year GnRHa treatment.Methods In 86 girls aged (8.04?1.28)years with CPP treated with GnRHa for more than 2 years,the data including target height,age of onset,pubertal course,chronological age,bone age,linear GV,serum estradiol level and mature index of vaginal smear were analyzed,then the correlations and stepwise regression were performed.Results During GnRHa therapy,GV decreased year by year.The GV in the second year(GV_(2nd))was negatively correlated with the age of onset,bone age(BA_0,BA_2)and chronologic age(CA_0,CA_2)at the onset and by the end of the first year of GnRHa therapy(r=-0.37,-0.59,-0.57,-0.51 and-0.52,respectively,all P
5.Relationship between Trace Elements and Asthenia TCM Syndromes in Embryonic Development Stops
Fenglou BAI ; Yu GAO ; Qingxue LI ; Jing LI ; Yang ZHAO ; Hong XU ; Huilan DU ; Rongxia LIU ; Zhe SONG ; Huirong MA
Chinese Journal of Information on Traditional Chinese Medicine 2013;(10):14-15,16
Objective To study the relationship between the asthenia TCM syndromes in embryonic development stops and the level of zinc, iron, copper, magnesium, phosphorus, calcium in serum, and provide thoughts for assisting reproduction and preventing miscarriage. Methods Totally 100 patients of embryonic development stops were selected randomly (6-10 weeks gestation) to be the investigated group, with other 100 cases of live fetus as the control group. The contents of trace elements in serum were detected with atomic absorption spectrometry. Results The levels of trace elements in embryonic development stops patients were generally lower than the control group. The serum iron in patients with spleen deficiency syndrome, and serum zinc and iron in patients with kidney deficiency syndrome were significant lower (P<0.05). Conclusion The contents of trace elements in serum have relationships with asthenia TCM syndromes in embryonic development stops. It should be paid attention to supplementing trace elements during the gestation period. For patients with deficiency of kidney and spleen, the supplement of zinc and iron should be given greater prominence.
6.The correlation between oxidized low density lipoprotein receptor CD36 and renal tubular injury in diabetic rats
Xiangju LONG ; Yanan SUN ; Zhe LIU ; Tiekun YAN ; Wei ZHAO ; Junya JIA ; Xiaoming WU ; Wei DU ; Shan LIN ; Hong ZHANG
Chinese Journal of Endocrinology and Metabolism 2016;32(7):602-606
Objective To observe the expressions of oxidized low density lipoprotein ( OxLDL ) receptor CD36 in kidney tissue of diabetic rats and in tubular cells incubated with OxLDL, and to explore the association of CD36 with the tubular injury and renal fibrosis in the process of diabetic nephropathy. Methods Diabetic rat model with hyperlipidemia was established by feeding with high sugar and fat diet and injection of low dose streptozotocin intraperitoneally. The expression of CD36 in kidney tissues was analyzed immunohistochemically. Meanwhile, the tubular sclerosis and fibrosis injury index were estimated and calculated. NRK-52E cells were stimulated with 50 mg/L OxLDL for 5, 10, 24, and 48 h, or 100 and 150 mg/L OxLDLs for 2 and 3 days. The protein expression of CD36 was detected by Western blot. Results The expression of CD36 in the renal tubulointerstitium of diabetic rats was increased comparing to that in control rats, and was localized mainly at tubular region. The renal tubular damage index(STI)ofdiabetesgroupwashigherthanthatincontrolgroup(5.54±1.5vs0.65±0.15,P<0.05). OxLDL stimulated CD36 expression in NRK-52E cells in a dose-and time-dependent manner. Conclusion The expression of CD36 was increased in renal tubular of diabetic rats, in consistent with STI. OxLDL increased CD36 expression in NRK-52E cells. These results suggest that the expression of CD36 is associated with renal tubular damages in experimental rat diabetes.
7.Distribution characteristics of common syndrome types and syndrome elements extracted by experts' experience in perimenopausal and postmenopausal women.
Yi XIN ; Tianfang WANG ; Caifeng DU ; Li LI ; Jie REN ; Zhe JIN ; Hong ZHAO ; Yan JING ; Xiaojuan ZOU ; Hongqi LIU ; Ying CHEN ; Lina WANG ; Ruifen LIU ; Qingguo WANG
Journal of Integrative Medicine 2009;7(6):522-6
To compare the distribution characteristics of common syndrome types and syndrome elements of menopause syndrome in perimenopausal and postmenopausal women on the basis of standardized syndrome differentiation extracted by experts' experiences.
8.A study on the integrated application of risk matrix and analytic hierarchy process in risk assessment of vaccination operation
Ben HE ; Ze-Lin XIANG ; Zhong-Wen CHEN ; Guo-Chu SHEN ; Zhe-Qun DU ; Hong-Liang ZHU
Journal of Preventive Medicine 2016;28(8):776-780
Objective To evaluate the risks of vaccination operation in order to provide scientific basis for policy makings of vaccination operation.Methods The risk matrix and analytic hierarchy process approach were used to evaluate the risks of vaccination operation,including the possibility,severity,risk weight,and risk level.Results Seven items for the first level and thirty one items for the second level vaccination risk factors were determined.In the first level,E level risk (Extremely serious risk ) was vaccination implementation risk,and H level risk (high risk ) was the risks of pre -notification and health education and risks of vaccine and cold chain management.Vaccination implementation risk accounted the largest weight (weight coefficient=38.95%).In second level,E level risk was three inspection and seven verification before vaccination,and H level risk were personnel professional quality,personnel responsibility,pre -inspection,informed before vaccination, vaccination route, site and dose, vaccination operation, post vaccination notification and retention,and three inspection and seven verification before vaccination,accounted the largest weight (weight coefficient=10.14%).The weight of the logical consistency of the test results were satisfactory (consistency ratio<0.1 ).Conclusion The integrated application of risk matrix and analytic hierarchy process in risk assessment of vaccination operation helps to further regulate vaccination services and has application and promotion value.
9.Diagnostic value of serum levels of β-human chorionic gonadotropin (β-hcG) combined with β-hcG in cerebrospinal fluid for determining locations of germinomas in children with precocious puberty.
Yan-hong LI ; Zhe SU ; Hua-mei MA ; Hong-shan CHEN ; Yu-fen GU ; Min-lian DU
Chinese Journal of Pediatrics 2010;48(10):771-774
OBJECTIVETo study the clinical manifestations of germinoma in children with precocious puberty and to evaluate the diagnostic value of serum levels of β-human chorionic gonadotropin (β-hcG) combined with detections of β-hcG in cerebrospinal fluid (CSF).
METHODTwelve male children with germinomas confirmed by pathology from Jan. 2005 to Dec. 2009, aged from 4.2 to 10.2 years, were enrolled in this study. Patients were classified into two groups according to tumor locations: intracranial group and non-intracranial group. Levels of β-hcG in serum as well as in CSF were detected before the initiation of therapy. Age and gender matched 5 children undergoing lumbar puncture for other diseases were set as control group for the determinations of β-hcG in CSF. Levels of β-hcG and testosterone in serum and CSF were compared between intracranial group and non-intracranial group, and levels of β-hcG in CSF were compared between non-intracranial group and control group.
RESULTThe 12 children showed elevated serum levels of testosterone: 10.43 (1.70-254.00) µg/L, 11 children had testicular volume > 4 ml, while response to LHRH stimulation tests were low; 6 children had gynecomastia. Serum levels of β-hcG were elevated in both intracranial and non-intracranial group and no significant differences were found between groups 63.75 (8.50-309.50) IU/L vs. 59.00 (25.10-71.77) IU/L, P = 0.644. No correlations were found between serum levels of β-hcG and ages, tumor locations, and courses of the patients. Levels of β-hcG in CSF were significantly higher in intracranial group than that in non-intracranial group 488.99 (17.30-1048.53) IU/L vs. 1.20 (1.20-1.50) IU/L, P = 0.009. Children with non-intracranial germinomas had similar levels of β-hcG in CSF as that in control group (P = 0.571).
CONCLUSIONThe main clinical manifestations in boys suffered from germinoma included pseudo-precocious puberty, disproportionate testicular volume and gynecomastia. Detection of serum levels of β-hcG combined with β-hcG levels in CSF may be useful for determination of the locations of germinomas in children with precocious puberty.
Brain Neoplasms ; complications ; diagnosis ; Case-Control Studies ; Child ; Child, Preschool ; Chorionic Gonadotropin, beta Subunit, Human ; blood ; cerebrospinal fluid ; Germinoma ; complications ; diagnosis ; Humans ; Male ; Mediastinal Neoplasms ; complications ; diagnosis ; Puberty, Precocious ; complications
10.Effect of gonadotropin-releasing hormone analog combined with stanazolol on final height in girls with idiopathic central precocious puberty and apparent decrease of linear growth.
Yan-hong LI ; Shun-ye ZHU ; Hua-mei MA ; Zhe SU ; Hong-shan CHEN ; Qiu-li CHEN ; Yu-fen GU ; Min-lian DU
Chinese Journal of Pediatrics 2013;51(11):807-812
OBJECTIVETo evaluate the effect of combined use of stanazolol (ST) on the final adult height (FAH) in girls with idiopathic central precocious puberty (ICPP) and apparently decreased linear growth during gonadotropin-releasing hormone analog (GnRHa) therapy.
METHODSixty-three girls with ICPP and decreased velocity of growth of height (HV<4 cm/yr) during GnRHa therapy were divided into 3 groups based on the following types of interventions:group 1 (n = 20), GnRHa+ST [25-30 µg/(kg·d) every 3-month followed by 3-month discontinuation], group 2 (n = 21), GnRHa+recombinant human growth hormone [rhGH, 1-1.1 U/(kg·w)], group 3 (n = 22), GnRHa alone.HV, the advancement of bone age (BA) for chronological age (CA) (ΔBA/ΔCA) and FAH were compared among groups.
RESULT(1)Total duration of ST combination therapy was (12.22 ± 3.62) months, while total duration of combination of rhGH was (13.22 ± 6.80) months. (2)HV increased significantly in both group 1 [ (2.79 ± 0.60) cm/yr vs. (6.27 ± 1.98) cm/yr, P < 0.01] and in group 2 [(2.80 ± 0.50) cm/yr vs. (6.25 ± 1.98) cm/yr, P < 0.01] during combined therapy, but maintained at low levels in group 3 [(3.95 ± 1.10) cm/yr vs. (3.34 ± 0.95) cm/yr, P > 0.05].No significant differences of ΔBA/ΔCA were found among the three groups [0.25(0.11∼0.28), 0.22(0.15∼0.31),0.19(0.10∼0.32), P > 0.05]. (3)FAH was significantly higher than predicted adult height (PAH) before combined therapy, as well as higher than target height (THt) in both group 1 [(156.25 ± 2.90) cm vs. (150.78 ± 3.70) cm, P < 0.01, (156.25 ± 2.90) cm vs. (153.94 ± 2.62) cm, P < 0.01], and in group2 [ (157.33 ± 4.69) cm vs. (152.61 ± 3.92) cm, P < 0.01, (157.33 ± 4.69) cm vs. (154.39 ± 4.72) cm, P = 0.01].In group 3, FAH was similar to PAH [(153.88 ± 2.6) cm vs. (152.54 ± 5.86) cm, P > 0.05], and was less than THt [(153.88 ± 2.6) cm vs. (155.60 ± 4.52) cm, P = 0.02]. (4)In girls treated with ST, no hirsutism, clitorism or hoarse voice was recorded.No polycystic ovary syndrome was found by B-mode ultrasound.
CONCLUSIONIntermittent combined use of low dose ST therapy can increase HV and thus improve FAH in girls with ICPP and apparently decreased linear growth during GnRHa therapy.
Body Height ; drug effects ; Bone Development ; Child ; Child Development ; drug effects ; Drug Therapy, Combination ; Female ; Gonadotropin-Releasing Hormone ; administration & dosage ; analogs & derivatives ; therapeutic use ; Growth Disorders ; drug therapy ; Human Growth Hormone ; administration & dosage ; therapeutic use ; Humans ; Puberty, Precocious ; drug therapy ; physiopathology ; Stanozolol ; administration & dosage ; therapeutic use ; Treatment Outcome