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.Longitudinal study of the pattern of pubertal development in Cantonese schoolgirls.
Yan-hong LI ; Hua-mei MA ; Hong-shan CHEN ; Zhe SU ; Yu-fen GU ; Min-lian DU
Chinese Journal of Pediatrics 2009;47(6):410-415
OBJECTIVETo investigate the pattern of pubertal development in healthy Cantonese schoolgirls.
METHODFrom 1992 to 2001, 311 normal Cantonese schoolgirls, ages from 6.25 to 8.83 yrs (7.24 +/- 0.38) at baseline, were followed up until they reached their final adult height (age 15.72 +/- 0.84 yrs, n = 238). Annual physical examinations including height and weight measurement were performed. From the 3rd visit, pubertal maturations (breast and pubic hair development) were also assessed annually until they were 14.5 years. Age of menarche was recorded.
RESULT(1) Median age at the entry of puberty (age at reaching B2) was 9.83 years (9.33-10.33). Median age at initiation of pubic hair development (PH2) was 10.67 (9.92-11.38) years. Menarche occurred at (12.35 +/- 1.30) years. The age at reaching B2, age at reaching PH2 and age of menarche were all later than that observed in the cross-section study performed in 2003, Guangzhou, China. Peak height velocity (PHV) was reached at (10.52 +/- 1.07) years, 1.00 (0.50-1.50) years after B2 was reached. Interval between "age at onset of breast development" and "age at menarche" was 2.92 (2.08-3.67) years. Duration of pubertal growth (defined as the time from age at B2 to age at which adult height was attained) was (4.80 +/- 0.85) years. (2) Average final adult height (FAH) was (158.74 +/- 5.74) cm. As compared with the cross-section studies held in Guangzhou, China, the FAH in our study was higher than that observed in 1985 but was lower than that observed in 2003. (3) Multiple linear regression analyses showed that the age reaching B2 was an independent factor associated with the age of menarche. (4) Durations of breast stages, interval between B2 and menarche and duration of pubertal growth were similar to that reported in the longitudinal studies in the United Kingdom (1969), Senegal (1995-2000), the United States (1986-1996).
CONCLUSIONIn healthy Cantonese schoolgirls, the timing of sexual maturation was in a trend of decline in the past 20 years, however it may have no significant impacts on the tempo of pubertal development and FAH.
Adolescent ; Adolescent Development ; Body Height ; Body Weight ; Child ; China ; Female ; Humans ; Longitudinal Studies ; Puberty ; Sexual Maturation ; Students
10.Determination of serum steroids in monitoring therapy of congenital adrenal hyperplasia.
Hui-wen XIAO ; Hua-mei MA ; Zhe SU ; Min-lian DU ; Yan-hong LI ; Hong-shan CHEN ; Qiu-li CHEN
Chinese Journal of Pediatrics 2012;50(4):301-307
OBJECTIVETo assess the utility of serum steroids measurement in monitoring the treatment of children with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21OHD).
METHODNineteen Patients with CAH 21OHD aged (3.67±1.54) years treated with hydrocortisone and fluorocortisone replacement were followed up at an intervals of 0.33 - 1.0 years over a period of (1.47±0.7) years. At each visit, roentgenograms of the hands and wrists were taken, fasting peripheral blood were collected to test serum dehydroepiandrosterone sulfate, progesterone, 17-hydroxyprogesterone (17-OHP), androstenedione (Δ4-A), testosterone, free testosterone, estrone, and estradiol concentrations at 8 AM in the morning before the first dose of glucocorticoid. Then the patients were classified as being in "Good Control" or in "Poor Control" based on clinical criteria including signs of androgen excess, growth velocity and bone age increment at each interval. Comparisons were carried out between the serum steroid concentrations of the two groups. The receiver operating characteristic (ROC) curves were used to determine the cut-off values for diagnosing "Poor Control".
RESULTBoth of serum Δ4-A and 17-OHP concentrations were higher in "Poor Control" group than those in "Good Control" group [5.95 (2.23-11.2) nmol/L versus 1.05 (1.05-9.89) nmol/L, t=2.19; 13.85 (6.06-20) µg/L versus 3.67 (0.42-21.1) µg/L, t=2.17; P<0.05, respectively]. The ROC curves for serum Δ4-A concentrations, serum 17-OHP concentrations, serum Δ4-A in combination with 17-OHP concentrations were constructed with areas under the ROC curves (95%CI) of 0.76 (0.62, 0.90), 0.75 (0.62, 0.88), 0.69 (0.54, 0.84), P<0.05, respectively. Serum Δ4-A of 3.9 nmol/L had 0.78 of sensitivity and 0.75 of specificity in diagnosing "Poor Control". Serum 17-OHP of 7.1 µg/L has 0.67 of sensitivity and 0.71 of specificity in diagnosing "Poor Control".
CONCLUSIONEach of serum 17-OHP or/and Δ4-A concentration was of significance in diagnosing "Poor Control" during the glucocorticoid replacement treatment of CAH 21OHD, with the diagnostic efficacy being serum Δ4-A concentration, serum 17-OHP concentration and serum Δ4-A in combination with 17-OHP concentration in descending order. Serum Δ4-A and 17-OHP concentrations may be used as the biochemical indicators to monitor the therapy of CAH 21OHD.
17-alpha-Hydroxyprogesterone ; blood ; Adrenal Hyperplasia, Congenital ; blood ; diagnosis ; therapy ; Androstenedione ; blood ; Child, Preschool ; Dehydroepiandrosterone Sulfate ; blood ; Female ; Humans ; Hydrocortisone ; blood ; Male ; Progesterone ; blood ; Steroid 21-Hydroxylase ; blood ; Testosterone ; blood