Observation on Honghua Xiaoyao Granules combined with tamoxifen in treatment of polycystic ovary syndrome / 中国综合临床

Objective@#To investigate the clinical effect of Honghua Xiaoyao granule combined with tamoxifen citrate tablets in the treatment of polycystic ovary syndrome (PCOS).@*Methods@#From June 2017 to January 2019, 92 patients with PCOS admitted to Chengde maternal and child health care hospital were selected as the study objects, and divided into control group (46 cases) and treatment group (46 cases) according to the order of admission.The patients in the control group took tamoxifen citrate tablets, 2 tablets/time, 1 time/day from the 5th day of menstrual cycle.The patients in the treatment group were treated with safflower Xiaoyao granules on the basis of tamoxifen citrate tablets, 3 bags/time, 3 times/day.After 21 days of continuous administration, 5 days of discontinuation was a course of treatment, and the two groups of patients were treated for 3 consecutive courses.The clinical effect, ovulation, blood glucose, insulin resistance index, sex hormone level and oxidative stress of the two groups were compared before and after treatment.@*Results@#The total effective rate of the treatment group was 95.65% (44/46), the ovulation rate was 97.83% (45/46), the control group was 80.43% (37/46), 84.78% (39/46), the difference between the two groups was statistically significant (χ2 value was 5.06, 4.93, P value was 0.025, 0.029). .Before and after treatment, the fasting insulin were (20.31±3.06) mU/L and (12.49±2.34) mU/L, and the homeostatic model assessment of insulin resistance were 4.84±1.30 and 2.92±0.83 in the treatment group, which were (20.14±2.55) mU/L, (16.15±2.17) mU/L, 4.86±1.08 and 3.86±0.93 in control group.There all were differences in two groups about the insulin resistance index before and after treatment, and there all were differences between two groups about the insulin resistance index after treatment (tvalue was 26.15 , 16.10, 19.68 and 12.17; all P<0.001). and there were statistically significant differences between the two indexes after treatment (t=0.77, 5.11, all P<0.001). Before and after treatment, the luteinizing hormone were (19.98±2.22) and (12.61±2.55) U/L, and the follicle stimulating hormone were (5.97±0.69) U/L and (4.52±0.79) U/L, and testosterone was (5.38±0.88) and (3.62±0.60) nmol/L, which was (20.44±2.23) U/L, (16.18±2.65) U/L, (6.09±0.59) U/L, (5.31±0.86) U/L, (5.44±0.77) nmol/L and (4.48±0.62) nmol/L in control group.The difference between the two groups before and after treatment was statistically significant (t value was 23.32, 15.29, 13.70, 8.67, 19.80 and 12.30, respectively; all P<0.001); and the difference between the groups after treatment was statistically significant (t value was 6.58, 4.61 and 6.70, respectively, all P<0.001). Before and after treatment, the malondialdehyde were (9.20±1.15) μmol/L and (5.63±0.94) μmol/L, and the superoxide dismutase were (62.99±5.37) U/L and (89.63±8.81) U/L, which were (9.45±1.08) μmol/L, (7.48±0.85) μmol/L, (61.88±5.78) U/L and (75.60±6.87) U/L in control group.There all were differences in two groups about the oxidative stress index before and after treatment, and there all were differences between two groups about the oxidative stress index after treatment (t value was 40.00, 19.84, 28.14, 15.24, 9.88 and 8.52, respectively, all P<0.001).@*Conclusion@#Honghua Xiaoyao Granules combined with Tamoxifen Citrate Tablets can effectively improved the clinical symptoms of patients with PCOS, promoting ovulation, reducing sex hormone level, improving insulin resistance and oxidative stress, which has a certain clinical application value.

Clinical Observation of Rupi Sanjie Capsules in the Treatment of Mammary Gland Hyperplasia after Minimally Invasive Rotation and Surgical / 中国药房

OBJECTIVE:To observe therapeutic efficacy and safety of Rupi sanjie capsules in the treatment of mammary gland hyperplasia after minimally invasive rotation and surgical. METHODS:A total of 180 patients with mammary gland hyperplasia or mammary gland hyperplasia combined with mammary fibroma were selected retrospectively from general surgery department of the First Affiliated Hospital of Soochow University during May 2015 to May 2017. They were divided into control group(n＝90)and observation group (n＝90) according to medication methods. Both groups received minimally invasive rotation and surgical treatment. After operation,control group was given Tamoxifen citrate tablets 10 mg orally,twice a day. Observation group was given Rupi sanjie capsules 2.12 g orally,3 times a day. Two groups stopped taking medication during menstruation,and both groups were treated for 8 weeks. Clinical efficacies of 2 groups were observed,and the levels of VEGF,FGF and MVD,the occurrence of ADR were observed before and after treatment. RESULTS:The total response rate of observation group(95.56%) was significantly higher than that of control group(86.67%),with statistical significance(P＜0.05). Before treatment,there was no statistical significance in the levels of VEGF,FGF and MVD between 2 groups (P＞0.05). After treatment,the levels of VEGF,FGF and MVD in 2 groups were significantly lower than before treatment,and the observation group was significantly lower than the control group,with statistical significance(P＜0.05). No obvious ADR was found in 2 groups during treatment. CONCLUSIONS:After minimally invasive rotation and surgical,Rupi sanjie capsules shows significant therapeutic efficacy for mammary gland hyperplasia,can reduce the levels of VEGF,FGF and MVD with good safety.

Efficacy of alpha-lipoic acid combined with tamoxifen citrate in the treatment of oligoasthenospermia / 中华男科学杂志

Objective@#To investigate the effect of alpha-lipoic acid (α-LA) combined with tamoxifen citrate (TC) in the treatment of oligoasthenospermia.@*METHODS@#From June to November 2016, we treated 60 patients with oligoasthenospermia in our Department of Andrology, 30 (the trial group) with oral α-LA (0.6 g, qd) + TC (20 mg, qd) and the other 30 (the control group) with oral L-carnitine (1g, bid) + TC (20 mg, qd). Before and after 3 months of medication, we examined the semen parameters of the patients and the levels of their seminal oxidative stress biomarkers, including methylenedioxyamphetamine (MDA) and total antioxidant capacity (TAC) in the seminal plasma. We also compared the pregnancy rate and adverse reactions between the two groups.@*RESULTS@#Totally, 57 of the patients completed the treatment, 28 in the trial group and 29 in the control. Compared with the baseline, the patients of the trial group showed significant improvement after 3 months of medication in the semen volume (［2.50 ± 0.71］ vs ［3.37 ± 0.70］ ml, P 0.05) except in TAC, which was markedly more improved in the former than in the latter (P 0.05). After 3 months of treatment, 3 pregnancies were achieved in the trial group and 1 in the control (10.7% vs 3.45%, P >0.05). No obvious adverse events occurred during the treatment.@*CONCLUSIONS@#Alpha-lipoic acid combined with tamoxifen citrate can evidently improve semen parameters in oligoasthenospermia patients by relieving oxidative stress injury.

Clinical Observation of Guizhi Fuling Capsule Combined with Tamoxifen Citrate Tablet in the Treatment of Breast Hyperplasia / 中国药房

OBJECTIVE:To observe the clinical efficacy and safety of Guizhi fuling capsule combined with Tamoxifen citrate tablet in the treatment of breast hyperplasia. METHODS:216 female patients with breast hyperplasia were randomly divided into control group and observation group. Control group was orally treated with Tamoxifen citrate tablet 10 mg,bid. Observation group was additionally orally treated with Guizhi fuling capsule 3 granules,tid. The treatment course was 3 months. Drug withdrawal was conducted in menstrual period. The clinic data was observed,including clinical efficacy,the maximum mass diameter and breast pain scores before and after treatment,and incidence of adverse reactions. RESULTS:The total effective rate in observation group was significantly higher than control group,the difference was statistically significant(P0.05). CONCLUSIONS:Guizhi fuling capsule combined with Tamoxifen citrate tablet has more significant efficacy than only Tamoxifen citrate tablet in the treatment of breast hyperplasia,with similar safety.

Comparative Studies on Dissolution and Bioavailability of Tamoxifen Citrate Loaded Binary and Ternary Solid Dispersions.

Aims: This study focused on comparing binary and ternary solid dispersions (SD's) of water-insoluble Tamoxifen citrate (TMC) regarding drug dissolution and oral bioavailability. Basically, the enhanced dissolution of this drug by water-soluble polymer has not yet been reported in literature. Study Design: In vitro and In-vivo characterization of Tamoxifen citrate loaded binary and ternary solid dispersion systems. Place and Duration of Study: Department of Pharmaceutics and Industrial Pharmacy, Helwan University, Cairo, Egypt between June 2012 and June 2013. Methodology: Amorphous SD's of TMC with two hydrophilic polymers, polyethylene glycol 6000 (PEG 6000) and Methyl cellulose (MC), were prepared by melting method. Binary SD's of TMC with PEG of different weight ratios were prepared. MC was used as third component to prepare ternary SD's. Physicochemical properties of SD's were characterized by FTIR, DSC, and In-vitro drug release in comparison with physical mixtures and the drug alone. Oral bioavailability of the optimized SD formula was compared with that of free TMC in rats. Results: Infrared spectroscopic studies suggested no interaction between TMC and polymers rather than H-bond formation. A remarkably improved dissolution of drug from the ternary solid dispersion systems when compared to the binary solid dispersion systems was detected. On the basis of % dissolution efficiency (% DE), the SD composed of PEG: TMC: MC in a ratio 4:1:2 w/w/w was selected as the optimized SD. The in-vivo studies showed extremely significant higher values of Cmax (P<.05), AUC0-24 (P<.05) and significantly (P<.05) lower values of Tmax exhibited by SD compared with free TMC. Conclusion: Highly enhanced TMC dissolution and bioavailability exhibited by PEG: TMC: MC ternary solid dispersion in a weight ratio 4:1:2 were promising to improve the therapeutic potential of TMC.

Investigation on the Dissolubilities of Tamoxifen Citrate Tablets Produced by Four Different Factories / 中国药房

OBJECTIVE:To compare the dissolubilities of Tamoxifen citrate tablets from four domestic pharmaceutical factories METHODS:Rotating basket method and paddle method were used,and Td were calculated by Weibull distribution RESULTS:Statistical analysis showed that there were significant differences in Td among the products from different factories,and the dissolubility of the same product detected by rotating basket was slower than that by paddle method CONCLUSION:The dissolubilities of Tamoxifen citrate tablets have significant differences among four different domestic products

Surveillance of the endometrium in women taking tamoxifen for breast carcinoma: A six month follow up report

Objective: To determine the role of transvaginal ultrasound, doppler velocimetry, saline infusion sonography and office hysteroscopy with endometrial biopsy and endocervical curettage in the detection of endometrial pathologies among breast cancer patients using Tamoxifen and subsequently recommend an acceptable cost effective protocol for the surveillance and follow up of these patients. Methodology: The study design is a descriptive type. Endometrial assessment was carried out using transvaginal ultrasound, doppler velocimetry, saline infusion sonography and office hysteroscopy with endometrial biopsy and endocervical curettage on initial consult. They were asked to follow up after 6 months during which time the same procedures will be repeated and performed. Results: Twenty one women were recruited to this study. The mean age of the subjects was 50.33 years. Of the 21 women in the study, 13 were postmenopausal and 8 were premenopausal. The mean age of menarche and menopause was 13.05 and 49.15 years, respectively. The body mass index was 23.92 (SD +/- 2.54). Other demographic characteristics were as follows; 19 percent had a history of oral contraceptive use, 35 percent were nulligravid, and 4.7 percent had a history of infertility x 9 years. The mean age when breast cancer was initially recognized was 47 years. Majority of patients (66.60 percent) had stage II disease. Seventy six percent was initially diagnosed by biopsy and the rest by fine needle aspiration cytology. All underwent modified radical mastectomy except for a 37 year old nulligravid who underwent quadrantectomy and axillary clearance. Eighteen (8-7.7 percent) of which showed ductal carcinoma on histopathologic examination. The mean duration of tamoxifen intake was 24 months. Women with breast cancer and taking Tamoxifen had a significant increase of vaginal bleeding on 6th month follow up. (P=0.00). On transvaginal ultrasound, a significant increase in the number of patients had thicker endometrium on 6th month follow up (P value 0.03). However, the role of Doppler and saline infusion sonography on the surveillance of the endometrium was not significant. Conclusion: A management scheme for the surveillance of the endometrium on breast cancer patients on Tamoxifen cannot be suggested at the moment and requires a long term follow up of these patients.