1.Analysis of gemcitabine adverse drug reactions and risk factors in Inner Mongolia
Shengnan YANG ; Wei SHI ; Yufang ZHAO ; Zhien LIU ; Wenpu LEI ; Yanan ZHANG ; Ke ZHAO ; Hao GUO
China Pharmacy 2025;36(4):486-490
OBJECTIVE To analyze the occurrence characteristics and risk factors of adverse drug reactions (ADR) of gemcitabine for injection in national centralized volume-based procurement (hereinafter referred to as “centralized procurement”), and provide reference for clinical safe drug use. METHODS A retrospective study was conducted to collect the relevant case reports of gemcitabine for injection reported to the National Adverse Drug Reaction Monitoring System by Inner Mongolia Autonomous Region from January 2022 to December 2023; basic information of patients, drug use status, patient outcomes, rational drug use and other information were collected, and the occurrence characteristics of ADRs with leukopenia, myelosuppression, neutropenia, thrombocytopenia and liver dysfunction were analyzed. Univariate analysis and multivariate Logistic regression were used to analyze the correlation of gender, age, combination of antitumor drugs, original malignant tumor and drug dose with ADR. RESULTS A total of 315 cases reports (315 patients) of gemcitabine-induced ADR were included in this study, with a male-to-female ratio of 1.42∶1 and age of (61.17±9.13) years. The primary malignant tumor was pancreatic cancer (73 cases, 23.17%). Leukopenia, myelosuppression and nausea were the most common ADR, followed by neutropenia, thrombocytopenia, liver dysfunction and so on. The severity grade of ADR was mainly 1-2, and the outcome of most ADR was good. Multivariate Logistic regression analysis showed that combination of antitumor drugs was a risk factor for myelosuppression and neutropenia (RR=2.154, 95%CI: 1.218- 3.807, P=0.008; RR=3.099, 95%CI: 1.240-7.744, P=0.016); gender (female) was a risk factor for leukopenia and liver dysfunction (RR=0.508, 95%CI: 0.302-0.853, P=0.010; RR=0.301, 95%CI: 0.102-0.887, P=0.029). In terms of drug use rationality, there were 143 cases (45.40%) of drug 126.com use in accordance with the indications of the label, and 172 cases (54.60%) of off-label drug use. Among them, the primary malignant tumors were bladder cancer, bile duct cancer and ovarian cancer, which ranked the top three off-label drug use. CONCLUSIONS The ADR caused by gemcitabine in Inner Mongolia is mainly in the blood and digestive systems. The severity of ADRs is mainly classified as 1-2 levels, and most ADRs have good outcomes. Gender (female) and combination medication are risk factors for gemcitabine-induced ADR. Appropriate chemotherapy regimen should be selected according to the patient’s condition and physical condition, and ADR monitoring in blood and digestive systems should be strengthened during medication of gemcitabine.
2.Discount rate setting and adjustment in international pharmacoeconomic evaluation guidelines
Yiwei LI ; Jingbo ZHANG ; Huiwen YANG ; Hanfei WANG ; Yusi SUO ; Han WANG ; Zhien GU ; Xuejing JIN
China Pharmacy 2025;36(20):2542-2547
OBJECTIVE To provide direction and reference for the adjustment of the discount rate (DR) in China’s pharmacoeconomic guidelines. METHODS Search was conducted on the official websites of the International Society for Pharmacoeconomics and Outcomes Research, health technology assessment agencies in various countries/regions, as well as relevant websites of other upper-middle-income or high-income countries/regions. The recommended DR, adjustment trends, and setting rationales in pharmacoeconomic evaluation guidelines across different countries/regions were then summarized and compared. Based on theoretical derivation and literature analysis, the effects of different DR on the incremental cost-effectiveness ratio (ICER) were examined. RESULTS & CONCLUSIONS Among the 40 included guidelines, the base-case DR ranged from 1.5% to 5%, with 5% being the most common value; the range for sensitivity analysis was 0 to 12%. Thirty-six countries/regions applied the same DR to both costs and health outcomes, while in the Netherlands, Belgium, Poland and Czech Republic, DR for costs was higher than for health outcomes. In recent years, Korea, France and Ireland had lowered their DR in response to economic changes, whereas the Netherlands and Czech Republic had raised their DR for cost. The setting of the DR was primarily based on the public project investment interest rate or referred to recommendations from internationally authoritative institutions and other relevant guidelines. The direction and magnitude of the impact of different DR on the ICER largely depended on the distribution of costs and health outcomes between the intervention and reference measure. The setting and adjustment of DR were closely associated with the economic environment. Based on international experience, the DR in China can be lowered by 0.5% to 1.5%, and localized empirical research can be conducted using internationally common estimation methods.
3.Analysis of children’s drug use in Inner Mongolia based on big data of drug monitoring
Yufang ZHAO ; Wenpu LEI ; Zhien LIU ; Shengnan YANG ; Yanan ZHANG ; Ke ZHAO ; Hao GUO
China Pharmacy 2024;35(23):2929-2935
OBJECTIVE To analyze the use of children’s drugs in public medical institutions in the Inner Mongolia Autonomous Region, and provide some reference for the rational use of children’s drugs and the improvement of children’s drug list in the whole region. METHODS The generic names, specifications, and dosage forms of children’s drugs were collected from all levels of public medical institutions in the Inner Mongolia Autonomous Region in 2023. The method of defined daily dose (DDD) and ranking ratio (B/A) were used to explore the frequency of drug use, daily average cost and cost-effectiveness of children’s drugs in this region, and the dosage forms, category, and drug use convergence of children’s drugs in medical institutions in the whole region. RESULTS In 2023, 1 751 public medical and health institutions in Inner Mongolia Autonomous Region were equipped with 267 kinds of children’s drugs, including 12 drug categories. The main dosage forms were granules, oral solutions, and syrups. The drugs that were frequently used in medical institutions at all levels were mainly antipyretic, analgesic, anti-inflammatory drugs (mostly Chinese patent medicines), and respiratory drugs. The daily average cost of children’s drugs with the highest DDDs in tertiary, secondary, and primary public medical institutions was low, and the B/A value of most drugs with higher DDDs was around 1. However, the B/A value of some drugs was high, which may lead to overuse. The drug use convergence between primary public medical institutions and secondary/tertiary public medical institutions was less than 50%. CONCLUSIONS The types of drugs involved in children’s drugs in Inner Mongolia Autonomous Region are comprehensive and the social and economic benefits are in good synchronization, but the dosage form is single and there are few special rules and dosage forms for children. The proportions of Chinese patent medicines in primary and secondary public medical institutions are high, and the risk of drug use should be paid attention. The cohesion between children’s drugs in primary public medical institutions and higher public medical institutions is slightly poor.
4.125I low-dose-rate prostate brachytherapy and radical prostatectomy in patients with prostate cancer
Zhien ZHOU ; Weigang YAN ; Yi ZHOU ; Xingcheng WU ; Zhibo ZHENG ; Fuquan ZHANG ; Zhigang JI ; Hanzhong LI
Chinese Journal of Urology 2020;41(5):362-367
Objective:To compare the outcomes of low-dose-rate prostate brachytherapy (BT) and radical prostatectomy (RP) in patients with T 1c-T 3a prostate cancer. Methods:A group of 745 patients with T 1c-T 3a prostate cancer between January 2010 and August 2017 at Peking Union Medical College Hospital were identified. The records of these patients, who were followed up for a minimum of 2 years, were reviewed. 384 cases received BT. Their characters included age(72.1±6.6), tPSA (12.4±6.1) ng/ml, prostate volume (33.6±13.8) ml, Gleason grade group (2.0±1.2). In this group, T 1c-T 2a stage was diagnosed in 189 cases, T 2b-T 2c stage in 182 cases and T 3a stage in 13 cases.361 cases received RP. Their characters included age(65.7±6.2), tPSA(12.6±6.4) ng/ml, prostate volume (37.2±17.8) ml, Gleason grade group (1.9±1.2). In this group, T 1c-T 2a stage was diagnosed in 177 cases, T 2b-T 2c stage in 170 cases and T 3a stage in 14 cases.The log-rank test compared survival rates between the two modalities, and Cox regression identified factors associated with bRFS. Results:Median follow-up was 60 months. Kaplan-Meier analysis did not show any statistically significant differences in terms of cRFS( P=0.321), cancer specific survival (CSS, P=0.643) and overall survival (OS, P=0.565) rate between the two groups. BT was associated with improved bRFS compared to RP( P=0.018). Risk of biochemical recurrence was significantly lower with BT compared with RP in the patients with a biopsy Gleason grade group 2 and 3 ( P=0.008), or prostate volume ≤35 ml ( P=0.027), or tPSA ≤10 ng/ml ( P=0.013), or the clinical T stages of T 2b and T 2C( P=0.031), or in the intermediate-risk group according to NCCN risk classification ( P=0.003). On multivariate analysis of all 745 patients, age≤ 70 and T stage≥T 2b was associated with significantly shorter bRFS. Conclusions:BT produced equivalent cRFS, CSS and OS compared to RP, while it was associated with improved bRFS. BT On multivariate analysis of all 745 patients, age≤ 70 and T stage≥T 2b was associated with significantly lower bRFS.
5.Influencing factors of weight gain in women with schizophrenia after treatment
Zhien CHEN ; Jing ZHANG ; Huihui LIU ; Liyan CHEN ; Runfang KANG
Chinese Journal of Primary Medicine and Pharmacy 2018;25(24):3215-3218
Objective To explore the influencing factors of weight gain in women with schizophrenia after treatment.Methods From January 2016 to December 2016,180 patients with schizophrenia who admitted to the Second People′s Hospital of Lishui for the first time and were treated with antipsychotics (APD) were followed up at hospital and 4 months after discharge.The height,weight and body mass index were observed.The joint general situation questionnaire,brief psychiatric scale(BPRS),negative symptoms(SANS),positive symptom scale(SAPS) and the clinical curative effect overall rating scale subscales of overall curative effect (CGI-GI) were comprehensively evaluated.The data were analyzed statistically.Results The weight gain was related to the type of antipsychotics (χ2=37.3,P<0.01),and the effect of aripiprazole and ziprasidone on body weight was significantly less than that in the case of weight(χ2=31.1,P<0.01).Single factor analysis showed that a medication time correlation (F=4.92,P<0.05),and each point GⅠscore had no correlation with weight gain,and weight gain was associated with BPRS,SAPS subtraction score at discharge (r=0.079,0.092,all P<0.01),and during follow-up weight gain was correlated with SANS score reduction (r=-0.063,-0.086,P<0.05 or P<0.01).Stepwise regression analysis showed that at the alpha=0.05 level,entered the regression equation factors in the order : APD types,maximum doses and taking the product of time,the negative symptoms,the best functional level at 1 year before disease.Conclusion It is important to control the weight gain of young women.The mediating role of diet and activity should not be underesti-mated.Appropriate APD was chosen to adjust the maintenance treatment strategy as appropriate,improve the negative symptoms and improve the level of individual social function as the main intervention measure .
6.Effect of enalapril maleate and folic acid tablets in the treatment of H type hypertension and its influence on blood homocysteine
Zhengchun YANG ; Zhien ZHANG ; Yaohui LIU
Chinese Journal of Primary Medicine and Pharmacy 2017;24(10):1511-1514
Objective To study the clinical effect of enalapril maleate and folic acid tablets in the treatment of H type hypertension, and to observe the blood homocysteine(Hcy), to provide the basis for clinical diagnosis and treatment.Methods 126 patients with H type hypertension were selected.They were divided into study group and control group according to the random number table method,63 cases in each group.The control group was given enalapril maleate, the study group was given enalapril maleate and folic acid tablets.The clinical efficacy of the two groups was compared.The systolic blood pressure, diastolic blood pressure and Hcy level before and after treatment in two groups were observed.Results The total effective rate of the study group was 90.5%(57/63),which of the control group was 74.6%(47/63),the difference was statistically significant(x2=15.371,P<0.05).There was no significant difference in systolic blood pressure and diastolic blood pressure before treatment between the two groups(P>0.05).The systolic pressure after treatment of the two groups were (129.3±5.7)mmHg and (137.9±4.9)mmHg, the diastolic blood pressure were (81.5±3.6)mmHg and (89.6±5.1)mmHg, the differences were statistically significant compared with before treatment(t=8.969,7.851,7.343,6.987,all P<0.05),the difference between the two groups was statistically significant(P<0.05).There was no significant difference in Hcy before treatment between the two groups(P>0.05), after treatment Hcy levels of the two groups were (8.93±0.63)μmol/L and (15.35±0.57)μmol/L respectively, the differences were statistically significant compared with before treatment(t=8.097,8.031,all P<0.05),the difference between the two groups was statistically significant(t=7.573,P<0.05).Conclusion Enalapril maleate and folic acid tablets in the treatment of H type hypertension has good clinical effect, can significantly lower blood pressure, improve Hcy level.
7.Clinical analysis of inflammatory myofibroblastic tumor of the kidney in 3 middle-aged and elderly cases and literature review
Zhien ZHOU ; Quanzong MAO ; Hanzhong LI ; Zhigang JI ; Xuebin ZHANG
Chinese Journal of Geriatrics 2015;34(6):645-647
Objective To retrospectively analyze the clinical data of 3 middle-aged and elderly cases with inflammatory myofibroblastic tumor (IMT) of the kidney,in order to improve its diagnosis and treatment.Methods The records of 3 patients who were diagnosed as IMT of the kidney by pathology in our hospital from Jan 2005 to Jun 2014 were reviewed to identify the characteristics including age,gender,clinical manifestation,tumor imaging and pathological features,treatment and prognosis.Results The mean age of the patients was 60 years.One patient underwent partial nephrectorny,1 patient underwent radical nephrectomy,and another patient received nephroureterectomy with bladder cuff excision.Patients were followed up for 8 months to 10 years,and no tumor recurrence was found.Conclusions IMT of the kidney is the tumor of low malignant potential with a good prognosis.Surgery is the first choice for the diagnosis and treatment.
8.Bilateral adrenal tumors from different tissues: 1case report and literature review
Yushi ZHANG ; Hanzhong LI ; Jianchun XIAO ; Yi ZHOU ; Zhien ZHOU ; Anli TONG
Journal of Endocrine Surgery 2012;06(3):179-181,187
Objective To improve the recognization of bilateral adrenal tumors from different tissues and to discuss the treatment.Methods One case of bilateral adrenal tumors from different tissues:pheochromocytoma in one side and adrenocortical adenoma in the other side was reported and the data of syptoms,physical features,auxillary examination,diagnosis and treatment were retrospectively reviewed.Results The patient was diagnosed as adrenocorticotropic hormone (ACTH) -independent Cushing's syndrome in other hospital and received laparoscopic adrenalectomy for right adrenal tumor.During the operation the blood pressure fluctuated seriously and was even more than 200 mm Hg.The pathological report showed the mass was pheochromocytoma.After the operation,the patient's clinical manifcstation was not changed.Half a year later the lab test showed blood ACTH was still less than 5 pg/ml,24 h urinary-free cortisol (UFC) was 571.32 μg,and 24 h urinary catecholamines (U CA) was:noradrenalin (NE) 22.80 μg,epinephrine (E) 2.55 μg,dopamine (DA) 92.92 μg.CT detected a mass in left adrenal gland.The patient received laparoscopic adrenalectomy for left adrenal tumor after being transferred to Peking Union Medical College Hospital.The tumor was proved as adrenocortical adenoma by postoperational pathology.One week after the operation,the 24 h UFC was 56.2 μg.Conclusions Bilateral adrenal tumors from different tissues are very rare in clinic.Adrenalectomy for tumors from both sides and remaining the normal adrenal glands are recommended.
9.Preparation and in vitro antioxidative activity of acetylated fucoidan extracted from Laminaria japonica
Jing WANG ; Quanbin ZHANG ; Zhongshan ZHANG ; Zhien LI
Chinese Journal of Marine Drugs 1994;0(01):-
Objective To explore the optimum method for preparation of acetylated fucoidan extracted from Laminaria japonica,and test the antioxidative activity of acetylated fucoidans prepared under different conditions in vitro.Methods Using acetic anhydride as acetylated reagent,N-Bromosuccinimide(NBS) as catalyst,the effects of reaction time,temperature and volume of acetylated reagent were tested by the orthogonal design method.The antioxidative activity of the prepared acetylated fucoidans in vitro was determined,including scavenging activity against superoxide,hydroxyl and DPPH radical and reducing power.Results Volume of acetylated reagent and reaction temperature were the significant factors(P
10.Application of microwave technique to extraction of free anthraquinones in Rheum emodi
Shouzhu HAO ; Hong ZHANG ; Li LIU ; Zhien LI ; Zuhong XU
Chinese Traditional and Herbal Drugs 1994;0(01):-
Object To apply microwave technique to the extraction of free anthraquinones from Rheum emodi Wall. and the methods of microwave extraction and traditional extraction were comparied. Methods The orthogonal test design was used to arrange sequent experiments to test the effect of the three main factors including microwave power, particle size of herb and extraction time on the extraction efficiency of free anthraquinones and to establish optimal extraction process. A parallel test was carried out using the three different methods including the optimal extraction process, the traditional decocting method and the alcohol refluxing method. Results Particle size of herb and microwave power are the significant factors with P

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