Objective To systematically evaluate whether taking calcium channel blockers(CCB)increases the risk of fractures. Methods Data were collected from Cochrane, PubMed, EMbase (OVID), CBM, VIP, CNKI and Wanfang databases.The Meta analysis was performed using RevMan5.2 software after evaluating the data quality. Results A total of 499 454 cases were included from 2 casecontrol studies and 2 cohort studies.Meta analysis showed no significant risk of fracture in patients taking CCB (OR＝1.23, 95% CI, 0.84-1.81, P＝0.29).Subgroup analysis showed that longterm treatment with CCB significantly decreased the risk of fractures (OR＝0.94, 95% CI, 0.92-0.96, P＝0.00), even though a trend of increased fracture risk existed in patients exposed to shortterm treatment (OR＝1.30, 95% CI, 0.83-2.03, P＝0.25). Conclusion Current evidence show that CCB administration does not increase the risk of fractures.The higher risk of fractures from short term use of CCB may result from the higher risk of falls,which remind us to improve the quality of nursing and strengthen selfawareness during the initial use of CCB.Restricted to the quantity and quality of literatures included, the Conclusion s are to be verified by more highquality studies.

Objective To study clinical application and safety of quetiapine fumarate in treating Alzheimer’s disease (AD). Methods A total of 74 patients with AD were randomly divided into treatment group(n=48)and control group(n=26).Patients in the control group were given 5 mg·d^-1 of donepezil chloride,patients in the treatment group were given 5 mg·d^-1 of donepezil chloride and 12.5 mg·d^-1 of quetiapine fumarate.Before and 1,2,4,8 and 12 weeks after the treatment,the patients were evaluated by mini-mental state examination(MMSE),the brief psychiatric rating scale(BPRS),neuropsychiatric inventory(NPI),NPI distress factor and activity of daily life(ADL). Results After 1 week of treatment,total NPI score of treatment group and control group was(72.830±10.45) and(78.057±10.97),respectively;NPI distress factor was(30.532±5.82) and(34.208±6.50),respectively(all P<0.05).After 4 weeks of treatment,BPRS scores of treatment group and control group was(30.277±6.43) and(35.01±7.38),respectively(P<0.05).After 8 weeks of treatment,NPI distress factor of treatment group and control group was(23.021±5.74) and(28.618±6.08)(P<0.05).After 12 weeks,MMSE score of treatment group and control group was(7.83±3.02) and(7.116±2.67),which was increased compared with that before treatment(all P>0.05). Conclusion Short-term use of quetiapine fumarate can reduce anguish of AD tender,and relieve psychological and behavioral symptoms of AD patients,and may have positive effects on cognitive function.

由美国辉瑞制药有限公司研制的劳拉替尼(lorlatinib)是第三代非小细胞肺癌(NSCLC)治疗新药,具有间变性淋巴瘤激酶(ALK)和c-ros原癌基因1(ROS1)双重受体酪氨酸激酶(RTK)抑制作用,用于治疗既往接受过至少一种ALK抑制药治疗,但病情进展的ALK阳性和(或)ROS1阳性转移性NSCLC患者。美国食品药品管理局(FDA)于2015年10月授予lorlatinib罕用药(orphan drug)认定,2017年4月27日获得FDA突破性治疗药资格和优先审评的待遇,并于2018年11月2日加速批准上市,制剂商品名为Lorbrena ^®;日本医药品医疗器械综合机构(PMDA)于2018年9月21日批准该药上市,片剂商品名为ロルラチニブ^®;欧洲药品管理局(EMA)人用药品委员会(CHMP)2019年2月底财政年度会议纪要中,对lorlatinib的安全性和有效性持正面意见,建议EMA批准上市,制剂商品名将命名为Lorviqua^®。该文对lorlatinib非临床和临床药理毒理学、临床研究、不良反应、适应证、剂量与用法、用药注意事项及知识产权状态和国内外研究进展等进行介绍。

摘要目的分析双氯芬酸钠所致不良反应，为临床安全、合理用药提供参考。 方法检索《中国医院数字图书馆》中有关双氯芬酸钠引起不良反应的文献资料（1994～2011年），按年龄、性别、剂量、合用药物、给药方法、药品不良反应发生时间分布、临床表现症状、治疗与转归进行统计分析。 结果双氯芬酸钠引起的不良反应与性别关系不大，年龄分布以41～60岁为主。所致的不良反应类型以泌尿系统损害（26.1%）和消化系统损害（23.9%）为主；前3位的表现形式为急性肾衰竭、血尿、消化道出血；发生时间以第1天发生不良反应为主，占58.7%。 结论要严密观察患者使用双氯芬酸钠时的异常反应，发现问题及时停药、及时处理，警惕严重不良反应（急性肾衰竭、血尿、过敏性休克）的发生，确保患者的用药安全。

Objective To study the preparation process of compound Xiecao shuxin dropping pills. Methods Dropping pills were prepared by dropping method.The effects of PEG4000/6000 matrix, drug-matrix ratio, dropping acceleration and liquid temperature on the preparation of the dropping pills were studied.Orthogonal test was conducted with the total scores of appearance, weight difference, and dissolution time as the factors to optimize the best preparation process of compound Xiecao shuxin dropping pills. Results The optimal preparation process of compound Xiecao shuxin dropping pill was as follows: PEG4000/6000 (1:1) was as the matrix, and the ratio of drug to matrix was 1:3.The temperature of the feeding liquid was 90 ℃, and the dropping acceleration was 35 drops per minute, and the temperature range of condensate liquid paraffin was from 5 to 15 ℃. Conclusion The optimized preparation technology is stable and feasible, which can provide necessary reference for the preparation of compound Xiecao shuxin dropping pills.

ObjectiveTo provide evidence for clinical trial and to evaluate the safety of total flavonoids from rhizome of drynariae MethodsThe maximum tolerance of gastrogavage in mice: twenty mice were fed 30 mL·kg^-1 with the total flavonoids solution (0.40 g·mL^-1 ) by gastrogavage， the bite and sup， activity， psychosis， coat and skin， urine and faeces， and body weight were observed The maximum tolerance of gastrogavage in rats: twenty rats were given the same dose total flavonoids solution， and the same observation were done The acute toxicity trial in mice, LD50 was carried out by abdominal injection with 7 dosage groups， and the mice were observed for 7 days after one injection ResultsThe mice and rats had no abnormal changes in bite and sup， activity， psychosis， coat and skin， urine and faeces， and body weight There were no significant changes(P＞0.05) Only a little remain of the fed sample was found in the abdomen anatomizing And there were no remarkable pathological changes in all organs The median lethal dose of the total flavonoids was 5.99 g·kg^-1 ConclusionThere are no abnormal changes in the acute toxicity trial with total flavonoids from rhizome of drynariae, and the flavonoids are safe in clinical use

With the gradual promotion of drug selection and evaluation in some provinces and cities in China,it is urgent for medical institutions to establish a complete and quantifiable drug selection and evaluation system. Based on the development of pharmacy and the adjustment of national drug policies in recent years,this guideline has revised and refined the evaluation indicators of drug evaluation and selection in medical institutions on the basis of the first version,so that the quantitative scoring can better reflect the priority of drugs in medical institutions,and also more fulfill the requirements of the national policy. Moreover,the scoring items are more detailed,clear and easy to use. In this guideline,five dimensions of pharmaceutical properties (28 points),effectiveness (27 points),safety (25 points),economy (10 points) and others (10 points) were quantified and scored,so as to objectively conduct selection and evaluation of drugs in medical institutions.

To assess the therapeutic effectiveness and safety rate of gatifloxacin hydrochloride in the treatment of infections of the respiratory or urinary system. Methods225 patients with infections of the respiratory or urinary system were randomly divided into 2 groups: the trial group (n＝114) and control group (n＝111). Patients of the trial group were given each 0.4 g of gatifloxacin hydrochloride tablets PO,q.d. while those of the control group were given each 0.2 g of levofloxacin, PO, b.i.d.. The course of treatment in both groups lasted 7－14 days. The therapeutic effectiveness and adverse reactions of the drugs were kept under observation. ResultsIn patients of the trial group and control group, the clinical effective rates were 88.60% and 92.79%, the bacteria elimination rates were 94.32% and 96.63% and the incidences of adverse reactions were 9.32% and 11.97%, respectively. Differences between the 2 groups with respect to the above mentioned data were insignificant (P＞0.05). ConclusionGatifloxcin hydrochloride was shown to be effective and safe in the treatment of infections of the respiratory or urinary system.

To determine whether mirtazapinne is clinically effective on the treatment of chronic insomnia and to compare the clinical effects between mirtazapine and alpazolam on chronic insomnia. MethodsSeventynine patients were randomly divided into two groups (38 and 41 for each), which received the treatments of mirtazapine and alprazolam respectively for 12 weeks as a course. The patients in mirtazapine group took 10－15 mg 0.5 hour before sleeping, while the patients in alpazolam group took 0.4－0.8 mg 0.5 hour before sleeping. The curative effects were evaluated with Pittsburgh Sleep Quality Index (PSQI) and sleeping dairy before and after the 4th, 8th, and 12th weeks of treatment. ResultsThe effective rate and significantly effective rate of mirtazapine on chronic insomnia were 96.9% and 90.6%, respectively, whereas those of alprazolam, 78.8% and 51.5% respectively. Mirtazapine played significantly better role in the treatment of chronic insomnia than alprazolam did(P＜0.05). The side effects of mirtazapine included sleepy, dizzy and getting weight, all of which were acceptable. ConclusionMirtazapine is surely effective on clinical treatment of chronic insomnia with mild side effects . For using mirtazapine, starting with the small dosage is suggested.

目的 建立测定参附注射液中人参皂苷Rg1、Re和Rb1含量的高效液相色谱法。方法 采用反相高效液相色谱法进行梯度洗脱，固定相： Lichrospher C18色谱柱；流动相A：水；流动相B：乙腈；流速：1.2 mL·min1；检测波长：203 nm；柱温：35℃。结果 人参皂苷Rg1、Re和Rb1分别在4～400，4～400和8～800 μg·mL1 范围内峰面积与浓度呈良好的线性关系。平均加样回收率分别为101.92%～106.79%(人参皂苷Rg1)，94.78%～100.65%(人参皂苷Re)，和 103.04%～106.62%(人参皂苷Rb1)。结论该方法简便、快速、准确，可同时测定参附注射液中人参皂苷Rg1、Re、Rb1的含量。

ObjectiveTo evaluate the efficacy and safety of lianhuaqingwen capsule for treating acute upper respiratory tract infection. MethodsThe clinical randomizedcontrolledtrails were conducted. VitC yinqiao tablets was used as control. A total of 206 subjects with acute upper respiratory tract infection were enrolled in our study, in which 102 patients randomly assigned in the treatment group were orally given lianhuaqingwen capsule (4 capsules, tid) for 3 d, and the other 104 patients were orally administered with VitC yinqiao tablets (2 pills,tid) for 3 d. ResultsThe clinical efficacy rates were 91.2% and 73.1% in lianhuaqingwen capsule group, and VitC yinqiao tablets group, respectively. Compared with control group, lianhuaqingwen capsule was more effective for improving main symptoms including fever, chill, headache and myalgia, with the therapeutic rates for whjch were 90.2%,85.4%,89.5%,91.0%, respectively. No significant difference on incidence of side effects in both groups was found (P＞0.05). ConclusionThe results suggest that lianhuaqingwen capsule is an effective and safe agent for treating acute upper respiratory tract infection, and is superior to VitC yinqiao tablets.

ObjectiveTo analyze the contents of amino acids in Dendrobium crystallinum Tchb. F. by using precolumn derivatization method. MethodsThe amino acids in Dendrobium devonianum were pretreated with 2，4dinitrofluorobenzene and their derivatives were analyzed on Waters 600 HPLC using Symmetry C18 column. Gradient eluent consisted of sodium acetate solution (pH=6.4) with 1% N，Ndimethylformamide， acetonitrile and water (1：1) was taken. The detection wavelength was 360 nm and column temperature was 35 ℃ and loading volume was 20 μL. ResultsThe calibration curves for amino acids showed good linearity(r=0. 999 5－1.000 0，n=5). The mean recoveries of amino acids were 99.34%－101.93% with RSD as 0.54%－1.91%(n=6). And the average content of amino acids was 3.79%. ConclusionThe method is quick，simple with minimum loss of amino acids, which provides a theoretical basis for the Dendrobium crystallinum development.

ObjectiveTo study the effect of ceftazidine on aminophylline pharmacokinetics in rats. MethodTwelve rats fasting for 12 h were randomized into two equal groups. The control group were given 18 mg.kg^-1 of aminophylline intragastrically, and the test group were given 18 mg·kg^-1 of aminophylline intragastrically and 100 mg·kg^-1 of ceftazidine, i.m.. The concentration of theophylline in rat serum was detected at 0, 0.08, 0.50, 1.00, 2.00, 4.00, 6.00, 8.00, 12.00 hours by FPLA.ResultsTheophylline was eliminated by one compartment model. The pharmacokinetics parameters had no significant difference between the two groups.ConclusionCeftazidine has no effect in the metabolism of aminophylline.

L-carnitine is a carrier that assist in transport of long-chain fatty acids into mitochondria and an effective drug for treating primary carnitine deficiency (PCD).Starting supplementation as early as possible before irreversible organ damage occured can alleviate organ damage,reduce the risk of sudden death,and improve the quality of life.However,in recent years,some studies have suggested that long-term oral L-carnitine has potential risks,the metabolism of L-carnitine through intestinal flora results in the production of trimethylamine oxide (TMAO),which can increase the risk of cardiovascular disease (CVD).Therefore,this paper summarizes the clinical research progress of L-carnitine in treating PCD to provide a theoretical basis for the clinical application of L-carnitine in PCD.

恩格列净(empagliflozin)由美国礼来公司和德国勃林格殷格翰公司合作研发,是钠葡萄糖共转运蛋白2(SGLT2)抑制药,用于改善2型糖尿病成年患者的血糖控制,对二甲双胍耐受性差、靠调节饮食与锻炼不能有效控制血糖的成年患者,可单药治疗或与其他降血糖药物联合用药. 该文对恩格列净的非临床和临床药理毒理学、临床研究、适应证、剂量与用法、用药注意事项、不良反应及知识产权状态和国内外研究进展等进行介绍.

［摘要］综述治疗泌尿系统结石（石淋）的10种基本中成药，介绍祖国医学对石淋的认识和研究，并归纳和总结现代医学对中药治疗泌尿系统结石的化学、药理和临床疗效研究。由经验方制成的中成药因具有疗效确切、价格低廉及使用方便的特点，具有良好的临床应用前景。但部分单味中药治疗结石的有效成分和药理至今尚不明确，少数中成药的临床研究报道较少，需加强国家基本药物的研究和应用。

Nanocarriers of skin functional ingredients have wide applicable prospects in transdermal drug delivery and cosmetics,with good effects of diseases treatment and skin care.This article introduces the characteristics of nanocarriers for skin functional ingredients and reviews the research progress on the nanocarriers for skin diseases treatment,barrier repairing,melanin inhibition,antioxidation,and anti-acne etc.

The “Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions” was developed by standards-based process from WHO.The guideline was referenced to the WHO Essential Medicines List,WHO Medicines and Health Products Programme Strategic Framework (2016—2030),and the relevant policy and system documents of developed countries and regions,including the United States, Europe, Japan and so on.Experts reached consensus on the scoring system for drug evaluation and selection were reached through the Delphi method in this guideline.In the end, to develop this guideline, we also took the actual conditions of Chinese medical institutions into account.

Objective Response surface methodology (RSM) was applied to optimize the ultrasonic extraction conditions for flavonoids from Coreopsis tinctoria Nutt. Methods The influence factors of ultrasonic extraction were evaluated using the Box-Behnken central component experiments and analyzed by RSM. Results The optimum extraction conditions were confirmed as follows:extraction time 30.0 min, ratio of liquid to solid 21:1, concentration of ethanol 60%.The yield of flavonoids under this condition was (4.65±0.036)% (n=3). Conclusion The flavonoids could be extracted with stability and higher yield from Coreopsis tinctoria Nutt under optimized conditions.

Objective To explore the relationship between intrapulmonary concentration and blood concentration of polymyxin in patients with ventilator-associated pneumonia. Methods The pharmacological effects of polymyxins were reviewed.Detection and calculation methods for the polymyxin concentration in lung tissue were introduced.The intrapulmonary concentration,blood concentration and lung tissue penetration of polymyxins in patients with ventilator-associated pneumonia were summarized.The relationship between intrapulmonary concentration and blood concentration was analyzed. Results When polymyxin was administered intravenously,the concentration was significantly lower in epithelial lining fluid than in the blood,or even below the detection limit; however,when polymyxin was administered by inhalation,the drug concentration in the lung was increased significantly,and the drug concentration in epithelial lining fluid could reach 100 to 1000 times over blood concentration.The greater the dose of intravenous infusion or aerosol inhalation was administered,the higher the concentration of polymyxins in the blood and lung tissue. Conclusion In the treatment of ventilator-associated pneumonia,more attention should be paid to the intrapulmonary concentration of polymyxins in patients,and adjustment of the administration route can help make the clinical use of polymyxins more effective.

分析镇痛药的市场现状,展望可能出现的市场销售热点,指出镇痛药中非处方药、国产普药、中药、老药新用及新药将在未来销售市场上占据有利形势,并介绍了镇痛药最新研究进展.

ObjectiveTo observe the therapeutic effects of puerarin injection combined with radix astragli injection on urine microprotein in patients with type 2 diabetic nephropathyMethodsSeventyeight patients with type 2 diabetic nephropathy randomised into the treatment group (41 cases) and the control group (37 cases). The control group were treated with radix astragli injection 30 mL·d^-1， iv， gtt， qd， and the treatment group received the same medicine combined with puerarin injection 500 mg·d^-1 iv， gtt， qd. Both groups were treated for 2 weeks. The parameters of blood plasma such as TC， TG， PAGT， FIB and UAER were tested before and after the treatment.Results In the treatment group， the average values of the tested parameters were decreased significantly after the treatment than before the treatment (P＜0.05 or P＜0.01) Except TC and LDL-C， the average values of the tested parameters were also lowered significantly in the treatment group than in the control group (P ＜0.05 or P ＜0.01). ConclusionPuerarin injection can lower the blood lipids， improve blood viscosity， and decrease urine protein. The combination of puerarin injection with radix astragli injection has better effect than radix astragli injection alone in the treatment of type 2 diabetic nephropathy.

Bupivacaine is a long-acting local anesthetic widely used clinically,but its 6-8 hours duration is insufficient for postoperative analgesia.Designing drug dosage forms to prolong the action time of local anesthetics is the research content of local anesthetics.In 2011,the FDA approved a bupivacaine liposome preparation based on DepoFoam TM technology:Exparel,which can be used for more than 72 hours.This article reviewed the clinical safety research of Exparel and the research progress of its application in clinical postoperative analgesia.

目的探讨高龄血流耐甲氧西林金黄色葡萄球菌(MRSA)感染伴肾损伤患者的抗感染治疗方案。方法在1例高龄血流MRSA感染伴肾损伤患者的治疗过程中,临床药师协助医生选择适宜的药物并调整剂量,优化抗感染治疗方案,并对患者进行药学监护。结果在临床药师参与下,患者感染被控制,抗感染指标好转,转入普通病房继续治疗。结论临床药师利用专业优势参与患者药物治疗,可保证患者用药安全,促进临床合理用药。

Through literature review,questionnaire surveys,medical case analysis and other methods,Chinese Hospital Association Pharmaceutical Specialized Committee conducted research on the current status and development direction of pharmacy administration and pharmacy practice in healthcare institutions,summarized systematically the key issues in the fields of pharmacy practice,pharmaceutical supply services and pharmacy administration in healthcare institutions,studied relevant domestic and foreign literature in recent years,referenced existing domestic laws,regulations and rules,as well as domestic and foreign standards,and ultimately established a group standard system framework.The group standard system was named “Pharmacy administration and Pharmacy practice in Healthcare institutions”,and included 51 volumes in four parts,which were general principles,pharmacy practice,pharmaceutical supply services and pharmacy administration.

ObjectiveTo detect the effect of astragalus for injection together with glucocorticoid on serum levels of IL-10 in children with idiopathic nephrotic syndrome(INS), to analyse their role in INS and the mechanism of astragalus' treatment for INS. MethodsSixtythree children with idiopathic nephrotic syndrome were divided into astragalus group including thirtythree cases and nonastragalus group including thirty cases. In astragalus group, patients were given prednisone 1.5－2.0 mg·kg^-1·d^-1，P.O., qd, astragalus for injection 0.5 mL·kg^-1·d^-1, and other symptomatic treatments. In nonastragalus group except astragalus for injection, other treatments were the same as the first group. The serum IL10 levels in all patients between initial stage and one month after therapy were detected. Other 25 healthy children were collected in control group. Serum IL10 levels were detected by a double antibody "sandwich" ELISA. ResultsIn initial stage, there was no significant difference in serum IL10 level between nonastragalus group and astragalus group (14.05±5.57) pg·mL^-1 vs (13.39±6.14) pg·mL^-1(t＝0.61，P＞0.05), and both were higher than control group ［(14.05±5.57) pg·mL^-1 vs (9.48±4.01) pg·mL^-1, t＝3.36, P＜0.01, and (13.39±6.14) pg·mL^-1 vs (9.48±4.01) pg·mL^-1, t＝2.77, P＜0.01］. Serum IL-10 levels in nonastragalus group after prednisone therapy were significantly lower than those before prednisone therapy (9.36±3.43) pg·mL^-1 vs (14.05±5.57) pg·mL^-1, t＝3.55, P＜0.01, and no significant difference was observed as compared with control group. Compared with those before treatment, Serum IL-10 levels in astragalus group were not significant different in initial stage and one month after prednisone together with astragalus therapy(t＝0.95，P＞0.05. Serum IL10 levels of astragalus group in one month after prednisone together with astragalus therapy were still significantly higher than those in control group(12.10±4.14) pg·mL^-1 vs (9.48±4.01) pg·mL^-1, t＝2.25,P＜0.05 and nonastragalus group in one month after prednisone therapy(12.10±4.14) pg·mL^-1 vs (9.36±3.43)pg·mL^-1, t＝2.40,P＜0.05).ConclusionAstragalus for injection can prevent the lowering of serum IL-10 levels in children with idiopathic nephrotic syndrome and counteract the inhibitory effect of hormone on the production of IL-10. This may be one of the mechanism of astragalus for injection to lower the urine protein content in children with INS.

In recent years, nano-silica has been widely used in the field of biomedicine due to its high specific surface area, high biocompatibility, and targeting properties. This review focuses on the preparation methods of mesoporous silica nano (MSN) materials, the research progress of MSNs in the diagnosis and treatment of various diseases, and the drug isolationand delivery, aiming at providing are ference for the further application of mesoporous nano-silica in the field of medicine.

ObjectiveTo investigate the clinical effect and safety of using yuxingcao nasal drops to treat acute and chronic rhinitis. MethodsTotally, 376 patients who suffer from acute or chronic rhinitis were recruited, including 142 patients with acute rhinitis, 138 patients with chronicsimple rhinitisand 96 patients with chronic hypertrophic rhinitis, scoring method was employed to invest the difference before and after the treatment. ResultsAfter using yuxingcao nasal drops, the patients’signs and symptoms general score was decreased, while the signs and symptoms general score of acute rhinitis and chronic simple rhinitis showed extremely significant difference before and after the treatment (P＜0.01), the decrease rate was 82.3% and 80.7% respectively, effective rate was 100%. The signs and symptoms general score of chronic hypertrophic rhinitis showed significant difference before and after the treatment ( P＜0.05 ), the decrease rate was 76.8%, effective rate was 100%. No side effect was observed during the treatment.ConclusionThe yuxingcao nasal drops was effective and safety to treat patients with acute and chronic rhinitis, no allergic reaction or bad event was occurred, it worth to be recommendin clinical treatment.