银黄胶囊质量标准研究

目的:建立银黄胶囊质量标准.方法:C1s柱(Hypersil ODS Agilent,4.6×200mm,5μm),流动相:甲醇与0.1%磷酸溶液进行梯度洗脱,检测波长为318mm,流速为1ml·min-1,柱温为室温.结果:绿原酸加样回收率为99.37%;RSD为0.35%;黄芩苷加样回收率为100.17%,RSD为1.23%.结论:方法简便、准确,可用于银黄胶囊的质量控制.     

阿莫西林胶囊溶出度的测定中自身对照液的影响研究

目的:使自身对照法测定阿莫西林胶囊溶出度的方法更加合理准确.方法:自身对照采用不同稀释步骤测定溶出度进行比较.结果:稀释步骤影响溶出度的测定.结论:方法更加准确,合理.     

复合氨基酸胶囊中水溶性维生素的含量测定

目的:建立复合氨基酸胶囊中5种水溶性维生素的含量测定方法.方法:采用高效液相色谱法,用乙腈与庚烷磺酸钠-磷酸钠的水溶液(pH=3.0)为流动相,流速1.0ml·min-1,色谱柱为C18(4.6×250mm,5μm),柱温40℃,检测波长为280nm,进样量为20μl.结果:维生素Bl、维生素B2、维生素B6、维生素C和烟酰胺分别在24.7～75.2μg·ml-1、15.0～44.9μg·ml-1、12.2～37.5μg·ml-1、99.2～299.9μg·ml-1和100.3～300.9μg·ml-1范围内呈线性关系,相关系数均为1.000,平均回收率均在100%±2%范围以内.RSD分别为0.19%、0.26%、0.46%、1.17%和0.52%.结论:本方法准确,简便,快捷,可以同时测定复合氨基酸胶囊中维生素B1、维生素B2、维生素B6、维生素C和烟酰胺的含量.     

Feasibility Study of Ultrasonographic Criteria for Microscopic and Macroscopic Extra-Thyroidal Extension Based on Thyroid Capsular Continuity and Tumor Contour in Patients with Papillary Thyroid Carcinomas

Our purpose was to evaluate the feasibility of using ultrasonographic criteria of thyroid capsular continuity and tumor contour to differentiate macroscopic extra-thyroidal extension (ETE) from microscopic ETE, as well as non-ETE from ETE. On ultrasonography, we evaluated thyroid capsular continuity (C0 = continuous, C1 = discontinuous, C2 = invisible), and thyroid tumor contour (P0 = in normal parenchyma, P1 = abutting, P2 = bulging), which were grouped into type 1–9 classifications. Either C1–2 or P1–2 was more prevalent in ETE than non-ETE. C1 and P2 tended to be associated with macroscopic ETE, whereas C0 and P1 were significantly associated with microscopic ETE. Types 6, 8 and 9 were more likely to have ETE than non-ETE; type 6 (C1 P2) and type 9 (C2 P2) were significantly associated with macroscopic ETE, whereas type 8 (C2 P1) was associated more with microscopic ETE. Macroscopic and microscopic ETE, as well as non-ETE and ETE, can be differentiated using these pre-operative ultrasonographic criteria.     

A Postmarketing Clinical Experience Study of Metadate® CD

Summary

Objective:The objective of the study was to investigate the effectiveness and safety of Metadate® CD (methylphenidate HCl, USP) Extended Release Capsules in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD), in actual clinical practice.

Method:This was a multicenter, open-label, postmarketing study. Eligible patients were aged 6-17 with a diagnosis of ADHD and receiving either no treatment or maintenance treatment with another approved methylphenidate (MPH) product. Metadate® CD was administered once daily for 3 weeks, titrated against reported and observed symptoms. Clinical Global Impression (CGI) scores at Week 3 were used for the primary efficacy evaluation. Patient treatment satisfaction was determined by questionnaire at the final evaluation visit. Safety was assessed through adverse event reporting, laboratory tests and vital sign measurements.

Results: Overall, of the 308 patients in the Intent-To-Treat population, the majority (65%) demonstrated a positive response to Metadate® CD (defined as CGI Global Improvement rating of very much or much improved). In addition, patients previously treated with immediate-release or extended-release tablet formulations of MPH were successfully converted to Metadate® CD at a comparable dose. Most patients (87%) were very satisfied or moderately satisfied with study treatment, and among previously treated patients, 71% rated Metadate® CD as much better or better than their previous MPH treatment. Adverse events were consistent with current FDA-approved product labeling for Metadate® CD.

Conclusions: Metadate® CD is effective and well-tolerated in actual clinical use for ADHD.     

补中益气颗粒联合多糖铁复合物治疗妊娠期缺铁性贫血疗效和安全性分析

目的：探讨补中益气颗粒联合多糖铁复合物治疗妊娠期缺铁性贫血（IDA）的临床疗效。方法：将120例妊娠期IDA患者按照随机数字表法分为2组，每组60例。对照组给予多糖铁复合物治疗，研究组给予补中益气颗粒联合多糖铁复合物治疗，均用药4周。比较2组治疗前后红细胞（RBC）计数、血红蛋白（Hb）含量、平均红细胞血红蛋白含量（MCH）、血清铁（SI）、血清铁蛋白（SF）、铁调素和可溶性转铁蛋白受体（sTfR），以及2组治疗总有效率、不良反应和不良妊娠结局发生率。结果：治疗后研究组RBC、Hb、MCH、SI和SF均高于对照组，铁调素和sTfR低于对照组，治疗总有效率高于对照组，差异均有统计学意义（均P＜0.05）。2组不良反应发生率和不良妊娠结局发生率差异无统计学意义（P＞0.05）。结论：补中益气颗粒联合多糖铁复合物可有效改善铁代谢，治疗妊娠期IDA效果显著，安全性较好。     

阿维A联合NB-UVB治疗寻常型银屑病的疗效分析

目的：观察阿维A联合NB-UVB照射治疗寻常型银屑病的疗效及安全性。方法：60例寻常银屑病患者随机分为2组，均予NB-UVB照射，3次/周。治疗组同时口服阿维A10mg（2次/d）。2组均治疗8周后判定疗效和随访6个月。结果：治疗组有效率90．0％，对照组63．34％，差异有统计学意义（P＜0．05）。结论：阿维A联合NB-UVB照射治疗银屑病有很好的临床疗效，不良反应小，值得推广应用。     

芪苈强心胶囊联合托伐普坦治疗中度充血性心力衰竭的临床研究

目的研究芪苈强心胶囊联合托伐普坦片治疗中度充血性心力衰竭的临床效果。方法选取2017年1月—2018年1月安阳地区医院收治的中度充血性心力衰竭患者80例为研究对象,采用随机数字表法随机分为对照组和治疗组,每组各40例。对照组口服托伐普坦片,起始剂量为15mg,服药24h后,根据血清钠浓度调整剂量,最大用药剂量为60mg,当血钠浓度145 mmol/L时停用。治疗组在对照组治疗的基础上温水口服芪苈强心胶囊,4粒/次,3次/d。两组患者均连续服用7d。观察两组的临床疗效,比较两组的血清Na~+、K~+浓度、体质量、心功能和炎性因子水平。结果治疗后,对照组和治疗组的总有效率分别为75.00%、92.50%,两组比较差异有统计学意义(P0.05)。治疗后,两组Na+浓度显著提高,而体质量显著减轻,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组体质量显著低于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组每搏量(SV)、心排血量(CO)和左心室射血分数(LVEF)值均显著升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组心功能指标水平均显著高于对照组,两组比较差异有统计学意义(P0.05)。治疗后,两组血浆一氧化氮(NO)和血清肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)水平均显著降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗后治疗组各炎性因子水平显著低于对照组,两组比较差异有统计学意义(P0.05)。结论芪苈强心胶囊联合托伐普坦片治疗中度充血性心力衰竭具有较好的临床疗效,能调节机体电解质平衡,改善心功能,安全性较好,具有一定的临床推广应用价值。     

百乐眠胶囊联合艾司唑仑治疗失眠症的疗效观察

目的探讨百乐眠胶囊联合艾司唑仑治疗失眠症的临床疗效。方法选取2016-2018年到云浮市人民医院接受治疗的210例失眠症患者,根据给药不同将所有患者分为3组,每组患者70例。百乐眠组口服百乐眠胶囊,4粒/次,2次/d;艾司唑仑组晚上入睡前30 min口服艾司唑仑片,1片/次,1次/d;联合组口服百乐眠胶囊联合艾司唑仑片,相关药物服用方法同以上两组。三组患者均连续治疗2周。观察三组的临床疗效,比较三组患者匹兹堡睡眠质量指数(PSQI)和不良反应发生情况。结果治疗后,百乐眠组、艾司唑仑组、联合组总有效率分别是74.28%、82.86%、97.14%,联合组总有效率显著高于百乐眠组、艾司唑仑组,差异有统计学意义(P<0.05)。治疗后,3组患者PSQI评分均有所降低(P<0.05);但治疗后,联合组患者PSQI各评分均显著低于百乐眠组、艾司唑仑组(P<0.05)。百乐眠组、艾司唑仑组、联合组不良反应发生率分别是8.57%、22.86%、10.00%,艾司唑仑组失眠症患者不良反应发生率明显高于百乐眠组、联合组(P<0.05)。结论百乐眠胶囊联合艾司唑仑治疗失眠症具有较好的临床疗效,可显著降低PSQI评分,改善患者睡眠质量,具有一定的临床推广应用价值。     

HPLC法同时测定磺啶新林胶囊中4个成分的含量

目的:建立同时测定磺啶新林胶囊中盐酸溴己新、盐酸氯丙那林、磺胺甲噁唑和甲氧苄啶含量的方法。方法:采用高效液相色谱法,Ecosil-C₁₈色谱柱（4.6 mm×250 mm,5μm）,以乙腈-0.001 5 mol·L^-1十二烷基硫酸钠的0.1%三乙胺溶液（用磷酸调pH值至3.0）（52:48）为流动相,流量1.0 mL·min^-1,检测波长为215 nm。结果:4个成分的峰面积与浓度的线性关系良好（r>0.999 9）;加样回收率为98.85%⁹9.58%。结论:该方法可用于磺啶新林胶囊中盐酸溴已新、盐酸氯丙那林、磺胺甲噁唑和甲氧苄啶4个成分的含量测定。