腹腔镜联合纤维胆道镜胆总管探查82例

目的 探讨腹腔镜联合纤维胆道镜胆总管探查术的方法及临床应用价值。方法 回顾分析我院应用腹腔镜联合纤维胆道镜施胆总管探查取石术82例临床资料。结果 82例手术均获成功，胆总管切开取石T管引流术64例，胆总管Ⅰ期缝合18例，平均手术时间110min，Ⅰ期缝合后胆漏1例，T管引流术后第21天拔T管出现胆漏1例，术后结石残留3例。结论 腹腔镜联合纤维胆道镜胆总管探查术治疗肝内外胆管结石是安全、可行的，治疗效果肯定，微创意义明显。     

复方对乙酰氨基酚胶囊治疗感冒发热、疼痛的疗效和安全性

目的:评价复方对乙酰氨基酚治疗由感冒引起的发热疼痛的效果及安全性。方法:随机双盲双模拟对照研究。入选139例,完成135例,其中A组(试验组n=68)服用复方对乙酰氨基酚胶囊+模拟片;B组(对照组n=67)服用对乙酰氨基酚片+模拟胶囊。2组按入组顺序服药,每日3次,疗程均为3~5d。观察2组疗效和不良反应。结果:试验组痊愈率为74 %,有效率达96 %,对照组痊愈率为69 %,有效率达91 % (P>0. 05),对发热和头痛的临床症状2组均有改善,试验组68例发热病人中有97 %病人恢复正常, 62例头痛病人有95 %的病人恢复正常;对照组65例发热病人和头痛病人分别有92 %和91 %恢复正常。试验组不良反应发生率为2 % (1 /68),对照组为3 % (2 /67) (P>0. 05)。未出现严重及预料之外的不良反应。结论:复方对乙酰氨基酚对治疗感冒具有明显的效果。2药的疗效相仿,无明显不良反应。     

人用药品注册技术要求国际协调会议关于通用技术文件的协调进展及其启示

本文旨在遵从药品注册技术要求一致化的原则下,对人用药品注册技术要求国际协调会议(ICH)所倡导执行的通用技术文件(CTD)进行比较全面的阐述和理解,详细介绍CTD在ICH6上的进展情况,就美国食品药品监督管理局对CTD的实施过程予以简介和研究,并深入探讨其对于我国药品注册规范等方面的影响和启示。     

中药三棱的化学成分及药理研究进展

近年来国内外中药三棱化学成分与药理作用研究进展的概述。三棱化学成分主要为黄酮类、皂苷类、苯丙素类、挥发油等;主要有抗血小板聚集、抗肿瘤、心血管系统活性、镇痛等药理作用。     

冷原子吸收光谱法测定常通口服液中重金属汞的含量

目的:测定中药常通口服液中重金属汞(Hg)的含量.方法:冷原子吸收光谱法.结果:重金属Hg在4～20 ng/mL浓度范围内线性关系良好(r=0.999 26),平均回收率为98.38%(n=5),RSD为2.41%.常通口服液中重金属Hg的含量符合规定.结论:冷原子吸收光谱法简单、快捷、灵敏.     

延参健胃胶囊治疗慢性萎缩性胃炎的临床研究

目的评价延参健胃胶囊治疗慢性萎缩性胃炎的临床疗效和安全性。方法采用随机、双盲双模拟与阳性对照药平行对照的方法,完成病例202例,其中试验组103例,对照组99例。观察中医证候表现及通过胃镜、胃粘膜活检了解胃粘膜腺体萎缩、肠上皮化生、不典型增生及幽门螺旋杆菌感染的变化。结果病理疗效试验组临床控制率21.36%,显效率28.16%,对照组临床控制率14.14%,显效率16.16%(P<0.05);证候疗效试验组临床痊愈率25.24%,显效率47.57%,对照组临床治愈率12.12%,显效率为36.36%(P<0.05)。临床试验过程中血、尿、便常规检查及心电图、肝、肾功能实验室检查,未见明显不良反应。结论延参健胃胶囊对慢性萎缩性胃炎,中医辨证属寒热错杂证的患者有确切的治疗作用,临床使用安全有效。     

感冒、水肿、便秘证治体会

结合多年的临床实践，总结了对感冒、水肿和便秘等中医内科疾病的独特认识，并附病案佐证。     

黑莴豆汤治疗原发性痛经60例疗效颜察

目的：观察黑莴豆汤治疗痛经的临床疗效。方法：对60例原发性虚寒型痛经患者运用黑莴豆汤随月经周期服用治疗，3个月经周期后统计疼痛情况的变化。结果：痊愈49例，显效7例，有效4例，无效0例，痊愈率为81．7％，愈显率为93．3％，总有效率为100％。结论：黑莴豆汤随月经周期服用治疗痛经有较好的临床疗效。     

Common cold and influenza symptom management: the use of pharmacokinetic considerations to predict the efficacy of a twice-daily treatment for colds and flu

SUMMARY

Objective: The objective of the two pharmacokinetic studies reported here was to compare the relative bioavailability of an ibuprofen/pseudoephedrine modified-release capsule with each of the active ingredients given alone as standard formulations.

Study design: Evaluation of two open, randomised, cross-over studies, one single dose and one multiple dose, in healthy male volunteers.

Methods: Healthy volunteers were randomised in a cross-over design to single or multiple doses of a combination of ibuprofen (600 mg) plus pseudoephedrine (90 mg) in a slow-release formulation and the individual active products alone as standard formulations; ibuprofen 400mg, pseudoephedrine 60 mg.

Results: The single-dose study demonstrated that the bioavailabilities of ibuprofen and pseudoephedrine achieved with the slow-release formulation were not significantly different from those with standard tablets of each ingredient alone. In addition, mean plasma levels of ibuprofen predictive of clinical efficacy were achieved within 0.5-1 h and lasted for 10-12 h thereafter. The time required to reach clinically effective blood levels of pseudoephedrine was longer, starting at approximately 2 h. However, the plasma levels predicted that the clinical effect would then last for at least a further 12 h. Trough levels from the multiple-dose study showed that clinically relevant analgesic and decongestant plasma levels were maintained for 24 h during twice-daily dosing. The slow-release formulation was well tolerated with only mild adverse events.

Conclusion: Blood levels would predict that the present slow-release fo rmulation of ibuprofen plus pseudoephedrine should offer reliable day and night control of cold and flu and sinus symptoms and be associated with a favourable safety profile.