药事管理学科科研问题及对策浅析

分析当前我国药事管理学科科研中存在的问题和原因。提出发展科研的思路与方法。     

对现代病证结合论治方法的整理与研究

半目前病证结合论治方法整理归纳为：西医诊病，中医治证；中医疾病的病证结合论治；用中医理论辨西医疾病之基本病机论治；西医疾病分期论治；专病专方治疗；专病专药治疗；中西医药联合治疗。并对每种形式的特点进行了分析研究。     

436例小儿肺炎的中西医结合治疗

对436例肺炎患儿在抗生素治疗的同时，给予清热宣肺，化痰平喘，健脾益气，养阴清肺中药口服，结果总有效率达97．25％。中西医结合治疗小儿肺炎可以缩短病程，减少抗生素的使用。     

胰岛素鼻腔给药微球剂的制备及药效学研究

目的 :制备胰岛素鼻腔给药微球剂并进行药效学研究。方法 :以可溶性淀粉为原料 ,利用聚乙二醇法制备淀粉微球 ,吸附胰岛素 ,制得含胰岛素的淀粉微球。根据Baldwin法进行药效学研究。结果 :制得的胰岛素微球鼻腔给药后可使血液中血糖浓度下降35 2%。结论 :胰岛素微球经鼻腔给药可明显降低血糖水平 ,药物作用呈现缓释特征。     

口服或阴道用米索前列醇用于人工流产术前宫口扩张的比较

目的 :比较在人工流产术前阴道或口服用米索前列醇后宫口扩张的临床效果。方法 :将 16 1例行人工流产术的早孕妇女分成 3组。第 1组 5 3例和第 2组 5 7例于术前 1h分别经阴道用米索前列醇和口服米索前列醇各 4 0 0 μg ,第 3组为对照组5 1例 ,术前不用任何药物。结果 :第 1组和第 2组宫口扩张有效率分别是 92 % (49/ 5 3)和 89% (5 1/5 7) ,明显高于对照组 0 (0 / 5 1,P <0 .0 1) ;前 2组术中无需使用局部麻醉 (0 / 5 3和 0 / 5 7) ,而对照组则有 74 % (38/ 5 1)的病人需加用局部麻醉 (P <0 .0 1) ;前 2组术中出血量为 (7±s 4 )mL和 (7± 3)mL ,也少于对照组 (12± 4 )mL ,差异有非常显著意义 (P <0 .0 1)。阴道用米索前列醇组与口服米索前列醇组相比 ,术中扩宫口作用差异无显著意义 (P >0 .0 5 ) ,但口服用药组不良反应多于阴道用药组。结论 :阴道用米索前列醇组、口服米索前列醇组术中扩宫口作用肯定 ,出血量小、不良反应轻 ,两者疗效相似     

In vivo efficacy of a novel double liposome as an oral dosage form of salmon calcitonin

A simple method for the preparation of the inner liposomes for double liposomes (DL) was developed. The encapsulation efficiency of erythrosine in liposomes prepared by this new method is superior to that of the previous method because of the concentration of the drug in the lipid membrane. To evaluate the usefulness of DL prepared by the glass‐filter method modified in this study as an oral dosage form of salmon calcitonin (SCT), a suspension of liposomes containing SCT was administered to rats at a dose of 10 μg SCT/kg. Each type of DL showed better efficacy than its inner liposomes alone. The decrease in plasma calcium level was dependent on the electrical charge and particle size of the inner liposomes. The hypocalcemic efficacy of DL encapsulating SCT‐loading cationic liposomes relative to that after subcutaneous administration of SCT at a dose of 1 μg/kg was 6.47%, which was the largest value obtained. These results indicated that not only the particle size but also the electrical charge of inner liposomes affect intestinal absorption. This study verified that the efficacy was increased because of the decrease in diameter of the inner liposomes and the use of lipid with a positive charge. These findings concluded that DL might be useful as an oral dosage form of SCT. Drug Dev. Res. 58:253–257, 2003. © 2003 Wiley‐Liss, Inc.     

5-FU超声雾化吸入联合放化疗治疗非小细胞肺癌的临床研究

探讨 5 FU超声雾化吸入联合放疗及全身化疗治疗非小细胞肺癌 (NSCLC)的疗效 ,探讨一种新的非手术综合治疗方案。60例非小细胞肺癌患者随机分为两个组。研究组采用 5 FU超声雾化吸入联合常规放疗及以顺铂为主的全身化疗 2个周期 ,对照组采用常规放疗及全身化疗。结果示研究组和对照组的总有效率分别为 86 67%(2 6/3 0 )和 63 3 3 % (19/3 0 ) ,χ2 =4 3 5 6,P <0 0 5。 1、2、3年生存率研究组为 79 89%、5 6 2 6%和 3 0 3 9% ;对照组分别为 5 1 5 7%、3 4 81%和 11 60 % ,χ2 =4 42 1,P <0 0 5。两组的毒副反应差别无统计学意义 ,P >0 0 5。 5 FU超声雾化吸入联合放疗和以顺铂为主的全身化疗提高了NSCLC的 1、2、3年生存率 ,毒副反应可耐受 ,是一种有效的非手术综合治疗方案。     

乐沙定为基础的化疗方案治疗晚期胃癌临床研究

评价乐沙定与氟尿嘧啶、四氢叶酸钙联合治疗晚期胃癌的疗效和耐受性。 1999年 5月～ 2 0 0 2年 3月住院的晚期胃癌患者 2 0例 ,进行乐沙定 5 FU 四氢叶酸钙联合用药 ,对其临床资料进行统计分析。全组CR为 2例 ,PR为 7例 ,SD为 8例 ,PD为 3例 ,有效率 45 0 % ( 9/2 0 )。主要的副反应为恶心、呕吐、骨髓抑制和神经感觉障碍 ,大多数为Ⅰ～Ⅱ度。中位缓解期 5 1个月 ,平均生存期 8 9个月。乐沙定联合氟尿嘧啶、四氢叶酸钙是治疗晚期胃癌的一种有效安全的化疗方案     

Intra-arterial administration of carboplatin and the blood brain barrier permeabilizing agent,RMP-7: A toxicologic evaluation in swine

RMP-7 is a bradykinin B2 receptor agonist shown to permeabilize the blood-brain barrier, especially that associated with brain tumors, when administered via both intracarotid and intravenous routes. Both routes of administration are currently being tested in human trials in combination with the chemotherapeutic agent carboplatin as therapy for gliomas. As an essential prerequisite to the initial intracarotid clinical trials, the potential neurotoxicity of intra-arterial administration of RMP-7 (at a high or low dose), alone and in combination with carboplatin, was assessed in anesthetized Red Duroc swine. Five treatment groups were evaluated with each pig receiving a series of alternating, intra-arterial infusions of RMP-7 (or saline) followed by carboplatin (or saline), as follows: (1) vehicle control: saline/saline; (2) carboplatin only control: saline/carboplatin (50 mg total); (3) RMP-7 only control: RMP-7 (750 ng/kg)/saline; (4) low dose combination: RMP-7 (75 ng/kg)/carboplatin (50 mg total); and (5) high dose combination: RMP-7 (750 ng/kg)/carboplatin (50 mg total). For each subject, one of the alternating dosing sequences (above) was repeated four times during a single dosing session which lasted approximately 40 minutes. Assessments during the in-life phase of the study in the pre- and post-treatment periods consisted of heart rate, arterial blood pressure (systolic, diastolic, and mean), blood gases, body weight, general clinical observations (including evaluation for neurological deficit) and clinical pathology (including a comprehensive battery of standard blood coagulation, hematological and serum chemistry tests). In addition, during the time of treatment, heart rate and arterial blood pressure were monitored. The animals were terminated two weeks after dosing and the brain and rete mirabile (distal to site of infusion) were evaluated for gross and histopathological abnormalities. The histopathology analysis included a reader-blinded analysis using low and high power light microscopic examination of both H&E and Kluver-Berrera stained sections through several key cortical and subcortical brain regions. Transient decreases in arterial blood pressure (mean of 10–25 mmHg) were observed in both groups receiving the high dose of RMP-7 (i.e., 750 ng/kg). No other side effects attributable to RMP-7 and/or carboplatin were observed, and clinical observations revealed no evidence of neurologic deficits. Post-mortem examination revealed no evidence of CNS or cerebral vascular pathology attributable to carboplatin and RMP-7. This study demonstrates that intracarotid administration of the maximum tolerated dose of RMP-7 (750 ng/kg) alone, or in combination with carboplatin (50 mg) is not accompanied by any serious adverse effect, apparent cerebrovascular abnormality or neuropathologic consequence and offers further evidence for the safety of this novel therapeutic approach for enhancing delivery of chemotherapeutics to brain tumors.     

双途径化疗治疗晚期肺癌并胸腔积液33例报道

目的观察双途径化疗对晚期非小细胞肺癌合并胸腔积液的疗效.方法采用胸腔穿刺、CVP管植入灌注顺铂＋地塞米松与长春瑞宾（NVB）＋顺铂（DDP）联合静脉化疗相结合的方法治疗33例肺癌.结果治疗胸腔积液的有效率为93.94%,肺部病灶治疗有效率为48.48%.结论双途径给药为临床上值得推广的方法.