Clinical study of astromicin administered by intravenous drip infusion against chronic complicated urinary tract infections

Astromicin (ASTM) was administered by intravenous drip infusion (i.v.d.) to 22 patients with chronic complicated urinary tract infections and the clinical efficacy and safety of this drug were evaluated. The overall clinical efficacy rate obtained was 71.4% (excellent 6; moderate 9) of 21 evaluable cases by the UTI committee's criteria. Concerning the response on clinical isolates, the drug was highly effective especially against strains of Escherichia coli, indole positive Proteus and Serratia marcescens. It was not effective, however, against 2 strains of Pseudomonas aeruginosa. As for adverse reactions, there was one case which complained of headache on the 3rd day after starting treatment. In this case the drug administration was discontinued at the 5th day. The symptom disappeared within 24 hours without any treatment. No any other adverse reactions were noted. With regard to clinical test values for peripheral blood, liver and renal functions, no abnormality was observed in any of the cases treated with the drug. In conclusion, ASTM was found to be a highly effective and safe drug when administered by intravenous drip infusion in the treatment of chronic complicated urinary tract infections.     

Clinical safety of flurbiprofen

Data from 58 premarketing studies of the nonsteroidal antiinflammatory drug flurbiprofen were pooled for analyses of adverse drug reactions (ADRs). These studies included 5602 patients treated with flurbiprofen (N = 4123), aspirin (N = 1033), or placebo (N = 446) for varying durations. Diagnoses included rheumatoid arthritis, osteoarthritis, and other painful musculoskeletal conditions. In these studies serious upper gastrointestinal ADRs occurred in flurbiprofen-treated patients at less than one half the rate seen in aspirin-treated patients. The incidence of serious urinary tract ADRs was lower with flurbiprofen than with aspirin. The flurbiprofen group had no serious clinical ADRs related to the hemic/lymphatic system. The most common laboratory abnormality was a decrease in hematocrit, which occurred less often than in the aspirin group. We also evaluated serious flurbiprofen-related ADRs in 4370 patients in a variety of other studies and reviewed published reports of flurbiprofen clinical trials and case reports. These reviews showed no additional, unanticipated patterns of intolerance. These clinical safety data indicate that in the doses studied, flurbiprofen is a well tolerated agent for patients requiring nonsteroidal antiinflammatory drug therapy.     

Results of a post-marketing surveillance of meropenem for children

The post-marketing surveillance of meropenem for children was conducted between May 2004 and September 2006. The safety and the efficacy were analyzed in 1210 cases and 1004 cases, respectively. The results of this surveillance were as follows: The incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 14.3% (173 cases), and the main ADRs were hepatic function abnormal, alanine aminotransferase increased, and aspartate aminotransferase increased, which were similar to these observed in the clinical study. And the efficacy was 88.6% (890 cases).     

75岁以上老年新型冠状病毒肺炎患者应用阿兹夫定安全性研究

目的 探讨阿兹夫定治疗75岁以上新型冠状病毒肺炎（COVID-19）的安全性。方法 通过医院电子病例系统收集2022年12月—2023年2月南京医科大学附属老年医院应用阿兹夫定治疗的≥75岁COVID-19患者病例资料,对阿兹夫定的不良反应发生情况（不良反应名称、发生时间、临床表现、严重程度、关联性评价等）以及转归等进行回顾性分析。结果 纳入74例患者发生不良反应的有28例（37.8%）。28例患者中,消化系统症状者20例（主要表现为肝功能异常10例、腹泻7例、恶心呕吐2例、淀粉酶升高1例）,血液系统不良反应6例（血小板升高）,泌尿系统（肌酐升高）3例,心血管系统症状（心动过速）2例,电解质紊乱1例;其中2例患者同时出现2个系统症状,分别为消化系统合并血液系统和消化系统合并心血管系统以及2例患者发生消化系统2个症状。发生1级不良反应26例（92.8%）,2级1例（3.6%）,严重不良反应患者1例（3.6%）。其中2例患者因不良反应停药,1例为不能耐受恶心呕吐停药,1例为严重肝功能损伤停药。结论 阿兹夫定治疗75岁以上老年COVID-19患者安全性较好,主要表现为轻微的消化系统症状,以肝功能异常、腹泻较为多见。     

阿比多尔联合甘草酸二铵肠溶胶囊治疗新冠肺炎的临床观察

目的：观察阿比多尔联合甘草酸二胺肠溶胶囊治疗新冠肺炎（COVID-19）的临床有效性和安全性，为新冠肺炎临床治疗提供参考。方法：回顾性抽取广西地区治疗COVID-19定点医院接受阿比多尔联合甘草酸二胺肠溶胶囊治疗的新冠肺炎患者，收集患者治疗前后临床症状，WBC计数、N%、血沉、PCT等感染性指标，CRP、IL-6等炎症指标，以及肝肾功能、不良反应等资料，分析治疗前后各项指标的差异，阐明阿比多尔联合甘草酸二胺肠溶胶囊治疗新冠肺炎的有效性和安全性。结果：46例患者主要的临床症状是低热、咳嗽、乏力。与治疗前相比，治疗后患者症状显著改善（P<0.05）；WBC计数、N%、血沉等感染性指标降低，其中N%具有显著差异（P<0.05）；淋巴细胞计数显著增加（P<0.05）；CRP、IL-6、PCT等炎症指标降低，其中IL-6具有显著差异（P<0.05）；白蛋白含量、ALT显著增高（P<0.05），其他肝肾功能指标无明显变化；未报告腹泻、呕吐等相关药物的不良反应，出现AST、ALT升高3例，单纯ALT升高5例；总体治愈率为63.04%，总体有效率为78.26%；治疗失败的患者中主要原因是核酸检测阳性，包括持续低热、症状未缓解、影像未改善等。结论：阿比多尔联合甘草酸二胺肠溶胶囊治疗新冠肺炎临床疗效可靠，可有效降低患者炎症反应，具有不良反应少，安全性高，是新冠肺炎治疗的一种可行选择方案。     

Clinical efficacy of sulbactam/ampicillin in comparison with cefotiam in the treatment of elderly patients with pneumonia

Clinical efficacy and safety of pareteral sulbactam/ampicillin (SBT/ABPC) was compared with cefotiam (CTM) in a randomized clinical trial of pneumonia in the elderly at 13 National Hospitals of Kyushu island. 37 patients received SBT/ABPC 3 g i.v., b.i.d., and 31 patients received CTM 1 g i.v., b.i.d. for 7 to 14 days. 1. 68 patients (37 for SBT/ABPC and 31 for CTM) were evaluated for safety. No statistical differences were noted in the patients' backgrounds of either group. 2. The clinical efficacy of SBT/ABPC was 96.3% (26/27 cases) while CTM was 75.2% (17/23 cases). This was found to be statistically significant (Fisher's exact test: p < 0.05). 3. 100% of evaluated cases (10 for SBT/ABPC and 4 for CTM) showed bacterial elimination. 4. No side effects were observed in the study. 5. Abnormal laboratory findings were noted in 10.8% (4/37 cases) for SBT/ABPC and 3.2% (1/31 cases) for CTM. The major adverse events were mild elevation of GOT, GPT and A1-P for SBT/ABPC, and mild platelets overproduction for CTM. No statistical differences were noted in both groups. These results are consistent with SBT/ABPC as a highly effective antibiotic in the treatment of elderly patients with pneumonia.     

2016—2018年东莞市人民医院注射用哌拉西林钠舒巴坦钠不良反应分析

目的 了解注射用哌拉西林钠舒巴坦钠发生药品不良反应（ADR）的特点及相关因素,探讨其安全性,为临床合理用药提供参考依据。方法 回顾性收集东莞市人民医院2016-2018年上报的药品不良反应中关于注射用哌拉西林钠舒巴坦钠并对其不良反应报告进行描述性统计分析。结果 共收集ADR 1 909例,关于注射用哌拉西林钠舒巴坦钠57例（2.98%）;其中一般不良反应33例（57.89%）,新的一般不良反应11例（19.30%）,严重不良反应有13例（22.8%）,新的严重不良反应6例（10.53%）;从发生的ADR的年龄段分析,主要发生在36~59岁患者（26.32%）和>60岁的患者（63.15%）;主要累及器官为皮肤及其附件（68.42%）、全身性损伤（28.07%）和免疫系统（17.54%）,主要临床表现为瘙痒、皮疹、潮红、血小板减少;发生ADR患者停药后症状均减轻,痊愈和好转患者55例（96.5%）;注射用哌拉西林钠舒巴坦钠很可能是不良反应的主要原因。结论 注射用哌拉西林钠舒巴坦钠发生药品不良反应不多,但存在新的不良反应,临床上应重视其所致的ADR,并加强合理用药,确保用药安全。     

维生素B12治疗周围神经病变的临床疗效比较

目的 比较目前临床应用相对较多的两种维生素B12制剂对周围神经病变临床症状的疗效.方法 选取天津市第一医院临床收纳的满足试验条件的神经卡压性周围神经病变患者,随机分为甲钴胺组(41例),腺苷钴胺组(39例)和针灸组(41例),甲钴胺组患者静脉滴注弥可保,每次0.5 mg,1次/d;腺苷钴胺组患者肌肉注射腺苷钴胺,每次0.5 mg,1次/d;针灸组选用针灸理疗、按摩等常规治疗.3组患者均治疗两周.观测治疗后患者的主观症状、各项体征,并严密观察、记录试验期间发生的不良反应事件.结果 3组治疗患者均未见不良反应,甲钴胺组在主观症状、客观体征方面改善均优于腺苷钴胺组及针灸组.结论 甲钴胺作为最新一代的维生素B12临床应用疗效、安全性方面均优于以往维生素B12,且西医治疗周围神经病变较单纯针灸治疗有明显疗效优势.     

脾氨肽联合布地奈德治疗小儿支气管哮喘的疗效及其对血清CD4+、CD8+、IgE水平的影响

目的:研究脾氨肽联合布地奈德治疗小儿支气管哮喘的临床疗效及对免疫功能的影响。方法:选取我院2015年2月至2017年1月收治的支气管哮喘患儿102例,其中轻度哮喘25例,中度哮喘52例,重度哮喘25例,所有患儿按照随机数字法分为对照组和观察组各51例,对照组患儿给予雾化吸入布地奈德混悬液,观察组患儿在此基础上口服脾氨肽2 mg/d 治疗,比较两组患儿的治疗总有效率、住院时间、症状消失时间、肺功能变化情况、血清免疫细胞水平以及不良反应发生率。结果:观察组治疗总有效率(94.12%)高于对照组(78.3%,P<0.05),观察组临床症状消失时间和住院时间均短于对照组(P<0.01);治疗后观察组的FVC、FEV1、FEV1/FVC、CD4+、CD8+水平均高于对照组(P<0.01),IgE水平低于对照组(P<0.01);观察组总不良反应发生率低于对照组(P<0.05)。结论:脾氨肽联合布地奈德治疗小儿支气管哮喘的临床疗效显著,可有效改善肺功能状态,提高患儿免疫力,促进患儿早日康复,且安全性较高,值得临床推广。     

Evaluation of the efficacy of ceftriaxone in acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media. A comparative study with cefotiam as the control

In order to objectively evaluate the efficacy and the safety of ceftriaxone (CTRX) using once daily administration of 1 g to cases of acute suppurative otitis media and acute exacerbation of chronic suppurative otitis media, a group comparison study by the envelope method was conducted using cefotiam (CTM) as the control drug (2 g twice daily). The results obtained are summarized as follows. 1. Clinical efficacies evaluated by the committee were 71% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 63% and 60%, respectively, for chronic suppurative otitis media. When all cases were considered both groups evidenced a clinical efficacy of 64%, and no significant difference was observed between the 2 groups. 2. Clinical efficacies evaluated by the physician in charge were 65% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 72% and 60%, respectively, for chronic suppurative otitis media. When all cases were considered efficacies were, respectively, 70% and 64%, showing no significant difference between the 2 groups. 3. Bacteriological efficacies were 88% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 74% and 62%, respectively, for chronic suppurative otitis media. With all cases bacterial eradication rates were, respectively, 76% and 67%. Bacterial eradication rates were always higher for the CTRX group than for the CTM group, but the difference was not significant between the 2 groups. 4. Against infections caused by Staphylococcus aureus alone, CTRX showed equal clinical and bacteriological efficacies to CTM. 5. As side effects, dermatitis, vomiting, and malaise were observed in 5 cases (4%) of the CTRX group and 3 cases (3%) of the CTM group. As clinical testing abnormalities, elevations of GOT, GPT, and Al-P, and thrombocytopenia were noted only in 3 cases (5%) of the CTRX group. Furthermore, all of these abnormalities were temporary and of moderate degree or mild, thus the safety of either drug was considered high. 6. Clinical utilities were 71% in the CTRX group and 86% in the CTM group for acute suppurative otitis media, and 72% and 62%, respectively, for chronic suppurative otitis media. When all cases were included, they were 72% and 66%, respectively, and there was no significant difference between the 2 groups. It is concluded from the above results that CTRX is a highly useful drug with once daily administration of 1 g in the treatment of suppurative otitis media.     

痰热清药物不良反应报告分析

目的了解痰热清不良反应发生的特点,为临床用药提供参考。方法采用回顾性调查方法对2007～2009年不良反应报表进行统计分析。结果中药制剂诱发的不良反应共41例,涉及18种中药制剂,其中痰热清注射液引起的不良反应为8例。不良反应主要表现为过敏反应、皮肤及附件损害等。结论痰热清注射液药物引起的不良反应不是很多,但在使用过程中仍需密切观察,以防止严重不良反应的发生,提高用药的安全性。     

Clinical evaluation of cefotiam therapy in children (author's transl)

Cefotiam (CTM) was evaluated for its safety and efficacy in children. Twenty-six patients were treated with 40 to 200 mg/kg per day of CTM by intravenous administrations. The diagnosis of the patients were acute pharyngitis (2), acute bronchitis (1), pneumonia (4), empyema (2), urinary tract infection (2), typhoid fever (1), acute enterocolitis (2), partially-treated purulent meningitis (1), and suspected septicemia in neuroblastoma (1); and the remaining ten patients were considered to have nonbacterial infections. The pathogens recovered were Streptococcus pyogenes (1), Streptococcus pneumoniae (1), Staphylococcus aureus (4), Haemophilus influenzae (4), Escherichia coli (1), enteropathogenic Escherichia coli (1), Salmonella typhi (1), and Campylobacter jejuni (1). All but two patients of bacterial infections were cured after the CTM therapy, and the rate of efficacy was 87.5%. Diarrhea (3), urticaria (1), transient elevation of GOT and GPT (1), and transient eosinophilia (3) were found to be associated with the CTM therapy. However, no severe adverse reactions were encountered. Half life of the serum CTM level was 0.93 +/- 0.13 hours, and excretion into the urine was rapid. CSF concentration obtained 1 hour after an intravenous injection of 21 mg/kg of CTM in a case with inflamed meninges was 1.5 mcg/ml, and the CSF/serum ratio was 9.0%. From these data, CTM appears to be a safe and effective antibiotic when used in children with susceptible bacterial infections.     

伏立康唑治疗血液病合并侵袭性真菌感染 42 例简

目的评价伏立康唑治疗血液病合并侵袭性真菌感染（IFI）的疗效和安全性。方法收集医院心血管中心血液病合并侵袭性真菌感染患者42例,均给予伏立康唑（汇德力康）,从临床表现、影像学和病原学3个方面评价其疗效和安全性,同时观察药品不良反应。结果伏立康唑治疗IFI总有效率为70．00％。单变量分析显示,延长伏立康唑治疗疗程和患者基础病稳定能显著提高疗效,其不良反应主要有神经精神症状、视觉异常和皮疹。结论伏立康唑治疗血液病侵袭性真菌感染高效广谱,安全性高,不良反应小,值得临床推广。     

Clinical experience with cefotiam in the otorhinolaryngologic field

Clinical investigation with cefotiam (CTM) was performed, the following results were obtained. CTM was administered to 18 cases of infectious diseases in the otorhinolaryngologic field. Clinical results were excellent in 7 cases, good in 5 cases, fair in 4 cases and poor in 2 cases. Clinical efficacy was 66.7%. No side reactions were noted in any cases.     

Safety aspects of a coumarin-troxerutin combination regarding liver function in a double-blind placebo-controlled study

OBJECTIVE: Coumarin is reported to elevate liver function tests (LFT) values. In a prospective, placebo-controlled, clinical trial, efficacy and safety of a coumarin-containing combination (SB-LOT) were evaluated in the treatment of chronic venous insufficiency. Here, we report on the drug safety of coumarin with special respect to liver reaction. METHODS: 114 patients were treated with SB-LOT (30 mg coumarin and 180 mg troxerutin t.i.d.) and 117 with placebo during a period of 16 weeks. LFT values (ALT, AST, AP and gamma-GT) were monitored at baseline, 4, 6, 8, 12 and 16 weeks of therapy. Adverse drug reactions were assessed regarding causality. Additionally, lymphocyte proliferation test was used to identify allergic reactions. Logistic regression analysis was performed to identify possible risk factors. RESULTS: No serious adverse drug reactions occurred. Elevations of LFT were assessed as biochemical abnormality. Specific clinical symptoms such as jaundice did not occur. Only 1 patient reported fatigue and exhaustion. Logistic regression estimated a basic risk for elevation of LFT of 4.9% under SB-LOT and 2.1% under placebo. Hepatitis in the history and diseases of the liver were identified as risk factors. CONCLUSION: This evaluation contributes to safety data of SB-LOT in man. LFT elevation is transient and the low risk of the SB-LOT therapy to increase LFT value can be limited when risk factors are considered.     

布地奈德对哮喘急性发作且伴有感染患儿的临床疗效

目的:分析布地奈德对支气管哮喘急性发作且伴有感染患儿的疗效及对肺功能指标的影响。方法:将本院收治的96例支气管哮喘急性发作且伴有感染的患儿作为研究对象,随机分为对照组和观察组各48例,两组患儿均给予常规抗感染治疗,对照组给予地塞米松雾化吸入,观察组给予布地奈德雾化吸入,比较两组患儿临床疗效和治疗前、治疗后1周第1秒用力呼气容积(FEV1)、FEV1占预计值百分比(FEV1%)、肺活量(VC)、用力肺活量(FVC)等肺功能指标的改善状况及不良反应的发生情况。结果:观察组治疗总有效率为95.83%,高于对照组的72.92%(P<0.05)。两组患儿治疗后1周肺功能指标FEV1、FEV1%、VC、FVC水平较治疗前均升高,且观察组各指标水平均显著高于对照组(P均<0.01)。观察组患儿不良反应发生率(4.17%)低于对照组(18.75%)(P<0.05)。结论:布地奈德联合常规抗感染对治疗支气管哮喘急性发作且伴有感染的患儿具有良好的临床疗效,可有效改善FEV1、FEV1%等肺功能指标,且不良反应发生率较低,具有较高的安全性,因此具有良好的临床应用价值。     

盐酸奥洛他定片治疗慢性特发性荨麻疹疗效和安全性的多中心临床研究

目的：观察盐酸奥洛他定片治疗慢性特发性荨麻疹的临床疗效及安全性。方法：采用随机、双盲双模拟、阳性药物平行对照、多中心的试验方法,试验组和对照组共纳入150例。分别采用盐酸奥洛他定片,每次1片,每日2次;氯雷他定片,每次1片,每日1次,2组分别给予盐酸奥洛他定和氯雷他定模拟片,连续给药4周。疗程结束时以症状体征总积分下降指数、总有效率及疾病总体改善情况等来评估其临床疗效,以不良事件及不良反应、实验室检查来评估其安全性。结果：纳入符合方案分析集（PPS）的病例数为143例,试验组72例,对照组71例。总有效率分别为83.33%和80.28%（P>0.05）。25例患者发生43例次不良事件（试验组14人20例次,对照组11人23例次）,其中37例次不良事件与药物相关,主要表现为口干、头晕、嗜睡、乏力、上腹痛、谷丙转氨酶ALT升高、谷草转氨酶AST升高等。2组间不良事件及不良反应发生率差异无统计学意义（P>0.05）,无严重不良事件发生。结论：盐酸奥洛他定片治疗慢性特发性荨麻疹,疗效显著,安全性好。     

基于真实世界数据的磷酸奥司他韦临床使用情况及安全性分析

目的 调查磷酸奥司他韦临床使用情况及安全性,分析其药品不良反应(ADR)的发生特点,为合理用药提供参考.方法 回顾性分析我院2016年2月1日至2018年2月28日门诊及住院患者使用磷酸奥司他韦的病例用药情况,对适应证、用药目的 、用法用量、联合用药及ADR进行统计分析,重点关注其用药合理性及安全性.探讨ADR与年龄、...     

Dexibuprofen: pharmacology, therapeutic uses and safety

Dexibuprofen is the single pharmacologically effective enantiomer of rac-ibuprofen. Racibuprofen and dexibuprofen differ in their physico-chemical properties, in terms of their pharmacological properties and their metabolic profiles. Several clinical trials and post-marketing surveillance studies were performed to broaden the findings on dexibuprofen. In the last 5 years 4836 patients have been exposed to dexibuprofen in clinical trials and PMS trials. Only in 3.7% of patients adverse drug reactions have been reported and 3 serious adverse drug reactions (0.06%) were observed. In the dose ratio of 1 : 0.5 (rac-ibuprofen vs. dexibuprofen) at least equivalent efficacy was proven in acute mild to severe somatic and visceral pain models. Dexibuprofen has proven at least comparable efficacy to diclofenac, naproxen and celecoxib and has shown a favourable tolerability. The results suggest that dexibuprofen processed in a special crystal form is a safe and effective treatment for different pain conditions.     

Clinical pharmacology: special safety considerations in drug development and pharmacovigilance.

The dose of a drug is a major determinant of its safety, and establishing a safe dose of a novel drug is a prime objective during clinical development. The design of pre-marketing clinical trials precludes the representation of important subpopulations such as children, the elderly and people with co-morbidities. Therefore, postmarketing surveillance (PMS) activities are required to monitor the safety profile of drugs in real clinical practice. Furthermore, individual variations in pharmacogenetic profiles, the immune system, drug metabolic pathways and drug-drug interactions are also important factors in the occurrence of adverse drug reactions. Thus, the safety of a drug is a major clinical consideration before and after it is marketed. A multidisciplinary approach is required to enhance the safety profile of drugs at all stages of development, including PMS activities. Clinical pharmacology encompasses a range of disciplines and forms the backbone of drug safety consideration during clinical drug development. In this review we give an overview of the clinical drug development process and consider its limitations. We present a discussion of several aspects of clinical pharmacology and their application to enhancing drug safety. Pharmacokinetic-pharmacodynamic modelling provides a method of predicting a clinically safe dose; consideration of drug pharmacokinetics in special populations may enhance safe therapeutics in a wider spectrum of patients, while pharmacogenetics provides the possibility of genotype-specific therapeutics. Pharmacovigilance activities are also discussed. Given the complex nature and unpredictability of type B reactions, PMS activities are crucial in managing the risks drugs pose to the general population. The various aspects of clinical pharmacology discussed make a strong case for this field as the backbone of optimising and promoting safe development and use of drugs.