Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine ...Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine (Lantus®) and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4 (DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods: This postmarketing surveillance was a prospective, observational, 24-week study that complied with the pharmaceutical affairs law and the ministerial ordinance of “Good Post-Marketing Study Practice (GPSP)” in Japan. Safety, efficacy and patient-reported outcomes (PROs);patients’ satisfaction with treatment (DTSQs and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630 patients were enrolled. Of the 2,602 patients in the safety analysis population, 161 patients experienced 175 cases of adverse drug reactions, and the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the incidence rate (episodes per patient-year) was 0.019. Basal supported oral therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2 hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL respectively. The mean weight was increased, however the change was +0.50 kg. In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index scores and EQ-VAS scores were significantly improved. Conclusion: Insulin glargine and OADs combination therapy was suggested to be effective and well tolerated. Patients’ satisfaction with treatment and their self-reported health improved in spite of the addition of injections to oral agents. The combination therapy of insulin glargine and OADs including DPP-4 inhibitors is likely to be considered an important therapeutic option in the diabetic patients.展开更多
Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the s...Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese patients undergoing different types of diagnostic imaging procedures.展开更多
Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸)on neck pain in realworld clinical practice.Methods:A multi-center,prospective,observational surveillance in 8 hospitals across Shanghai was cond...Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸)on neck pain in realworld clinical practice.Methods:A multi-center,prospective,observational surveillance in 8 hospitals across Shanghai was conducted.During patients receiving 4-week Qishe Pill medication,Visual Analogue Scale(VAS)and Neck Disability Index(NDI)assessments have been used to assess their pain and function,while safety monitoring have been observed after 2 and 4 weeks.Results:Results from 2,023 patients(mean age 54.5 years)suggest that the drug exposure per unit of body mass was estimated at 3.41±0.62 g/kg.About 8.5%(172/2,023)of all participants experienced adverse events(AEs),while 3.8%(78/2,023)of all participants experienced adverse reaction.The most common AEs were gastrointestinal events and respiratory events.The VAS score(pain)and NDI score(function)significantly decreased after 4-week treatment.An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3–4 g/kg,at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS.Conclusion:These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function.(Registration No.NCT01875562).展开更多
This contribution complements Forest Ecosystems＇ Thematic Series on ＂Forest Observational Studies＂. We provide essential clarification regarding the definition and purpose of long-term field studies, review some of...This contribution complements Forest Ecosystems＇ Thematic Series on ＂Forest Observational Studies＂. We provide essential clarification regarding the definition and purpose of long-term field studies, review some of the extensive literature and discuss different approaches to collecting field data. We also describe two newly established forest observational networks that serve to illustrate the scope and diversity of forest field studies. The first is a large-scale network of forest observational studies in prominent natural forest ecosystems in China. The second example demonstrates observational studies in mixed and uneven-aged pine-oak forests which are selectively managed by local communities in Mexico. We summarize the potential for analysing and modeling forest ecosystems within interdisciplinary projects and provide argumentation in favour of long-term institutional commitment to maintaining forest observational field studies.展开更多
Objectives To find out whether there are also penicillinresistant str eptococcus pneumoniae and the resistant rate in China Methods A surveillance study which is a part of the international surve illance on pneumoco...Objectives To find out whether there are also penicillinresistant str eptococcus pneumoniae and the resistant rate in China Methods A surveillance study which is a part of the international surve illance on pneumococci resistance to penicillin and other antimicrobial agents w as conducted in Beijing, China More than 900 pediatric patients with respirato r y tract infections aged from six months to three years selected from two pediatr ic units were enrolled in the study Perthroat swabs were immediately streaked o nto blood agar plates Isolates were identified as pneumococci by their typical appearance, gram stain, confirmation tests Antibiotic susceptibility was asses s ed by the disk diffusion method and minimal inhibition concentration (MIC) deter mination according to Protocol and National Committee for Clinical Laboratory St andards (NCCLS). Results Of the 51 streptococcus pneumoniae isolates, 5 strains had zone s of inhibition indicative of penicillin resistance, of which two had penicillin MICs01?mg/L and were considered to be relatively or fully resistant to pen i cillin The MICs of two penicillin resistant strains were 2?mg/L and 4?mg/L R esistant rates to ceftriaxone and cefotaxime were 0% and 10% respectively For the othe r ten antimicrobial agents, the resistant rates were as follows: ampicillin 12% , piperacillin 26%, furbenicillin 14%, cefuroxime 6%, erythromycin 54%, clarithr omycin 52%, meleumycin 64%, roxithromycin 52%, chloramphenicol 35%, tetracycline 100% Conclusions The study suggested that penicillin resistant streptococcus pneumoniae strains existed in China and were also resistant to ampicillin, pipe racillin, furbenicillin and cefuroxime Moreover, the resistant rates of penici llin resistant streptococcus pneumoniae to macrolides and tetracycline were high展开更多
文摘Aims: In the Add-on Lantus®?to Oral Hypoglycaemic Agents 2 (ALOHA 2) Study in Japanese adults with type 2 diabetes mellitus (T2DM), data on the safety and efficacy of combination therapy with insulin glargine (Lantus®) and oral anti-hyperglycaemic drugs (OADs) including dipeptidyl peptidase-4 (DPP-4) inhibitors in a real-life setting were collected and analyzed. Methods: This postmarketing surveillance was a prospective, observational, 24-week study that complied with the pharmaceutical affairs law and the ministerial ordinance of “Good Post-Marketing Study Practice (GPSP)” in Japan. Safety, efficacy and patient-reported outcomes (PROs);patients’ satisfaction with treatment (DTSQs and DTSQc) and patients’ self-reported health (EQ-5D and EQ-VAS) of combination therapy of insulin glargine and OADs were evaluated. Results: A total of 2,630 patients were enrolled. Of the 2,602 patients in the safety analysis population, 161 patients experienced 175 cases of adverse drug reactions, and the major adverse drug reaction was hypoglycaemia (140 patients, 5.38%). Out of those with hypoglycaemia, 11 patients (0.42%) had severe hypoglycaemia and the incidence rate (episodes per patient-year) was 0.019. Basal supported oral therapy (BOT) with insulin glargine substantially reduced the HbA1c, FPG and 2 hour-PPG levels for 24 weeks by -1.61%, -54.4 mg/dL and -74.5 mg/dL respectively. The mean weight was increased, however the change was +0.50 kg. In addition, the treatment satisfaction scores of DTSQs (mean treatment satisfaction score increased 3.6 from baseline to last observation) and DTSQc, EQ-5D index scores and EQ-VAS scores were significantly improved. Conclusion: Insulin glargine and OADs combination therapy was suggested to be effective and well tolerated. Patients’ satisfaction with treatment and their self-reported health improved in spite of the addition of injections to oral agents. The combination therapy of insulin glargine and OADs including DPP-4 inhibitors is likely to be considered an important therapeutic option in the diabetic patients.
文摘Background: Iopromide (Ultravist®) has been shown to be a very safe CM agent in previous post-marketing surveillance studies on Western and Asian populations. Our study aimed to analyse data pertaining to the safety, tolerability and diagnostic image quality of Iopromide in an unselected sub-set of the Chinese population. Methods: we analysed data for Chinese ambulatory and in-patients who received Iopromide for an imaging procedure (in accordance with the local package insert and routine clinical practice), as part of an international post-marketing surveillance study. Use of premedication was at the discretion of the attending physician. Patient demographics, clinical history, type of examination, contrast quality and tolerability, including pre-specified adverse drug reactions, were recorded. All statistical analyses were descriptive. Results: case report forms for 20,000 Chinese patients (61.3% men) were analysed, of whom 153 patients (0.77%) had risk factors for idiosyncratic contrast media reactions (at-risk group). Use of premedication, most commonly corticosteroids, was recorded for 5658 patients (28.3%) and 86 at-risk patients (56.2% of the at-risk group), respectively. The mean (±standard deviation) dose of iodine administered was 29 ± 5.5 g. During the physician’s evaluation of image parameters, contrast quality was considered to be “good” (64.7%) or “excellent” (29.3%) in the majority of patients. 571 patients (2.9%) experienced at least one adverse drug reaction [most frequently nausea (0.70%) and dysgeusia (0.62%)], which were typically transient and of mild intensity. Two serious adverse drug reactions were reported [edema (n = 1), decreased blood pressure and dyspnea (n = 1)]. The incidence of adverse drug reactions was increased in the at-risk group versus the overall patient population, and tended to reduce with premedication (mainly corticosteroids). Conclusions: Iopromide was well tolerated and proved to be an efficient contrast agent in a large, non-selected sub-set of Chinese patients undergoing different types of diagnostic imaging procedures.
基金Supported by the National Science Fundation for Young Scholars of China(No.81804115,No.81873317,No.81930116 and No.82074454)the State Key Program of National Natural Science of China(No.81330085 and No.81930116)+3 种基金Shanghai Sailing Program(No.18YF1423800)Shanghai TCM Medical Center of Chronic Disease(No.2017ZZ01010)Municipal Science and Technology Commission of Shanghai-TCM Key Project(No.16401970100)National Thirteenth Five-Year Science and Technology Major Special Project for New Drug Innovation and Development(No.2017ZX09304001)。
文摘Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸)on neck pain in realworld clinical practice.Methods:A multi-center,prospective,observational surveillance in 8 hospitals across Shanghai was conducted.During patients receiving 4-week Qishe Pill medication,Visual Analogue Scale(VAS)and Neck Disability Index(NDI)assessments have been used to assess their pain and function,while safety monitoring have been observed after 2 and 4 weeks.Results:Results from 2,023 patients(mean age 54.5 years)suggest that the drug exposure per unit of body mass was estimated at 3.41±0.62 g/kg.About 8.5%(172/2,023)of all participants experienced adverse events(AEs),while 3.8%(78/2,023)of all participants experienced adverse reaction.The most common AEs were gastrointestinal events and respiratory events.The VAS score(pain)and NDI score(function)significantly decreased after 4-week treatment.An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3–4 g/kg,at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS.Conclusion:These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function.(Registration No.NCT01875562).
文摘This contribution complements Forest Ecosystems＇ Thematic Series on ＂Forest Observational Studies＂. We provide essential clarification regarding the definition and purpose of long-term field studies, review some of the extensive literature and discuss different approaches to collecting field data. We also describe two newly established forest observational networks that serve to illustrate the scope and diversity of forest field studies. The first is a large-scale network of forest observational studies in prominent natural forest ecosystems in China. The second example demonstrates observational studies in mixed and uneven-aged pine-oak forests which are selectively managed by local communities in Mexico. We summarize the potential for analysing and modeling forest ecosystems within interdisciplinary projects and provide argumentation in favour of long-term institutional commitment to maintaining forest observational field studies.
文摘Objectives To find out whether there are also penicillinresistant str eptococcus pneumoniae and the resistant rate in China Methods A surveillance study which is a part of the international surve illance on pneumococci resistance to penicillin and other antimicrobial agents w as conducted in Beijing, China More than 900 pediatric patients with respirato r y tract infections aged from six months to three years selected from two pediatr ic units were enrolled in the study Perthroat swabs were immediately streaked o nto blood agar plates Isolates were identified as pneumococci by their typical appearance, gram stain, confirmation tests Antibiotic susceptibility was asses s ed by the disk diffusion method and minimal inhibition concentration (MIC) deter mination according to Protocol and National Committee for Clinical Laboratory St andards (NCCLS). Results Of the 51 streptococcus pneumoniae isolates, 5 strains had zone s of inhibition indicative of penicillin resistance, of which two had penicillin MICs01?mg/L and were considered to be relatively or fully resistant to pen i cillin The MICs of two penicillin resistant strains were 2?mg/L and 4?mg/L R esistant rates to ceftriaxone and cefotaxime were 0% and 10% respectively For the othe r ten antimicrobial agents, the resistant rates were as follows: ampicillin 12% , piperacillin 26%, furbenicillin 14%, cefuroxime 6%, erythromycin 54%, clarithr omycin 52%, meleumycin 64%, roxithromycin 52%, chloramphenicol 35%, tetracycline 100% Conclusions The study suggested that penicillin resistant streptococcus pneumoniae strains existed in China and were also resistant to ampicillin, pipe racillin, furbenicillin and cefuroxime Moreover, the resistant rates of penici llin resistant streptococcus pneumoniae to macrolides and tetracycline were high
