Objective To analyze the adverse drug reactions (ADR) of Ciwujia injection and the relative influence factors. Methods We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. The relevant information such as the diseases for treatment; menstruum, dosage and compatibility of Ciwujia injection; the age, gender and allergic history of patients; and the category, treatment and prognosis of ADR were collected and analyzed. Results In the 800 clinical studies, only 97 (12.1%) reported 285 ADR cases, 144 ADR reports including 236 ADR cases. Of the ADR cases, the male to female ratio was 1׃1.34, mainly in 40 to 69 years group; The ADR cases mainly including anaphylactic shock and local pain in ADR reports and clinical studies, respectively; 72.3 percent ADR cases were Ⅲ to Ⅳ class, 4 anaphylactic shock cases died; the diseases for treatment of ADR cases mainly were coronary artery heart disease and cerebral infarction; 27 (11.4%) ADR cases had allergic history; The menstruum of Ciwujia injection mainly were 5% glucose, 0.9% NaCl and 10% glucose, drug incompatibility in 36 ADR cases; The usual dosage of Ciwujia injection was 20-60 ml; 196 (83.0%) ADR cases occurred in first time medication, mainly in the early 30 minutes of medication used. Conclusion (1) In both ADR reports and clinical studies of Ciwujia injection, there are some problems of ADR and adverse drug events (AE) were not easily distinguishable, key information of total prescriptions divided by drug persons were lacking, so we can’t calculate the ADR rate, the reporting quality remained to be improved. (2) To support the rational drug use, the basic researches of Ciwujia injection remains to be further studied, especially the dose-finding studies. (3) As one of the most frequently reported ADR of traditional Chinese medicine (TCM) injection, high quality ADR monitoring, normative ADR reporting and timely analyzing the ADR reason of Ciwujia injection is extremely urgent.
Objective To assess the efficacy and safety of glimepiride for type 2 diabetes mellitus (T2DM). Methods We searched the literature from PubMed, Ovid (All EBM Reviews), CNKI, Wanfang, VIP, CBM and other databases. Evaluating the quality of the study according to Cochrane systematic reviews, Meta-analysis was performed for the results of homogeneous studies by The Cochrane Collaboration’s software RevMan 5.0, and the heterogeneous data conducted a descriptive qualitative analysis. Results Six RCTs included in the analysis and Meta-analysis was not performed due to the insufficient data (for the median or standard deviation). Six RCTs are multi-center, randomized, double-blind, placebo-controlled trials. The results showed that glimepiride groups to reduce glycosylated hemoglobin, lower fasting and postprandial blood glucose, postprandial plasma insulin enhance the efficacy were statistically significant differences (Plt;0.05) compared to placebo groups. Four studies informed the impact of fasting plasma insulin (FI) and 3 studies showed that the glimepiride groups improving the fasting plasma insulin (FI) were statistically significant differences (Plt;0.05), but 1 study showed the two groups had no significant difference (Pgt;0.05). All studies showed minor adverse reactions of glimepiride. Conclusion Glimepiride can reduce the glycosylated hemoglobin, lower the fasting and postprandial blood glucose, improve fasting and postprandial plasma insulin for type 2 diabetes patients, and have minor adverse reactions. In a word, glimepiride is an effective and security sulfonylureas drug.
Objective To investigate the method and effect of continuous improvement of adverse drug reaction (ADR) monitoring in a major public hospital’s cooperating branch hospital. Methods PDCA cycle management was used to continuously improve the quality of ADR monitoring. ADR report network platform was established in the fourth quarter of 2014; ADR report specification training for the medical personnel was held in the first quarter of 2015; a examine mechanism was built in the second quarter of 2015. The quality and quantity of ADR monitoring before and after the PDCA cycle management were analyzed. Results ADR report timeliness conform to the requirements increased from 45.5% (from the first to third quarter of 2014) to 98.1% (from the fourth quarter of 2014 to the second quarter of 2015); accurate ADR types checking, normal name writting, and complete process description increased from 68.6%, 65.7%, 8.6% (from January 2014 to Frequency 2015) to 92.9%, 96.4%, 85.7% (from March to June 2015); the quantity of ADR report was obviously improved. Conclusion Learning from public hospital’s experience and considering its own condition in ADR monitoring, cooperating branch hospital utilizes PDCA cycle management which could continuously improve the ADR monitoring.
Objective To evaluate the safety of Rongbisu capsule used for treating benign prostatic hyperplasia. Methods A total of 218 patients (average age 63.73±7.50 years old) with phase Ⅰor Ⅱ benign prostatic hyperplasia were treated with oral Rongbisu capsule at a dose of 3 granules twice daily. The therapeutic course was 6 weeks and hepatic function was determined every 2 weeks. Results The median value of ALT in 218 patients rose significantly after the patients took Rongbishu capsule for 6 weeks (P=0.001 7). There were 17 patients whose ALT level rose from normal to abnormal, the incidence was 7.80%. There were 3 patients whose hepatic function was seriously impaired (ALT＞200 IU/L). Conclusions The essential component of Rongbishu capsule is edible tulip which has been recorded in the medical literature as being toxic. Airpotato yam of which the alias is also edible tulip is easily mistaken for edible tulip. Airpotato yam is the tuber of dioscorea bulbifera L. (family dioscoreaceae) which has confirmed hepatotoxcity. Our study result indicates that in order to insure the safety of Chinese crude drug, the origin of Chinese crude drug should be defined in the formulation according to the standard of Chinese drugs preparation. Pharmaceutical enterprises should strictly abide by the standards to identify the origin of Chinese crude drugs when approving the raw materials, especially for species which are poisonous and easily mistaken.
A total of 109 varieties of Chinese medicine injections have been approved by the State Food and Drug Administration of China, all of which have the potential to induce adverse drug reactions (ADRs). Major ADRs include systemic anaphylaxis, anaphylactic shock, acute intravascular hemolysis, hepatorenal damage, skin lesion, cardiac damage, respiratory system injury, and gastrointestinal disorders. Contributing factors of ADRs include healthcare workers’ inadequate attention to ADRs of Chinese medicine injections, complex ingredients, allergic uncertainties, and inappropriate drug use in children and the aged. To decrease ADRs resulting from Chinese medicine injections, it is essential to improve the selection of drug indications, delivery of proper dosage regimens, compliance with drug instructions, and selection of solvents for the drugs.
Objective To evaluate the efficacy and safety of metformin for metabolic syndrome. Methods We searched The Cochrane Library, MEDLINE, EMBASE, China Biological Medicine Database, VIP, and CMAC up to the year of 2007. Handsearches and additional searches were also conducted. Randomized controlled trials of metformin for metabolic syndrome were included. Two reviewers independently extracted data from eligible studies and evaluated the quality of included studies. Meta-analysis was performed for the results of homogeneous studies by The Cochrane Collaboration’s software RevMan 4.2.9. Results Six trials involving a total of 2442 patients with metabolic syndrome were included. Meta-analysis was not performed due to the apparent heterogeneity. Metformin, compared with placebo, exhibited more favorable effects in reducing the proportion of patients with metabolic syndrome (RR 1.27, 95% CI 1.01 to 1.60), the proportion of patients with low HDL-c (RR 1.61, 95%CI 1.16 to 2.23), wide waist circumference (RR 1.64, 95%CI 1.06 to 2.55), and high FPG (RR 1.55, 95%CI 1.17 to 2.05). Metformin was also more effective in improving FPG and insulin sensitivity. The addition of metformin to atenolol plus nitrendipine was superior to atenolol plus nitrendipine alone in reducing the proportion of patients with high TG (RR 5.57, 95%CI 1.56 to 19.84), abdominal obesity (RR 14.47, 95%CI 3.34 to 62.61), and IGT (RR 16.51, 95%CI 6.06 to 45.0). Compared with low-fat diet therapy, metformin was superior in improving FPG, 2-hour postload plasma glucose, and insulin sensitivity. No differences were observed between metformin and acarbose in the reduction of TG and FPG, but metformin was less effective than acarbose in improving 2-hour postload plasma glucose. No adverse drug reactions were reported. Conclusion Metformin has beneficial effects in reducing the incidence of high FPG, IGT, and abdominal obesity. It also proved beneficial in reducing the prevalence of metabolic syndrome and increasing insulin sensitivity. The therapeutic effects of metformin on blood pressure, obesity, and lipid profile are uncertain. There is insufficient evidence to recommend the use of metformin in the treatment of metabolic syndrome due to low methodological quality, small sample size, and limited number of trials. More high quality, large-scale randomized controlled trials are required.
Objective To assess reduction of adverse drug reaction incidence in patients with colorectal cancer receiving Jianpi herbs combined with chemotherapy. Methods The randomized controlled trials (RCTs) comparing Jianpi herbs combined with chemotherapy were searched through CBMdisc, CJFD, Wangfang Data and PubMed. The search was updated to September 2007. Software RevMan5, provided by Cochrane Library, was used to perform meta-analysis. Results Six RCTs were identified in this systematic review. All the methodology quality of the enrolled RCTs was gaded C. The pooled analysis showed that Jianpi herbs combined chemotherapy significantly reduced the incidences of grade I and grade II leucopenia [grade I with RR= 0.50 and 95%CI (0.31 to 0.80); grade II with RR= 0.37 and 95%CI (0.21 to 0.66)], grade II nausea and vomiting [RR= 0.51, 95%CI (0.31 to 0.84)] compared with routine chemotherapy. There was no statistical difference in reduction of neurotoxicity between the two groups. Conclusion The methodological quality of the RCTs using Jianpi herbs combined with chemotherapy on treating colorectal cancer should be improved. Based on this systematic review, Jianpi herbs combined with chemotherapy may reduce the incidence of mild to moderate adverse drug reaction, such as leucopenia and nausea and vomiting, in patients with colorectal cancer. Well-designed RCTs are needed in the future.
Objective To evaluate the safety of mycophenolate mofetil (MMF) versus azathioprine (AZA) for rejection after renal transplantation. Methods We searched MEDLINE (1966 to Jun. 2004), EMBASE (1984 to Jun. 2004), The Cochrane Library (Issue 2, 2004) and Chinese Biomedical Database (CBM, 1979 to Jun. 2004). Randomized controlled trials (RCTs) comparing MMF with AZA for rejection after renal transplantation were included. The quality of included studies such as randomization, blinding, allocation concealment was evaluated and meta-analysis was performed using RevMan 4.1.1 software. Results Twenty-Four RCTs comparing MMF (2 g/day or 3 g/day) with AZA for rejection after renal transplantation were identified. The digest system morbidity of MMF group was higher than that of AZA group. The incidence of vomiting, bellyache and diarrhea of MMF 3 g/day group was statistical by higher than that of AZA group (P＜0.05). The cytom egalovirus (CMV) infection morbidity of MMF 3 g/day group during 6 months, 1 year and 2 years follow-up was higher than AZA group with statistical difference, but for MMF 2 g/day group, this difference was only seen during 1 year follow-up. Leukopenia incidence of MMF 3g/day group was higher than AZA group with statistical difference, but this difference was not seen in MMF 2 g/day group. Thrombocytopenia incidence of MMF 3 g/day group was lower than AZA group with statistical difference. For skin carcinoma morbidity, no statistical difference was found among MMF 3 g/day, MMF 2 g/day and AZA groups. Conclusions Compared with AZA, MMF represents higher digest system side-effects incidence, higher morbidity of leucopenia and CMV infection and lower incidence of thrombocytopenia. The dose-response relationship of adverse drug reaction is found.
Objective While reporting of adverse drug reactions (ADR) and adverse drug events (AE) following Chinese medicine injection (CMI) is becoming more common, the reporting quality is of concern. Methods A checklist about the reporting quality of ADR/AE was set up, and the ADR/AE reporting of Herba Houttuyniae injection was chosen as an example. Electronic databases Chinese Journal Net (CJN) (1994-2009) and Chinese Science and Technological Journal Net (VIP) (1989-2009) were searched for target literature. Results Based on our search strategy, 210 articles were included, with 175 articles reporting single or several cases of ADR/AE following Herba Houttuyniae injection (type I report). There were 7 reports from regional or national ADR monitoring centers (type II report), and 28 summary reports from a single hospital or medical center (type III report). All 210 papers mentioned ‘adverse effect,’ ‘safety’ or related meaning words in their titles, but 199 articles did not have abstract. Patient demographic characteristics were not fully reported in these articles. In type I articles, only 97 cases (43.11%) mentioned whether patients had or did not have a history of allergies, while 128 cases (56.89%) in Type II papers and Fourteen (50%) type III papers, did not mention allergic history of patients. Only three articles (3/210, 1.43%), all of them type I, mentioned the syndrome type in Chinese medicine. None of the papers gave clear indications of the type and grade of ADR/AE of patients. Most papers did not report details of the CMI procedure, such as the drug company, product serial number, or the drug’s validity period. Data about the occurrence time and management of ADR/AE was also inadequately reported. Conclusion and recommendations The current reporting format of ADR/AE in clinical CMIs is not standardized. Much fundamental information of ADR/AE following CMI is therefore missing. A standard reporting format for ADR should be developed, and should include the following: 1) a title mentioning adverse effects and safety; 2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; 3) demographic characteristic of the patients (gender, age, etc.); 4) clinical characteristics of patients (disease, syndrome, etc); 5) allergic history of patients; 6) diagnosis and syndrome based on Chinese medicine theory; 7) detailed information about the Chinese materia medica intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); 8) concomitant drug use; 9) time and symptoms of ADR/AE; 10) type and grading of ADR/AE; 11) physiological systems affected by ADR/AE; 12) specific treatment and prognosis for ADR/AE; 13) evidence of the cause and effect of ADR/AE; 14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.
In phase II clinical trial of Compound Prescription of Huangyaozi (Dioscorea bulbifera L.), 7 cases out of 37 developed (18.92%) impairment of liver function. As a result, the ethic committee required researchers to report all data of safety of the drug and have all subjects rechecked about their liver function so as to provided reasonable evidence for the scientifical evaluation of the relationship between the drug and the adverse event and the succedent suspending of the clinical trial.