No abstract available.
Aged* ; Drug Therapy* ; Drug-Related Side Effects and Adverse Reactions ; Humans

Antineoplastic Agents ; adverse effects ; Drug-Related Side Effects and Adverse Reactions ; therapy ; Humans ; Neurotoxicity Syndromes ; therapy

There is nothing that is harmless ; the dose alone decides that something is no poison(Paracelsus. 1493-1541). So, in a point of view to maximize the therapeutic efficacy of drug therapy in a was that minimize the drug toxicity, the knowledges of the drug-interactions as well as the pharmacokinetic and pharmacodynamic principles of every therapeutic drug used in the medical clinic cannot be emphasized too much. Many drug interactions can be predicted if the pharmacokinetic properties, pharmacodynamic mechanisms of action of the interacting drugs are known and most adverse interactions can be avoided. In this paper, the clinical importance, classification, and general principles of clinical drug-interactions are presentated with a few explanatory examples.
Classification ; Drug Interactions* ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions

PURPOSE: The aim of this study was to evaluate the responsiveness to CPT-11 with respect to hMLH1 and hMSH2 protein expressions in primary colorectal tumors. MATERIAL AND METHODS: 91 patients with colorectal cancer treated having undergone surgery and postoperative CPT-11-based adjuvant chemotherapy, between 1997 and 2002, were prospectively recruited. Tumor samples were immunohistochemically analyzed for the expressions of hMLH1, hMSH2, p53 and CEA proteins. RESULTS: Of the 91 tumors, 6 (6.6%) and 4 (4.4%) showed loss of hMLH1 and hMSH2 protein expressions, respectively. The response rate of patients with tumors not expressing either hMLH1 or hMSH2 was higher than that of those expressing either of these proteins (p=0.026). Patients with tumors not expressing hMLH1 showed a significantly better response to CPT-11 (p=0.04). The responsiveness was not associated with the expressions of hMSH2, p53 or CEA. There were no correlations between drug toxicity and the expressions of hMLH1, hMSH2 or p53. The overall survival was better in patients responsive to CPT-11-based chemotherapy compared to non-responders. CONCLUSION: The immunohistochemical determination of loss of hMLH1 and hMSH2 expressions may be used in determining the responsiveness to CPT-11-based chemotherapy. Our results suggest that hMLH1 protein expression may be a predictor for CPT-11 responsiveness in patients with colorectal cancer.
Chemotherapy, Adjuvant ; Colorectal Neoplasms* ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Prospective Studies

Children should be treated with medicines that have been tested for efficacy and safety in the given age groups. In reality the majority of drugs being used in children lack such information, inevitably leading to the "off-label use." Over decades there have been concerns regarding risk of adverse effects with such off-label uses. However, in most countries rational application of off-label uses have not been prohibited, since it may be the only available and perhaps the best possible treatment option. In contrast, in an effort to minimize such use and per se 'protect' children from possible harm associated with it, Korea has launched "Drug Utilization Review" system, which included age group-specific contraindications, based on the labeling information approved by Ministry of Food and Drug Safety. The problem lies in the definition and scope of 'contraindication.' Lack of evidence for safety and concern for risk of serious adverse drug reactions are the basis for contraindication. This leads to branding of off-label uses as contraindications in certain age groups. This policy is restricting the already scarce treatment options and suffocating the initiative for developing better pharmacotherapy for children. We should learn from other countries that have travailed more to provide better medicines to children. Clinical trials of new drugs as well as existing drugs in pediatric populations are strongly encouraged. Simple prohibition of off-label use is not the answer, but rather systematized management of off-label use as well as conduct of clinical trials in pediatric age groups must be encouraged and supported.
Child* ; Drug Therapy* ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Korea ; Off-Label Use*

Captopril ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Hypertension ; drug therapy ; Iatrogenic Disease

Drug-Related Side Effects and Adverse Reactions ; Heart ; Humans ; Immune Checkpoint Inhibitors ; Neoplasms/drug therapy*

BACKGROUND: Some depressed patients receive acupuncture as an adjunct to their conventional medications. OBJECTIVE: This review aims to provide evidence on whether acupuncture can enhance the therapeutic effectiveness of antidepressants for treating depression, and explore whether acupuncture can reduce the adverse reactions associated with antidepressants. SEARCH STRATEGY: English and Chinese databases were searched for randomized controlled trials (RCTs) published until December 1, 2021. INCLUSION CRITERIA: RCTs with a modified Jadad scale score ≥ 4 were included if they compared a group of participants with depression that received acupuncture combined with antidepressants with a control group that received antidepressants alone. DATA EXTRACTION AND ANALYSIS: Meta-analysis was performed, and statistical heterogeneity was assessed based on Cochran's Q statistic and its related P-value. Primary outcomes were the reduction in the severity of depression and adverse reactions associated with antidepressants, while secondary outcomes included remission rate, treatment response, social functioning, and change in antidepressant dose. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework was used to evaluate the overall quality of evidence in the included studies. RESULTS: This review included 16 studies (with a total of 1958 participants). Most studies were at high risk of performance bias and at low or unclear risk of selection bias, detection bias, attrition bias, reporting bias, and other bias. Analysis of the 16 RCTs showed that, compared with antidepressants alone, acupuncture along with antidepressants reduced the Hamilton Depression Rating Scale-17 (HAMD-17) scores (standard mean difference [SMD] -0.44, 95% confidence interval [CI] -0.55 to -0.33, P < 0.01; I² = 14%), Self-rating Depression Scale (SDS) scores (SMD -0.53, 95% CI -0.84 to -0.23, P < 0.01; I² = 79%), and the Side Effect Rating Scale (SERS) scores (SMD -1.11, 95% CI -1.56 to -0.66, P < 0.01; I² = 89%). Compared with antidepressants alone, acupuncture along with antidepressants improved World Health Organization Quality of Life-BREF scores (SMD 0.31, 95% CI 0.18 to 0.44, P < 0.01; I² = 15%), decreased the number of participants who increased their antidepressant dosages (relative risk [RR] 0.32, 95% CI 0.22 to 0.48, P < 0.01; I² = 0%), and resulted in significantly higher remission rates (RR 1.52, 95% CI 1.26 to 1.83, P < 0.01; I² = 0%) and treatment responses (RR 1.35, 95% CI 1.24 to 1.47, P < 0.01; I² = 19%) in terms of HAMD-17 scores. The HAMD-17, SDS and SERS scores were assessed as low quality by GRADE and the other indices as being of moderate quality. CONCLUSION: Acupuncture as an adjunct to antidepressants may enhance the therapeutic effectiveness and reduce the adverse drug reactions in patients receiving antidepressants. These findings must be interpreted with caution, as the evidence was of low or moderate quality and there was a lack of comparative data with a placebo control. SYSTEMATIC REVIEW REGISTRATION INPLASY202150008.
Acupuncture Therapy/methods* ; Antidepressive Agents/adverse effects* ; Depression/drug therapy* ; Drug-Related Side Effects and Adverse Reactions/drug therapy* ; Humans

OBJECTIVETo observe clinical therapeutic effect and safety of combination of acupuncture with medication for treatment of spontaneous tremor.

METHODSWith randomized controlled trial method, 26 cases of spontaneous tremor were divided into a treatment group (n = 13) treated with acupuncture plus western medicine, and a control group (n = 13) treated with simple western medicine. They were treated for 6 weeks. Scores of tremor before and after treatment and adverse effects were investigated.

RESULTSThe total effective rate of 84.6% in the treatment group was better than 61.5% in the control group (P < 0.05) and there was less adverse effects in the treatment group.

CONCLUSIONCombination of acupuncture with medication is a safe and effective therapy for spontaneous tremor.

Adverse drug reaction (ADR) causality judgement is a routine procedure in pharmacovigilance, no unified judgement standard and categories standard are established. Temporal relations, consistency, specificity, intensity of reaction are the basic principle of ADR causality jugement we should abide by. There are many ADR causality assessment methods, which classifies standard algorithms, expert judgement, bayesian approches. The implicit definitions of some categories standard, incomplete information from case reports coupled with vast differences in the application of clinical judgements are the major problems facing ADR evaluation. Almost every kind of method shares certain common feature, that is, causal relationship of ADR is classified about five categories. However, causality assessment methods differ in basic principle, evaluation standard, specificity and sensitivity. There are some advantages and disadvantages among methods, but no causality assessment method can be applied to all ADR evaluation to date.
Adverse Drug Reaction Reporting Systems ; standards ; China ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; Humans ; Pharmaceutical Preparations ; administration & dosage