This paper discusses the rational use of traditional Chinese medicine based on chemical composition, body state and biological effect. The essence and connotations of traditional Chinese medicine are explained by modern scientific theory and technical means, and the mechanism of traditional Chinese medicine in the treatment of diseases is defined in modern medicine language, which is conducive to promoting rational and safe clinical use of drugs. Based on the chemical composition of traditional Chinese medicine,the selected genuine medicinal materials were collected and processed in a standardized way, and then used in the combination with other traditional Chinese medicines, with the aim to improve the efficacy of traditional Chinese medicine in clinical indications, increase the advantages, eliminate the disadvantages, and adapt to flexible and safe clinical drug demands. Based on the body state elements, clinical diagnosis and treatment shall be patient-centered, and doctors shall distinguish the differences of pathogenesis, symptoms and diseases, and consider the drug contraindications of special groups. According to the " dose-effect-toxicity" relationship, doctors shall select the appropriate dosage form, control the drug dosage, balance the benefits and risks of drugs, and carry out appropriate medical treatment. Based on the biological effect elements and the regulatory mechanism of traditional Chinese medicine on the target and pathway of disease, traditional Chinese medicine shall strengthen the precise positioning, provide accurate treatment; evaluate the safety of traditional Chinese medicine combination, explore the adverse reaction mechanism, strengthen the clinical safety monitoring of traditional Chinese medicine, and guide the clinical rational use of drugs, in the expectation of ensuring the safe use of traditional Chinese medicine and maximize the clinical efficacy of traditional Chinese medicine.
Contraindications, Drug ; Drug Dosage Calculations ; Drugs, Chinese Herbal/therapeutic use* ; Humans ; Medicine, Chinese Traditional ; Practice Patterns, Physicians'

Objective: To investigate the association between three single nucleotide polymorphism (SNP) genes DRD2 (rs1800497, rs6275, and rs1799978) and the dosage used on methadone maintenance treatment (MMT). Methods: From the methadone maintenance treatment centers, 257 MMT patients were recruited to participate in a case-control study and divided into two groups-control groups under low dosage (n=89) and case (n=168) group with high dosage. Quanto software was used to estimate the sample size as 180. Information related to social-demographic status, history on drug use and medication were collected. And DRD2 SNPs were genotyped to explore the relationship between polymorphism of DRD2 gene and the dosage of methadone maintenance treatment. Results: Distributions of DRD2 rs6275 between different groups were significantly different. Patients carrying TC genotype needed lower dose of methadone when compared to the patients that carrying CC genotype counterparts (OR=0.338, 95% CI: 0.115-0.986). Patients that carrying C allele at rs6275 needed lower methadone dose than those that carrying genotype TT (OR=0.352, 95% CI: 0.127-0.975). Distributions of genotypes, alles in the other two SNPs (rs1800497, rs1799978) were not significantly different between groups under different dosages. Conclusion: DRD2 rs6275 was associated with dosage of methadone used for the MMT patients. However, no significant associations were found between rs1800497, rs1799978 and the dosage of methadone.
Alleles ; Case-Control Studies ; Drug Dosage Calculations ; Genotype ; Humans ; Methadone/therapeutic use* ; Opiate Substitution Treatment ; Opioid-Related Disorders/rehabilitation* ; Polymorphism, Single Nucleotide/genetics* ; Receptors, Dopamine D2/genetics*

BACKGROUND: The high cost of intrathecal morphine pump (ITMP) implantation may be the main obstacle to its use. Since July 2014, the Korean national health insurance (NHI) program began paying 50% of the ITMP implantation cost in select refractory chronic pain patients. The aims of this study were to investigate the financial break-even point and patients' satisfaction in patients with ITMP treatment after the initiation of the NHI reimbursement. METHODS: We collected data retrospectively or via direct phone calls to patients who underwent ITMP implantation at a single university-based tertiary hospital between July 2014 and May 2016. Pain severity, changes in the morphine equivalent daily dosage (MEDD), any adverse events, and patients' satisfaction were determined. We calculated the financial break-even point of ITMP implantation via investigating the patient's actual medical costs and insurance information. RESULTS: During the studied period, 23 patients received ITMP implantation, and 20 patients were included in our study. Scores on an 11-point numeric rating scale (NRS) for pain were significantly reduced compared to the baseline value (P < 0.001). The MEDD before ITMP implantation was 0.59 [IQR: 0.55–0.82]. The total MEDD increased steadily to 0.77 [IQR: 0.53–1.08] at 1 year, which was 126% of the baseline (P < 0.001). More than a half (60%) responded that the ITMP therapy was somewhat satisfying. The financial break-even point was 28 months for ITMP treatment after the NHI reimbursement policy. CONCLUSIONS: ITMP provided effective chronic pain management with improved satisfaction and reasonable financial break-even point of 28 months with 50% financial coverage by NHI program.
Chronic Pain ; Drug Dosage Calculations ; Humans ; Insurance ; Insurance, Health ; Korea* ; Morphine* ; National Health Programs ; Patient Satisfaction ; Retrospective Studies* ; Tertiary Care Centers

OBJECTIVES: The primary purpose of this study was to investigate the factors related with additional administration of sedative agent during intravenous conscious sedation (IVS) using midazolam (MDZ). The secondary purpose was to analyze the factors affecting patient satisfaction. MATERIALS AND METHODS: Clinical data for 124 patients who had undergone surgical extraction of mandibular third molar under IVS using MDZ were retrospectively investigated in this case-control study. The initial dose of MDZ was determined by body mass index (BMI) and weight. In the case of insufficient sedation at the beginning of surgery, additional doses were injected. During surgery, peripheral oxygen saturation, bispectral index score (BIS), heart rate, and blood pressure were monitored and recorded. The predictor variables were sex, age, BMI, sleeping time ratio, dental anxiety, Pederson scale, and initial dose of MDZ. The outcome variables were additional administration of MDZ, observer's assessment of alertness/sedation, intraoperative amnesia, and patient satisfaction. Descriptive statistics were computed, and the P-value was set at 0.05. RESULTS: Most patients had an adequate level of sedation with only the initial dose of MDZ and were satisfied with the treatment under sedation; however, 19 patients needed additional administration, and 13 patients were unsatisfied. In multivariable logistic analysis, lower age (odds ratio [OR], 0.825; P=0.005) and higher dental anxiety (OR, 5.744; P=0.003) were related to additional administration; lower intraoperative amnesia (OR, 0.228; P=0.002) and higher BIS right before MDZ administration (OR, 1.379; P=0.029) had relevance to patient dissatisfaction. CONCLUSION: The preoperative consideration of age and dental anxiety is necessary for appropriate dose determination of MDZ in the minor oral surgery under IVS. The amnesia about the procedure affects patient satisfaction positively.
Amnesia ; Blood Pressure ; Body Mass Index ; Case-Control Studies ; Conscious Sedation* ; Dental Anxiety ; Drug Dosage Calculations ; Heart Rate ; Humans ; Midazolam* ; Molar, Third* ; Oxygen ; Patient Satisfaction ; Retrospective Studies ; Risk Factors* ; Surgery, Oral

The objective of this study was to externally validate a new dosing scheme for busulfan. Thirty-seven adult patients who received busulfan as conditioning therapy for hematopoietic stem cell transplantation (HCT) participated in this prospective study. Patients were randomized to receive intravenous busulfan, either as the conventional dosage (3.2 mg/kg daily) or according to the new dosing scheme based on their actual body weight (ABW) (23×ABW(0.5) mg daily) targeting an area under the concentration-time curve (AUC) of 5924 µM·min. Pharmacokinetic profiles were collected using a limited sampling strategy by randomly selecting 2 time points at 3.5, 5, 6, 7 or 22 hours after starting busulfan administration. Using an established population pharmacokinetic model with NONMEM software, busulfan concentrations at the available blood sampling times were predicted from dosage history and demographic data. The predicted and measured concentrations were compared by a visual predictive check (VPC). Maximum a posteriori Bayesian estimators were estimated to calculate the predicted AUC (AUC(PRED)). The accuracy and precision of the AUC(PRED) values were assessed by calculating the mean prediction error (MPE) and root mean squared prediction error (RMSE), and compared with the target AUC of 5924 µM·min. VPC showed that most data fell within the 95% prediction interval. MPE and RMSE of AUCPRED were -5.8% and 20.6%, respectively, in the conventional dosing group and −2.1% and 14.0%, respectively, in the new dosing scheme group. These fi ndings demonstrated the validity of a new dosing scheme for daily intravenous busulfan used as conditioning therapy for HCT.
Adult* ; Area Under Curve ; Behavior Therapy ; Body Weight ; Busulfan* ; Drug Dosage Calculations ; Hematopoietic Stem Cell Transplantation* ; Hematopoietic Stem Cells* ; Humans ; Pharmacokinetics ; Prospective Studies*

Child ; Dose-Response Relationship, Drug ; Drug Dosage Calculations ; Humans ; Precision Medicine

OBJECTIVETo study the anti-immune inflammation efficacy and toxicity of Tripterygium wilfordii decoction, in order to provide experimental basis for studies on its "efficacy-toxicity" correlation.

METHODThe delayed hypersensitivity model was established by dinitrofluorobenzene in mice. Different doses of T. wilfordii decoction was administered for 5 consecutive days. The ear swelling inhibition ratio and the toxic action were observed. After the final administration, the biochemical indexes of PGE2, TNF-α, IL-2, ALT, AST, PA, TBA, TBIL in serum were detected, and the visceral indexes of heart, liver, spleen and kidney were measured.

RESULTThe DNFB-induced ear swelling could be notably inhibited by multiple oral administration of T. wilfordii decoction, with the ED50 and its 95% confidence limit of 0.34 (0.21-0.42) g x kg(-1). The contents of PGE2, TNF-α, IL-2 in serum decreased in a dose-dependent manner. The activities of serum AST, ALT, TBA, TBIL and the PA content reduced.

CONCLUSIONT. wilfordii decoction shows a significant anti-immune inflammation efficacy within the dosage range between 0.59 and 2.34 g x kg(-1) in a dose-dependent manner. With a certain hepatotoxicity, high dose (2.34-4.68 g x kg(-1)) of T. wilfordii decoction can cause substantial liver injury, with a dose dependence in liver function index. Therefore, the efficacy and toxicity of T. wilfordii is dose dependent, which provides reference for preventing adverse drug reactions in clinic and developing early-warning schemes and ensure the clinical medication safety of T. wilfordii.

Animals ; Anti-Inflammatory Agents ; administration & dosage ; chemistry ; toxicity ; Drug Dosage Calculations ; Drug Evaluation, Preclinical ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; toxicity ; Edema ; drug therapy ; genetics ; immunology ; Humans ; Interleukin-2 ; genetics ; immunology ; Male ; Mice ; Tripterygium ; chemistry ; toxicity ; Tumor Necrosis Factor-alpha ; genetics ; immunology

OBJECTIVETo optimize the prescription dose of Mahuang decoction in a multi-target manner, in order to provide reference for the quantitative optimization of the prescription dose of the traditional Chinese medicine compound.

METHODThe number of diaphoretic spots in rats, the tracheal antispasmodic rate in guinea pigs and the writhing times by acetic acid in mice were taken as the indexes for evaluating the diaphoretic, antispasmodic and analgesic effects. According to the experimental results of the 16 orthogonal combination prescriptions, a mathematical dose-effect model was built by support vector regression (SVR) and quadratic response surface regression (RSR) respectively. The multi-target optimization was achieved by elitist non-dominated sorting genetic algorithm (NSGA-II) and entropy weight TOPSIS method.

RESULTThe optimal dose of Mahuang decoction after being optimized by SVR modeling contained 17.71 g of Ephedrae Herba, 9.57 g of Cinnamomi Ramulus, 11.75 g of Armeniacae Semen Amarum and 4.39 g of Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle. The optimized result by RSR modeling contained 13.37 g of Ephedrae Herba, 11.61 g of Cinnamomi Ramulus, 11.98 g of Armeniacae Semen Amarum and 5.67 g of Glycyrrhizae Radix et Rhizoma Praeparate Cum Melle. SVR was superior to RSR in both of the forecast capacity and optimization results.

CONCLUSIONSVR-NSGA-II-TOPSIS method could be adopted for the multi-target optimization for the dose of Mahuang decoction and other traditional Chinese medicine compounds. It is proved to be the optimal prescription with the best efficacy, and could provide scientific quantitative basis for determining the dose of traditional Chinese medicine compound prescriptions and developing new traditional Chinese medicines.

Animals ; Cinnamomum ; chemistry ; Drug Compounding ; methods ; Drug Dosage Calculations ; Drug Prescriptions ; Ephedra ; chemistry ; Ephedra sinica ; chemistry ; Glycyrrhiza ; chemistry ; Guinea Pigs ; Mice ; Rats

Due to the limitation of science and technology in ancient times, traditional Chinese medicines (TCMs) could have prepared only in traditional dosage forms, such as pills, powders, ointments and pellets. Though studies on multi-component TCMs have become one of major development orientations of TCM, the druggability of their preparations has always been neglected. On the basis of two key difficulties--the integration of studies on multi-component TCMs and TCM theory as well as the evaluation on their druggability, the essay proposes methods and technologies that can be adopted in studies on multi-component TCM preparations, including the characteristic physicochemical property of multi-component TCMs and its correlation with forming process, the release-modified micro pill preparation technology based on prescription-symptom-dosage, and the evaluation technology on release of release-modified micro pill components based on mathematical set model.
Chemical Phenomena ; Drug Compounding ; Drug Dosage Calculations ; Medicine, Chinese Traditional ; methods ; Models, Theoretical

Chinese Pharmacopoeia I (2010 edition) covers dosage and usage of traditional Chinese medicinal herbs and decoction pieces, and provides dosage ranges of most of decoction pieces. By using the descriptive statistical method, the article discusses the distribution of maximum dosage, minimum dosage and dosage range of decoction pieces set forth in Chinese Pharmacopoeia, and compares toxic drugs and non-toxic drugs. Altogether 617 drugs are included into the study. Except for 16 decoction pieces whose dosages are not clear, all of the remaining decoction pieces are covered by Chinese Pharmacopoeia, with the maximum common dosage, minimum common dosage and dosage range of 3, 10 and 6 g. Upon comparison, we discovered that Chinese Pharmacopoeia sets stricter standards for toxic drugs than non-toxic drugs. Compared with dosages in classical prescriptions and actual clinical usages, dosage ranges described in Chinese Pharmacopoeia are much narrower. There is no significant difference between drugs that can be used as foods or healthcare foods and other drugs according to Chinese Pharmacopoeia.
Drug Dosage Calculations ; Drug Therapy ; standards ; Drugs, Chinese Herbal ; chemistry ; pharmacology ; toxicity ; Humans ; Prescriptions ; standards