Effect of repeated Shengmai-San administration on nifedipine pharmacokinetics and the risk/benefit under co-treatment

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Abstract

Herbal interactions with nifedipine/felodipine through cytochrome P450 (CYP) 3A inhibition is significant in humans. Shengmai-San (SMS), a three-herbal formula of Chinese medicine, is commonly prescribed in Asia populations for cardiovascular disorders. This study aimed to elucidate the impact of SMS on nifedipine/felodipine treatment by the findings from rat pharmacokinetic study of nifedipine to the retrospective cohort study of patients with hypertension. The 3-week SMS treatment increased the systemic exposure to nifedipine by nearly two-fold and decreased nifedipine clearance by 39% in rats. Among the ingredients of SMS component herbs, schisandrin B, schisantherin A, and methylophiopogonanone A, inhibited the nifedipine oxidation (NFO) activities of rat hepatic and intestinal microsomes, as well as human CYP3A4. Methylophiopogonanone A was identified as a time-dependent inhibitor of CYP3A4. After 1:5 propensity score matching, 4,894 patients with nifedipine/felodipine use were analyzed. In patients receiving nifedipine/felodipine, the subgroup with concurrent SMS treatment had a higher incidence of headache (92.70 per 1,000 personyears) than the subgroup without SMS treatment (51.10 per 1,000 person-years). There was a positive association between headache incidence and cumulative doses of SMS (1–60 g SMS: hazard ratio (HR): 1.39; 95% confidence interval (CI): 1.11–1.74; >60 g SMS: HR: 1.97; 95% CI: 1.62–2.39; p < 0.0001). However, patients who had higher cumulative SMS doses had a lower risk of all-cause mortality (1–60 g SMS: HR: 0.67; 95% CI: 0.47–0.94; >60 g SMS: HR: 0.54; 95% CI: 0.37–0.79; p = 0.001). Results demonstrated increased rat plasma nifedipine levels after 3-week SMS treatment and increased headache incidence should be noted in nifedipine/felodipine-treated patients with prolonged SMS administration.

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Is Open Access

PROTEIN MEASUREMENT WITH THE FOLIN PHENOL REAGENT

OliverH. Lowry, NiraJ. Rosebrough, A. Lewis Farr … (1951)

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Negative controls: a tool for detecting confounding and bias in observational studies.

Marc Lipsitch, Eric Tchetgen Tchetgen, Ted Cohen (2010)

Noncausal associations between exposures and outcomes are a threat to validity of causal inference in observational studies. Many techniques have been developed for study design and analysis to identify and eliminate such errors. Such problems are not expected to compromise experimental studies, where careful standardization of conditions (for laboratory work) and randomization (for population studies) should, if applied properly, eliminate most such noncausal associations. We argue, however, that a routine precaution taken in the design of biologic laboratory experiments--the use of "negative controls"--is designed to detect both suspected and unsuspected sources of spurious causal inference. In epidemiology, analogous negative controls help to identify and resolve confounding as well as other sources of error, including recall bias or analytic flaws. We distinguish 2 types of negative controls (exposure controls and outcome controls), describe examples of each type from the epidemiologic literature, and identify the conditions for the use of such negative controls to detect confounding. We conclude that negative controls should be more commonly employed in observational studies, and that additional work is needed to specify the conditions under which negative controls will be sensitive detectors of other sources of error in observational studies.

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Validation of the National Health Insurance Research Database with ischemic stroke cases in Taiwan.

Ching-Lan Cheng, Yea-Huei Yang Kao, Swu-Jane Lin … (2011)

The National Health Insurance Research Database (NHIRD) is commonly used for pharmacoepidemiological research in Taiwan. This study evaluated the validity of the database for patients with a principal diagnosis of ischemic stroke. This cross-sectional study compares records in the NHIRD with those in one medical center. Patients hospitalized for ischemic stroke in 1999 were identified from both databases. The discharge notes, laboratory data, and medication orders during admission and the first discharge visit were reviewed to validate ischemic stroke diagnoses and aspirin prescribing in the NHIRD. Agreement between the two databases in comorbidities of ischemic stroke diagnosis was evaluated using ICD-9 codes. Three hundred and seventy two cases were identified from the NHIRD; among them, 364 cases (97.85%) were confirmed as ischemic stroke by radiology examination and clinical presentation. Among these confirmed cases, 344 (94.51%) were assigned 'ischemic stroke' as the principal diagnosis in the NHIRD. The overall agreement of comorbid diagnoses between the databases was 48.39%. The PPV for selected conditions also varied widely, from 0.50 for fracture to 1.00 for colon cancer. The accuracy of recorded aspirin prescriptions was higher in first post-discharge visits (PPV = 0.94) than during hospitalization (PPV = 0.88). The accuracy of the NHIRD in recording ischemic stroke diagnoses and aspirin prescriptions was high, and the NHIRD appears to be a valid resource for population research in ischemic stroke. Copyright © 2010 John Wiley & Sons, Ltd.

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Author and article information

Journal

Journal ID (nlm-ta): J Food Drug Anal

Journal ID (iso-abbrev): J Food Drug Anal

Title: Journal of Food and Drug Analysis

Publisher: Taiwan Food and Drug Administration

ISSN (Print): 1021-9498

ISSN (Electronic): 2224-6614

Publication date (Electronic, collection): 2022

Publication date (Electronic, pub): 15 March 2022

Volume: 30

Issue: 1

Pages: 111-127

Affiliations

[a ]School of Pharmacy, National Defense Medical Center, Taipei, Taiwan

[b ]Division of Clinical Chinese Medicine, National Research Institute of Chinese Medicine, Taipei, Taiwan

[c ]Institute of Hospital and Health Care Administration, National Yang Ming Chiao Tung University, Taipei, Taiwan

[d ]Department of Pharmacy, National Yang Ming Chiao Tung University, Taipei, Taiwan

[e ]Division of Basic Chinese Medicine, National Research Institute of Chinese Medicine, Taipei, Taiwan

[f ]Institute of Biopharmaceutical Sciences, School of Pharmaceutical Sciences, National Yang Ming Chiao Tung University, Taipei, Taiwan

[g ]Division of Chinese Medicinal Chemistry, National Research Institute of Chinese Medicine, Taipei, Taiwan

[h ]Graduate Institute of Medical Sciences, College of Medicine, Taipei Medical University, Taipei, Taiwan

[i ]Cell Physiology and Molecular Image Research Center, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan

Author notes

[* ]Corresponding author at: Division of Basic Chinese Medicine National Research Institute of Chinese Medicine 155-1, Li-Nong Street, Sec. 2, Taipei 112, Taiwan. Fax: +886 2 28264266. E-mail address: ueng@ 123456nricm.edu.tw (Y.-F. Ueng).

[1]

Equal contribution.

Article

Publisher ID: jfda-30-111

DOI: 10.38212/2224-6614.3401

PMC ID: 9931008

PubMed ID: 35647719

SO-VID: dfaf0751-716d-4618-abb5-6053ce802c75

License:

This is an open access article under the CC-BY-NC-ND license ( http://creativecommons.org/licenses/by-nc-nd/4.0/).

History

Date received : 28 July 2021

Date revision received : 16 October 2021

Date accepted : 18 January 2022

Funding

Funded by: National Research Institute of Chinese Medicine, Ministry of Health and Welfare, Taiwan

Award ID: MOHW107-NRICM-D-315-000005

Award ID: MOHW108-NRICM-D-325-113101

Award ID: MOHW110-NRICM-D-325-000101

Funded by: National Defense Medical Center, Taiwan

Award ID: MAB-106-078

This work was supported by grants from the National Research Institute of Chinese Medicine, Ministry of Health and Welfare, Taiwan [MOHW107-NRICM-D-315-000005, MOHW108-NRICM-D-325-113101, MOHW110-NRICM-D-325-000101]; and National Defense Medical Center, Taiwan [MAB-106-078].