Safety Evaluation of Natural Drugs in Chronic Skeletal Disorders: A Literature Review of Clinical Trials in the Past 20 years

Chronic skeletal disorders (CSDs), including degenerative diseases such as osteoporosis (OP) and autoimmune disorders, have become a leading cause of disability in an ageing society, with natural drugs being indispensable therapeutic options. The clinical safety evaluation (CSE) of natural drugs in CSDs has been given priority and has been intensively studied. To provide fundamental evidence for the clinical application of natural drugs in the elderly population, clinical studies of natural drugs in CSDs included in this review were selected from CNKI, Web of Science, PubMed, Science Direct and Google Scholar since 2001. Seventeen randomized controlled trials (RCTs) met our inclusion criteria: four articles were on OP, seven on osteoarthritis (OA), four on rheumatoid arthritis (RA) and two on gout. Common natural drugs used for the treatment of OP include Epimedium brevicornu Maxim [Berberidaceae], Dipsacus asper Wall ex DC [Caprifoliaceae] root, and Phalaenopsis cornu-cervi (Breda) Blume & Rchb. f[ Orchidaceae], which have been linked to several mild adverse reactions, such as skin rash, gastric dysfunction, abnormal urine, constipation and irritability. The safety of Hedera helix L [Araliaceae] extract, Boswellia serrata Roxb [Burseraceae] extract and extract from perna canaliculus was evaluated in OA and upper abdominal pain, and unstable movements were obsrerved as major side effects. Adverse events, including pneumonia, vomiting, diarrhoea and upper respiratory tract infection, were reported when RA was treated with Tripterygium wilfordii, Hook. F [Celastraceae][TwHF] polyglycosides and quercetin (Capsella bursa-pastoris (L.) Medik [Brassicaceae]). The present review aimed to summarize the CSE results of natural drugs in CSDs and could provide evidence-based information for clinicians.

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PROBLEMS OF PARASITIC SAFETY EVALUATION OF WATER IN SOURCES USED BY POPULATION

Periódico Tchê Química ◽

10.52571/ptq.v16.n31.2019.564_periodico31_pgs_558_564.pdf ◽

2019 ◽

Vol 16 (31) ◽

pp. 558-564

Author(s):

K. Y. KUZNETSOVA ◽

O. P. ZELYA ◽

Z. V.; ZHNAKINA ◽

T. R. MANIYA

Keyword(s):

Russian Federation ◽

Safety Evaluation ◽

Community Acquired Pneumonia ◽

Water Bodies ◽

Upper Respiratory Tract ◽

State Monitoring ◽

Factors Affecting ◽

Independent Expert ◽

The Russian Federation ◽

Tract Infections

The importance of state monitoring of water bodies on parasitological indicators is actualized in the article. It was established that summary reports of federal enterprises involved in the state monitoring of water bodies are formed without taking into account natural parasitic systems and insufficient detection of local parasitological pollution. At the same time, the incidence rate in the Russian Federation regarding giardiasis due to the water transport factor has been consistently high for several years. Cryptosporidiosis among the population is not detected due to the use of insensitive methods of diagnosis. With such an unexplored state of factors affecting public health, the level of unidentified etiological causes of acute intestinal infections, upper respiratory tract infections, and community-acquired pneumonia remains high in the Russian Federation: 70% and 90%, respectively. The article presents data on parasitic contamination of water bodies in the catchment area of the Moskva River, obtained with an independent expert survey.

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Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials

Pharmacovigilance ◽

10.1002/9780470059210.ch7 ◽

2007 ◽

pp. 75-84

Author(s):

Patricia M. Reed ◽

Stuart J. Mair ◽

Stephen Freestone

Keyword(s):

Adverse Events ◽

Phase I ◽

Safety Evaluation ◽

Phase I Trials ◽

Clinical Safety

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Enzymology in Preclinical Safety Evaluation

Toxicologic Pathology ◽

10.1177/0192623392020003207 ◽

1992 ◽

Vol 20 (3-2) ◽

pp. 501-505 ◽

Cited By ~ 6

Author(s):

Dai T. Davies

Keyword(s):

Enzyme Activities ◽

Drug Effect ◽

Safety Evaluation ◽

Diagnostic Information ◽

Maximum Amount ◽

Adverse Drug Effect ◽

Short Paper ◽

Clinical Safety ◽

Blood Samples ◽

Preclinical Safety

This short paper will briefly discuss the merits of determining plasma enzyme activities in pre-clinical safety evaluation. Emphasis is placed on the value of selecting the appropriate enzymes and collecting blood samples at the appropriate times during the study, so as to gain the maximum amount of diagnostic information. Examples of actual results will be cited to illustrate some of the points. These examples are drawn from the 2 commonly used toxicology species—the laboratory white rat and the beagle—and serve to demonstrate the importance of enzymology in monitoring the progress or resolution of an adverse drug effect.

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