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1.
Zhongguo Zhong Yao Za Zhi ; 49(16): 4273-4278, 2024 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-39307763

RESUMO

Oral Chinese patent medicine is the essence of effective prescriptions created and summarized by Chinese medical scientists through thousands of years of medical practice. It is portable and convenient, with an obvious curative effect and other characteristics. However, at present, oral Chinese patent medicine is rich in dosage forms, various in types, complex in mechanism of action, and broad in clinical positioning. In clinical application, there are often cases of drug use without reference to instructions,repeated drug use, and prolonged drug use, which highlights safety problems such as adverse reactions and hepatorenal toxicity. Oral Chinese patent medicine pharmacovigilance is facing challenges. World Health Organization(WHO) has issued the WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH) has issued the ICH E2 pharmacovigilance guidelines. The United States has issued the Pharmacovigilance management standards and pharmacoepidemiological assessment guidelines, and the European Union has issued the Guidelines on good pharmacovigilance practices. Japan, South Korea, and other countries in the Asia Pacific region have established their own pharmacovigilance systems, but currently, there are no pharmacovigilance guidelines related to oral Chinese patent medicine in China. Therefore, experts from many disciplines and fields in China were invited to jointly develop the Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines, which aims to develop pharmacovigilance guidelines for clinical application that are consistent with China's national conditions and highlight the characteristics of oral Chinese patent medicine, and provide guidance for clinically safe and rational drug application in medical institutions.


Assuntos
Medicamentos de Ervas Chinesas , Farmacovigilância , Humanos , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/normas , Medicamentos sem Prescrição/efeitos adversos , Administração Oral , Medicina Tradicional Chinesa/normas , China , Guias como Assunto
2.
Zhongguo Zhong Yao Za Zhi ; 49(16): 4285-4290, 2024 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-39307765

RESUMO

There are many kinds and dosage forms of Chinese patent medicines for external use on the market, which are widely used in clinical departments. The common adverse reactions of Chinese patent medicines for external use are skin reactions, and those for the rare severe diseases include palpitation, chest tightness, dyspnea, and anaphylactic shock. At present, World Health Organization(WHO), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH),the United States, the European Union, and Asia-Pacific countries(such as Japan and South Korea) have not issued any pharmacovigilance guideline of Chinese patent medicines for external use. China has not issued any pharmacovigilance guideline for these medicines, only releasing the standard Evaluation of skin adverse reactions caused by Chinese patent medicines for external use(T/CACM 005-2017). To standardize the safe and reasonable use of Chinese patent medicines for external use, Pharmacovigilance guidelines for clinical application of Chinese patent medicines for external use was developed with the joint efforts of experts in diverse disciplines. The guideline provides guidance on the monitoring and reporting of adverse reactions/events, identification and assessment of risk signals, and risk control measures in the clinical application of Chinese patent medicines for external use to guide the rational use of these medicines in clinical practice. At the same time, the possible risks and risk control measures in clinical application of Chinese patent medicines for external use are listed for clinical reference. In addition, the guideline provides guidance for risk minimization plans and the standardization of activities related to pharmacovigilance of Chinese patent medicines for external use in China.


Assuntos
Medicamentos de Ervas Chinesas , Farmacovigilância , Humanos , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos de Ervas Chinesas/normas , China , Medicamentos sem Prescrição/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
3.
Zhongguo Zhong Yao Za Zhi ; 49(16): 4261-4265, 2024 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-39307761

RESUMO

Drug administration law of the People's Republic of China(2019 revised edition), which came into effect on December 1, 2019, proposed that " the state shall establish a pharmacovigilance system". Pharmacovigilance work of Chinese patent medicines is more difficult, and it is necessary to carry out Pharmacovigilance activities that are in line with the characteristics of Chinese patent medicines. Pharmacovigilance guidelines of Chinese patent medicines(T/CACM 1563. 1-2024), based on the principles of Drug Administration Law of the People's Republic of China(2019 revised edition) and Pharmacovigilance quality management standards(No. 65 of 2021) of the National Medical Products Administration, draws on the EU Pharmacovigilance regulation and the secondary guidelines of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH), and it is drafted in accordance with the provisions of Guidelines for standardization work part 1: structure and drafting rules of standardization documents(GB/T1. 1-2020) based on the characteristics of Chinese patent medicines. It serves as a general document for a series of pharmacovigilance guidelines of Chinese patent medicines, such as Guidelines for construction of traditional Chinese medicine pharmacovigilance system in medical institutions(T/CACM 1563. 2-2024), Pharmacovigilance guidelines for clinical application of oral Chinese patent medicines(T/CACM 1563. 3-2024), Pharmacovigilance guidelines for clinical application of traditional Chinese medicine injections(T/CACM 1563. 4-2024), Pharmacovigilance guidelines for clinical application of Chinese patent medicines for external use(T/CACM 1563. 5-2024), and Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration(T/CACM 1563. 6-2024), including four major elements of pharmacovigilance monitoring and reporting of Chinese patent medicines, signal identification, risk evaluation, and risk control, as well as pharmacovigilance activities for Chinese patent medicines, ensuring the safety of public drug use.


Assuntos
Medicamentos de Ervas Chinesas , Farmacovigilância , Humanos , China , Medicamentos de Ervas Chinesas/normas , Medicamentos de Ervas Chinesas/efeitos adversos , Medicamentos sem Prescrição/normas , Medicamentos sem Prescrição/efeitos adversos , Guias como Assunto , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
4.
Zhongguo Zhong Yao Za Zhi ; 49(16): 4291-4297, 2024 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-39307766

RESUMO

The group standard Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration was released on January 16, 2024, on the national group standards information platform by the Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences and School and Hospital of Stomatology of Peking University, under the centralized management by the China Association of Chinese Medicine. The standard number is T/CACM 1563.6-2024. It aims to propose key elements and specify technical methods for safety monitoring and reporting, signal identification, risk assessment, and risk control based on the Drug administration law of the People's Republic of China(revised in 2019), which establishes normative pharmacovigilance guideline of Chinese patent medicine for mucosal administration that is in line with the characteristics of traditional Chinese Medicine(TCM) based on the pharmacovigilance content for clinical application of Chinese patent medicine for mucosal administration. The group standard has been discussed by internal and external experts through multiple rounds of consultation. It serves as a guiding document for stakeholders involved in pharmacovigilance activities, including pharmaceutical license holders, drug manufacturers, medical institutions, research institutes, and pharmaceutical trading enterprises.


Assuntos
Medicamentos de Ervas Chinesas , Farmacovigilância , Humanos , Medicamentos de Ervas Chinesas/normas , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/efeitos adversos , China , Administração através da Mucosa , Medicina Tradicional Chinesa/normas , Medicamentos sem Prescrição
5.
Zhongguo Zhong Yao Za Zhi ; 49(16): 4537-4544, 2024 Aug.
Artigo em Chinês | MEDLINE | ID: mdl-39307790

RESUMO

Chinese patent medicine constitutes a vital segment of the traditional Chinese medicine(TCM) industry and stands as a significant emblem of TCM modernization. At present, the quality stability between batches of Chinese patent medicine preparations has become a pivotal factor directly restricting the high-quality development of the TCM industry. Consequently, addressing the homogeneity of Chinese patent medicines, this paper proposes a research scheme of homogenization feeding. It systematically elaborates on the object and pretreatment of homogenization, operational procedures of homogenization feeding, selection of homogenization evaluation indices, homogenization feeding algorithm, and homogenization feeding process. With the key quality control indicators as the homogenization target, the homogenization feeding process and its quality analysis were discussed. Finally, a demonstration strategy for homogenization feeding of Chinese patent medicine was formed, providing the scientific basis for advancing the research of quality consistency across batches of Chinese patent medicine preparations.


Assuntos
Medicamentos de Ervas Chinesas , Medicina Tradicional Chinesa , Controle de Qualidade , Medicamentos de Ervas Chinesas/química , Medicamentos de Ervas Chinesas/normas , Medicamentos sem Prescrição/química , Composição de Medicamentos/métodos
6.
Zhongguo Zhong Yao Za Zhi ; 49(17): 4786-4800, 2024 Sep.
Artigo em Chinês | MEDLINE | ID: mdl-39307813

RESUMO

The effectiveness and safety of various oral Chinese patent medicines combined with conventional western medicine in treatment of gastro-esophageal reflux disease(GERD) were evaluated using network Meta-analysis. CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science were searched for randomized controlled trial(RCT) of oral Chinese patent medicines combined with conventional western medicine in treatment of GERD from inception to September 2023. The quality of the included studies was assessed using the Cochrane risk-of-bias tool, and data analysis was conducted using RevMan 5.4 and Stata 16 software. Forty-seven RCTs were included, involving 10 oral Chinese patent medicines, including Jianwei Yuyang Tablets, Qizhi Weitong Granules, Dalitong Granules, Liuwei Anxiao Capsules, Kangfuxin Liquid, Weisu Granules, Zhizhu Kuanzhong Capsules, Xiaochaihu Granules, Xiaoyao Pills, and Danweikang Capsules. Network Meta-analysis showed that:(1)in terms of effective rate of clinical symptoms, intervention measure ranked first by SUCRA was Dalitong Granules + conventional western medicine.(2)In terms of endoscopic effective rate, intervention measure ranked first by SUCRA was Liuwei Anxiao Capsules + conventional western medicine.(3)In terms of increasing serum gastrin levels, intervention measure ranked first by SUCRA was Weisu Granules + conventional western medicine.(4)In terms of increasing plasma motilin level, intervention measure ranked first by SUCRA was Xiaoyao Pills + conventional western medicine. In terms of symptom scores, quality of life and recurrence rate, only descriptive analyses were performed due to the heterogeneity of the studies, but all studies reported that oral Chinese patent medicines combined with conventional western medicine improved the outcome indicators better than conventional western medicine alone, and the differences were statistically significant. In terms of adverse reactions, there was no significant difference between oral Chinese patent medicine combined with conventional western medicine and conventional western medicine alone. Through cluster analysis, it was found that the comprehensive efficacy of Dalitong Granules + conventional western medicine, Danweikang Capsules + conventional western medicine, Qizhi Weitong Granules + conventional western medicine, Kangfuxin Liquid + conventional western medicine, and Liuwei Anxiao Capsules + conventional western medicine were more prominent, and could improve clinical symptoms and endoscopic inflammation at the same time. The results indicated that oral Chinese patent medicines combined with conventional western medicine in treatment of GERD could improve comprehensive efficacy, alleviate clinical symptoms, and regulate gastrointestinal motility. However, due to limitations such as sample size and quality of the included literature, the conclusions need to be further verified by more large-sample, high-quality studies.


Assuntos
Medicamentos de Ervas Chinesas , Refluxo Gastroesofágico , Humanos , Medicamentos de Ervas Chinesas/administração & dosagem , Medicamentos de Ervas Chinesas/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Ensaios Clínicos Controlados Aleatórios como Assunto , Metanálise em Rede , Medicamentos sem Prescrição , Administração Oral , Adulto , Resultado do Tratamento , Masculino , Pessoa de Meia-Idade , Feminino , Quimioterapia Combinada
7.
Nursing ; 54(10): 44-47, 2024 Oct 01.
Artigo em Inglês | MEDLINE | ID: mdl-39302751

RESUMO

ABSTRACT: Allergic rhinitis (AR), commonly called hay fever, is primarily caused by the release of histamine after exposure to an allergen. This article reviews over-the-counter nasal spray options for the prevention and treatment of AR, including mechanisms of action, risks and benefits, and patient education.


Assuntos
Sprays Nasais , Medicamentos sem Prescrição , Educação de Pacientes como Assunto , Rinite Alérgica Sazonal , Humanos , Rinite Alérgica Sazonal/tratamento farmacológico , Medicamentos sem Prescrição/administração & dosagem , Medicamentos sem Prescrição/uso terapêutico , Medicamentos sem Prescrição/efeitos adversos
8.
Sci Rep ; 14(1): 21971, 2024 09 20.
Artigo em Inglês | MEDLINE | ID: mdl-39304685

RESUMO

We analyzed data from positively tested COVID-19 outpatients to describe self-medication with OTC drugs and use of other remedies against symptoms of SARS-CoV-2 infection. We specifically considered their type and frequency, as well as associations with patient characteristics, and reasons for use. Data were collected between May 1, 2020 and February 22, 2021 with two questionnaires in an observational cohort study with PCR-confirmed SARS-CoV-2-positive adult outpatients in the district of Western Pomerania in Germany. 523 out of 710 outpatients (74%; 340 women and 183 men) reported using drugs and other remedies to relieve COVID-19-symptoms. Overall, participants reported utilization of 1282 finished dosage products or remedies, including 213 different ingredients. In the population of 710 outpatients, utilization of ibuprofen (26%), acetaminophen (21%), metamizole (14%), and acetylsalicylic acid (10%) was most commonly reported. Phytopharmaceuticals, herbal and animal products as well as vitamins and minerals were also frequently reported. Among the 523 participants who used drugs and other remedies, most commonly mentioned reasons for use were headache (40%), other kinds of pain (e.g. myalgia; 37%), fever (24%) and cough (16%). Our analysis showed that a majority of the participants tried to alleviate COVID-19-symptoms using drugs and other remedies. Especially analgesic and antipyretic agents, followed by herbal medicines, were used very frequently.Trial registration: German Register for Clinical Studies DRKS00021672, first registration on December 1st, 2020.


Assuntos
Tratamento Farmacológico da COVID-19 , COVID-19 , Pacientes Ambulatoriais , SARS-CoV-2 , Automedicação , Humanos , Feminino , Masculino , Automedicação/estatística & dados numéricos , Alemanha/epidemiologia , Pessoa de Meia-Idade , COVID-19/epidemiologia , Adulto , Pacientes Ambulatoriais/estatística & dados numéricos , Idoso , SARS-CoV-2/isolamento & purificação , Ibuprofeno/uso terapêutico , Medicamentos sem Prescrição/uso terapêutico , Acetaminofen/uso terapêutico , Inquéritos e Questionários , Dipirona/uso terapêutico
9.
Ugeskr Laeger ; 186(36)2024 Sep 02.
Artigo em Dinamarquês | MEDLINE | ID: mdl-39320073

RESUMO

Sales of over-the-counter decongestant nasal sprays in Denmark from 2011 to 2023 have doubled. This article highlights the potential risks associated with prolonged use of decongestant nasal sprays, such as rhinitis medicamentosa. We conclude that there is an urgent need for increased patient education on proper use and possible side effects of over-the-counter decongestant nasal sprays, as well as a need for more substantial data on side effects related to decongestant nasal sprays to guide health authorities in future regulation.


Assuntos
Descongestionantes Nasais , Medicamentos sem Prescrição , Rinite , Humanos , Descongestionantes Nasais/efeitos adversos , Descongestionantes Nasais/administração & dosagem , Descongestionantes Nasais/uso terapêutico , Medicamentos sem Prescrição/efeitos adversos , Medicamentos sem Prescrição/administração & dosagem , Rinite/tratamento farmacológico , Rinite/induzido quimicamente , Dinamarca , Sprays Nasais
10.
Pediatr Ann ; 53(9): e330-e336, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39240181

RESUMO

There has been an overall increase in the number of suspected suicide attempts by self-poisoning among the adolescent population. Incidences of self-poisoning have increased since the coronavirus 2019 pandemic, particularly among patients age 10 to 19 years. Common agents used in self-poisoning include over-the-counter and prescription medications. It is crucial to identify adolescent patients with risk factors and provide appropriate resources to reduce the likelihood of intentional toxic ingestion. This article aims to summarize the current state of intentional toxic ingestions by adolescents, provide an overview of the most common agents implicated in self-poisoning, and discuss the best practices in screening patients. [Pediatr Ann. 2024;53(9):e330-e336.].


Assuntos
Tentativa de Suicídio , Humanos , Adolescente , Tentativa de Suicídio/estatística & dados numéricos , Intoxicação/epidemiologia , Intoxicação/diagnóstico , Fatores de Risco , Criança , Overdose de Drogas/epidemiologia , COVID-19/epidemiologia , Medicamentos sem Prescrição/intoxicação
12.
Support Care Cancer ; 32(9): 577, 2024 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-39112734

RESUMO

IMPORTANCE: Patients undergoing cancer treatment experience a multitude of skin, hair, and nail adverse events, prompting them to use non-evidence-based and often restrictive over-the-counter (OTC) recommendations to alleviate their symptoms. Comprehensively assessing evidence-based OTC modalities is crucial to enable cancer patients to comfortably resume their lives post-treatment and integrate clinically sound practices into their self-care routines. OBJECTIVE: Perform a systematic review and assessment of evidence-based OTC skin, hair, and nail care recommendations for adult patients undergoing cancer treatment. EVIDENCE REVIEW: PubMed, Cochrane, Embase, and Medline databases were searched in March 2023 to identify English articles addressing OTC skin, hair, and nail care recommendations for adult patients before, during, and after cancer chemotherapy or radiation therapy (RT). Quality was assessed with Oxford Centre for Evidence Based Medicine criteria. FINDINGS: 2192 unique articles were screened, of which 77 met inclusion criteria consisting of 54 randomized controlled trials (RCT), 8 non-randomized controlled cohorts, 1 non-randomized controlled clinical trial, 3 controlled prospective cohorts, 4 prospective cohorts, 2 controlled clinical trials, 1 prospective comparative study, 2 case reports, and 2 case series discussing 9322 patients. An additional article outside of our database search was included for a total of 78 articles. OTC skin care treatments with the best quality of evidence included moisturizing creams. Our review revealed a paucity of evidence-based hair and nail care practices. CONCLUSIONS AND RELEVANCE: This systematic review serves to highlight the efficacy of diverse OTC skin, hair, and nail care recommendations for adult cancer patients while encouraging further clinical trials to establish evidence-based management guidelines.


Assuntos
Doenças da Unha , Neoplasias , Medicamentos sem Prescrição , Humanos , Neoplasias/terapia , Neoplasias/radioterapia , Medicamentos sem Prescrição/administração & dosagem , Medicamentos sem Prescrição/uso terapêutico , Adulto , Doenças da Unha/terapia , Higiene da Pele/métodos , Dermatopatias/terapia
13.
Complement Ther Med ; 85: 103077, 2024 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-39181170

RESUMO

OBJECTIVES: To analyze the methodology, evidence, recommendations, quality, and implementation of traditional Chinese patent medicine (CPM) guidelines. METHODS: We retrieved clinical application guidelines of CPM published from 2019 to 2022. Independent screening and data extraction were performed by two evaluators. The basic information about the guidelines, including evidence and recommendations, were extracted and statistically analyzed. Quality and implementation were evaluated using the Implementation Evaluation Tool and Appraisal of Guidelines for Research & Evaluation (AGREE) II. RESULTS: In total, 29 guidelines were analyzed, including 262 recommendations and 2308 references. All the CPM guidelines followed the principle of "evidence as a core, consensus as a supplement, and experience as a reference" and the methods provided by WHO Handbook. An average of 89 references were cited in each guideline and 8 in each recommendation. Randomized controlled trials and systematic reviews constituted 89 % and 0.9 %, respectively, of all references. Low or very low-quality evidence characterized 74.5 % and weak recommendations characterized 83.6 %. Of all recommendations, 13.7 % were based on expert consensus, and 9.5 % of strong recommendations were based on low or very low-quality evidence. The AGREE II scores for each domain were: scope and purpose (79.63 %) and editorial independence (79.27 %), followed by clarity of presentation (72.59 %), stakeholder involvement (69.99 %), rigor of development (53.97 %) and applicability (5.11 %). The implementation quality of most guidelines was either high (44.8 %) or moderate (55.2 %). CONCLUSIONS: The results for CPM guidelines were impressive in terms of methodology, quality, and implementation. However, confidence in CPM recommendations was downgraded by low quality of evidence.


Assuntos
Medicina Tradicional Chinesa , Guias de Prática Clínica como Assunto , Humanos , China , Medicamentos de Ervas Chinesas/uso terapêutico , Medicamentos sem Prescrição/uso terapêutico
14.
BMJ Case Rep ; 17(8)2024 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-39214584

RESUMO

A woman in her mid-60s who is a high hypermetrope presented with bilateral eye pain and headache approximately 1 hour after taking a single dose of a widely available decongestant containing paracetamol, guaifenesin and phenylephrine hydrochloride for coryzal symptoms. She had previous successful bilateral peripheral iridotomies performed for narrow angles. At presentation, her intraocular pressures (IOPs) were significantly raised at 72 mm Hg and 66 mm Hg in the right and left eye, respectively, with bilateral corneal oedema. Her IOP was normalised with urgent treatment using 500 mg intravenous acetazolamide, pilocarpine 2%, dexamethasone 0.1% and IOP-lowering drops. She was listed for cataract surgery and was advised to avoid the precipitating agent and other over-the-counter decongestants. This is the first reported case of bilateral angle closure triggered by a decongestant with such a combination of ingredients. Clinicians should be aware of this rare side effect for prompt diagnosis and management.


Assuntos
Acetaminofen , Acetazolamida , Glaucoma de Ângulo Fechado , Humanos , Glaucoma de Ângulo Fechado/induzido quimicamente , Glaucoma de Ângulo Fechado/tratamento farmacológico , Feminino , Pessoa de Meia-Idade , Acetazolamida/uso terapêutico , Acetazolamida/administração & dosagem , Acetaminofen/efeitos adversos , Acetaminofen/administração & dosagem , Acetaminofen/uso terapêutico , Fenilefrina/efeitos adversos , Fenilefrina/administração & dosagem , Fenilefrina/uso terapêutico , Medicamentos sem Prescrição/efeitos adversos , Medicamentos sem Prescrição/administração & dosagem , Guaifenesina/efeitos adversos , Guaifenesina/administração & dosagem , Guaifenesina/uso terapêutico , Descongestionantes Nasais/efeitos adversos , Descongestionantes Nasais/administração & dosagem , Pressão Intraocular/efeitos dos fármacos , Medicamentos Compostos contra Resfriado, Influenza e Alergia/efeitos adversos , Pilocarpina/uso terapêutico , Pilocarpina/administração & dosagem , Pilocarpina/efeitos adversos , Dexametasona/administração & dosagem , Dexametasona/uso terapêutico , Dexametasona/efeitos adversos , Dor Ocular/induzido quimicamente , Dor Ocular/etiologia , Doença Aguda
15.
J Obstet Gynecol Neonatal Nurs ; 53(5): 464-476, 2024 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-39153740

RESUMO

In July 2023, the U.S. Food and Drug Administration approved Opill (norgestrel 0.075 mg), a progestin-only tablet to prevent pregnancy to be used without a prescription. Although progestin-only birth control pills were approved in 1973, it has taken 50 years for the first oral contraceptive pills to be sold over the counter. In this column, I review the evidence on the barriers to access oral contraceptive pills, the efficacy, preferences and support of a nonprescription progestin-only pill, the cost, and policy implications for health insurance coverage. I conclude with recommendations from professional organizations on over-the-counter access to hormonal contraception.


Assuntos
Medicamentos sem Prescrição , Humanos , Feminino , Estados Unidos , United States Food and Drug Administration , Anticoncepcionais Orais/administração & dosagem , Acessibilidade aos Serviços de Saúde , Aprovação de Drogas , Gravidez
16.
Syst Rev ; 13(1): 222, 2024 Aug 31.
Artigo em Inglês | MEDLINE | ID: mdl-39217375

RESUMO

BACKGROUND: Chinese patent medicines (CPMs) are widely used in China as an adjuvant treatment in dilated cardiomyopathy with heart failure (DCM-HF). However, comprehensive and systematic evidence supporting the beneficial effects of CPMs combined with current complementary and alternative medicine (CAM) treatments against DCM-HF was limited. This network meta-analysis (NMA) aimed to assess and rank the relative efficacy of eight different CPMs for DCM-HF. METHODS: To retrieve randomized controlled trials (RCTs) focusing on the use of CPMs combined with CAM for DCM-HF, the databases of PubMed, Embase, Web of Science Core Collection, Cochrane Library, ProQuest, China National Knowledge Infrastructure (CNKI), China Science Periodical Database (CSPD), Chinese Citation Database (CCD), Chinese Biomedical Literature Database (CBM), and ClinicalTrials.gov were comprehensively searched from their inception to 29 February 2024. The quality of the included RCTs was examined using the Cochrane Risk of Bias assessment tool, version 2.0 (RoB 2). Surface under the cumulative ranking curve (SUCRA) probability values were applied to rank the relative efficacy. Bayesian network meta-analysis was designed to assess the efficacy of different CPMs. RESULTS: After applying the inclusion and exclusion criteria, a total of 77 eligible RCTs involving 6980 patients were enrolled. The outcomes assessed included clinical effectiveness rate (CER), left ventricular ejection fraction (LVEF), left ventricular end-diastolic dimension (LVEDD), 6-min walk test (6MWT), brain natriuretic peptide (BNP), and cardiac output (CO). The results of the NMA indicated that Qili Qiangxin capsule (QLQX), Wenxin granule (WX), Tongxinluo capsule (TXL), Qishen Yiqi dropping pill (QSYQ), Shexiang Baoxin pill (SXBX), Yangxinshi tablet (YXST), Yixinshu capsule (YXSC), and Getong Tongluo capsule (GTTL) combined with CAM significantly improved performance compared with CAM alone in treating DCM-HF. YXST + CAM (MD = - 9.93, 95% CI - 12.83 to - 7.03) had the highest probability of being the best treatment on account of the enhancement of LVEF. WX + CAM had the highest likelihood of being the best treatment considering the improvement in LVEDD (MD = - 11.7, 95% CI - 15.70 to - 7.79) and 6MWT (MD = - 51.58, 95% CI - 73.40 to - 29.76). QLQX + CAM (MD = - 158.59, 95% CI - 267.70 to - 49.49) had the highest likelihood of being the best intervention for the reduction in BNP. TXL + CAM (MD = - 0.93, 95% CI - 1.46 to - 0.40) might be the optimal choice for increasing CO levels in DCM-HF patients. No serious treatment-emergent adverse events were observed. CONCLUSION: This NMA suggested that adding CPMs to the current CAM treatment exerted a more positive effect on DCM-HF. Thereinto, QLQX + CAM, TXL + CAM, WX + CAM, and YXST + CAM showed a preferable improvement in patients with DCM-HF when unified considering the clinical effectiveness rate and other outcomes. Furthermore, due to the lack of information on CPMs against DCM-HF and the uneven distribution of included studies among interventions, more high-quality studies are needed to provide more robust evidence to support our findings. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42023482669).


Assuntos
Teorema de Bayes , Cardiomiopatia Dilatada , Medicamentos de Ervas Chinesas , Insuficiência Cardíaca , Metanálise em Rede , Humanos , Cardiomiopatia Dilatada/tratamento farmacológico , Medicamentos de Ervas Chinesas/uso terapêutico , Insuficiência Cardíaca/tratamento farmacológico , Medicina Tradicional Chinesa/métodos , Medicamentos sem Prescrição/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto , Volume Sistólico , Resultado do Tratamento
17.
Zhongguo Zhong Yao Za Zhi ; 49(14): 3952-3962, 2024 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-39099368

RESUMO

Evidence mapping was performed to systematically search and review the clinical studies about the treatment of insomnia with Chinese patent medicines. The evidence distribution in this field was analyzed and the problems of the studies were summarized. Chinese-and English-language articles of the studies involving the Chinese patent medicines specified in three national drug catalogs for the treatment of insomnia were searched against the databases with the time interval from inception to August 2023. Figures and tables were established to present the results. Finally, 23 Chinese patent medicines were screened out, which were mentioned in 299 articles involving 236 randomized controlled trials(RCTs), 35 non-randomized controlled trials(non-RCTs), 7 retrospective studies, 17 systematic reviews/Meta-analysis, and 4 guidelines/expert recommendations or consensus. Bailemian Capsules, Wuling Capsules, and Yangxue Qingnao Granules were mentioned in a large proportion of articles. The outcome indicators included sleep rating scale, clinical response rate, safety indicators, and anxiety and depression scores. The results showed that the studies about the treatment of insomnia with Chinese patent medicines were growing. However, there was a scarcity of research evidence, and the available studies were single-center with small sample sizes and short periods. These studies spanned broad clinical scopes with inadequately emphasized advantages of TCM and insufficient outcome indicators about quality of life, follow-up, and recurrence rate. RCT exhibited a high risk of bias, and the systematic reviews/Meta-analysis demonstrated low overall quality. The retrospective studies received suboptimal scores, and the non-RCT failed to mention follow-up time, loss rate to follow-up, and sample size estimations, which compromised result reliability. It is recommended that the research protocol for Chinese patent medicines in treating insomnia should adhere to the clinical research standards of TCM. The TCM syndrome score can serves as a crucial outcome measure, and emphasis should be placed on patients' quality of life, follow-up, and recurrence prevention. Measures should be taken to enhance the accessibility and affordability of Chinese patent medicines and strengthen the connection between medical insurance policies and the policies pertaining to Chinese patent medicines. Furthermore, it is advisable to reasonably increase the inclusion of Chinese patent medicines with well-established efficacy and safety evidence in the category A list of medical insurance.


Assuntos
Medicamentos de Ervas Chinesas , Distúrbios do Início e da Manutenção do Sono , Distúrbios do Início e da Manutenção do Sono/tratamento farmacológico , Humanos , Medicamentos de Ervas Chinesas/uso terapêutico , Medicamentos sem Prescrição/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto
18.
Zhongguo Zhong Yao Za Zhi ; 49(14): 3936-3951, 2024 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-39099367

RESUMO

Network Meta-analysis was performed to compare the efficacy and safety of Chinese patent medicines in treating chronic pulmonary heart disease. CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, EMbase, and Cochrane Library were searched for randomized controlled trial(RCT) of treating chronic pulmonary heart disease with Chinese patent medicines with the time interval from inception to December 2023. The Cochrane risk-of-bias tool was used for quality assessment of the included articles. RevMan 5.4 and Stata 17.0 were employed to establish the risk of bias map and perform the network Meta-analysis, respectively. Ultimately, a total of 95 RCTs involving 8 787 cases and 11 different Chinese patent medicines were included. Network Meta-analysis yielded the following results based on the surface under the cumulative ranking curve(SUCRA).(1)In terms of cardiac function improves clinical total effective rate, SUCRA the top three were Wenxin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(2)For improving forced expiratory volume in the first se-cond(FEV1), SUCRA the top three were Danting Feixin Granules + conventional western medicine, Tongxinluo Capsules + conventional western medicine, and Bufei Huoxue Capsules + conventional western medicine.(3)Regarding increasing the FEV1/forced vital capacity(FVC%) value, SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Shexiang Baoxin Pills + conventional western medicine, and Qishen Yiqi Dropping Pills + conventional western medicine.(4)In terms of increasing the partial pressure of oxygen(PaO_2), SUCRA the top three were Qili Qiangxin Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(5)In terms of reducing the partial pressure of carbon dioxide(PaCO_2), SUCRA the top three were Tongxinluo Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(6)In terms of increasing left ventricular ejection fraction(LVEF), SUCRA the top three were Bufei Huoxue Capsules + conventional western medicine, Qishen Yiqi Dropping Pills + conventional western medicine, and Shexiang Baoxin Pills + conventional western medicine.(7)In terms of decreasing brain natriu-retic peptide(BNP), SUCRA the top three were Compound Danshen Dropping Pills + conventional western medicine, Qili Qiangxin Capsules + conventional western medicine, and Tongxinluo Capsules + conventional western medicine.(8)In terms of improving the hematocrit level, SUCRA the top three were Qishen Yiqi Dropping Pills + conventional western medicine, Compound Danshen Dropping Pills + conventional western medicine, and Tongxinluo Capsules + conventional western medicine. In terms of safety, 26 RCTs reported adverse reactions, which primarily involved the circulatory and digestive systems. The combination of Chinese patent medicines with conventional western medicine has demonstrated enhanced therapeutic effects on chronic pulmonary heart disease. However, due to the varying quality and sample sizes of included studies and the absence of direct comparisons between Chinese patent medicines, the conclusions should be further validated by multicenter studies with larger sample sizes and higher methodological rigor.


Assuntos
Medicamentos de Ervas Chinesas , Doença Cardiopulmonar , Medicamentos de Ervas Chinesas/uso terapêutico , Humanos , Doença Cardiopulmonar/tratamento farmacológico , Doença Cardiopulmonar/fisiopatologia , Doença Crônica/tratamento farmacológico , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Medicamentos sem Prescrição/uso terapêutico
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