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28 February 2023, Volume 21 Issue 2
    

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    Guideline and Consensus
  • CLINICAL MEDICATION JOURNAL. 2023, 21(2): 1-6. https://doi.org/10.3969/j.issn.1672-3384.2023.02.001
    Abstract ( ) Download PDF ( )   Knowledge map   Save
    Pharmaceutical precursor chemicals refer to the raw materials and single preparations of substances such as lysergic acid, ergotamine, ergometrine, ephedrine and pseudoephedrine in precursor chemicals, and are a class of drugs that require special management. The current Regulations on Precursor Chemicals and the Measures for the Administration of Pharmaceutical Precursor Chemicals stipulate the safety management content of the above chemicals in the fields of production, operation and circulation, but do not prompt the circulation and application management of the above chemicals in medical institutions. It makes medical institutions around the country inconsistent in the way and intensity of drug precursor chemicals management, and also brings some confusion and controversy in pharmacy administration and hospital accreditation. In response to this problem, the Clinical Medication Journal Agency organized many experts from several provinces in pharmacy, clinical care, nursing, hospital sense management and other fields to carry out many full discussions and content modifications, and voted to form this expert opinion. This opinion includes 21 "statements" in the two parts of "scope and principles of pharmaceutical precursor chemicals management" and "contents and methods of pharmaceutical precursor chemicals management", involving procurement, acceptance, storage, use, prescription issuance, residue disposal, dynamic monitoring and quality management of pharmaceutical precursor chemicals, and puts forward some operational work suggestions. It aims to provide reference for medical institutions to carry out effective and systematic management of pharmaceutical precursor chemicals.
  • CLINICAL MEDICATION JOURNAL. 2023, 21(2): 7-16. https://doi.org/10.3969/j.issn.1672-3384.2023.02.002
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    To further promote the standardization and homogenization of pharmacists in the management of cholesterol lowering drug therapy in patients with atherosclerotic cardiovascular disease (ASCVD), Beijing Anzhen Hospital, Capital Medical University, Peking University First Hospital, the First Affiliated Hospital of Chongqing Medical University, Tongji Hospital of Tongji University, the Fifth Chinical Medical College of Henan University of Chinese Medicine (Zhengzhou People's Hospital) and the First Affiliated Hospital, Sun Yat-sen University, commissioned by China Medicine Education Association, have jointly formulated the Expert Consensus on the Management of Cholesterol Lowering Drugs in Patients with Atherosclerotic Cardiovascular Diseases. The consensus closely focuses on the whole process of cholesterol lowering drug therapy management for ASCVD patients, including information collection, analysis and evaluation, plan implementation, and follow-up. The consensus also contains standardized management pathways, record forms and assessment tools, and 7 tips for the assessment of cholesterol lowering drug treatment regimens, including assessment of efficacy, therapeutic drug selection, dosage, adverse reactions, interactions, economy, and compliance, to provide reference for clinical practice.
  • Review
  • TANG Lian, QIAN Qing, HU Nan, YANG Xu-ping, CHEN Rong, WANG Li-ying
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 17-21. https://doi.org/10.3969/j.issn.1672-3384.2023.02.003
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    Transplant recipients are prone to invasive fungal disease due to the use of immunosuppressants and broad-spectrum antibiotics, and the incidence has increased year by year recently. Echinocandins, as new antifungal drugs, have strong antibacterial activity, high safety, and broad antibacterial spectrum. This paper collected literature on the population pharmacokinetics of echinocandins in transplant recipients. The factors that affected the population pharmacokinetic parameters of echinocandins in transplant recipients were summarized, including demographic characteristics, liver function, concomitant medication, operation time and graft volume, etc. It will provide a reference for guiding the individualized treatment of echinocandins transplant recipients with through a population pharmacokinetic model.
  • Comment of New Drug
  • LIU Wei, WAN Li, WANG Tang-le, CAO Shuang
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 22-26. https://doi.org/10.3969/j.issn.1672-3384.2023.02.004
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    Reproxalap is a novel small molecule reactive aldehyde species (RASP) inhibitor, which covalently binds free aldehydes and reduces excess RASP levels. Reproxalap's broad activity and unique mechanism provide therapeutic promise for a variety of ocular inflammatory diseases. Reproxalap has been shown to be effective in the treatment of allergic conjunctivitis and dry eye syndrome in several clinical trials. This article reviews the basic information, pharmacological effects, clinical efficacy and safety of reproxalap, so as to provide a reference for clinical use.
  • CHEN Min, WANG Qian, FANG Yi
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 27-30. https://doi.org/10.3969/j.issn.1672-3384.2023.02.005
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    Amivantamab, a bispecific antibody targeting both epidermal growth factor receptor (EGFR) and cellular-mesenchymal epithelial transition factor (c-MET), was approved for marketing by the FDA on May 21, 2021. Amivantamab is the first targeted therapy for subset of adult patients with non-small cell lung cancer, whose tumors have specific types of genetic mutations: EGFR exon 20 insertion mutations. Clinical studies have shown that amivantamab has significant efficacy in its indicated population and is one of the potential treatment strategies for patients with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) resistance. In order to further deepen the understanding of amivantamab for clinical practitioners, this paper mainly reviewed the mechanism of action, pharmacokinetics, efficacy, safety and immunogenicity of amivantamab in the treatment of non-small cell lung cancer, and summarized the latest research progress.
  • Original Article
  • SHI Wei-min, LIU Bang, WANG Wen-qin
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 31-35. https://doi.org/10.3969/j.issn.1672-3384.2023.02.006
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    Objective To explore the efficacy of iguratimod combined with disease-modifying anti-rheumatic drugs (DMARDs) in the treatment of patients with rheumatoid arthritis (RA) and osteoporosis (OP), so as to provide reference for clinical rational drug use of patients with RA complicated with OP. Methods RA combined with OP admitted to Jinhua People's Hospital from June 1, 2017 to June 1, 2020 were prospectively selected and divided into control group and observation group using random number table method. The control group received with methotrexate (10 mg/week) and hydroxychloroquine (200 mg/twice a day), while the observation group received add-on treatment with iguratimod (25 mg/twice a day) on the basis of control group. Serum indexes, bone density, clinical symptoms and occurrence of adverse reactions were compared between the two groups. Results A total of 124 patients were included, with 62 cases in each group. After treatment, the average values of erythrocyte sedimentation rate (ESR) and rheumatoid factor (RF) in the observation groups were (20.45±5.23) mm/h and (38.74±10.23) U/mL compared with the average values of (58.66±10.25) mm/h and (108.77±22.54) U/mL before treatment (P<0.05), and the observation group was significantly lower than the control group [(28.74±6.85) mm/h, (50.61±14.37)U/mL;P<0.05]. After treatment, the bone density level of the control group had no statistical difference compared with that before treatment (P>0.05), but the bone density of the observation group was apparently higher than that before treatment and the control group (P<0.05). After treatment, the bone-derived alkaline phosphatase (BALP), type Ⅰ collagen cross-linked C-terminal peptide (CTX-Ⅰ), IL-1β and IL-6 levels in both groups were apparently lower in comparison with those before treatment (P<0.05), and the observation group were signifficantly lower than the control group (P<0.05). After treatment, the disease activity score 28 (DAS28) and morning stiffness in both groups were signifficantly lower in comparsion with those before treatment (P<0.05), and the observation group were signifficantly lower than the control group (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). Conclusion Iguratimod combined with DMARDs have a significant effect in the treatment of RA with OP, which can effectively improve the clinical symptoms, reduce inflammation, maintain bone metabolism balance, improve bone density, and at the same time have good safety.
  • LEI Xiao-ting, WU Yu-cheng, HAI LAN, CHENG Bao-sheng
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 36-40. https://doi.org/10.3969/j.issn.1672-3384.2023.02.007
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    Objective To explore the effect of sacubitril valsartan on altitude sickness in hypertensive patients. Methods Patients with scoop type hypertension who visited Tianshui First People's Hospital from November 2020 to November 2021 were included. According to whether patients received sacubitril valsartan treatment, they were divided into the observation group and control group. Acute mountain sickness clinical symptom scale (AMS) scores were compared between the two groups. Oxygen uptake (VO2 max), finger pulse oxygen and blood oxygen saturation (SpO2), oxygen saturation (SaO2) and vital capacity (VC) were measured and compared. Adverse reactions were recorded, including angioedema, hypotension, renal impairment, and hyperkalemia. Results A total of 159 patients were included, 102 patients in the observation group, and 57 patients in the control group. The AMS score of the observation group was statistically higher than that of the control group at 4 h (t=7.299, P<0.01) and 6 h (t=5.552, P<0.01). For VO2 maxt=15.204, P<0.01), SaO2t=6.502, P<0.01), SpO2t=2.918, P<0.01), the VO2 max level of the observational group was statistically lower than the control group, SaO2 and SpO2 levels were higher than the control group. The correlation between the laboratory indicators was analyzed by Pearson test. AMS score was negatively correlated with VO2 max, while AMS score was positively correlated with SaO2 and SpO2, respectively (P<0.05). Concerning safety, the observational group had statistically lower incidence of angioedema (10.78% vs 28.07%, χ2=7.750, P<0.01), hypotension (5.88% vs 26.32%, χ2=13.319, P<0.01), renal impairment (15.78% vs 22.81%, χ2=5.997, P=0.014) and hyperkalemia (0.98% vs 8.77%, χ2 =6.113, P=0.013) compared with the control group. The random walking model reflected that the observation group had a lower number of walking steps and a higher positive increase rate compared with the control group, which is more suitable for clinical application. Conclusion Sacubitril valsartan may have therapeutic effect on altitude sickness in hypertensive patients.
  • CUI Xin, LI Wei, WANG Chun-ping, HE Yu-mei, ZHU He, SHI Feng-hao, XIE Yan-ming, HAN Sheng
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 41-45. https://doi.org/10.3969/j.issn.1672-3384.2023.02.008
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    Objective To evaluate the economic efficiency of guanxin shutong capsules plus conventional therapy in the treatment of angina pectoris (AP), so as to provide reference for rational allocation of medical medication resources. Methods In this study, Treeage Pro software was used to analyze the cost-effectiveness of guanxin shutong capsules plus conventional therapy versus conventional therapy for AP intervention. The cost parameters were obtained from the Menet database and related literature. At the same time, the economic efficiency of the two treatment plans in short term was evaluated according to the effect parameters (angina efficacy) obtained from a meta-analysis. The intervention time is 4 weeks. Single factor sensitivity analysis (whirlwind plot) and probabilistic sensitivity analysis were used to verify the robustness of the results of this study. Results The basic analysis results showed that the ICER of the two groups was 1078.38 yuan. That is, compared with conventional therapy alone, the conventional therapy combined with guanxin shutong capsules would cost 1078.38 yuan more for each additional effective AP patient. When the patient's personal willingness to pay was higher than 1078.38 yuan, the probability of economic benefit of guanxin shutong capsules plus conventional therapy was better than that of conventional therapy alone. The results of sensitivity analysis verified the robustness of the results of the basic analysis. The clinical efficacy of the guanxin shutong capsules group and the conventional treatment cost of AP had a great impact on the results of the study. When the patients' personal willingness to pay was more than 1050.00 yuan, the intervention plan with higher economic probability was consistent with the results of the basic analysis. Conclusion When the individual willing ness to pay in more than 1050.00 yuan, guanxin shutong capsules puls conventional therapy is more economical for AP patients than conventional therapy alone.
  • MA Ying-lin, LIU Min, LE Kai-di, YAN Jia-qing, DONG Bin, WANG Meng-yang, LI Ying, LI Guo-hui
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 46-50. https://doi.org/10.3969/j.issn.1672-3384.2023.02.009
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    Objective To evaluate the safety of lapatinib ditosylate in breast cancer patients in real world, analyze the risk factors of adverse reactions, and provide reference for the safe use of lapatinib ditosylate in breast cancer patients. Methods We conducted a retrospective analysis of breast cancer patients treated with lapatinib ditosylate in Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from November 2016 to January 2020. The basic characteristics and adverse reactions were collected. The correlation between clinical characteristics and ADRs was analyzed by logistic regression. Results A total of 135 patients were included in this study. Among them, 92 patients (68.15%) had adverse reactions, most of which were grade 1 or grade 2. The most common ADRs were diarrhea (16.08%), rash (15.58%), and hand foot syndrome (11.56%). Multivariate logistic regression analysis showed that patients with an initial dose of 500-1000 mg had a lower risk of adverse reactions than patients with 1250 mg (OR=3.198, 95%CI:1.424-7.184, P=0.005); patients with surgery history had an increased risk of adverse reactions compared with patients without surgery (OR=6.309, 95%CI:1.484-26.820, P=0.013). Conclusion The adverse reactions of lapatinib ditosylate in the treatment of breast cancer are tolerable, the initial dose and surgery history are the risk factors for adverse reactions.
  • LIU Xin, HU Li-hua, YU Yun-cui, LIU Xiao-hui, MA Jin-jing, WANG Xiao-ling
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 51-56. https://doi.org/10.3969/j.issn.1672-3384.2023.02.010
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    Objective To evaluate the effectiveness of pharmacist-led pharmaceutical care in the treatment of bronchial asthma in children. Methods Electronic databases such as PubMed, Cochrane Library, Web of Science, Embase, CNKI, Wanfang and VIP databases were searched from inception to March 31,2022. We screened the studies according to the inclusion and exclusion criteria, extracted the data and assessed the quality of the included studies. Meta-analysis was performed using RevMan 5.4 software. Results A total of 12 RCT were collected, including 1455 children. Meta-analysis showed that there was significant difference in improving medication adherence between pharmaceutical care group and the control group (RR=1.87, 95%CI: 1.63 to 2.15, P<0.01). In addition, compared to the control group, the pharmaceutical care group statistically improved the pulmonary function of asthmatic children [forced expiratory volume in one second to forced vital capacity ratio (FEV1%)](MD=4.92, 95%CI: 3.67 to 6.17, P<0.01); and the asthma control level (MD=2.43, 95%CI: 0.69 to 4.17, P=0.006). Conclusion Pharmaceutical care can effectively improve the medication adherence in asthmatic children, and positively influence pulmonary function, asthma control and other clinical parameters.
  • HE Xiao-jin, ZHONG Xu-li, SONG Yuan
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 57-61. https://doi.org/10.3969/j.issn.1672-3384.2023.02.011
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    Objective To establish a training course of medication consultation for pediatric pharmacists guarantee the quality of pediatric pharmaceutical care and improve the knowledge structure of pediatric pharmacists. Methods We performed questionnaire survey on the status quo of pediatric pharmacists' competency and the Delphi method expert questionnaire. The survey data were figured out and analyzed, and specific training courses of medication consultation for pediatric pharmacists were screened and extracted. Results A total of 113 pharmacists participated in the statusque survey in China,with response rate of 75.33%.The results showed that pediatric consulting pharmacists lacked standard operation procedure and needed improvement in drug clinical application, disease diagnosis and treatment norms, and humanistic communication. Two rounds of Delphi survey were conducted among 21 experts in China, and the positive coefficient of experts in each round was 100%. Expert authority coefficient (Cr) was 0.81±0.10, 0.81±0.11, and expert coordination coefficient was 0.27,0.40. Finally,14 key indicators were selected to meet the average importance score ≥4.0, the coefficient of variation (CV)<0.25, the percentage of unimportance (R)<50%,and the percentage of inclusion (P)>70%. Conclusion Pharmacists have strong demands, and the expert opinions are highly consistent. The combination of the two questionnaire methods can systematically and comprehensively screen out the training courses of medication consultation for pediatric pharmacists, and the method has high credibility.
  • JIANG Ning, WU Ming-fen, YAN Yao-dong
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 62-67. https://doi.org/10.3969/j.issn.1672-3384.2023.02.012
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    Objective To analyze the research status, hotspots and development trends of dupilumab in the world. Methods The research literature on dupilumab included in the Web of Science database from inception to August 31, 2022 was searched, and the retrieved literatures were visually analyzed using VOSviewer and CiteSpace software. Results A total of 645 articles were retrieved, and the number of articles increased year by year, of which the United States was the country with the highest number of articles, Sanofi and Regeneron Pharmaceutical were the research institutions with the highest number of publications; at present, the research hotspots in this field mainly focus on the application of dupilumab in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyp. In recent years, the research frontier is the exploration of dupilumab in the treatment of prurigo nodularis and chronic rhinosinusitis with nasal polyp. Conclusion In recent years, the research on dupilumab has attracted more and more scholars' attention, and Chinese scholars can learn from its international research hotspots and combine the characteristics of the domestic population to carry out relevant efficacy and safety research to promote the research progress in this field in China.
  • YIN Yue, ZHANG Yan-hua
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 68-73. https://doi.org/10.3969/j.issn.1672-3384.2023.02.013
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    Objective To investigate the influencing factors of immune-related thyroid foundation abnormality adverse (TFA-irAES) in patients with malignant melanoma (MM) treated with pembrolizumab and construct a predictive model. Methods We conducted a retrospective analysis of MM patients treated with pembrolizumab in Peking University Cancer Hospital from January 1, 2020 to January 31, 2020. Clinical data including gender, age, underlying diseases, body surface area, and stage, etc. Univariate analysis and multivariate logistic regression analysis were used to determine the influencing factors of TFA-irAEs treated with pembrolizumab, and a predictive model was established. Receiver operating characteristic (ROC) curve was used to evaluate the prediction model. Results A total of 126 patients were included in this study. Among them, 91 cases (72.2%) had adverse reactions, including 36 cases (28.6%) of TFA-irAEs. The logistic regression analysis showed, the influencing factors of TFA-irAEs included gender, underlying diseases, course of treatment, combined targeted drugs, combined chemotherapy or chemotherapy plus targeted drugs, the area under the ROC curve was 0.934±0.024 (95%CI:0.886~0.979), with a specificity of 77%, sensitivity of 91.4%, positive predictive value of 68.6%, and negative predictive value of 92.8%. When the predictive model equation logit (P) ≥0.2879152, it could be used as a criterion to determine whether TFA-irAEs occurred after the use of pembrolizumab. Conclusion Gender, underlying diseases, course of treatment, combined treatment with targeted drugs and chemotherapy drugs are the influencing factors of TFA-irAEs in patients with pembrolizumab. The results of the fitted prediction model are reliable.
  • CHAI Shuang, LIU Bo-lin, ZHAN Jing-lun, LIU Xiao-dong
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 74-79. https://doi.org/10.3969/j.issn.1672-3384.2023.02.014
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    Objective To retrieve the adverse event reports of tigecycline using the FAERS database, and conduct data mining and analysis to provide reference for safe drug use. Methods The adverse event reports of tigecycline from January 1, 2005 to September 30, 2021 were retrieved and analyzed. Results A total of 2239 adverse event reports related to tigecycline were retrieved. Using the reporting odds ratio (ROR) method and the combined method of the UK Medicines and Health Products Regulatory Agency (MHRA), signals of adverse events involving multiple systems such as blood and lymphatic system, gastrointestinal system, and hepatobiliary system were identified. The events with the higher signals were gallstone intestinal obstruction (PRR=2882.77), hypofibrinogenemia (PRR=1267.48), and non-thrombocytopenic purpura (PRR=1067.69). In addition, there were also some adverse events with strong signals but not listed in label, such as gallstone intestinal obstruction (PRR= 2882.77) and non-thrombocytopenic purpura (PRR=1067.69). Conclusion When using tigecycline, medical staffs should not only pay colser attention to adverse events already recorded in the drug's instructions such as hypofibrinogenemia, but also closely monitor adverse events with strong signal not yet listed in the instructions, such as gallstone intestinal obstruction, to ensure the safety and efficacy of the drug use for patients.
  • Drug and Clinic
  • HE Ya-ping, ZHANG Xiao-jian
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 80-83. https://doi.org/10.3969/j.issn.1672-3384.2023.02.015
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    Iron deficiency anemia is one of the most prevalent nutrient deficiencies in the world, which seriously affects human health. Iron-carbohydrate complexes have become the research focus owing to their advantages of high bioavailability and low adverse reactions. This article reviewed the clinical application, research progress and development direction of iron-carbohydrate complexes, and introduced the research progress and trend of iron-carbohydrate complexes in detail, so as to provide reference for the research and development of new iron supplements.
  • Case Research
  • WU Xiao, ZHANG Hai-yue, SONG Hai-qing, TIAN Fei
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 84-86. https://doi.org/10.3969/j.issn.1672-3384.2023.02.016
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    A case of drug hypersensitivity syndrome caused by cefoperazone sodium and sulbactam sodium. After the 73-year-old male patient was admitted to hospital for viral encephalitis, he was given intravenous injection of cefoperazone sodium and sulbactam sodium due to complications of pulmonary infection. After 6 days of treatment, the patient appeared scattered erythema in the chest and abdomen, and the skin temperature increased. Cefoperazone sodium and sulbactam sodium was stopped, and anti-allergy treatment was given. However, the number of skin rashes gradually increased and the scope expanded, and the patient was intermittently treated with symptomatic support such as corticosteroids, human immunoglobulin, antihistamine, liver protection and local topical drugs. The patient's skin rashes gradually subsided, and there was no recurrence after 3 months of follow-up. After screening the drugs used, it is suspected that cefoperazone sodium and sulbactam sodium may cause drug hypersensitivity syndrome, and the adverse reaction correlation evaluation result is possible. This article analyzes the occurrence and treatment of drug hypersensitivity syndrome in this case, so as to provide reference for clinical rational drug use.
  • NIU Qian-qian, ZHAO Shan, YANG Li, TANG Kun
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 87-89. https://doi.org/10.3969/j.issn.1672-3384.2023.02.017
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    A 51-year-old male patient developed swelling pain and stiffness in the upper limb of the infusion side after intravenous administration of carbazochrome sodium sulfonate for the purpose of preventing bleeding after renal biopsy. The above symptoms gradually improved after infusion. When the drug was injected again, the same symptoms as above appeared quickly. In consideration of the adverse reaction of carbazochrome sodium sulfonate, the clinical pharmacist advised discontinuation of the drug. The above symptoms improved after 6 days of drug withdrawal, and returned to normal after 11 days of drug withdrawal. In this paper, a rare and serious adverse reaction of upper limb swelling, pain and movement limitation caused by carbazochrome sodium sulfonate was reported and analyzed, so as to draw attention to such adverse reactions in clinical practice.
  • JIANG Ying-ying, XU Xiang-xiang, SHEN Yan-lin
    CLINICAL MEDICATION JOURNAL. 2023, 21(2): 90-92. https://doi.org/10.3969/j.issn.1672-3384.2023.02.018
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    This paper records a case of clinical pharmacist participating in the whole process of a patient who has severe Chlamydia psittaci pneumonia. After confirming the diagnosis of severe Chlamydia psittaci pneumonia, the clinical pharmacist reviewed a series of literatures related to the characteristics of pathogenic bacteria, combined with professional judgment on the characteristics of critically ill patients, and finally put forward a suggestion to use doxycycline combined with meropenem for individualized treatment. This case is expected to provide a reference for clinical diagnosis and treatment of Chlamydia psittaci pneumonia.