RÉSUMÉ
To provide prevention and control strategies of occupational exposure risks to cytotoxic drug in medical institutions, improve the awareness of protection among medical staff,and reduce potential occupational exposure risks,the Guidelines for the Prevention and Control of Occupational Exposure Risk to Cytotoxic Drugs in Medical Institutions is developed. Based on the World Health Organization Guidelines Development Manual,the exposure risk issues of the cytotoxic drug collected from the time that it entered the hospital to the several stages after delivery to hospital,such as transportation,receipt,storage,unpacking,dispensing,use of finished products,and waste disposal. Delphi method is used to construct identification of clinical issues,and evidence-based research method is used to develop relevant evidence. Quality evaluation is conducted by using the recommended GRADE method. The consensus is reached on the recommendation opinions and evidence levels through expert consensus method. By combining engineering controls,administrative controls and personal protective equipment at different levels,a graded control approach is established. A total of 37 clinical issues are identified,resulting in 36 recommendations. This guideline provides reference and supplementation for the formulation of cytotoxic drug prevention and control measures in medical institutions.
RÉSUMÉ
Antibody-drug conjugates (ADCs) are a class of targeted biological agents that link cytotoxic drugs to monoclonal antibodies through linkers. The monoclonal antibody targets tumor cells and transports small-molecule cytotoxic drugs for specific delivery and minimal off-target side effects. September 30, 2022, 14 anti-tumor ADC drugs have been approved for marketing in the world, and four ADCs have been approved in China. With the improvement of the clinical accessibility of ADC drugs, clinicians urgently need to understand the molecular characteristics and mechanisms of ADCs, and clarify the indications for rational use of drugs. Patients' survival mainly depends on the appropriate dose and course of treatment and also on proper management of adverse reactions. In view of this, on the basis of the "Expert Consensus on the Clinical Application of Antibody-drug Conjugates for the Treatment of Malignant Tumors (2020 edition)", Professional Committee on Clinical Research of Oncology Drugs, Chinese Anti-Cancer Association fully combines the existing clinical research evidence and the feasibility of current ADC drugs in China to update the consensus content. This consensus aims to provide a systematic overview of ADC drugs, so as to provide practical and effective suggestions and references for clinicians to apply and manage ADC drugs more accurately.
RÉSUMÉ
Antibody-drug conjugates (ADCs) are a class of targeted biological agents that link cytotoxic drugs to monoclonal antibodies through linkers. The monoclonal antibody targets tumor cells and transports small-molecule cytotoxic drugs for specific delivery and minimal off-target side effects. September 30, 2022, 14 anti-tumor ADC drugs have been approved for marketing in the world, and four ADCs have been approved in China. With the improvement of the clinical accessibility of ADC drugs, clinicians urgently need to understand the molecular characteristics and mechanisms of ADCs, and clarify the indications for rational use of drugs. Patients' survival mainly depends on the appropriate dose and course of treatment and also on proper management of adverse reactions. In view of this, on the basis of the "Expert Consensus on the Clinical Application of Antibody-drug Conjugates for the Treatment of Malignant Tumors (2020 edition)" , Professional Committee on Clinical Research of Oncology Drugs, Chinese Anti-Cancer Association fully combines the existing clinical research evidence and the feasibility of current ADC drugs in China to update the consensus content. This consensus aims to provide a systematic overview of ADC drugs, so as to provide practical and effective suggestions and references for clinicians to apply and manage ADC drugs more accurately.
Sujet(s)
Humains , Immunoconjugués/usage thérapeutique , Consensus , Tumeurs/traitement médicamenteux , Antinéoplasiques/effets indésirables , Anticorps monoclonaux/usage thérapeutiqueRÉSUMÉ
The incidence of thyroid cancer has continued to increase. Most thyroid cancer patients have good prognosis, but there are still some patients who will develop into the middle or late stage. The status of cytotoxic treatment in thyroid cancer treatment is controversial. Chemotherapy, as a classical malignant tumor treatment, has its unique significance for the special type and the special period of thyroid cancer. Chemotherapy can be an option for systemic treatment if no other treatment is available for patients of differentiated thyroid carcinoma refractory to radiodine in rapid progression and life-threatening period. For patients of anaplastic thyroid cancer in progression period, chemotherapy can be selected if there are no other treatments in clinical trials. And "Chemical therapy plus" treatment model might play an important role in thyroid treatment, because with the development of targeted drugs and immunotherapy, chemotherapy combined with other treatments can reduce the dosage of chemotherapy drugs to reduce the toxic side effect, and can improve other therapeutic effects.
RÉSUMÉ
Antibody-drug conjugate (ADC) is a type of targeted biological agent which connect cytotoxic drug to monoclonal antibody by a connector head, which enables monoclonal antibody acted as a carrier to efficiently transport small molecular cytotoxic drugs to target tumor cells. It is very important for clinicians to have an in-depth understanding of the molecular characteristics and mechanism of ADC drugs, rationally choose the appropriate dose, course of treatment and manage adverse reactions according to the indications during the clinical application of ADC drugs, which may even affect the survival of patients. Therefore, the consensus aims to conduct a systematic overview of commercially available ADC drugs, provide effective recommendations and references for clinicians to better apply and manage ADC drugs.
Sujet(s)
Humains , Anticorps monoclonaux/usage thérapeutique , Antinéoplasiques/usage thérapeutique , Consensus , Immunoconjugués/usage thérapeutique , Tumeurs/traitement médicamenteuxRÉSUMÉ
OBJECTIVE: To investigate the actual data of chemotherapy drugs for discharged patients under 18 years old in our hospital, and to firstly provide the real status and risk of chemotherapy drugs during carrying and use at home. METHODS A retrospective research was adopted to statistically analyze 1 955 discharged orders of the patients, under the age of 18, with chemotherapy drugs in our hospital from December 1, 2017 to May 31, 2018. RESULTS: During the sampling period, there were 153 patients with chemotherapy drugs discharged under the age of 18 years old. Thirty kinds of chemotherapy drugs were involved, and 17 drugs with the remaining drug amount regarding to its dosage regimen. CONCLUSION: It was found that it is common and necessary to continue treatment with chemotherapy drugs after discharged. One drug needs to be refrigerated and the other needs to be kept in a shade place, which is difficult to reach the preservation conditions during the journey. There is a residual amount of medications over its usage for young patients, of the total 1 955 medical orders, 898 have the problem of residual amount, which account for 57.11% in cancer patients and 7.09% in non-cancer patients, respectively. For pharmacists,it is time exploring medication education and follow-up for discharged patients, especially for young patients and their guardians.
RÉSUMÉ
OBJECTIVE: To strengthen the occupational protection of pharmacy intravenous admixture service (PIVAS) staff, and to ensure the safe and timely delivery of drugs. METHODS: The cytotoxic drug packing bag was made by oxford cloth, velvet cotton, pearl cotton, silica gel, activated carbon, rope, etc. Taking Paclitaxel liposomes for injection as an example, the application effect of packing bags was observed. A total of 156 medical orders of PIVAS formulated Paclitaxel liposomes for injection were selected and divided into test group and control group aoccording to random number table. The dispensing drugs were packed with cytotoxic drug packing bag in trial group, and packed with previous plastic packing bag in control group. The packing time of each drug, the delivery time, leaking and shattering, the breakage processing time and loss amount were compared between 2 groups. RESULTS: There was no statistical significance in the delivery time between 2 groups (P>0. 05). The packing time of trial group was significantly longer than control group; there were 16 bottles of leaking in the control group, and 8 bottles of shattering; In trial group, 3 bottles were leaking but not spilled over (infiltrated in the silica gel layer), and there was no shattering bottle; the breakage processing time of trial group was significantly shorter than that of control group; the loss amount was significantly less than that of control group, with statistical significance (P<0. 05). CONCLUSIONS: The cytotoxic drug packaging bag developed in this study can play a spill-proof, anti-seismic role, reduce the loss of valuable drugs, and also strengthen the occupational safety and health protection of medical staff.
RÉSUMÉ
The authors give an account of the basic concept and classification of cytotoxic drugs. A center for compounding cytotoxic drugs has been set up in their hospital by using for reference the management experience of the US in this aspect. The center stresses centralized management in compounding cytotoxic drugs, strict operating rules and protective actions, and reduction of possible toxic damages resulting from cytotoxic drugs and infection caused by them in other sectors, thus guaranteeing the physical and mental health of the medical staff. At the same time, the authors call on all medical institutions to pay attention to the disposition of cytotoxic drugs and exert efforts to help a relevant national standard to come out as soon as possible.
RÉSUMÉ
OBJECTIVES: Of 339 patients with systemic lupus erythematosus(SLE) observed at Seoul National University Hospital in Seoul, 221 fulfilled criteria for lupus nephritis. We evaluated the clinicopathologic findings, outcomes and prognostic factors of patients' survival. METHODS: We searched computer system of our center using disease code for SLE from January 1973 to January 1995 and found 339 SLE patients among whom there were 221 definite lupus nephritis patients. We retrospectively reviewed medical records and investigated the influence of multiple prognostic factors on patients' survival using Cox hazard function analysis. RESULTS: Of 221 patients, 89.6% were female. The mean age of onset of SLE was 27.7+/-10.4 years and the mean follow-up duration was 42.5+/- 40.2 months. The most frequent symptoms at diagnosis were skin manifestations. Hypertension was diagnosed in 21.7% of patients and 21.6% had serum creatinine greater than 1.4mg/dL. Overall, 37.7% were nephrotic. Renal biopsy performed on 159 patients showed the following World Health Organization Class distribution : Class I 1.3%, class II 8.8%, class III 6.3%, class IV 65.4%, class V 13.2%, class IV+V 5.0%. Remission of nephritis was observed in 31.3% of patients. At the last follow-up period, there were 23 patients with deteriorated renal function among 168 patients and renal failure developed in 3.2%. Twenty eight patients died, primarily from infection, with 86.2% and 78.3% 5-year and 10-year survival rates, respectively. Initial presence of renal insufficiency(serum creatinine>or=1.4mg/dL) and treatment with prednisolone only were most important in predicting patients' survival. Combination treatment of high dose prednisolone and cytotoxic drug(azathioprine, oral cyclophosphamide, or iv cyclophosphamide) appeared to be beneficial for nephritis. Treatment modality was only independent risk factor associated with lower survival probability. CONCLUSION: The characteristics of our patients were not so different from those of others. Treatment modality and renal function were important predictors of fatality. Treatment with high dose prednisolone and cytotoxic drug improved the clinical outcome of lupus nephritis, as compared with prednisolone alone.