Concerned about the safety of Chinese and Western medicine compound vitamin C Yinqiao tablets

Victoria C Yinqiao tablets are made of honeysuckle, Forsythia, Nepeta, Soybean, Arctium, Campanulaceae, Peppermint Oil, Reed, Phyllostachys pubescens, Glycyrrhiza, Vitamin C, Chlorpheniramine Maleate, Acetaminophen 13 Herbs made of Chinese and Western medicine compound preparation, with Xin Liang solution table, the role of heat detoxification. For fever caused by fever headache, cough, dry mouth, throat pain.

From January 1, 2004 to April 30, 2010, the number of cases reported by the National Drug Adverse Drug Reaction Monitoring Center was 1885, and the adverse events / events mainly involved the central and peripheral nervous system, Digestive system, skin and appendages. Among them, there were 48 cases of serious cases reported in Victoria C Yinqiao Tablet, accounting for 2.55% of all reports, no death report.

First, the clinical manifestations of serious cases

The adverse reactions / events of the severe cases of skin C and Alkaline tablets were as follows: 75% of skin and appendage damage, systemic rash rash with itching, severe urticaria, severe erythema multiforme drug eruption, bullous epidermis Symptoms of allergic shock, allergic reactions, fainting; urinary system damage accounted for 4.17%, manifested as interstitial nephritis; blood System damage accounted for 4.16%, manifested as leukopenia, hemolytic anemia.

Typical case 1: patients, male, 42 years old, due to "sore throat 1 day" since the purchase of Victoria C Yinqiao tablets, oral 2 hours after the "skin itching, breathing difficulties, chest tightness", immediate treatment. Physical examination: blood pressure 90/40 mmHg, pulse 104 times / min, missing, two law, skin red rash, pressure fade, two lungs sound tone, arrhythmia, not heard and noise. Immediately given dexamethasone injection 10 mg intravenous injection, promethazine injection 25 mg intramuscular injection, 5% glucose 250 ml + 10% calcium gluconate injection 20 ml intravenous infusion, 1 hour later, the symptoms were reduced, measured blood pressure 110 / 60 mmHg.

Typical case 2: patients, women, 33 years old, due to "fever, sore throat" to the pharmacy to buy Victoria C Yinqiao tablets, oral 3 times / day, each 3, medication 3 days, the body did not drop but rose to 39 degrees Above, with anorexia, upper abdominal discomfort. The results showed that: alanine aminotransferase 364U / L, aspartate aminotransferase 265U / L, r-glutamyl transpeptidase 189U / L, alkaline phosphatase 259U / L, total bile acid 58.8μmol / L , Lactate dehydrogenase 407U / L, hepatitis A antibody, hepatitis C antibody, hepatitis E antibody were negative. Patients with normal liver function before 1 month, hepatitis B surface antibody positive. Disable all drugs, given sarmentos particles, inosine oral solution, vitamin C treatment, three months after the review of normal liver function.

Second, ultra-manual drug analysis

National Center database in Victoria C Yinqiao tablets adverse reactions / event report analysis shows that the product exists super-manual use of the phenomenon, the main performance is as follows:

1. Not in accordance with the instructions recommended usage usage

In the adult area, about 14% of the patients received the use of Victoria C Yinqiao tablets each 3-4 tablets, 3 days per day Times.

Typical case 3: patients, male, 38 years old, due to "cold" to the local clinic for treatment, to Victoria C Yinqiao tablets oral 3 times / day, each 4. 3 days later, the patient generalized erythema, consciously minor itching. To the hospital for treatment, examination: T 36.8 ℃, P 88 times / min, BP 152 / 82mmHg, sanity clear; limbs trunk erythema, partial fusion, pressure of the fade, grain to broad bean size, skin temperature is not high. Diagnosis: rash-type drug eruption. Given methylprednisolone 20mg intravenous infusion, Kai Ruitan 10mg oral treatment, the patient improved discharge.

2. At the same time combined with the use of this product similar to other drugs

Wei C Yinqiao tablets manual tips: This product can not take the same ingredients with this product is similar to other anti-cold medicine. The National Center received a number of cases in the case of serious cases reported that the use of other components similar to the anti-cold medicine.

Typical case 4: patients, male, 8 years old, due to "fever, sore throat" oral vitamin C Yinqiao tablets and 100 service Ning (commonly known as acetaminophen) 3 days later, lips appear erosion, with pain, trunk, limbs Scattered erythema with itching, body temperature began to rise to 39 ℃, to the hospital for treatment. Examination: the face, limbs, trunk scattered in the size of 0.3-1.0cm edema dark red spots, round or oval. To be methylprednisolone, hydrocortisone succinate, prednisone treatment, 10 days after recovery.

3. The ingredients contained in this product allergy medication.

Dimensional C Yinqiao tablets instructions in the tips: allergic to the goods disabled, allergy with caution. National Center database analysis shows that individuals with certain ingredients contained in this product are allergic to the patient, after the use of serious adverse reactions.

Typical case 5: patients, male, 28 years old, due to "on the sense of" self-serving C Yinqiao tablets and Banlangen granules, medication the next day found two arms, bilateral lower limbs, chest and back and scrotum Department of a number of round Purple red patch, diameter 3-6cm, no itching, no treatment. The third day part of the purple red patch center blisters, blister diameter of about 2cm, blister wall thin, easy to break, scrotum Department of erosion, then visit the emergency department, diagnosed as "erythema multiforme drug eruption", patients with penicillin, Paracetamol allergy history, for further treatment of treatment hospital. After admission to give methylprednisolone 40mg intravenous infusion, loratadine 10mg 1 day 1, berberine liquid, boric acid solution with wet compress and other treatment, 10 days after the condition improved significantly, blister scab, erosion surface exudate , Improved to discharge.

Third, the impact of dimensional C Yinqiao tablets security factors analysis

The adverse effects of acetaminophen (also known as "paracetamol") are mainly rash, urticaria, drug fever, liver and kidney function Damage and severe allergic reactions; its composition of maleic acid chlorpheniramine (also known as "chlorpheniramine") adverse reactions mainly show drowsiness, weakness, sleepiness, dry mouth, sore throat, palpitations and so on. At present, the national center database dimension C Yinqiao tablets case analysis suggested that the safety of the product and its related components have a certain relevance.

Fourth, the relevant recommendations

1. Recommended doctor prescription or pharmacies selling drugs, suggesting that Victoria C Yinqiao tablets for the Western medicine compound preparation, this product contains maleic acid chlorphenamine sensitive, acetaminophen, vitamin C. Allergic to the ingredients contained in this product are disabled, allergy with caution. The use of this product may not drink alcohol or alcoholic beverages; not at the same time taking this product similar to other anti-cold medicine; liver and kidney damage with caution; bladder neck obstruction, hyperthyroidism, glaucoma, hypertension and prostate Hypertrophy should be used with caution; pregnant women and lactating women with caution; medication during the driving machine, car, boat, not engaged in high-altitude operations, mechanical operations and operation of precision instruments.

2. It is recommended to strictly follow the instructions medication, to avoid overdose, long-term continuous medication, medication should be closely observed after the skin itching, rash, dyspnea and other early allergic symptoms should be immediately discontinued and promptly treated or immediate treatment; loss of appetite, Skin yellow dye and other symptoms should be immediately discontinued, timely treatment, and monitoring of liver function.

3. It is recommended that the manufacturer should improve the product specification and packaging, label, increase the relevant safety information, and strengthen the post-marketing security research to ensure that the product safety information is communicated to the patient and the doctor in time.