- ISSN 1008-5734
- CN 11-4015/R
- 1999年创刊
- 主管: 中国科学技术协会
- 主办: 中华医学会
ObjectiveTo explore the function of half hemolytic dose(HD50) detection in alerting hemolytic adverse drug reactions caused by Xuesaitong injections and analyze the cause of abnormal hemolysis. Methods The red cell suspension (volume fraction 1.1%) was prepared with blood taken from the ear edge vein of rabbits and physiological saline solution. The red cell suspension was added into the different concentrations of Xuesaitong injections produced by different pharmaceutical factories and their hemolytic degrees were detected using spectrophotometry. Curve relationship between concentrations and hemolytic degrees were performed using Sigmaplot 10.0 software and half hemolytic dosage was calculated. Full wavelength scanning for hemoglobin in the red cell suspension of rabbit which had been added Xuesaitong injections, gallic acid or tannic acid was conducted and the changes of maximum absorbance wavelength were analyzed. The contents of phenols and tannin in the Xuesaitong injections were measured according to the method described in Chinese pharmacopeia. ResultsNormal (red blood cells ruptured and the supernatant changed into red) and abnormal hemolysis (the supernatant changed from red to brown or reddish brown) caused by Xuesaitong injections could be observed by naked eyes. The differences of HD50 were marked among injections produced in the different pharmaceutical factories and even among different batch numbers of the same pharmaceutical factory. The highest HD50 value was about 60 times of the lowest one. The characteristic absorption peak of hemoglobin disappeared in the scan spectra after the red cells suspension of rabbit were added into gallic acid, tannic acid or some Xuesaitong injections, suggesting that the abnormal hemolysis induced by some Xuesaitong injections were similar to that induced by tannin. The contents of phenols and tannin were higher relatively in the Xuesaitong injections with stronger hemolytic ability. ConclusionHD50 detecting could reflect the hemolytic activity of traditional Chinese medicine injections and alert the abnormal hemolysis induced by them. The abnormal hemolysis may be related to the higher contents of phenols and tannin in the traditional Chinese medicine injections.
ObjectiveTo explore the effect of traditional Chinese medicine injections (TCMI) on expression of immune cell surface molecules and provide reference for evaluating the allergenicity of TCMI. Methods Using a random block design, the female BALB/c mice were divided into the control group and 12 kinds of TCMI groups［the Yadanzi (鸦胆子), the Aidi (艾迪), the Xiangdan(香丹), the Gegensu(葛根素), the Honghua (红花), the Xingnaojing (醒脑静), the Xiyanping (喜炎平), the Shuxuening (舒血宁), the Yuxingcao (鱼腥草), the Shengmai (生脉), the Huangqi (黄芪), and the Dengzhanxixin (灯盏细辛) groups］. Each group comprised 7 mice. According to the equivalent dose used in the clinical practice, TCMI 50 μl was subcutaneously injected into the toe of left hind limb of each mouse in the TCMI groups, respectively. Equal volume of phosphate buffer solution was injected into the same site of each mouse in the control group. The mice were sacrificed on day 5 after injections, and the left popliteal fossa lymph node (PLN) was removed and the cell suspension were prepared. The ratio of CD4+ and CD8+ T cells, B cells, CD11c+ cells, F4/80 cells and the expression of early activation molecules CD69, MHCⅡ, co-stimulatory molecules CD86, CD80 and CD40 were detected using flow cytometry. Results Compared with the control group, the ratio of CD4+ T cells and the expression of CD69 molecule decreased in the Yadanzi group; the ratio of CD8+ T cells and the expression of CD69 molecule decreased in the Aidi group; however, the ratio of B cells increased and its expression of CD69 molecule decreased in the above-mentioned 2 groups；the ratio of the B cells increased and expression of CD69 molecule decreased in the Gegensu, Xiangdan and Xiyanping groups, the expression of CD69 molecule decreased in the T cells in the Gegensu group; the ratio of CD8+ T cells decreased in the Xiangdan and Xiyanping groups, the ratio of CD8+ T cells and the expression of CD69 molecule decreased in the Xingnaojing group; the expression of CD69 in the CD8+ T and B cells in the Yuxingcao and Dengzhanxixin groups, the ratio of CD8+ T cells decreased in the Honghua group. Compared with the control group, the ratio of CD11c+ and F4/80 cells increased in the Yadanzi, Aidi and Xiangdan groups; the ratio of F4/80 cells increased in the Honghua and Gegensu groups; the expression of MHCⅡ molecule on the CD4+ T cell surface increased in 10 kinds of TCMI groups except the Shuxuening and Yuxingcao groups; the expression of CD40 molecule on the CD11c+ cell surface increased in the Yadanzi, Aidi and Gegensu groups; the expression of CD80 molecule on the CD11c+ cell surface increased in the Xingnaojing group; the expression of CD86 molecule on the CD11c+ cell surface increased and the expression of CD40 molecule on the F4/80 cell surface decreased in the Xiangdan and Honghua groups. Compared with the control group, the expression of CD44 molecule on the CD4+ T cell surface increased in the Xiangdan and Xiyanping groups and decreased in the Huangqi group; the expression of CD44 molecule on the CD8+ T cell surface increased in the Yadanzi, Aidi, Xiangdan, Honghua, Xiyanping and Xingnaojing groups. ConclusionDifferent kinds of TCMI can cause various changes of immune cell surface molecules; a comprehensive investigation of these molecules can provide scientific basis and reference for allergy evaluation of TCMI.
ObjectiveTo compare the analgesic efficacy and safety between domestic disposable postoperative local anesthesia analgesic system and imported disposable intravenous infusion analgesia device. Methods A prospective, randomized, double-center controlled trial was conducted. The subjects who were underwent intra-abdominal or abdominal wall surgeries in Peking University Third Hospital and Peking University First Hospital from January to September 2008 were divided into the test group and the control group by randomized block method. Each group comprised 80 patients. The patients in the test group and the control group used domestic disposable postoperative local anesthetic analgesic system and imported disposable intravenous infusion analgesia device, respectively. Visual analogue scale(VAS), satisfaction’s degree to analgesic systems or device, whether analgesics were used, whether discomfort sensation appeared, whether activities were affected, whether inflammation or leakage of liquid occurred, and whether the adverse reactions or events happened were observed 24 and 48 hours after operation, respectively. ResultsThe test group comprised 47 males and 33 females with average age (50.3±14.6) years. The control group comprised 48 males and 32 females with average age (49.5±12.7) years. There were no significant differences in age, gender, height, body weight, operation types and the initial analgesic VAS scores between the two groups 24 and 48 hours after operation (P＞0.05 for all comparisons). There were no significant differences in VAS scores, using of analgesic, degree of satisfaction’s discomfort sensation, affecting of activity and incidence of inflammation between the two groups(P＞0.05 for all comparisons). The number of cases with leakage of liquid in the test group (10 cases,12.5%) was higher than that in the control group(2 cases, 2.5%), the difference was statistically significant(P＜0.05). The main reason of higher incidence of leakage of liquid in the test group was associated with improper location of infusion catheter of local anesthesia analgesic system. ConclusionBoth domestic disposable postoperative local anesthesia analgesic system and imported disposable intravenous infusion analgesia device have favorable analgesic efficacy and safety.
Opioids are the most widely used medications for managing moderate to severe clinical pain. During the past several years, sex differences in opioids adverse reactions including respiratory depression, gastrointestinal disorders, cardiovascular effects, analgesia tolerance and dependence have received increasing attention. Further study on sex differences in opioids adverse reactions will improve individualized therapies.
Objective: Tardive dystonia (TDt) is one of extrapyramidal symptoms that starts after long-term use of antipsychotic drugs. It has been reported that the incidence of TDt ranged from 2.7% to 5.3%. Its main clinical feature is that voluntary movements of one or more voluntary muscles are difficult, or abnormal postures because of difficult voluntary movements. The mechanism of TDt is generally considered to be associated with postsynaptic dopamine receptor supersensitivity caused by sustained inhibition of the dopaminergic neurotransmission or anti-noradrenergic effect of antipsychotics. TDt should be distinguished from acute dystonia, tardive dyskinesia, idiopathic dystonia, secondary dystonia, familial dystonia and conversion symptoms. Once TDt developed, dopamine receptor antagonists should be stopped, atypical antipsychotic drugs or other drugs or deep brain stimulation could be used. Symptoms might improve after such treatment.
A 15-year-old female patient, who was given oral prednisone with an initial dose of 60 mg/d and a maintained dose of 15 mg/d once every other day for two years because of dermatomyositis, developed fever, headache, vomiting, and weakness of lower limbs. The patient did not have any improvement despite receiving cefoperazone sodium and sulbactam sodium, ribavirin, vitamin C, and vitamin B6. Her symptoms worsened progressively and she became difficult to walk. Physical examination showed a temperature of 38.0 ℃, nuchal rigidity, brown maculae covering bilateral lower limbs with purulent spot in its center, grade Ⅲ muscle strength, hypomyotonia, diminished tendon reflexes, and positive Kernig’s sign and Brudzinski’s sign. Routine cerebrospinal fluid test revealed a large number of fungi, a WBC count of 1×106/L, a protein content of 890 mg/L, a glucose level of 1.4 mmol/L, and a chloride level of 99.7 mmol/L. The indian-ink staining of cerebrospinal fluid showed Cryptococcus neoformans and Cryptococcus neoformans meningitis was diagnosed. The patient died from respiratory and circulatory failure despite active resuscitation.
An 88-year-old male, received clopidogrel sulfate, aspirin, metoprolol tartrate, telmisartan, simvastatin, dalteparin sodium and nitroglycerin for acute coronary syndrome. On day 5 of treatment, the dosage of simvastatin was increased from 20 mg every night to 40 mg every night. On day 8, telmisartan was stopped and amlodipine besylate and diltiazem 15 mg thrice daily were added. On day 42, the patient developed severe skeletal muscular weakness and myalgia. Laboratory tests revealed the following levels: creatine kinase(CK) 8100 U/L, creatine kinase-MB 305 U/L, troponin 0.046 μg/L, alanine aminotransferase (ALT) 102 U/L, aspartate aminotransferase (AST) 151 U/L. Simvastatin was stopped and he was given by an IV infusion of tiopronin. On day 16 of simvastatin withdrawal, repeat biochemical blood tests revealed the following levels: CK 55 U/L, ALT 13 U/L, and AST 14 U/L. Eight days later, simvastatin 10mg every night was administered again combined with diltiazem 30 mg thrice daily. Abnormalities of CK and liver function tests were not seen with a 22-day of treatment.
A 22-year-old woman was hospitalized with viral encephalitis accompanied by symptomatic epilepsy and received an IV infusion of acyclovir 0.5 g in 0.9% sodium chloride 250 ml every eight hours, oral perphenazine 4 mg every eight hours, oral olanzapine 2.5 mg every morning and 5 mg every night, and oral valproate sodium 0.5 g every twelve hours. Before admission, she had been prescribed oral perphenazine 4 mg every eight hours and olanzapine 5 mg every night for 7 days because of viral encephalitis. On day 5 after admission, she developed galactorrhea and, on day 6, her prolactin (PRL) level was 5.93 nmol/L. Then the dose of perphenazine was reduced by 2 mg each day and, until twelve days after admission, perphenazine was stopped. However, acyclovir, olanzapine, and valproate sodium were continued. On the day of drug withdrawal, her PRL level was 4.11 nmol/L. On day 8 of perphenazine discontinuation, her symptom of galactorrhea vanished and the PRL level returned to normal range (1.28 nmol/L).
A 71-year-old man was hospitalized with acute cerebral infarction, ventricular premature beats and hyperhomocysteinemia. He received an IV infusion of Shuxuetong (疏血通) injection 6 ml, Xingnaojing (醒脑静) injection 20 ml and piracetam injection 250 ml once daily, and oral administration of aspirin 0.1 g，folic acid 5 mg and mecobalamin 500 μg once daily. In addition, the patient received atorvastatin calcium 10 mg once daily for bilateral carotid atherosclerosis which was diagnosed using ultrasonography. His creatine kinase(CK) was 90 U/L on admission and was increased to 777 U/L and 1332 U/L on days 3 and 6 of atorvastatin calcium therapy, respectively. The dark urine appeared and urinary occult blood test was positive. Atorvastatin calcium was withdrawn and other treatment was unchanged. The CK level was decreased to 1126 and 129 U/L on days 3 and 7 of drug withdrawal, respectively. The urine became light yellow in color and urine occult blood test was negative.
A 57-year-old female patient underwent total hip arthroplasty for left femoral neck fracture. On day 17 after surgery, the patient developed fever and, on day 20, her blood culture was positive for Staphylococcus warneri. She was prescribed an IV infusion of teicoplanin 0.4 g dissolved in 100 ml of 0.9% sodium chloride solution every twelve hours and oral ceftizoxime 2.0 g twice daily. On day 4, she presented with ecchymosis on her bilateral calves and her platelet count decreased from 249×109/L to 25×109/L. Teicoplanin was stopped and ceftizoxime was continued. On day 7, the platelet count returned to 104×109/L and her ecchymosis subsided basically.
A 48-year-old woman received an IV infusion of sodium valproate 400 mg every 12 hours via a pump for secondary epilepsy. Moxifloxacin, propafenone, and nifedipine were given at same time. On the third day, oral sodium valproate 200 mg thrice daily was added to the regimen. On days 1 to 7 of sodium valproate use, the prothrombin time (PT) was 11.0, 12.9, 12.9, 14.7, 18.5, 23.3, 37.7 s (the result of the second test on day 6), and 41.5 s, respectively. And the activated partial thromboplastin time (APTT) was 30.0, 44.7, 50.9, 43.3, 66.8, 52.6, 65.0 s (the result of the second test on day 6), and 69.0 s, respectively. Sodium valproate was withdrawn immediately and other three medications continued. Two days after drug discontinuation, her PT was 12.9 s and APTT was 41.2 s.
A 74-year-old female patient underwent synthetic vascular bypass grafts and, after surgery, received an IV infusion of heparin 8.33 U·Kg-1·min-1 via pump, oral clopidogrel 50 mg once daily, sarpogrelate 100 mg thrice daily, and warfarin 3 mg/d. On the second day after surgery, heparin was withdrawn and switched to subcutaneous dalteparin sodium 0.4 ml once every 12 hours. On day 7 after surgery, her platelet count was 301×109/L and dalteparin sodium was stopped. Meanwhile, simvastatin 20 mg/d was added to the regimen and oral clopidogrel, sarpogrelate, and warfarin were given according to original dosage. At the sixth postoperative month, warfarin was discontinued and other three medications were continued. At that moment, reexamination showed a platelet count of 240×109/L. At the ninth postoperative month, retests revealed that the platelet count decreased to 1×109/L and the levels of white blood cell and hemoglobin were normal. Clopidogrel and sarpogrelate were withdrawn immediately and oral simvastatin was continued. At 4 weeks after discontinuation, her platelet count returned to 156×109/L.
A 74-year-old man with high uric acid received oral allopurinol 0.1 g twice daily. On day 16, the patient presented with generalized itching and, on day 21, pin tip-like red rash on his skin of chest and back appeared. No improvement occurred despite the drug was discontinued and a 2-day symptomatic therapy was given. Aggravated rash, dizziness, and chest tightness appeared in the patient and then he was admitted to hospital. After admission, examinations showed the following levels and values: heart rate 73 beats / min, blood pressure 70/46 mm Hg, alanine aminotransferase 124 U/L， aspartate aminotransferase 80 U/L, blood urea nitrogen 22.6 mmol/L, serum creatinine 151 μmol/L, and uric acid 738 μmol/L. After admission, his heart rate decreased to 42 beats/min on one occasion. After a 21-day symptomatic and supportive treatment, his rash disappeared basically and blood pressure, heart rate and renal function normalized, while liver function remained abnormal.
A 74-year-old male patient received insulin, arasaponin, and oxiracetam for diabetes mellitus and cerebral circulation insufficiency. On day 3，an IV infusion of cefodizime sodium 1.0 g in 0.9% sodium chloride solution 100 ml twice daily was added to his regimen for pneumonia. On day 5 of combination therapy，his cough and expectoration improved while the patient experienced eruption on trunk and limbs with a high temperature of 39 ℃. Cefodizime sodium, arasaponin, and oxiracetam were all stopped and he was given anti-allergic and other symptomatic therapy．One day after drug discontinuation, his temperature decreased to 37.8 ℃ and the eruption was lighter in color than before. However, new eruption appeared on his head and face. Liver function examinations showed an aspartate aminotransferase (AST) level of 596 U/L, an alanine aminotransferase (ALT) level of 768 U/L, and a total bilirubin (TBil) level of 39.1 μmol/L. After receiving a 7-day anti-allergic and liver protective treatment, his generalized eruption vanished basically and liver function gradually return to normal (AST 56 U/L, ALT 25 U/L, and TBil 12.5 μmol/L). Cefodizime sodium was not administered again and the above-mentioned adverse reactions did not recur after readministration of arasaponin and oxiracetam.
A 57-year-old female with lung cancer received an IV infusion of fat-soluble vitamin (Ⅱ) for injection 10 ml dissolved in 250 ml of 0.9% sodium chloride injection at a rate of 60 drops/min. One minute after intravenous drip of the fat-soluble vitamin (Ⅱ) for injection, the patient developed a feeling of numbness, convulsion, unconsciousness, generalized redness, and lip cyanosis. The fat-soluble vitamin (Ⅱ) for injection was discontinued immediately, adrenaline 0.5 mg and dexamethasone 10 mg and dopamine 40 mg were given by IV bolus, and nasal cannula oxygen inhalation was given. After five minutes the patient’s consciousness was restored. ECG monitoring revealed a heart rate of 127 beats/min and an blood oxygen saturation was 0.85, her blood pressure was undetectable. Dopamine 200 mg dissolved in 50 ml of 0.9% sodium chloride injection and adrenaline 2 mg dissolved in 50 ml of 0.9% sodium chloride injection were given via IV pump, and 500 ml of 0.9% sodium chloride injection and dextran 40 injection 500 ml were given by intravenous drip. Two hours later, her blood pressure was 80/50 mm Hg. Three hours later, the blood pressure increased to 130/70 mm Hg and the blood oxygen saturation increased to 0.98, her anaphylactic symptoms disappeared.
A 50-year-old male with pulmonary infections received levofloxacin, as a result of poor effect, was ready to switch to cefoperazone sodium and tazobactam sodium. About 10 minutes after a skin allergy test was carried out, the patient experienced chest distress, palpitations, shortness of breath, dyspnea, heart rate was 120 beats/min. Cefoperazone sodium and tazobactam sodium-induced anaphylactic reactions was considered, dexamethasone 10 mg was given by IV bolus immediately and underwent electrocardiogram monitoring. His symptoms such as chest distress, shortness of breath, and dyspnea were improved 1.5 hours later. Blood gas analysis indicated：PCO2 26 mm Hg, PO2 47 mm Hg, HCO3- act 19 mmol/L, HCO3- std 22 mmol/L, pH 7.49. After 8 hours, the symptoms of allergic reactions subsided.
A 57-year-old woman with inactive HBsAg carrier had normal hepatic function and hepatitis B virus (HBV) DNA levels < 500 copies/ml during the past 10 years of follow-up. She received 3 capsules of Xianlinggubao (仙灵骨葆) 0.5 g twice daily due to fracture. Two months later, omeprazole 20 mg once daily and 2 capsules of Dengzhanshengmai (灯盏生脉) 0.18 g twice daily were added to her treatment regimen for stomach discomfort. After three months of concomitant use of these medications, her liver function tests were abnormal as follows: alanine aminotransferase (ALT) 389 U/L and aspartate aminotransferase (AST) 229 U/L. She was diagnosed with drug-induced hepatitis and hepatitis B virus reactivation. The above-mentioned drugs were stopped and she was given diammonium glycyrrhizinate capsules and Shenqigankang (参芪肝康) capsules for liver protection treatment. A week later, repeat liver function tests showed the following levels: ALT 236 U/L，AST 120 U/L，HBV DNA 1.25×106 copies/ml. Two weeks later, the laboratory indices revealed the following levels: ALT 73 U/L AST 54 U/L，HBV DNA 2.36×105 copies /ml.
A 30-year-old female patient with psoriasis took Keyin Wan 10 g twice daily for one month by herself. After drug withdrawal, asthenia, yellowish skin and sclera, anorexia, and dark urine appeared in the patient. Laboratory tests showed the following values: alanine aminotransferase (ALT)196 U/L, aspartate aminotransferase (AST)133 U/L, gamma-glutamyltransferase (γ-GT)59 U/L, total bilirubin (TBil)577.7 μmol/L, direct bilirubin (DBil)392.5 μmol/L, and indirect bilirubin (IBil)185.2 μmol/L. She was treated with glucurolactone, polyene phosphatidyl choline, ademetionine, and other symptomatic therapy for 15 days, and then her symptoms improved gradually and liver function tests revealed an ALT level of 56 U/L, an AST level of 62 U/L, a γ-GT level of 42 U/L, a TBil level of 96.7 μmol/L, a DBil level of 56.4 μmol/L, and a IBil level of 68.8 μmol/L.
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