DRuG SaFETy EXERCIsE
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中医循证医学
Which of the following are adverse events?
Which are serious adverse events?
1. A 68 year old female patient was receiving oral lamotrigine 50mg, once daily, for biopolar disorder. During the study she was admitted to hospital as her family could not cope with her at home. She continued in the study. The investigator considered the event was unrelated to use of lamotrigine.
, 百拇医药
2. A 22 year old female patient was receiving oral naratriptan 2.5mg, as required, for treatment of migraine. At study entry she was scheduled to undergo a tonsillectomy. During the study she experienced intermittent tonsillitis which necessitated the date of her tonsillectomy to be brought forward. The operation proceeded uneventfully and the patient made a good recovery. The investigator considered the tonsillitis was unrelated to the use of study medication.
, 百拇医药
3. A 28 year old male patient was receiving oral lamivudine 150mg, twice daily, for treatment of HIV infection. Concurrent medication included AZT. After five months in the study routine blood sampling revealed anaemia with a haemoglobin level of 8.2g/dL. The patient was admitted to hospital for a blood transfusion. The investigator considered the event was possibly related to the use of study medication.
4. A 65 year old male patient had received oral ranitidine bismuth citrate 400mg twice daily for 29 days in co-prescription with oral clarithromycin 500mg twice daily for the first 14 days of treatment for the eradication of Helicobacter pylori. During the study the patient mentioned that he was losing blood in his stools. A subsequent colonscopy, performed twelve days after completing the course of study medication, led to a diagnosis of malignant left sigmoidal neoplasia. The investigator considered the event was unrelated to study medication.
, 百拇医药
5. A 40 year old male patient was receiving an infusion of acyclovir for prophylaxis of CMV infection prior to bone marrow transplantation. During the infusion the patient experienced an episode of blindness which resolved on cessation of study drug. When study drug was re-commenced a few hours later the blindness recurred. The patient was consequently withdrawn from the study. The investigator considered the event was possibly related to the study medication.
, 百拇医药
6. A 70 year old male patient was receiving salmeterol. He developed a headache and dizziness and was kept in hospital for 24 hours for observation. He was discharged and his condition had resolved completely. The investigator considered the event was probably related to the study drug.
7. A 22 year old male patient injured his knee whilst playing football in October 1995. He was entered onto a valaciclovir study in December 1995. In February 1996 the patient elected to undergo surgery on his knee even though his condition had not worsened. He was hospitalised for two days and the pain in his knee resolved two days later.
, 百拇医药
8. A 25 year old male patient was in hospital receiving lamivudine (3TC) for HIV infection. He subsequently developed pneumocystis carnii and was treated with intravenous co-trimoxazole, gentamicin and vancomycin. Ten minutes later the patient developed generalised urticaria, stridor and hypotension (BP = 80/48). He was treated with adrenaline, chlorpheniramine and hydrocortisone and his condition improved. The investigator considered the event was unrelated to the study drug.
, 百拇医药
9. At baseline a patient states that she experienced pain and swelling in her fingers about once each month which improves when she takes a non-steroidal anti-inflammatory drug (NSAID). After study drug administration, she states that the pain and swelling are occurring weekly and that she no longer gets relief from the NSAID. The investigator considers this to be unrelated to study medication.
10. A 34 year old female patient while participating in a ranitidine study was hospitalised for elective rhinoplasty on 0l Apr97. The surgery went well without incident and was scheduled to be discharged the following day. On 02 Apr97 the patient developed a fever of unknown origin and was started on Ceftin. She remained hospitalised for two additional days. The fever resolved and she was discharged on 04 Apr97
, 百拇医药
11. A patient enrolled in an ondansetron study came into office for their week 2 study visit. They stated that they took their medication as prescribed; however, the tablets smelled like rotten fish and tasted like burnt toast.
12. A 30 year old male fireman was receiving lamivudine 150mg twice daily for suppression of HIV infection. Concurrently he received diazepam and aspirin. While enrolled in the study, he responded to an emergency call to save Fluffy, Mrs Robinson's pet cat, from the town oak tree. He was so ecstatic about saving the lovely cat, he inadvertently took double the highest recommended dose as per the protocol. Upon realising his error, he decided he should take ten diazepam to counteract the additional study drug he ingested. Fortunately, he reported no side effects and got a good nights sleep., http://www.100md.com
Which are serious adverse events?
1. A 68 year old female patient was receiving oral lamotrigine 50mg, once daily, for biopolar disorder. During the study she was admitted to hospital as her family could not cope with her at home. She continued in the study. The investigator considered the event was unrelated to use of lamotrigine.
, 百拇医药
2. A 22 year old female patient was receiving oral naratriptan 2.5mg, as required, for treatment of migraine. At study entry she was scheduled to undergo a tonsillectomy. During the study she experienced intermittent tonsillitis which necessitated the date of her tonsillectomy to be brought forward. The operation proceeded uneventfully and the patient made a good recovery. The investigator considered the tonsillitis was unrelated to the use of study medication.
, 百拇医药
3. A 28 year old male patient was receiving oral lamivudine 150mg, twice daily, for treatment of HIV infection. Concurrent medication included AZT. After five months in the study routine blood sampling revealed anaemia with a haemoglobin level of 8.2g/dL. The patient was admitted to hospital for a blood transfusion. The investigator considered the event was possibly related to the use of study medication.
4. A 65 year old male patient had received oral ranitidine bismuth citrate 400mg twice daily for 29 days in co-prescription with oral clarithromycin 500mg twice daily for the first 14 days of treatment for the eradication of Helicobacter pylori. During the study the patient mentioned that he was losing blood in his stools. A subsequent colonscopy, performed twelve days after completing the course of study medication, led to a diagnosis of malignant left sigmoidal neoplasia. The investigator considered the event was unrelated to study medication.
, 百拇医药
5. A 40 year old male patient was receiving an infusion of acyclovir for prophylaxis of CMV infection prior to bone marrow transplantation. During the infusion the patient experienced an episode of blindness which resolved on cessation of study drug. When study drug was re-commenced a few hours later the blindness recurred. The patient was consequently withdrawn from the study. The investigator considered the event was possibly related to the study medication.
, 百拇医药
6. A 70 year old male patient was receiving salmeterol. He developed a headache and dizziness and was kept in hospital for 24 hours for observation. He was discharged and his condition had resolved completely. The investigator considered the event was probably related to the study drug.
7. A 22 year old male patient injured his knee whilst playing football in October 1995. He was entered onto a valaciclovir study in December 1995. In February 1996 the patient elected to undergo surgery on his knee even though his condition had not worsened. He was hospitalised for two days and the pain in his knee resolved two days later.
, 百拇医药
8. A 25 year old male patient was in hospital receiving lamivudine (3TC) for HIV infection. He subsequently developed pneumocystis carnii and was treated with intravenous co-trimoxazole, gentamicin and vancomycin. Ten minutes later the patient developed generalised urticaria, stridor and hypotension (BP = 80/48). He was treated with adrenaline, chlorpheniramine and hydrocortisone and his condition improved. The investigator considered the event was unrelated to the study drug.
, 百拇医药
9. At baseline a patient states that she experienced pain and swelling in her fingers about once each month which improves when she takes a non-steroidal anti-inflammatory drug (NSAID). After study drug administration, she states that the pain and swelling are occurring weekly and that she no longer gets relief from the NSAID. The investigator considers this to be unrelated to study medication.
10. A 34 year old female patient while participating in a ranitidine study was hospitalised for elective rhinoplasty on 0l Apr97. The surgery went well without incident and was scheduled to be discharged the following day. On 02 Apr97 the patient developed a fever of unknown origin and was started on Ceftin. She remained hospitalised for two additional days. The fever resolved and she was discharged on 04 Apr97
, 百拇医药
11. A patient enrolled in an ondansetron study came into office for their week 2 study visit. They stated that they took their medication as prescribed; however, the tablets smelled like rotten fish and tasted like burnt toast.
12. A 30 year old male fireman was receiving lamivudine 150mg twice daily for suppression of HIV infection. Concurrently he received diazepam and aspirin. While enrolled in the study, he responded to an emergency call to save Fluffy, Mrs Robinson's pet cat, from the town oak tree. He was so ecstatic about saving the lovely cat, he inadvertently took double the highest recommended dose as per the protocol. Upon realising his error, he decided he should take ten diazepam to counteract the additional study drug he ingested. Fortunately, he reported no side effects and got a good nights sleep., http://www.100md.com