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metastron(Strontium chloride, SR-89) injection, powder, lyop(二)
2013-07-22 19:24:09 来源: 作者: 【 】 浏览:3519次 评论:0
5.0% 31.8% 35.0%
(n=44) (n=35) (n=34) (n=24) (n=22) (n=20)

At each visit, treatment success, defined as a reduction in a patient's pain score without any increase in analgesic intake and without any supplementary radiotherapy at the index site, was more frequent among patients assigned to Metastron than to placebo.

Table 3 compares the number and percentage of patients treated with Metastron or placebo as an adjunct to radiotherapy who were pain free without analgesic at the intervals shown.

Table 3: Comparison of the effects of Strontium-89 and placebo, as adjunct to radiotherapy, on reduction of pain score and analgesic score to zero. Months Post-Treatment
 1 2 3 4 5 6 9
Metastron 6 5 5 3 4 4 2
14.3% 13.2% 15.2% 11.1% 18.2% 18.2% 18.2%
(n=42) (n=38) (n=33) (n=27) (n=22) (n=22) (n=11)
Placebo 3 3 2 0 1 1 0
6.8% 8.6% 5.9%  4.5% 5% 
(n=44) (n=35) (n=34) (n=24) (n=22) (n=20) (n=17)

The number of patients classified at each visit as treatment successes who were pain free at the index site and required no analgesics was consistently higher in the Metastron group.

New pain sites were less frequent in patients treated with Metastron.

In another clinical trial, pain relief was greater in a group of patients treated with Metastron compared with a group treated with non-radioactive strontium-88.

INDICATIONS AND USAGE
Metastron (Strontium-89 Chloride Injection) is indicated for the relief of bone pain in patients with painful skeletal metastases.

The presence of bone metastases should be confirmed prior to therapy.

CONTRAINDICATIONS
None known.

WARNINGS
Use of Metastron in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Metastron, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient's peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Metastron. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient's disease or additional therapy intervenes.

In considering repeat administration of Metastron, the patient's hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully eva luated.

Verification of dose and patient identification is necessary prior to administration because Metastron delivers a relatively high dose of radioactivity.

Metastron may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

PRECAUTIONS
Metastron is not indicated for use in patients with cancer not involving bone. Metast

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