Clinical evaluation of flurbiprofen adhesive topical transdermal delivery system (FP-A) on periarthritis scapulohumeralis. Double blind comparative study with FP-A base.:—<I>double blind comparative study with FP-A base</I>—
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概要
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The present clinical trial was attempted to compare and evaluate the degree of usefulness of flurbiprofen adhesive topical transdermal delivery system (FP-A) as a non-steroidal anti-inflammatory analgesic that reduces systemic side effects, enhanced drug concentration within the tissues of the local inflammatory site beside eliciting a persistent relieving effect on the affected site. The trial was performed under double blind comparative study with subjects suffering from periarthritis scapulohumeralis and where the FP-A base was used as the control. The following results were obtained:<BR>(1) Of the total of 191 cases with periarthritis scapulohumeralis, 141 achieved general consequent improvement, overall safety index for 182 cases, and 147 cases had degree of usefulness on analysis of the subjects studied.<BR>(2) In cases where general consequent improvement was seen, a excellent improvement was noted in 35.6% (26/73 cases) when compared to FP-A base group of 16.2 % (11/68 cases) with the former group showing a significant (P<0.05) improvement. For cases with above "good improvement", improvement was seen in 64.4% (47/73 cases) in the FP-A goup whereas 42.6% (29/68 cases) in the FP-A base group, indicating the former to register a significant (P<0.05) improvement over the latter.<BR>(3) With regards to the overall safety index, cases that were judged to "have problems in safety margin" included 2.2% (2/89 cases) and 4.3% (4/49 cases) in the FP-A and FP-A base groups, respectively. Moreover, for cases that wore categorized as "not safe" in the FP-A group, a only 1.1% (1/93 cases) was observed.<BR>Side effects were seen confined to the sites where the adhesive was patched. Appearance of these side effects and safety margin was not at all significant between the 2 groups.<BR>(4) On the degree of usefulness, cases that categorized as above "extremely useful" were 34.2% (26/76 cases) in the FP-A group against 15.5% (11/71 cases) in the FP-A base group. For those that were above "good useful", 63.2% for the former and 42.3% for the latter were noted. For the 2 categories above, treatment given to the FP-A group was significantly (P<0.05) beneficial when compared to the FP-A base group.<BR>The above findings reveal FP-A to elicit a clinically beneficial effect on, and therefore is a beneficial medicament for, periarthritis scapulohumeralis.
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