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2005ᖳ5᭮20᪝䟺㔘䟻
♣ఌ೸ᗛ༈Ꮥᇱ♇䜽䜱䝯II
ᵋ㏸໩ᢊ㘋䛮CONSORTኇ᪺
~ㄵᩝ䜘ㄖ䜆䛥䜇䛱䝿ㄵᩝ䜘᭡䛕䛥䜇䛱~
ா㒌ኬᏕኬᏕ㝌༈Ꮥ◂✪⛁೸ᗛ᝗ሒᏕ
୯ᒜ೸ኰ
1
௑᪝䛴┘ᵾ

㈻䛴Ⰳ䛊᝗ሒὮ㏳䛴っⅤ䛑䜏䚮ᵋ㏸໩ᢊ
㘋䛴ណ⩇䜘Ꮥ䛼䚯

ᵋ㏸໩ᢊ㘋䛴රమⓏ䛰ᙟᘟ䛮䚮྘㡧┘䛭
オ㏑䛟䜑හᐖ䜘Ꮥ䛼䚯

⮣ᗃモ㥺ሒ࿈䛴㈻ྡྷ୕䜘┘ᣞ䛟䚸䠕䠡䠠䠥
䠡䠤䠦ኇ᪺䚹䛵䛞䜇䚮䜬䝗䝋䝷䜽䛴㐲ว䛰
షᠺ䝿ฺ⏕䛱㛭䜕䜑ᅗ㝷Ⓩᥞ᱄䜘▩䜑䚯
2
㻨㻥㻰ᐁ᪃䝿ᬉཀྵ䛴㐛⛤
㻔䠀⛁ᏕⓏ䛰᰷ᣈ䛴షᠺ䟺䜬䝗䝋䝷䜽䜘ష䜑䟻
䠄䠀⛁ᏕⓏ䛰᰷ᣈ䛴཭㞗䝿フ౮䝿ᥞ౩䟺䜬䝗䝋
䝷䜽䜘ఎ䛎䜑䟻
䠅䠀᰷ᣈ䛱ᇱ䛫䛕༈⒢䟺䜬䝗䝋䝷䜽䜘౐䛌䟻
3
䠗䠔䠟䝛䝱䜿䜽䛱䛐䛗䜑
1ḗ᝗ሒ䛮2ḗ᝗ሒ
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䠃ḗ᝗ሒ䝿䝿䝿䝘䜦䝰䝗䝩䞀ヽ䛱᥎㍍䛛䜒䛥ཋⴥ
ㄵᩝ䛒௥⾪䚯
䠄ḗ᝗ሒ䝿䝿䝿䟺䠗䠔䠟䛴䝙䝰䞀䝤䝳䞀䜳䛭䛵䟻1ḗ
᝗ሒ䛴㞗⣑䛱䜎䛩䛬ష䜏䜒䛥᝗ሒ䚯䜻䜽䝊䝢
䝊䜧䝇䜳䝿䝰䝗䝩䞀䜊チ⒢䜰䜨䝍䝭䜨䝷䛒௥⾪䚯
– Ἰណ䠌⏍䝋䞀䝃䛱䜦䜳䜿䜽䛵䛭䛓䛰䛊䛒䚮䛣䜒䛒ฦ
ᯊ䛛䜒䛥᝗ሒ䜘䛛䜏䛱ຊᕝ䛟䜑䜎䛌䛰䜈䛴䜈䠄ḗ᝗
ሒ䛮䛛䜒䜑䚯䚭䠕䠸.䚭secondary research 䟺Ử᩷ฦ
ᯊ䚮༈⒢⤊ῥⓏฦᯊ䚭䛰䛯䟻
4
1ḗ᝗ሒ䛮2ḗ᝗ሒ
䠌ᵋ㏸໩ᢊ㘋䛴っⅤ䛑䜏

䠃ḗ᝗ሒ䛵䝿䝿䝿
– ◂✪⩽䟺ⴥ⩽䟻䛵䟺ཋⴥ䟻ㄵᩝ䜘᭡䛕㝷䛱䚮◂✪䛴┘
Ⓩ䡗᪁Ἢ䛴᪺☔໩䜘ị䜇䜏䜒䜑䚯
– 䝘䜦䝰䝗䝩䞀ヽ䛴⥽㞗ጟဤఌ䛴ᙲ๪

䠄ḗ᝗ሒ䛵䝿䝿䝿
– ◂✪⩽䛒షᠺ䛟䜑ሔྙ䟺䜻䜽䝊䝢䝊䜧䝇䜳䝿䝰
䝗䝩䞀䚮チ⒢䜰䜨䝍䝭䜨䝷䛴షᠺ䛰䛯䟻
– 䠄ḗ᝗ሒヽ䛴䛥䜇䛱షᠺ䛟䜑ሔྙ䟺ၛᴏฝ∟♣䛴
⥽㞗⩽䚮abstractors䚮䝋䞀䝃䝝䞀䜽షᠺ⩽䛒ᢰᙔ䟻
5
ᵋ㏸໩ᢊ㘋䛴ᒈ㛜
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1987 ༈Ꮥᩝ⊡䛴ᢀึⓏྨ࿝䛴䛥䜇䚮Ad Hoc
Working Group䛒䠉㡧┘䛴ᵋ㏸໩ᢊ㘋䜰䜨䝍䝭䜨䝷䜘
Ⓠ⾪䚯Ann Intern Med 1987;106(4):598-604䚭ྜྷヽ
䛵107(1)䛑䜏᤿⏕䜘㛜ጙ䚯
1988 䝰䝗䝩䞀ㄵᩝ䛱ᑊ䛟䜑䜰䜨䝍䝭䜨䝷䟺䠈㡧┘䟻Ⓠ
⾪䚭Ann Intern Med 1988;108(4):613-5
1990 Haynes䜏䚮䜰䜨䝍䝭䜨䝷䛴ᨭゖ∟䜘Ⓠ⾪䊲䠊㡧
┘∟䛴ᥞ᱄䚭Ann Intern Med 1990;113(1):69-76
1993 ⏍∸༈Ꮥ㞟ヽ䛴⤣ୌᢖ✇ぞ⛤䛭ḿᘟ䛱᥆ዜ
6
ᵋ㏸໩ᢊ㘋䟺Structured Abstract䟻
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ᢊ㘋䝿䝿䝿ᩝ⊡᝗ሒ䛴㞗⣑Ⅴ
㟸ᵋ㏸໩ᢊ㘋䛑䜏IMRAD䛾
– Introduction, Methods, Results and Discussion
䟺┘Ⓩ䚮᪁Ἢ䚮⤎ᯕ䚮⤎ㄵ䛱┞ᙔ䟻
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8㡧┘∟䛴ᥞ᱄䝿䝿䝿 Haynes RB, et al.
More informative abstracts revisited.
Ann Intern Med 1990;113(1):69-76
1.┘Ⓩ䚭䠄.◂✪䝋䜺䜨䝷䚭䠅.䜿䝇䝊䜧䝷䜴
䠆.ᑊ㇗ᝀ⩽䟺䜄䛥䛵ཤຊ⩽䟻䚭5. ௒ථ
6. ୹䛰䜦䜪䝌䜯䝤フ౮䚭7. ⤎ᯕ䚭8.⤎ㄵ
7
㟸ᵋ㏸໩ᢊ㘋䛴ౚ
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Ⲡᕖぞ▬⏠䚮௙䠀䚭䜦䝷䜼䜮䝊䝷䜻䝷IIུᐖమᣍᢘⷾCS866(Olmesartan Medoxomil)䛴ᮇឺᛮ㧏⾉ᅸ⑍ᝀ⩽䜘ᑊ㇗䛮䛝䛥
䝢䝰䜨䝷㓗䜬䝎䝭䝛䝮䝯䛮䛴஦㔔┛᳠Ẓ㍉モ㥺䠀⮣ᗃ༈ⷾ
2004;20(2):115-9
CS-866(10mg䡐20mg,20mg䛴ₖቌἪ)䛴᭯ຝᛮ,Ꮽධᛮ䛐䜎䛹᭯
⏕ᛮ䛱䛪䛊䛬㜾ᅸຝᯕ,ᴣᣋᏭධᗐ,᭯⏕ᗐ䛭䛈䜑䝢䝰䜨䝷㓗䜬䝎䝭
䝛䝮䝯䜘ᑊ↯ⷾ䛮䛝䛥஦㔔┛᳠Ẓ㍉モ㥺䜘⾔䛩䛥.ᢖ୙ᑊ㇗ᝀ⩽䛵
㍇⑍䝿୯➴⑍ᮇឺᛮ㧏⾉ᅸᝀ⩽䛭,⑍ౚᩐ䛵྘110ౚ,ゝ220ౚ䛭┞
பష⏕䛒⩻䛎䜏䜒䜑ⷾ๠䛴ె⏕䛵⚏Ḿ䛝䛥.㜾ᅸຝᯕ䛴ึᏽᇱ‵
䛵཭⦨᭿⾉ᅸ20௧୕,ᣉᘿ᭿⾉ᅸ10௧୕,ᖲᆍ⾉ᅸ13௧୕䛴ୖ㜾
䜘䚸ୖ㜾䚹䛮ึᏽ䛝䛥.ᐁ㝷䛴⑍ౚ䛵CS-866⩄148ౚ(CS⩄),䝢䝰䜨䝷
㓗䜬䝎䝭䝛䝮䝯⩄151ౚ(EN⩄)䛭㞫⬲ౚ䜘㝎አ䛝䛥139ౚ䛮145ౚ䛱
䛪䛊䛬᭯ຝᛮ䜘᳠ゞ䛝,ධౚ䜘ᑊ㇗䛱Ꮽධᛮ䛮᭯⏕ᛮ䜘᳠ゞ䛝䛥.᭯
ຝᛮ䛴୹さ㡧┘䛭䛈䜑⾉ᅸຝᯕ䛵CS⩄75.5%,EN⩄63.4%䛭䛈䛩
䛥.᭯ᐐ஥㇗䛮䛝䛬䛴⮤௙て⑍≟䛴Ⓠ⌟⋙䛵CS⩄䛭58.8%,EN⩄䛭
70.2%䛭䛈䛩䛥.ဌႻ䛴Ⓠ⌟ౚᩐ䛵CS⩄3.4%,EN⩄29.8%䛭䛈䜐,
⮣ᗃ᳠ᰕೋ␏ᖏንິ䛵CS⩄19.7%,EN⩄10.7%䛭䛈䛩䛥.἖㥺ⷾ䛮
ᅄᯕ㛭౿䛒ྫྷᏽ䛭䛓䛰䛊㔔⠔䛰᭯ᐐ஥㇗䛵䛰䛑䛩䛥.Ꮽධ⋙䛵CS
⩄79.1%,EN⩄58.3%䛭䛈䜐,௧୕䛑䜏,CS-866䛵EN䜎䜐䜈㜾ᅸຝᯕ,
Ꮽධᛮ䛮䜈䛱ඁ䜒⮣ᗃⓏ䛱᭯⏕䛰㜾ᅸⷾ䛭䛈䜑䛙䛮䛒☔ヾ䛛䜒䛥8
ᵋ㏸໩ᢊ㘋䛴ౚ
:Introduction, Methods, Results and Discussion
(IMRAD)
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Singh BN et al. Amiodarone versus sotalol for atrial fibrillation. N Engl J Med.
2005 May 5;352(18):1861-72.
BACKGROUND: The optimal pharmacologic means to restore and maintain sinus
rhythm in patients with atrial fibrillation remains controversial.
METHODS: In this double-blind, placebo-controlled trial, we randomly assigned 665
patients who were receiving anticoagulants and had persistent atrial fibrillation to receive
amiodarone (267 patients), sotalol (261 patients), or placebo (137 patients) and
monitored them for 1 to 4.5 years. The primary end point was the time to recurrence of
atrial fibrillation beginning on day 28, determined by means of weekly transtelephonic
monitoring.
RESULTS: Spontaneous conversion occurred in 27.1 percent of the amiodarone group,
24.2 percent of the sotalol group, and 0.8 percent of the placebo group, and directcurrent cardioversion failed in 27.7 percent, 26.5 percent, and 32.1 percent, respectively.
The median times to a recurrence of atrial fibrillation were 487 days in the amiodarone
group, 74 days in the sotalol group, and 6 days in the placebo group according to
intention to treat and 809, 209, and 13 days, respectively, according to treatment
received. Amiodarone was superior to sotalol (P<0.001) and to placebo (P<0.001), and
sotalol was superior to placebo (P<0.001). In patients with ischemic heart disease, the
median time to a recurrence of atrial fibrillation was 569 days with amiodarone therapy
and 428 days with sotalol therapy (P=0.53). Restoration and maintenance of sinus
rhythm significantly improved the quality of life and exercise capacity. There were no
significant differences in major adverse events among the three groups.
CONCLUSIONS: Amiodarone and sotalol are equally efficacious in converting atrial
fibrillation to sinus rhythm. Amiodarone is superior for maintaining sinus rhythm, but
9
both drugs have similar efficacy in patients with ischemic heart disease. Sustained sinus
rhythm is associated with an improved quality of life and improved exercise performance.
ᵋ㏸໩ᢊ㘋䛴ౚ䠌䠊㡧┘∟
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Lindholt JS, et al. Screening for abdominal aortic aneurysms: single centre
randomised controlled trial. BMJ. 2005 Apr 2;330(7494):750. Epub 2005 Mar 9.
OBJECTIVE: To determine whether screening Danish men aged 65 or more for
abdominal aortic aneurysms reduces mortality.
DESIGN: Single centre randomised controlled trial.
SETTING: All five hospitals in Viborg County, Denmark.
PARTICIPANTS: All 12,639 men born during 1921-33 and living in Viborg County. In
1994 we included men born 1921-9 (64-73 years). We also included men who became 65
during 1995-8.
INTERVENTIONS: Men were randomised to the intervention group (screening by
abdominal ultrasonography)
ultrasonography) or control group. Participants with an abdominal aortic
aneurysm > 5 cm were referred for surgical evaluation, and those with smaller aneurysms
were offered annual scans.
OUTCOME MEASURES: Specific mortality due to abdominal aortic aneurysm, overall
mortality, and number of planned and emergency operations for abdominal aortic
aneurysms.
RESULTS: 4860 of 6333 men were screened (attendance rate 76.6%). 191 (4.0% of
those screened) had abdominal aortic aneurysms. The mean follow-up time was 52
months. The screened group underwent 75% (95% confidence interval 51% to 91%)
fewer emergency operations than the control group. Deaths due to abdominal aortic
aneurysms occurred in nine patients in the screened group and 27 in the control group.
The number needed to screen to save one life was 352. Specific mortality was
significantly reduced by 67% (29% to 84%). Mortality due to non-abdominal aortic
aneurysms was non-significantly reduced by 8%. The benefits of screening may increase
with time.
10
CONCLUSION: Mass screening for abdominal aortic aneurysms in Danish men aged 65
or more reduces mortality.
షᠺ⩽
ཉ⏍ຘ഼⛁Ꮥ◂✪
:EBM䜘ᣞྡྷ䛝䛥䚸チ⒢䜰䜨䝍䝭䜨
䝷䚹䛮༈Ꮥ䝋䞀䝃䝝䞀䜽䛱ฺ⏕䛛
䜒䜑䚸ᵋ㏸໩ᢊ㘋䚹షᠺ䛴᪁Ἢㄵ
䛴㛜Ⓠ䛮䛣䜒䜏䛴ུᐖᛮ䛱㛭䛟
䜑◂✪(2001䡐3ᖳᗐ)
⮣ᗃᐓ
チ⒢࢝࢕ࢺࣚ࢕ࣤ
⾔ᨳ
◂✪⩽
༈Ꮥヽ⥽㞗⩽
ᵋ㏸໩ᢊ㘋
䝋䞀䝃䝝䞀䜽షᠺ⩽
ᝀ⩽䝿༈⒢ᾐ㈕⩽
Ἢᚂᐓ
♣ఌୌ⯙䟺༈⒢䛴ུ䛗ᡥ䟻
⮣ᗃᐓ
䝿䝿Stakeholders䟺ฺ─㛭౿⩽䟻
䛴Crossroads
11
ᵋ㏸໩ᢊ㘋䛵ㄵᩝ䛴㈻䜘㧏䜇䜑䛑䠑䟺䠃䟻
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㻷㼄㼇㼇㼌㼒㻃㻤㻃㼈㼗㻃㼄㼏㻑㻃㻴㼘㼄㼏㼌㼗㼜㻃㼒㼉㻃㼑㼒㼑㼖㼗㼕㼘㼆㼗㼘㼕㼈㼇㻃㼄㼑㼇
㼖㼗㼕㼘㼆㼗㼘㼕㼈㼇㻃㼄㼅㼖㼗㼕㼄㼆㼗㼖㻃㼒㼉㻃㼒㼕㼌㼊㼌㼑㼄㼏㻃㼕㼈㼖㼈㼄㼕㼆㼋
㼄㼕㼗㼌㼆㼏㼈㼖㻃㼌㼑㻃㼗㼋㼈㻃㻥㼕㼌㼗㼌㼖㼋㻃㻰㼈㼇㼌㼆㼄㼏㻃㻭㼒㼘㼕㼑㼄㼏㻏㻃㼗㼋㼈
㻦㼄㼑㼄㼇㼌㼄㼑㻃㻰㼈㼇㼌㼆㼄㼏㻃㻤㼖㼖㼒㼆㼌㼄㼗㼌㼒㼑㻃㻭㼒㼘㼕㼑㼄㼏㻃㼄㼑㼇㻃㼗㼋㼈
㻭㼒㼘㼕㼑㼄㼏㻃㼒㼉㻃㼗㼋㼈㻃㻤㼐㼈㼕㼌㼆㼄㼑㻃㻰㼈㼇㼌㼆㼄㼏㻃㻤㼖㼖㼒㼆㼌㼄㼗㼌㼒㼑㻑
㻦㻰㻤㻭㻑㻃㻔㻜㻜㻗㻞㻔㻘㻓㻋㻔㻓㻌㻝㻔㻙㻔㻔㻐㻘㻑
㻔㻜㻛㻛㻐㻔㻜㻜㻕ᖳ䛱䠅ヽ䛱Ⓠ⾪䛛䜒䛥䠅䠂䠂ㄵᩝ䛴
ᢊ㘋䜘䠊㡷ᇡ䟺ᵋ㏸໩ᢊ㘋㡧┘䛱ᑊᚺ䟻䛭フ౮
㼔㼘㼄㼏㼌㼗㼜㻃㼖㼆㼒㼕㼈䝿䝿䝿㟸ᵋ㏸໩ᢊ㘋㻓㻑㻘㻚䚮ᵋ㏸໩ᢊ
㘋㻃㻓㻑㻚㻗䚯
12
ᵋ㏸໩ᢊ㘋䛵ㄵᩝ䛴㈻䜘㧏䜇䜑䛑䠑䟺䠄䟻
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㻶㼆㼋㼈㼕㼈㼕㻃㻵㻺㻃㻉㻃㻦㼕㼄㼚㼏㼈㼜㻃㻥㻑㻃㻵㼈㼓㼒㼕㼗㼌㼑㼊㻃㼒㼉㻃㼕㼄㼑㼇㼒㼐㼌㼝㼈㼇㻃㼆㼏㼌㼑㼌㼆㼄㼏
㼗㼕㼌㼄㼏㻃㼇㼈㼖㼆㼕㼌㼓㼗㼒㼕㼖㻃㼄㼑㼇㻃㼘㼖㼈㻃㼒㼉㻃㼖㼗㼕㼘㼆㼗㼘㼕㼈㼇㻃㼄㼅㼖㼗㼕㼄㼆㼗㼖㻑䚭㻭㻤㻰㻤㻑
㻔㻜㻜㻛㻞㻕㻛㻓㻋㻖㻌㻝㻕㻙㻜㻐㻚㻕㻑
ᵋ㏸໩ᢊ㘋᤿⏕ヽ㻤㼕㼆㼋㼌㼙㼈㼖㻃㼒㼉㻃㻲㼓㼋㼗㼋㼄㼏㼐㼒㼏㼒㼊㼜㻃㻋㻔㻜㻜㻕㻐㻔㻜㻜㻗㻌
㻏㻲㼓㼋㼗㼋㼄㼏㼐㼒㼏㼒㼊㼜㻃㻋㻔㻜㻜㻔㻐㻔㻜㻜㻖㻌䛮㟸᤿⏕ヽ㻤㼐㼈㼕㼌㼆㼄㼑㻃㻭㼒㼘㼕㼑㼄㼏㻃㼒㼉
㻲㼓㼋㼗㼋㼄㼏㼐㼒㼏㼒㼊㼜䟺㻔㻜㻜㻔㻐㻔㻜㻜㻗㻌䛴ㄵᩝᮇᩝ䜘㻦㻲㻱㻶㻲㻵㻷ኇ᪺䜘ฺ
⏕䛝䛬フ౮㻑
䚸ᵋ㏸໩ᢊ㘋䚹䛴᤿ྫྷ䛱䜎䛩䛬ሒ࿈䛴㈻䛱㐢䛊䛰䛑䛩䛥䚯
䝿䝿䝿ධᩝ䜘⢥ㄖ䛝䛬フ౮䛛䜒䛥ㄵᩝ䛴㈻䛒䚸ᵋ㏸໩ᢊ㘋䚹䛴᤿
ྫྷ䛮㛭㏻䛝䛬䛊䛰䛑䛩䛥䛮䛝䛬䜈䚮䚸ᵋ㏸໩ᢊ㘋䚹䛱䜎䛩䛬ⴥ⩽
䛵ၡ㢗ណㆉ䛮᪁Ἢㄵ䛴᪺☔໩䜘ị䜇䜏䜒䚮ㄖ⩽䛵▯᫤㛣䛱ຝ
⋙䜎䛕ᚪさ᝗ሒ䜘ᢍᥩ䛭䛓䜑䛭䛈䜓䛌䚯
13
ᵋ㏸໩ᢊ㘋䛴ᬉཀྵᗐ



Harbourt䝿䝿䝿1989ᖳ䛑䜏1991ᖳ䛴MEDLINE཭㍍ㄵᩝ䛑
䜏structured abstracts䜘䜈䛪3873௲䜘ㆉื䚯ㄵᩝᩐ䛮᤿
⏕ヽᩐ䛴୦㟻䛑䜏ቌຊലྡྷ䚯 structured abstracts 䜘᤿
⏕䛝䛬䛊䛥ㄵᩝ䛴᪁䛒௛୙䛛䜒䛬䛊䛥䠟䠷䠥䠚ᩐ䛒ኣ䛑䛩
䛥䚯Bull Med Libr Assoc. 1995;83:190-5
Kulkarni䝿䝿䝿1990ᖳᚃ༖䛑䜏1995ᖳ๑༖䜄䛭䛱MEDLINE
䛱཭㍍䛛䜒䛥clinical trialsㄵᩝ䛴28.5%䛒ర䜏䛑ᙟᘟ䛭
ᵋ㏸໩䛛䜒䛬䛊䜑䛙䛮䜘♟䛝䚮1995ᖳ䛱䛣䛴Ẓ⋙䛒71%
䛱୕᪴䛝䛬䛊䜑䛙䛮䜘ሒ࿈䚯
Ann Intern Med 1996 Apr 1;124(7):695-6
㟯ᮄ䝿䝿䝿᪝ᮇ༈Ꮥఌ䝿ฦ⛁ఌ䠋䠃ᏕఌⓆ⾔䛴䠃䠄䠈ヽ䛴ㄢ
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᤿⏕䛝䛬䛊䜑䛴䛵䠈ヽ䟺4.8%䟻䛴䜅䚯
14
ᾇአᩝ⊡䛴ᵋ㏸໩ᢊ㘋᤿⏕≟Ἓ
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
᪁Ἢ䡗䡗䡗㻬㻶㻬♣䛴㻭㼒㼘㼕㼑㼄㼏㻃㼒㼉㻃㻦㼌㼗㼄㼗㼌㼒㼑㼖㻃㻵㼈㼓㼒㼕㼗㼖
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
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15

䟺㻱㼄㼎㼄㼜㼄㼐㼄㻃㼈㼗㻃㼄㼏㻑㻃㻭㻃㻰㼈㼇㻃㻯㼌㼅㼕㻃㻤㼖㼖㼒㼆㻑㻃㻕㻓㻓㻘㻞㻜㻖㻝㻕㻖㻚㻐㻗㻕㻑䟻
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
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㻔㻗ヽ䟺㻘㻕䟸䟻䚮ᮅ᤿⏕䛒㻛ヽ䟺㻖㻓㻈䟻䚯

ᵋ㏸໩ᢊ㘋㻔㻛㻛௲䛴䝕䝃䞀䝷䛱ᑊ䛟䜑䜳䝭䜽䝃䞀
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䜯䝊䜸䝮䞀䛱ฦ㢦䛛䜒䛥䚯
16
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Haynes RB, et al.
More informative
abstracts
revisited.
Ann Intern Med.
1990;113:69-76.
19
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20
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Long-term weight loss with sibutramine: a
randomized controlled trial.
JAMA 2001;286(11):1331-9

CONTEXT: Treatment of obesity requires long-term therapy, which can be

OBJECTIVE: To compare the effectiveness of 2 distinct sibutramine regimens with

PATIENTS: A total of 1102 obese adults (body mass index, 30-40 kg/m(2)) entered

INTERVENTIONS: Patients were randomly assigned to receive 15 mg/d of

MAIN OUTCOME MEASURE: Weight loss during the randomized treatment
hampered by difficulties in achieving patient compliance. The effectiveness of
sibutramine hydrochloride in treating obesity has been shown in randomized
controlled trials.
each other and with placebo for weight reduction among obese persons. DESIGN:
Randomized, double-blind, parallel-group placebo-controlled trial from April 1997 to
September 1998. SETTING: One hundred eight private practices and 3 outpatient
departments of university hospitals in Germany.
the 4-week open-label run-in period with 15 mg/d of sibutramine,
sibutramine, 1001 of whom had
weight loss of at least 2% or 2 kg were randomized into the 44-week randomized
treatment period.
sibutramine continuously throughout weeks 1-48 (n = 405); 15 mg/d of sibutramine
intermittently during weeks 1-12, 19-30, and 37-48, with placebo during all other
weeks (n = 395); or placebo for weeks 5-48 (n = 201).
period, compared among all 3 groups.
24

RESULTS: Mean weight loss in the intention-to-treat population during

CONCLUSIONS: Sibutramine, administered for 48 weeks to a typically
the 44-week randomized treatment period was 3.8 kg (4.0%) in patients
receiving continuous therapy (95% confidence interval [CI], - 4.42 to - 3.20
kg) and was 3.3 kg (3.5%) in patients receiving intermittent therapy (95%
CI, - 3.96 to - 2.66 kg), vs a mean weight gain of 0.2 kg (0.2%) (95% CI, 0.60 to 0.94 kg) in patients receiving placebo. Therapeutic equivalence of the
2 active treatments could be shown. Although there was a greater weight
loss in the continuous than in the intermittent group, this difference was
nonsignificant (P =.28) and the 95% CIs were within the predefined range of
therapeutic equivalence-0 +/-1.5 kg (-1.37 to 0.28 for the intent-to-treat
population). Overall weight loss during the 48-week period was 7.9 kg and
7.8 kg in the continuous and intermittent groups, respectively, but was 3.8
kg in the sibutramine run-in placebo group. Waist circumference reduction,
triglyceride levels, and high-density lipoprotein cholesterol concentrations
were also positively influenced by sibutramine treatment. Systolic and
diastolic blood pressures were stable across all 3 groups. Overall, adverse
events occurred at similar frequencies across all treatment groups, but the
proportion was lowest in the group receiving intermittent therapy.
obese population, results in clinically relevant weight loss compared with
placebo. Regarding effectiveness, continuous and intermittent sibutramine
therapies are equivalent and the safety profiles for both treatments are
25
comparable. (427 words)
Continuous and intermittent sibutramine
were equally effective at 44 weeks for
reducing weight in obese persons



ACP Journal Club. 2002 Mar-Apr;136:49.
Wirth A, Krause J. Long-term weight loss with
sibutramine: a randomized controlled trial.
JAMA. 2001 Sep 19;286:1331-9.
Question
– In obese persons, is sibutramine effective for reducing
weight?
26

Design
– Randomized (allocation concealed*), blinded (investigators
and patients),* placebo-controlled trial with 44-week followup after randomization.

Setting
– 108 private practices and 3 hospital outpatient departments in
Germany.

Patients
– 1001 patients who were 18 to 65 years of age (mean age 43 y,
77% women), had a body mass index (BMI) of 30 to 40
kg/m2, and had 1 previous unsuccessful attempt at losing
weight by using dietary measures. Exclusion criteria were
serious cardiovascular or metabolic diseases; history of drug
or alcohol abuse; need for antidepressants, β-blockers, or any
drugs influencing body weight; or inadequate contraception
in women of childbearing age. 79% of patients completed the
study; all patients were included in the analysis.
27





Intervention
– Patients who responded (i.e., weight loss of 2% or 2 kg) to
sibutramine, 15 mg/d, during a 4-week run-in period were
allocated to 1 of 3 groups for 44 more weeks: continuous
sibutramine, 15 mg/d (n = 405); intermittent sibutramine, 15
mg/d during weeks 1 to 12, 19 to 30, and 37 to 48 (n = 395); or
placebo (n = 201).
Main outcome measure
– Weight loss.
Main results
– Analysis was by intention to treat. Mean weight loss at 44 weeks
after randomization was 3.8 kg (95% CI 3.2 to 4.4) for continuous
sibutramine and 3.3 kg (CI 2.7 to 4.0) for intermittent
sibutramine; patients in the placebo group gained weight (mean
0.2 kg, CI 䌝㻓.6 to 0.9) (P < 0.001 for the difference between each
treatment group and placebo). More patients in each of the
treatment groups than in the placebo group lost 5% and 10% of
their baseline weight (P < 0.001 for all comparisons) (Table). The
2 treatment groups did not differ for weight loss.
Conclusion
– In obese persons, continuous or intermittent sibutramine were
equally effective for reducing weight. (305 words)
28
Commentary
Continuous sibutramine (CS), intermittent sibutramine (IS), or placebo for obesity†
Outcomes at 44
wk
Comparisons
Event rates
RBI (95% CI)
NNT (CI)
5% weight loss
CS vs placebo
65% vs 35%
86% (54 to 130)
4 (3 to 5)
IS vs placebo
63% vs 35%
81% (49 to 123)
4 (3 to 6)
CS vs placebo
32% vs 13% 148% (71 to 266)
6 (4 to 9)
IS vs placebo
33% vs 13% 154% (75 to 276)
6 (4 to 8)
10% weight loss
RBI: relative benefit increase EER - CER|/CER.
29
Prolonged antibiotic treatment did
not relieve chronic symptoms in
Lyme disease

ACP Journal Club. 2002 Mar-Apr;136:57.
Klempner MS, Hu LT, Evans J, et al.
Two controlled trials of antibiotic treatment
in patients with persistent symptoms and a
history of Lyme disease. N Engl J Med. 2001
Jul 12;345:85-92.

Question

– In patients with chronic symptoms after treatment for
Lyme disease, does prolonged antibiotic treatment
relieve symptoms?
30

Design
– 2 randomized {allocation concealed*}†, blinded {patients,
physicians, nurses, study coordinators, statisticians, and outcome
assessors}†,* placebo-controlled trials with 180-day follow-up.

Setting
– {New York, Connecticut, Rhode Island, and Massachusetts, USA.}
†

Patients
– 129 patients who were 18 years of age (mean age 54 y, 53%
men); had a history of acute Lyme disease acquired in the United
States; had 1 of history of single or multiple erythema migrans
skin lesions, early neurologic or cardiac symptoms of Lyme
disease, radiculoneuropathy, or Lyme arthritis; had been
previously treated for acute Lyme disease with antibiotics; and
had 1 symptom (widespread musculoskeletal pain, cognitive
impairment, radicular pain, paresthesias, or dysthesias) that
interfered with functioning, beginning within 6 months of the
initial infection and continuing for 6 months but < 1 year.
Exclusion criteria included use of parenteral antibiotics for 60
days and coexisting conditions that could account for symptoms.
Follow-up was 89%.
31

Intervention
– Patients were allocated to antibiotics (n = 64) or placebo (n = 65).
Antibiotics were intravenous (IV) ceftriaxone, 2 g/d for 30 days, followed
by oral doxycycline, 100 mg twice daily for 60 days.

Main outcome measure
– Improvement in patients' health-related quality of life (Medical Outcomes
Study 36-item Short-Form General Health Survey [SF-36]).

Main results
– The studies were stopped early because of lack of efficacy. Analysis was
by intention to treat for the 115 patients who had enrolled 180 days
before enrollment was stopped. The groups did not differ for
improvement on the SF-36 at 180 days (Table).

Conclusion
– In patients with chronic symptoms after treatment for Lyme disease,
prolonged treatment with antibiotics was not better than placebo for
relieving symptoms.
(285 words)

†Information provided by author.

Commentary
32
Antibiotics vs placebo for chronic symptoms in Lyme disease at 180 days‡
SF-36 outcome
category
Antibiotics
Placebo
RBI (95% CI)
NNT
Improved by > 2
SE
40%
36%
11% (_30 to 78) Not significant
Unchanged
28%
29%
4.2% (_69 to 46) Not significant
Worse (decline by
> 2 SE)
32%
34%
8.4% (_54 to 46) Not significant
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33
Two controlled trials of antibiotic treatment
in patients with persistent symptoms and a
history of Lyme disease. N Engl J Med 2001;345(2):8592

BACKGROUND: It is controversial whether prolonged

METHODS: We conducted two randomized trials: one in 78
antibiotic treatment is effective for patients in whom symptoms
persist after the recommended antibiotic treatment for acute Lyme
disease.
patients who were seropositive for IgG antibodies to Borrelia
burgdorferi at the time of enrollment and the other in 51 patients who
were seronegative. The patients received either intravenous
ceftriaxone, 2 g daily for 30 days, followed by oral doxycycline, 200
mg daily for 60 days, or matching intravenous and oral placebos.
Each patient had well-documented, previously treated Lyme disease
but had persistent musculoskeletal pain, neurocognitive symptoms, or
dysesthesia, often associated with fatigue. The primary outcome
measures were improvement on the physical- and mental-healthcomponent summary scales of the Medical Outcomes Study 36-item
Short-Form General Health Survey (SF-36)--a scale measuring the
34
health-related quality of life--on day 180 of the study.

RESULTS: After a planned interim analysis, the data and safety

CONCLUSIONS: There is considerable impairment of health-related
monitoring board recommended that the studies be discontinued because
data from the first 107 patients indicated that it was highly unlikely that a
significant difference in treatment efficacy between the groups would be
observed with the planned full enrollment of 260 patients. Base-line
assessments documented severe impairment in the patients' health-related
quality of life. In intention-to-treat analyses, there were no significant
differences in the outcomes with prolonged antibiotic treatment as compared
with placebo. Among the seropositive patients who were treated with
antibiotics, there was improvement in the score on the physical-component
summary scale of the SF-36, the mental-component summary scale, or both
in 37 percent, no change in 29 percent, and worsening in 34 percent; among
seropositive patients receiving placebo, there was improvement in 40 percent,
no change in 26 percent, and worsening in 34 percent (P=0.96 for the
comparison between treatment groups). The results were similar for the
seronegative patients.
quality of life among patients with persistent symptoms despite previous
antibiotic treatment for acute Lyme disease. However, in these two trials,
treatment with intravenous and oral antibiotics for 90 days did not improve
symptoms more than placebo. (350 words)
35
䜻䜽䝊䝢䝊䜧䝇䜳䡗䝰䝗䝩䞀ཀྵ䛹
䝥䝃䜦䝎䝮䜻䜽

䜷䝷䝊䜱䜽䝌䟺⫴ᬊ䟻䠌䚭ᢊ㘋䛴᭡䛓ฝ䛝䛵䚮ᐼᰕ
ၡ㢗䛱䛐䛗䜑⮣ᗃ୕䟺䜄䛥䛵䛣䛴௙䟻䛴㔔さᛮ䜘ㄕ
᪺䛝䛥䠃䡐䠄䜿䝷䝊䝷䜽䛴ᩝ䛑䜏ጙ䜇䜑䛙䛮䚯

┘Ⓩ䠌䚭ᐼᰕ䛱䛐䛗䜑ḿ☔䛑䛪୹さ䛰┘Ⓩ䜘㏑䛿
䜑䛙䛮䚯䛙䛴䜽䝊䞀䝌䝥䝷䝌䛴↌Ⅴ䜘䛯䛙䛱⨠䛕䛑䛱䛪
䛊䛬䛵䚮ཋᅄ䚮チ᩷䚮஢ᚃ䚮἖⒢䚮䛈䜑䛊䛵஢㜭䛰䛯
䛮䛊䛩䛥さᅄ䛴ᐼᰕ䛱䛐䛗䜑㔔さᛮ䛱䜎䛩䛬ึ᩷䛟
䜑䛮䜎䛊䚯䜄䛥ᐼᰕᑊ㇗䛮䛰䛩䛬䛊䜑≁ᏽ䛴ẍ㞗ᅆ䚮
௒ථ䚮᭒㟚䚮䛣䛝䛬モ㥺䜄䛥䛵⤎ᯕ䛱䛪䛊䛬䛴᝗ሒ
䜈ྱ䜇䜑䛙䛮䚯
36

䝋䞀䝃䝁䞀䜽䟺䝋䞀䝃䛴ฝᡜ䟻䠌
– ᳠⣬䛛䜒䛥ᖳ䜘ྱ䜇䛥䚮䝋䞀䝃䛴ฝᡜ䛱䛪䛊䛬䛴⠾₡䛰ᴣ
さ䜘㏑䛿䜑䚯
– ฝᡜ䛴ು⿭䛮䛝䛬ᣪ䛘䜏䜒䜑䛴䛵䚮䜷䝷䝘䝩䞀䝃䞀䝿䝋䞀䝃
䝝䞀䜽䚮ฝ∟䛛䜒䛬䛊䜑ⶮ᭡┘㘋䚮Ⓡ㘋ᡜ䚮ᢊ㘋䛴ᑚ෇Ꮔ䚮
ఌ㆗㘋䚮㛭㏻䛟䜑オ஥䜊᭡∸䛴ᘤ⏕ᩝ⊡䛑䜏᪺䜏䛑䛱䛛䜒
䛥ཤ⩻ᩝ⊡䚮䛣䛴ฦ㔕䛭Ὡ㌅䛟䜑ᑍ㛓ᐓ䜄䛥䛵◂✪ᶭ㛭䚮
䛣䛝䛬ᐼᰕᑊ㇗䛭䛈䜑モⷾ䜄䛥䛵ⷾဗ䛴⿿㏸ఌ♣䛰䛯䚯
– ཤ⩻ᩝ⊡䝋䞀䝃䝝䞀䜽䛒⏕䛊䜏䜒䛥ሔྙ䛵䚮ㄵᩝ䛴᳠⣬䛱
౐䜕䜒䛥ḿ☔䛰⣬ᘤ⏕ㄊ䜘㏑䛿䜑䚯
– 䛙䛴䛮䛓䚮䛰䜙䜏䛑䛴โ⣑䟺ౚ䛎䛶ⱝㄊ䜊ெ䜘ᑊ㇗䛱⏕䛊䛥
ሔྙ䟻䛒䛈䜒䛶䛣䜒䛱䛪䛊䛬㏑䛿䚮䜄䛥᳠⣬䛴᪝௛䜈♟䛟䚯
– ᢊ㘋䛴䜽䝞䞀䜽䛴㒌ྙ䛱䜎䜐䚮䛙䛴䝰䝝䝯䛴レ⣵䛰ㄕ᪺䛒
ྊ⬗䛭䛰䛊ሔྙ䛵䚮ฝᡜ䛱䛪䛊䛬䛵さⅤ䛴䜅䜘㏑䛿䚮᳠⣬
䛛䜒䛥䝋䞀䝃䝝䞀䜽ཀྵ䛹᪝௛䛮ྙ䜕䛡䛬ᢊ㘋䛱オ㍍䛝䚮ᢊ㘋
䛱オ㍍䛝䛓䜒䛰䛑䛩䛥᝗ሒ䛱䛪䛊䛬䛵䚸ᡥἪ䚹䛴䜿䜳䜻䝫䝷䛭
㏑䛿䜑䚯
37
 ◂✪䛴㐽ᢝ䠌
– 䝌䝘䝇䜳䛱㛭㏻䛟䜑䛮䛛䜒䛥◂✪ධᩐ䛴୯䛑䜏䚮
レ⣵䛰ᐼᰕ䛴ᑊ㇗䛮䛟䜑◂✪䜘ᢜ⢃䛟䜑䛥䜇
䛱䚮ໜᣋぞ‵ཀྵ䛹㝎አᇱぞ‵䜘⏕䛊䛥ሔྙ䛵䚮
䛙䜒䛱䛪䛊䛬オ㏑䛟䜑䚯
– 㐽ᢝ䛴レ⣵䛰ㄕ᪺䛱䛵䚮≁ᏽ䛴ẍ㞗ᅆ䚮௒ථ䚮
⤎ᯕ䚮䜄䛥䛵᪁ἪㄵⓏ䝋䜺䜨䝷䛱䛪䛊䛬䛴オ㏑
䛒ྱ䜄䜒䛬䛊䜑䛙䛮䚯
– 䛙䜒䜏䛴ぞ‵䜘㐲⏕䛟䜑䛥䜇䛱⏕䛊䛥ᡥἪ䜘᪺
オ䛟䜑䛙䛮䟺ౚ䛎䛶䚮┛᳠ᐼᰕ䚮䜷䝷䜿䝷䜹䜽䚮々
ᩐᐼᰕဤ䟻䚯
– ᭩ิ䛱⏕ណ䛛䜒䛥◂✪ධᩐ䛴䛌䛧㐽ᢝぞ‵䛱ྙ
⮬䛝䛥◂✪䛴๪ྙ䜘♟䛟䛙䛮䚯
38

䝋䞀䝃᢫ฝ䠌
– 䝋䞀䝃䜘᢫ฝ䛝䚮䜄䛥䝋䞀䝃䛴㈻ཀྵ䛹ጂᙔᛮ䜘フ౮䛟䜑䛥䜇䛱⏕䛊䜏䜒䜑䜰
䜨䝍䝭䜨䝷䟺ཋᅄ᥆ᏽ䛴䛥䜇䛴ぞ‵➴䟻䜘オ㏑䛟䜑䚯
– 䜰䜨䝍䝭䜨䝷䛴㐲⏕᪁Ἢ䜘♟䛟䟺ౚ䛎䛶䚮々ᩐ䛴ふᐳ⩽䛒྘⮤≺❟䛝䛬⾔䛩
䛥᢫ฝ䟻䚯

䝋䞀䝃䛴⥪ྙ䠌
– 䝰䝗䝩䞀⤎ᯕ䛱䛪䛊䛬䚮㈻Ⓩ䚮㔖Ⓩ䛴䛊䛠䜒䜈䚮䛣䛴୹さ⤎ᯕ䜘♟䛟䚯
– ⤎ᯕ䜘ᚋ䜑䛥䜇䛱⏕䛊䜏䜒䛥ᡥἪ䛱䛪䛊䛬䛣䛴さⅤ䜘㏑䛿䜑䚯
– 䝥䝃䜦䝎䝮䜻䜽䛱䛪䛊䛬䛵䚮䝛䞀䝯䛛䜒䛥୹䛰⤎ᯕ䜘♟䛟䟺䜮䝇䜾Ẓ䜄䛥䛵᭯
ຝ䜹䜨䜾䚮䜄䛥ྊ⬗䛭䛈䜒䛶វᗐฦᯊ䜈ྱ䜇䜑䟻䚯
– ᩐೋ⤎ᯕ䜘♟䛟㝷䛵䚮㐲ว䛰ሔྙ䛵ಘ㢏༇㛣䜈ྙ䜕䛡䛬♟䛝䚮䛣䛝䛬ḿ☔䛰
⤣ゝⓏ᭯ណỀ‵䜘♟䛟䚯
– 䜽䜳䝮䞀䝏䝷䜴ཀྵ䛹チ᩷䝊䜽䝌䛴フ౮䛱䛐䛊䛬䛵䚮វᗐ䚮≁␏ᗐ䚮ᑦᗐ䚮ROC
᭜⥲䚮䛣䛝䛬஢ῼೋ➴䛴ၡ㢗䛱䛪䛊䛬♟䛟䚯
– ஢ᚃ䛴フ౮䛱䛐䛊䛬䛵䚮⏍Ꮛ≁ᚡཀྵ䛹㛭㏻䛟䜑ንᩐ䛱䛪䛊䛬ᴣᣋ䛟䜑䛙䛮䚯
々ᩐ䛴◂✪䛴㛣䛭᪺䜏䛑䛱䛰䛩䛥୹䛰䛶䜏䛪䛓䛴ཋᅄ䜘♟䛟䚯
– 䛙䜒䛱䛵䚮἖⒢䝛䝱䝌䜷䝯䚮භྜྷ௒ථ䚮ஹ⤙䚮⤎ᯕᣞᵾ䚮䝙䜭䝱䞀䜦䝇䝛᭿㛣䚮
䛣䛝䛬⬲ⴘ⩽䛴Ẓ⋙䜈ྙ䜕䛡䛬♟䛟䚯

⤎ㄵ䠌
– ⤎ㄵཀྵ䛹䛣䛴ᚺ⏕䟺⮣ᗃ䜈䛝䛕䛵䛣䛴௙䟻䛱䛪䛊䛬᪺☔䛱♟䛝䚮䛣䛴よ㔐䛱䛪
䛊䛬䛵ᐼᰕ䛴⠂ᅑහ䛱Ḿ䜇䜑䚯
– ⿭㊂Ⓩ䛰◂✪䛴ᚪさᛮ䛱䛪䛊䛬䜈ᥞ᱄䛟䜑䛮䜎䛊䚯
39
䜷䜳䝭䝷䝿䜻䜽䝊䝢䝊䜧䝇䜳䝿䝰䝗䝩䞀䛴
ᵋ㏸໩ᢊ㘋㡧┘







BACKGROUND
OBJECTIVES
SEARCH STRATEGY
SELECTION CRITERIA
DATA COLLECTION AND ANALYSIS
MAIN RESULTS
REVIEWER'S CONCLUSIONS
40
CONSORTኇ᪺䚭䟺䠃䟻

⮣ᗃモ㥺䛭ሒ࿈䛟䛿䛓හᐖ䛮ᐁ㝷䛴ᩝ⊡䛭
ප㛜䛛䜒䛬䛊䜑හᐖ䛱ኬ䛓䛰㝰䛥䜐䛒䛈䜑

ㄖ⩽䚮ᰕㄖ⩽䚮⥽㞗⩽䛒䛣䛴ጂᙔᛮ䜘ึ᩷䛭
䛓䛰䛊

ᚪさ䛰㡧┘䛒䜈䜒䛰䛕オ㍍䛛䜒䜑䜎䛌䛰ᣞ㔢䛒
ᚪさ
41
CONSORTኇ᪺䚭䟺䠄䟻








Standard of Reporting Trials (SORT)䜴䝯䞀䝛䚭㻔993.3
Asilomar Working Group on Recommendations for
Reporting of Clinical Trials in the Biomedical Literature
1994.3
䝿䝿䝿୦䜴䝯䞀䝛䛴ྙྜྷఌ㆗䚭㻔995.9
CONSORT statement 1996䚭䝅䜫䝇䜳䝮䜽䝌䚮䝙䝱䞀䝄䜨䜦䜴䝭䝤
䚭㻕001ಞḿ∟Ⓠ⾪
Lancet 2001;357:1191-1194, Annals of Internal Medicine
2001;134:657-662, JAMA 2001;285:1987-1991
http://www.consort-statement.org/
http://homepage3.nifty.com/cont/CONSORT_Statemen
t/menu.html
⮣ᗃモ㥺䛴஥๑Ⓡ㘋โᗐ䛮䜈㛭㏻䛝䛬ᾇአ䛭䛵Ἰ┘䊱
42
㛭㏻䛴ཱི䜐⤄䜅



䝥䝃䝿䜦䝎䝮䜻䜽䝿䝿䝿QUOROM statement.
䟺Quality of Reporting of Meta-analyses,
Lancet. 1999;354(9193):1896-900䟻
ふᐳ◂✪䛴䝥䝃䝿䜦䝎䝮䜻䜽䝿䝿䝿 MOOSE
proposal. (Meta-analysis Of Observational
Studies in Epidemiology, JAMA.
2000;283(15):2008-12.)
チ᩷◂✪䝿䝿䝿STARD initiative. (The Standards
for Reporting of Diagnostic Accuracy, BMJ.
2003 Jan 4;326(7379):41-4.)
43
௑᪝䛴䜄䛮䜇

ᵋ㏸໩ᢊ㘋䛵㈻䛴Ⰳ䛊᝗ሒ䛴Ὦ㏳䛱᭯⏕䛭䛈䜑䚯

ཋⴥㄵᩝ䜘୹䛮䛟䜑䝘䜦䝰䝗䝩䞀ヽ䛮䚮ㄖ⩽䛾䛴
䜹䞀䝗䜽䜘୹䛮䛟䜑䠄ḗ᝗ሒヽ䛮䛭䛵䚮ᵋ㏸໩ᢊ㘋
䛴షᠺ䝛䝱䜿䜽䛒␏䛰䜑䚯

ᵋ㏸໩ᢊ㘋䛴ヾ▩䛵㧏䜄䜐䛪䛪䛈䜑䛒䚮䜎䜐Ⰳ䛊
ᙟ䟺≁䛱ཋⴥ䛭䛵䠊㡧┘∟䛴ᥞ᱄䟻䛭䛴ୌᒒ䛴ᬉ
ཀྵ䛒᭻䜄䜒䜑䚯

䜬䝗䝋䝷䜽䛴ฺ⏕⩽䛮䛝䛬䜈షᠺ⩽䛮䛝䛬䜈䚮◂✪
ㄵᩝ䛴オ㏑ᵕᘟ䛱㛭䛟䜑ᅗ㝷Ⓩᥞ᱄䜘▩䜑ណ⩇
䛵ኬ䛓䛊䚯
44