本文關(guān)鍵詞：奧替溴銨和匹維溴銨治療腹瀉型腸易激綜合征的療效和安全性對比研究　出處：《福建醫(yī)科大學(xué)》2015年碩士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 腸易激綜合征 選擇性鈣通道阻滯劑 奧替溴銨 匹維溴銨 胃腸道癥狀 短程治療

【摘要】：目的:評估奧替溴銨(OB)和匹維溴銨(PB)治療腹瀉型腸易激綜合征(IBS-D)的臨床療效和安全性。方法:采用前瞻性、開放標(biāo)簽、單中心、隨機(jī)平行對照、二階段交叉設(shè)計的臨床試驗(yàn)。將符合研究標(biāo)準(zhǔn)的IBS-D患者根據(jù)隨機(jī)數(shù)字表法隨機(jī)分為OB組和PB組。OB組為OB 40mg,3次/d,;PB組為PB 50mg,3次/d;此外2組都加用整腸生(0.5,3次/d)和谷參腸銨(2粒,3次/d)。第14天時,若癥狀總評分減少超過50%則繼續(xù)用藥2周,若未達(dá)標(biāo)則切換成另一種藥物(OB或PB)再治療2周,總療程為4周。治療前、后分別評估消化道癥狀評分,并記錄不良事件。首要結(jié)局指標(biāo)是腹痛、次要結(jié)局指標(biāo)是腹脹、腹瀉和患者滿意度。結(jié)果:1、納入IBS-D 84例,男/女為38/46,平均年齡(41.15±10.54)歲,中位病程4年,其中OB組43例、PB組41例。第14天時,OB組的腹痛減分率是43.45±28.28、PB組是45.53±28.48,差異無統(tǒng)計學(xué)意義(P=0.757);2組的腹痛頻率減少值也無統(tǒng)計學(xué)差異(1.68±1.25 vs 2.13±1.21,P=0.144)。第28天時,OB組和PB組的腹痛減分率(68.82±27.59 vs63.33±22.22,P=0.520)、腹痛頻率減少值(2.41±1.48 vs 2.75±1.44,P=0.350)差異無統(tǒng)計學(xué)意義。2、第14天時,OB組和PB組的腹脹減分率(40.30±34.31 vs 33.53±25.12,P=0.478)、腹瀉減分率(39.04±31.31 vs 43.93±30.54,P=0.471)之間差異無統(tǒng)計學(xué)意義。第28天時,兩組的腹脹減分率(57.50±29.16 vs 50.00±27.84,P=0.596)、腹瀉減分率(58.18±28.72 vs 70.95±22.34,P=0.112),兩組間差異無統(tǒng)計學(xué)意義。第28天時,OB組和PB組的總療效分別是70.00%、71.05%,差異無統(tǒng)計學(xué)意義(P0.05)。第14天無效者,切換用藥后腹脹、腹痛、腹瀉減分率和腹痛頻率減少值均高于切換前(P0.05)。3、OB組和PB組的不良反應(yīng)率是16.28%、14.63%;整體滿意度是82.50%、84.21%,兩組間差異無統(tǒng)計學(xué)意義(P0.05)。結(jié)論:短程使用奧替溴銨或匹維溴銨都有效緩解IBS-D患者的腹痛、腹脹、腹瀉等癥狀,兩者療效基本一致,安全性好,都可以作為IBS-D癥狀發(fā)作時的“緊急”用藥選擇,并且可以切換使用。
[Abstract]:Objective: To evaluate the otilonium bromide (OB) and pinaverium bromide (PB) in treatment of diarrhea type irritable bowel syndrome (IBS-D) clinical efficacy and safety. Methods: the clinical trials of prospective, open label, single center, random parallel control and two stage cross design were used. The IBS-D patients were randomly divided into group OB and group PB according to the random digital table method. The OB group is OB 40mg, 3 /d, PB; group PB 50mg, 3 /d; in addition to the 2 group with Zhengchangsheng (0.5,3 /d) and entero ammonium (2 capsules, 3 times /d). At fourteenth days, if the total score of the symptoms was reduced by more than 50%, the drug was continued for 2 weeks. If the score was not reached, it was switched to another drug (OB or PB) for 2 weeks, and the total course was 4 weeks. The scores of digestive tract symptoms were evaluated before and after treatment, and adverse events were recorded. The primary outcome index is abdominal pain and secondary outcome indicators are abdominal distention, diarrhea, and patient satisfaction. Results: 1. 84 cases were included in IBS-D. The male / female was 38/46, the average age was (41.15 + 10.54) years, and the median course of disease was 4 years, of which 43 cases in group OB and 41 cases in group PB. On the fourteenth day, the abdominal pain reduction rate of group OB was 43.45 + 28.28, group PB was 45.53 + 28.48, the difference was not statistically significant (P=0.757), and there was no significant difference between the 2 groups in the frequency of abdominal pain reduction (1.68 + 1.25 vs 2.13, 1.21, P=0.144). On the twenty-eighth day, the abdominal pain reduction rate in group OB and group PB (68.82 + 27.59 vs63.33 + 22.22, P=0.520) and the frequency of abdominal pain reduction (2.41 + 1.48 vs 2.75 + 1.44, P=0.350) were not statistically significant. On days 2 and fourteenth, there was no significant difference in abdominal distension reduction rate between group OB and group PB (40.30 + 34.31 vs, 33.53 + 25.12, P=0.478) and diarrhea reduction rate (39.04 + 31.31 vs 43.93, 30.54, P=0.471). On the twenty-eighth day, the abdominal distension reduction rate of the two groups (57.50 + 29.16 vs, 50 + 27.84, P=0.596) and the diarrhea reduction rate (58.18 + 28.72 vs 70.95, 22.34, P=0.112) were not significantly different between the two groups. At twenty-eighth days, the total curative effect of group OB and PB group was 70% and 71.05% respectively, and the difference was not statistically significant (P0.05). After fourteenth days, the reduction rate of abdominal distention, abdominal pain, diarrhea and the frequency of abdominal pain were all higher than that before switching (P0.05). The adverse reaction rates of group 3, OB and PB were 16.28% and 14.63%, and the overall satisfaction was 82.50% and 84.21%, and there was no statistical difference between the two groups (P0.05). Conclusion: the short-term use of otilonium bromide or ammonium pinaverium bromide are effective to alleviate IBS-D patients with abdominal pain, abdominal distension, diarrhea and other symptoms, the two effects are basically the same, good safety, can be used as IBS-D symptoms at the onset of the "emergency" drug selection, and can be used to switch.
【學(xué)位授予單位】：福建醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2015
【分類號】：R574

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