包含不同劑量雷貝拉唑、不同療程含鉍劑四聯(lián)療法根除幽門螺桿菌療效分析—浙江省多中心、隨機、平行對照臨床研究
發(fā)布時間：2018-07-21 16:05
【摘要】：研究背景：幽門螺桿菌(Helicobacter pylori,下稱H. pylori)與慢性胃炎、消化性潰瘍、胃癌以及胃黏膜相關(guān)淋巴組織(MALT)淋巴瘤密切相關(guān),是胃癌的Ⅰ類致癌因子。近年來,隨著耐藥情況日益顯著,傳統(tǒng)治療方案根除率越來越低,臨床工作者不斷嘗試新方法試圖提高成功率。 研究目的：通過多中心、隨機、平行對照的臨床研究,探討不同劑量雷貝拉唑、不同療程含鉍四聯(lián)療法H.pylori根除效果并分析各方案社會經(jīng)濟價值,旨在為臨床醫(yī)師在藥物劑量及療程選擇上提供理論參考。 研究方法：來自浙江省11個中心277例因相關(guān)癥狀門診就診行胃鏡診斷為H.pylori相關(guān)性慢性胃炎、消化性潰瘍的H.pylori感染初治者,隨機分入不同治療組。A:雷貝拉唑10rmg+呋喃唑酮0.1g+阿莫西林1g+膠體果膠鉍0.20g,BID,10天；B:雷貝拉唑20rmg+呋喃唑酮0.1g+阿莫西林1g+膠體果膠鉍0.20g,BID,10天；C:雷貝拉唑10rmg+呋喃唑酮0.1g+阿莫西林1g+膠體果膠鉍0.20g,BID,14天。所有入組患者療程結(jié)束后停用抗生素、質(zhì)子泵抑制劑(proton pump inhibitor,下稱PPI)至少4周,采用13C尿素呼氣試驗(13C-Urea Breath Test,13C-UBT)評估H.pylori根治情況,并按依據(jù)意向性(Intention To Treat, ITT)分析和符合方案集(Per-protocol,PP)分析統(tǒng)計根除率,進行不同方案療效評價并計算成本-效果比(C/E)。 研究結(jié)果： 1.不同方案根除率比較 A、B、C三組方案H.pylori根除率根據(jù)ITT分析分別為65.2%(60/92)、72.7%(72/99)、70.9%(61/86),PP分析分別為68.2%(60/88)、79.1%(72/91)、74.4%(61/82),差異無統(tǒng)計學(xué)意義(均P0.05)。 2.不同疾病狀態(tài)根除率比較 ITT分析,非糜爛性胃炎、糜爛性胃炎與消化性潰瘍組根除率分別為68.7%(68/99)、66.2%(51/77)和73.3%(74/101);PP分析,三組根除率分別為73.1%(68/93)、70.8%(51/72)及77.1%(74/96),消化性潰瘍患者組根除率最高,但差異無統(tǒng)計學(xué)意義(均P0.05)。 3.不同年齡組根除率比較 ITT分析,18～59歲年齡組根除率71.0%(164/231),60～70歲年齡組為63.0%(29/46);PP分析分別為75.6%(164/217)、65.9%(29/44),差異無統(tǒng)計學(xué)意義(均P0.05)。 4.各方案成本-效果比 各組成本-效果比分別為2.0、2.7、2.6。 研究結(jié)論：在雷貝拉唑聯(lián)合阿莫西林、呋喃唑酮含鉍劑四聯(lián)10天療程方案中,標準劑量與加倍劑量雷貝拉唑療效相當(dāng)。同時,延長含鉍劑四聯(lián)方案10天至14天并未顯示出更好的療效。本研究中含標準劑量雷貝拉唑10天療程方案成本效果比最低,但上述三種方案根除率均未達到可接受的最低治療標準,其中A方案遠低于80%,故有待進一步探討影響根除率低的其他因素。非糜爛性胃炎、糜爛性胃炎與消化性潰瘍患者之間、18～59歲與60～70歲年齡組之間根除率無顯著性差異。上述研究結(jié)果還需更大樣本量的驗證支持。
[Abstract]:Background: Helicobacter pylori (H. pylori) is closely related to chronic gastritis, peptic ulcer, gastric cancer and gastric mucosa associated lymphoid tissue (MALT) lymphoma. It is the type I carcinogenic factor of gastric cancer. In recent years, with the increasing drug resistance, the eradication rate of traditional therapy is becoming lower and lower, and the clinical workers continue to continue. Try new methods to try to improve the success rate.
Objective: To explore the effect of H.pylori eradication on different doses of H.pylori with different doses of bismuth containing quadruple therapy and to analyze the socioeconomic value of each scheme through a multicenter, randomized, parallel controlled clinical study. The purpose of this study is to provide a theoretical reference for the clinicians to choose the dosage and course of treatment.
Methods: from 11 centers in Zhejiang Province, 277 patients with H.pylori related chronic gastritis and H.pylori infection of peptic ulcer were randomly divided into different treatment groups,.A: 10rmg+ furazolidone 0.1g+ amoxicillin 1g+ colloid bismuth 0.20g, BID, 10 days; B: reamazole 20rmg+. Furazolidone 0.1g+ amoxicillin 1g+ colloid bismuth 0.20g, BID, 10 days, C: 0.20g 10rmg+ furazolidone 0.1g+ amoxazolone 0.1g+ amoxicillin 1g+ colloid bismuth 0.20g, BID, 14 days. All the patients were stopped after the course of treatment and stopped using antibiotics, proton pump inhibitors (proton pump) at least 4 weeks, adopt urea breath test ATH Test, 13C-UBT) evaluated the H.pylori radical cure, and analyzed the rate of eradication according to the intention (Intention To Treat, ITT) and conforms to the program set (Per-protocol, PP), evaluated the curative effect of different schemes and calculated the cost effect ratio (C/E).
The results of the study:
1. comparison of the eradication rate of different schemes
The eradication rates of the three groups of A, B and C were 65.2% (60/92), 72.7% (72/99), 70.9% (61/86), and 68.2% (60/88), 79.1% (72/91) and 74.4% (61/82), respectively, with no statistical significance.
2. comparison of the rate of eradication of different diseases
ITT analysis showed that the eradication rates of non erosive gastritis, erosive gastritis and peptic ulcer group were 68.7% (68/99), 66.2% (51/77) and 73.3% (74/101), and PP analysis showed that the eradication rates of three groups were 73.1% (68/93), 70.8% (51/72) and 77.1% (74/96), but the rate of eradication in the patients with peptic ulcer was the highest, but the difference was not statistically significant (all P0.05).
3. comparison of eradication rates in different age groups
ITT analysis showed that the eradication rate of 18~59 year old age group was 71% (164/231) and 63% (29/46) in 60~70 year old age group; PP analysis was 75.6% (164/217) and 65.9% (29/44), and the difference was not statistically significant (P0.05).
4. cost effectiveness ratio of each scheme
The cost effectiveness ratio of each group is 2.0,2.7,2.6.
Conclusion: the standard dose and redoubled dose of redoubled dose of ranalazol combined with amoxicillin and furazolidone containing bismuth in the 10 day course of treatment were equivalent to the redoubled dose of rizole. Meanwhile, the extension of the quadruple regimen containing bismuth containing 10 days to 14 days did not show a better effect. The cost effectiveness ratio of the standard dose of Rana and Bella in the 10 day course of treatment was compared. The lowest eradication rate of the above three schemes did not reach the lowest acceptable standard of treatment, in which the A scheme was far below 80%. Therefore, the other factors that affected the low eradication rate need to be further explored. There was no significant difference in the rate of eradication between 18~59 years old and 60~70 years old. The results of the study need more sample validation support.
【學(xué)位授予單位】：浙江大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R57
本文編號：2136053
[Abstract]:Background: Helicobacter pylori (H. pylori) is closely related to chronic gastritis, peptic ulcer, gastric cancer and gastric mucosa associated lymphoid tissue (MALT) lymphoma. It is the type I carcinogenic factor of gastric cancer. In recent years, with the increasing drug resistance, the eradication rate of traditional therapy is becoming lower and lower, and the clinical workers continue to continue. Try new methods to try to improve the success rate.
Objective: To explore the effect of H.pylori eradication on different doses of H.pylori with different doses of bismuth containing quadruple therapy and to analyze the socioeconomic value of each scheme through a multicenter, randomized, parallel controlled clinical study. The purpose of this study is to provide a theoretical reference for the clinicians to choose the dosage and course of treatment.
Methods: from 11 centers in Zhejiang Province, 277 patients with H.pylori related chronic gastritis and H.pylori infection of peptic ulcer were randomly divided into different treatment groups,.A: 10rmg+ furazolidone 0.1g+ amoxicillin 1g+ colloid bismuth 0.20g, BID, 10 days; B: reamazole 20rmg+. Furazolidone 0.1g+ amoxicillin 1g+ colloid bismuth 0.20g, BID, 10 days, C: 0.20g 10rmg+ furazolidone 0.1g+ amoxazolone 0.1g+ amoxicillin 1g+ colloid bismuth 0.20g, BID, 14 days. All the patients were stopped after the course of treatment and stopped using antibiotics, proton pump inhibitors (proton pump) at least 4 weeks, adopt urea breath test ATH Test, 13C-UBT) evaluated the H.pylori radical cure, and analyzed the rate of eradication according to the intention (Intention To Treat, ITT) and conforms to the program set (Per-protocol, PP), evaluated the curative effect of different schemes and calculated the cost effect ratio (C/E).
The results of the study:
1. comparison of the eradication rate of different schemes
The eradication rates of the three groups of A, B and C were 65.2% (60/92), 72.7% (72/99), 70.9% (61/86), and 68.2% (60/88), 79.1% (72/91) and 74.4% (61/82), respectively, with no statistical significance.
2. comparison of the rate of eradication of different diseases
ITT analysis showed that the eradication rates of non erosive gastritis, erosive gastritis and peptic ulcer group were 68.7% (68/99), 66.2% (51/77) and 73.3% (74/101), and PP analysis showed that the eradication rates of three groups were 73.1% (68/93), 70.8% (51/72) and 77.1% (74/96), but the rate of eradication in the patients with peptic ulcer was the highest, but the difference was not statistically significant (all P0.05).
3. comparison of eradication rates in different age groups
ITT analysis showed that the eradication rate of 18~59 year old age group was 71% (164/231) and 63% (29/46) in 60~70 year old age group; PP analysis was 75.6% (164/217) and 65.9% (29/44), and the difference was not statistically significant (P0.05).
4. cost effectiveness ratio of each scheme
The cost effectiveness ratio of each group is 2.0,2.7,2.6.
Conclusion: the standard dose and redoubled dose of redoubled dose of ranalazol combined with amoxicillin and furazolidone containing bismuth in the 10 day course of treatment were equivalent to the redoubled dose of rizole. Meanwhile, the extension of the quadruple regimen containing bismuth containing 10 days to 14 days did not show a better effect. The cost effectiveness ratio of the standard dose of Rana and Bella in the 10 day course of treatment was compared. The lowest eradication rate of the above three schemes did not reach the lowest acceptable standard of treatment, in which the A scheme was far below 80%. Therefore, the other factors that affected the low eradication rate need to be further explored. There was no significant difference in the rate of eradication between 18~59 years old and 60~70 years old. The results of the study need more sample validation support.
【學(xué)位授予單位】：浙江大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R57
【共引文獻】
相關(guān)碩士學(xué)位論文 前2條
1 初菁菁;Markov決策模型在乳腺癌篩查衛(wèi)生經(jīng)濟學(xué)評價中的應(yīng)用[D];浙江大學(xué);2014年
2 何石林;腹腔鏡與開腹肝切除術(shù)治療肝硬化肝癌的安全性及預(yù)后分析[D];浙江大學(xué);2014年
，本文編號：2136053
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