包含不同剂量雷贝拉唑、不同疗程含铋剂四联疗法根除幽门螺杆菌疗效分析—浙江省多中心、随机、平行对照临床研究
发布时间：2018-07-21 16:05
【摘要】：研究背景：幽门螺杆菌(Helicobacter pylori,下称H. pylori)与慢性胃炎、消化性溃疡、胃癌以及胃黏膜相关淋巴组织(MALT)淋巴瘤密切相关,是胃癌的Ⅰ类致癌因子。近年来,随着耐药情况日益显著,传统治疗方案根除率越来越低,临床工作者不断尝试新方法试图提高成功率。 研究目的：通过多中心、随机、平行对照的临床研究,探讨不同剂量雷贝拉唑、不同疗程含铋四联疗法H.pylori根除效果并分析各方案社会经济价值,旨在为临床医师在药物剂量及疗程选择上提供理论参考。 研究方法：来自浙江省11个中心277例因相关症状门诊就诊行胃镜诊断为H.pylori相关性慢性胃炎、消化性溃疡的H.pylori感染初治者,随机分入不同治疗组。A:雷贝拉唑10rmg+呋喃唑酮0.1g+阿莫西林1g+胶体果胶铋0.20g,BID,10天；B:雷贝拉唑20rmg+呋喃唑酮0.1g+阿莫西林1g+胶体果胶铋0.20g,BID,10天；C:雷贝拉唑10rmg+呋喃唑酮0.1g+阿莫西林1g+胶体果胶铋0.20g,BID,14天。所有入组患者疗程结束后停用抗生素、质子泵抑制剂(proton pump inhibitor,下称PPI)至少4周,采用13C尿素呼气试验(13C-Urea Breath Test,13C-UBT)评估H.pylori根治情况,并按依据意向性(Intention To Treat, ITT)分析和符合方案集(Per-protocol,PP)分析统计根除率,进行不同方案疗效评价并计算成本-效果比(C/E)。 研究结果： 1.不同方案根除率比较 A、B、C三组方案H.pylori根除率根据ITT分析分别为65.2%(60/92)、72.7%(72/99)、70.9%(61/86),PP分析分别为68.2%(60/88)、79.1%(72/91)、74.4%(61/82),差异无统计学意义(均P0.05)。 2.不同疾病状态根除率比较 ITT分析,非糜烂性胃炎、糜烂性胃炎与消化性溃疡组根除率分别为68.7%(68/99)、66.2%(51/77)和73.3%(74/101);PP分析,三组根除率分别为73.1%(68/93)、70.8%(51/72)及77.1%(74/96),消化性溃疡患者组根除率最高,但差异无统计学意义(均P0.05)。 3.不同年龄组根除率比较 ITT分析,18～59岁年龄组根除率71.0%(164/231),60～70岁年龄组为63.0%(29/46);PP分析分别为75.6%(164/217)、65.9%(29/44),差异无统计学意义(均P0.05)。 4.各方案成本-效果比 各组成本-效果比分别为2.0、2.7、2.6。 研究结论：在雷贝拉唑联合阿莫西林、呋喃唑酮含铋剂四联10天疗程方案中,标准剂量与加倍剂量雷贝拉唑疗效相当。同时,延长含铋剂四联方案10天至14天并未显示出更好的疗效。本研究中含标准剂量雷贝拉唑10天疗程方案成本效果比最低,但上述三种方案根除率均未达到可接受的最低治疗标准,其中A方案远低于80%,故有待进一步探讨影响根除率低的其他因素。非糜烂性胃炎、糜烂性胃炎与消化性溃疡患者之间、18～59岁与60～70岁年龄组之间根除率无显著性差异。上述研究结果还需更大样本量的验证支持。
[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.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R57
本文编号：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.
【学位授予单位】：浙江大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R57
【共引文献】
相关硕士学位论文 前2条
1 初菁菁;Markov决策模型在乳腺癌筛查卫生经济学评价中的应用[D];浙江大学;2014年
2 何石林;腹腔镜与开腹肝切除术治疗肝硬化肝癌的安全性及预后分析[D];浙江大学;2014年
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