Perioperative Cimetidine Administration Enhances Tumor Infiltration Lymphocytes and HLA-DR Expression in Colorectal Cancer~*

Objective： It has been shown in our previous study that cimetidine （CIM） can boost the hosts＇ cellular immunity in patients with gastrointestinal cancer. This study was conducted to evaluate CIM＇s effects on tumor infiltrating lymphocytes （TIL） and HLA-DR expression in tumor stroma in colorectal cancer （CRC）, so as to investigate its role in local immune response at the tumor site in CRC. Methods： Forty-nine CRC patients were randomized into treatment group of 25 patients who took CIM 7 days before curative surgery till the operation day, and control group of 24 patients who received similar treatment except for CIM intervention. TIL responses and HLA-DR expression were studied on tumor tissues taken before and after surgical resection. Results： The percentage of significant TIL response was increased from 32% （8/25） to 76% （19/25） （P〈0.005） in the CIM treatment group, whereas there were no significant changes in TIL response in the control group [25% （6/24） at recruitment vs. 33% （8/24） at operation, P〉0.50]. Moreover, the percentages of HLA-DR expression were increased from 36% （9/25） to 72% （18/25） in the CIM treatment group, but there were no significant differences in HLA-DR expression in the control group [41.7% （10/24） before resection vs 45.8% （11/24） after resection, P〉0.50]. Conclusion： CIM used before surgery might promote TIL responses and increase the HLA-DR expression in stroma cells in CRC patients, leading to enhanced host immunity against tumor.

Gastric mucosal injury due to hemorrhagic reperfusion and efficacy of Salvia miltiorrhizae extract F and cimetidine

AIM: To observe the gastric mucosal injury caused by hemorrhagic shock and reperfusion and to compare the effect between Salvia miltiorrhizae extract F (SEF) and cimetidine (CI) on it. METHODS: A model of hemorrhage/reperfusion injury was produced by Itoh method. Wistar rats were randomly divided into three groups: 0.9% sodium chloride treatment group (NS group), SEF treatment group (SEF group), and CI treatment group (CI group). Saline, SEF and CI were injected respectively. The index of gastric mucosal lesions (IGML) was expressed as the percentage of lesion area in the gastric mucosa. The degree of gastric mucosal lesions was categorized into grades 0, 1, 2, 3. Atom absorption method was used to measure the intracellular calcium content. Radioimmunoassay was used to measure the concentrations of prostaglandins. RESULTS: IGML (%) and grade 3 (%) were 23.18±6.82, 58.44±9.07 in NS group, 4.42±1.39, 20.32±6.95 in SEF group and 3.74±1.56, 23.12±5.09 in CI group, and the above parameters in SEF group and CI group decreased significantly (IGML: SEF vs NS, t=6.712, P=0.000<0.01; CI vs NS, t=6.943, P=0.000<0.01; grade 3: SEF vs HS, t=8.386, P=0.000; CI vs HS, t=8.411, P= 0.000), but the grade 0 and grade 1 damage in SEF group (22.05±5.96, 34.12±8.12) and CI group (18.54±4.82, 30.15±7.12) were markedly higher than those in NS group (3.01±1.01, 8.35±1.95; grade 0: SEF vs HS, t=8.434, P=0.000<0.01; CI vs NS, t=7.950, P=0.000<0.01; grade 1: SEF vs NS, t =8.422, P=0.000<0.01; CI vs NS, t=8.448, P=0.000<0.01). The intracellular calcium content (μg/mg) in SEF group (0.104±0.015) and CI group (0.102±0.010) was markedly lower than that in NS group (0.131±0.019, SEF vs NS, t=2.463, P=0.038<0.05; CI vs HS, t=3.056, P=0.017<0.05). The levels (pg/mg) of PGE_2, 6-keto-PGF_(1α) and 6-keto-PGF_(1α)/TXB_2 were 540±183, 714±124,17.38±5.93 in NS group and 581±168, 737±102, 19.04±8.03 in CI group, 760±192,1 248±158, 33.42±9.24 in SEF group, and the above parameters in SEF group markedly raised (PGE_2: SEF vs NS, t=2.282, P=0.046<0.05; SEF vs CI, t=2.265, P=0.047<0.05; 6-keto-PGF_(1α): SEF vs NS, t=6.583, P=0.000<0.000; SEF vs CI, t=6.708, P=0.000<0.01; 6-keto-PGF_(1α)/TXB_2: SEF vs NS, t=3.963, P=0.003<0.001; SEF vs Cl, t=3.243, P=0.009<0.01), whereas TXB_2 level in SEF group (45.37±7.54) was obviously lower than that in NS group (58.28±6.74, t=3.086, P=0.014<0.05) and CI group (54.32±6.89, t=2.265, P=0.047<0.05). No significant difference was shown between NS group and CI group (PGE_2: t=0.414, P=0.688>0.05; 6-keto-PGF_(1α): t=0.310, P=0.763>0.05; TXB_2: t=1.099, P=0.298>0.05; 6-keto-PGF_(1α)/TXB_2: t=0.372, P=0.718>0.05). CONCLUSION: Both SEF and CI could inhibit reperfusioninduced injury in gastric mucosa, but with different mechanisms. SEF could not only enhance the protective effect of gastric mucosa, but also abate the injury factors, while CI can only abate the injury factors.

Radioprotective effects of cimetidine on rats irradiated by long-term, low-dose-rate neutrons and ^(60)Coγ-rays

Background: Cimetidine, an antagonist of histamine type II receptors, has shown protective effects against γ-rays or neutrons. However, there have been no reports on the effects of cimetidine against neutrons combined with γ-rays. This study was carried out to evaluate the protective effects of cimetidine on rats exposed to long-term, low-dose-rate neutron and γ-ray combined irradiation(n-γ LDR).Methods: Fifty male Sprague-Dawley(SD) rats were randomly divided into 5 groups: the normal control group, radiation model group, 20mg/(kg·d) cimetidine group, 80mg/(kg·d) cimetidine group and 160mg/(kg·d) cimetidine group(10 rats per group). Except for the normal control group, 40 rats were simultaneously exposed to fission neutrons(^(252)Cf, 0.085 m Gy/h) for 22 h every day and γ-rays(^(60)Co, 0.097Gy/h) for 1.03 h once every three days, and the cimetidine groups were administered intragastrically with cimetidine at doses of 20, 80 and 160mg/kg each day. Peripheral blood WBC of the rats was counted the day following exposure to γ-rays. The rats were anesthetized and sacrificed on the day following exposure to ^(252)Cf for 28 days. The spleen, thymus, testicle, liver and intestinal tract indexes were evaluated. The DNA content of bone marrow cells and concanavalin A(Con A)-induced lymphocyte proliferation were measured. The frequency of micronuclei in polychromatic erythrocytes(f MNPCEs), superoxide dismutase(SOD), malondialdehyde(MDA), and glutathione peroxidase(GSH-Px) in the serum and liver tissues were detected.Results: The peripheral blood WBC in the cimetidine groups was increased significantly on the 8th day and the 26 th day compared with those in the radiation model group. The spleen, thymus and testicle indexes of the cimetidine groups were higher than those of the radiation model group. The DNA content of bone marrow cells and lymphocyte proliferation in the cimetidine groups were increased significantly, and fMNPCE was reduced 1.41-1.77 fold in cimetidine treated groups. The activities of SOD and GSH-Px in the cimetidine groups were increased significantly, and the content of MDA in the cimetidine groups was decreased significantly.Conclusions: The results suggested that cimetidine alleviated damage induced by long-term, low-dose-rate neutron and γ combined irradiation via antioxidation and immunomodulation. Cimetidine might be useful as a potent radioprotector for radiotherapy patients as well as for occupational exposure workers.

甲氰咪胍(Cimetidine)的试制

抗消化性溃疡新药甲氰咪胍,为组胺 H_2-受体拮抗剂,目前国内外已广泛应用于临床。本文主要叙述了采用还原法制备关键性中间体咪唑醇的新工艺;以乙酰乙酸乙酯为起始原料,经氯化、环合反应而得咪唑酯,再由咪唑酯还原成咪唑醇。由于采用了独创的还原方法,因而为本品的投产,创造了成本低廉、原料易得和操作安全的有利条件。合成总收率中试为19.2～19.9%,小试验可达21.4～22%,高于文献记载的水平。

Effects of temperature and wavelength choice on in-situ dissolution test of Cimetidine tablets

The effects of temperature and wavelength choice on in-situ dissolution test instrument of Cimetidine were studied. Absorbance （A）〈 1.0 is required when using a fiber-optic dissolution test system. The detection wavelength of 2 （218 nm） was replaced by 244 nm to carry out this test. The absorbance of Cimetidine solution at different temperature showed an obvious change. Calibration of Cimetidine solution should be tested at the same temperature （37° C） with the test solution. A suitable wavelength with smaller tangent slope could be chosen for in-situ dissolution test of Cimetidine tablets.

EFFECTS OF PERIOPERATIVE CIMETIDINE ADMINISTRATIONON NATURAL KILLER CELLS IN PATIENTS WITHGASTROINTESTINAL CANCER

Objective: To study the effects of perioperative use of cimetidine on natural killer (NK) cells in gastrointestinal (GI) cancer patients. Methods: 49 GI cancer patients were randomized into treatment group which took cimetidine in the perioperative period, and control group which did not take the drug. NK cells were measured by immunocytochemical method, using mouse-anti-human CD57 monoclonal antibody as the primary antibody. Blood samples from 20 healthy volunteers were treated in the same way as normal control. Comparisons were made within and between groups. Results: The NK cell percentage of normal control was 18.50±2.31. Both groups of patients had significantly lower than normal NK percentages before treatment (P<0.05). NK cell percentages at admission, before operation, on the 2nd and the 10th postoperative days were 14.60±3.91, 15.64±3.61, 17.40±3.28, 20.68±4.13, respectively, for the treatment group, and 14.88±2.76, 13.17±2.93, 14.50±2.77, 15.67±2.55, respectively, for control group. The difference between the two groups was statistically significant. Conclusion: Perioperative cimetidine application can help restore NK cells. The drug may be useful to reverse postoperative immuno-depression in GI cancer patients.

Reduction of Praziquantel Elimination by Cimetidine in Rats

The effect of cimetidine on the elimination of praziquantel(PQT)in rats was studied. The results showed that cimetidine 100 mg/kg,ip 2 reduced the clearances of intravenous and oral PQT by 60 and 69 percent respectively.Cimetidine also markedly reduced liver blood flow of rats(a reduction of 58%)and inhibited PQT metabolism in hepatic microsomes of rats(an inhibition of 55%). The reduction in clearance of intravenous PQT could be attributed to the result of cimetidine lowering liver blood flow,whereas the reduction in clearance of oral PQT might be related mainly to the inhibition of cimetidine on the activity of hepatic drug-metabolizing enzymes.

Effects of Cimetidine on IL－2 and T Suppressor Cell Function in Rats with Obstructive Jaundice

Susceptibility to infection in patients with obstructive jaundice is much more higher than non-jaundiced patients. The reasons for this are not completely understood. It is postulated that this may have some relation to changes of patients′immune function. This article reported the changes of splenocyte IL-2 production and T Suppressor cell activity in rats with obstructive jaundice. Meanwhile, we also investigated effects of cimetidine on immune function in rats with bile duct ligation. The results show that IL-2 production in obstructive jaundiced rats significantly decreased and T suppressor cell activity markably increased. Cimetidine could remarkably enhance IL-2 production and suppress T Suppressor cell activity. Abmormaility of immune function may be one reason for high susceptibility to infection in patients with obstructive jaundice in perioperative period. Cimetidine, which could clearly improve immune function in rats with obstructive jaundice, might be a valuable agent for strengthening the capacity of fighting infection in patients with obstructive jaundice.

EFFECTS OF PERIOPERATIVE CIMETIDINE ADMINISTRATION ON TUMOR CELL NUCLEAR MORPHOMETRY AND DNA CONTENT IN PATIENTS WITH GASTROINTESTINAL CANCER

Objective: To explore the effects of perioperative cimetidine administration on tumor cell nuclear morphometric parameters and DNA content in patients with gastrointestinal adenocarcinoma. Methods: 49 patients with pathologically confirmed gastrointestinal adenocarcinoma were randomized into test group (n=25) and control group (n=24). The test group started oral cimetidine intake 400 mg, tid, 7–10d before operation, followed by standard curative operation. The control group did not receive cimetidine. Tumor specimens were paraffin embedded for microsection and stained with hematoxylin and eosin (HE) and Feulgen stain. Morphometric studies and DNA content of tumor nuclei were performed on IBAS Image Analyzer. Results: The tumor cell nuclear area (μm2), nuclear perimeter (μm), maximal nuclear diameter (μ) for test group/control group were 23.54 5.08/34.69110.08 (P<0.001), 22.064.43/24.884.05 (P<0.05), 7.8411.64/ 8.6211.24 (P<0.05), 4.4210.61/5.4110.89 (P<0.001), Respectively. The percentages (%) of diploidy, triple-tetraploidy, quintuple ploidy, and >quintuple ploidy tumor cells for test group/control group were 16.6412.58/5.3312.14 (P<0.002), 39.8412.28/35.7013.58 (P>0.50), 12.4215.00/14.4810.74 (P>0.20), 31.1116.86/ 45.9713.82 (P<0.005), respectively. Conclusion: Perioperative administration of cimetidine in gasgtrointestinal cancer patients could decrease the nuclear size and raise the percentage of diploid tumor cells, and convert high aneuploid tumor cells into low-aneuploid tumor cells, which might help reduce the invasiveness of tumor cells.

Perioperative Cimetidine Application Modulates Natural Killer Cells in Patients with Colorectal Cancer: A Randomized Clinical Study

Thirty-eight colorectal cancer patients were randomly assigned to treatment group, which took cimetidine in the perioperative period, and control group to which no drug was given. Twenty healthy volunteers served as normal controls. NK cells were measured by immunocytochemical technique.The results showed that NK percentages before treatment in both groups of patients were sig-nificantly lower than those in normal controls (P<0. 05). NK cell percentages at admission, before operation, on the 2nd and the 10th postoperative days were 14. 84± 4. 41, 15. 74 ± 3. 75, 17. 21 ± 3. 69, 21. 05 ± 4. 54, respectively, for the treatment group, and 15. 00±2. 77, 13.05± 2. 46, 14. 21± 2. 19, 15. 58± 1. 68,respectively, for control group. The difference was statistically significant (P<0. 01 ), suggesting that the perioperative administration of cimetidine could help restore NK cells in colorectal cancer patients.

Liver Damage by the Interaction of Malathion with Cimetidine in Rat

In this study the authors aimed to evaluate the oxidative stress enzymes indicative of liver damage in rats exposed to malathion （M）, subchronic form using cimetidine （C） and cimetidine plus malathion （M ＋ C）. Malathion, widely used organophosphorus insecticide worldwide, induces oxidative liver damage type; cimetidine is an antagonist of histamine H2-receptor, it has been shown to be an inhibitor of various CYP45o isoforms. Male Wistar rats weighing 200-250 g were studied, exposed to malathion orally for 3 weeks （0.15 mg/kg/day, 2 mg/kg/day, 15 mg/kg/day） and cimetidine 10 mg/kg/day. Malathion plus cimetidine affect susceptibility to oxidative stress and possibly modifies the antioxidant defense capacity directly or indirectly.

5－Fu、Cimetidine对急性胰腺炎患者的免疫调节作用

应用单克隆抗体技术测定４５例急性胰腺炎外周血Ｔ淋巴细胞亚群，通过对５－Ｆｕ、Ｃｉｍｅｔｉｄｉｎｅ治疗组和抑肽酶治疗组的对照分析以及治疗后的动态观察发现：急性胰腺炎患者存在细胞免疫平衡紊乱，表现为１４↓、Ｔ８↑、Ｔ４／Ｔ８↓，治疗组于治疗后７～９天起Ｔ细胞亚群恢复，而对照组仅Ｔ４恢复，认为急性胰腺炎免疫平衡紊乱可能是感染性易感性增高的原因之一。５－Ｆｕ、Ｃｉｍｅｔｉｄｉｎｅ不仅能有效地抑制胰腺外分泌功能，还可改善患者免疫状况，提高抗感染能力。

Meta-Analysis of the Efficacy of Cimetidine in the Treatment of Mumps

Objective:To compare the efficacy of cimetidine and ribavirin in the treatment of mumps by meta-analysis.Methods:Controlled trials of cimetidine and ribavirin in the treatment of mumps were searched through China National Knowledge Infrastructure(CNKI),Wanfang data,Cqvip,Pubmed,The Cochrane Library and EMBase databases up to September 2022.The effective rate,the time of swelling regression in parotid gland area and the rate of adverse reactions were analyzed by Review Manager 5.3 software.Results:The final 10 articles included 920 children,including 427 in the trial group and 447 in the control group.Meta analysis showed that the effective rate of cimetidine in the treatment of mumps was higher than that of ribavirin in routine treatment,with a statistically significant difference(odds ratio[OR]=5.2,P<0.00001);The time of swelling regression was statistically significant(OR=-1.28,P<0.00001);The difference of adverse reaction rate was not statistically significant(OR=0.73,P=0.62).Conclusions:Compared with ribavirin,cimetidine is more effective in the treatment of mumps,with shorter swelling regression time without increases of adverse reactions.

Vitamin B12-induced spermatogenesis recovery in cimetidine-treated rats： effect on the spermatogonia number and sperm concentration

The H2-receptor antagonist cimetidine is an antiulcer drug also used for the treatment of cancer due to its antiangiogenic effect. However, this drug has caused structural changes in the seminiferous tubules. Vitamin B12 has been used as a therapeutic agent for the treatment of male infertility. The supplementation of rats with vitamin B12 during cimetidine treatment has recovered the damaged seminiferous tubules, but how this vitamin restores the seminiferous epithelium has not been clarified. In this study, we evaluated whether vitamin B12 improves the number of spermatogonia, spermatocytes, and sperm concentration in cimetidine-treated rats. Adult male rats were treated for 50 days as follows： cimetidine group received 100 mg kg^-1 b.w. of cimetidine, cimetidine-B12 group received cimetidine and 3 μg of vitamin B12-hydroxocobalamin, B12 group received only 3 μg of vitamin, and control group received saline. Sperm concentration was calculated and historesin-embedded testes sections were used for the quantitative analyses of spermatogonia （A; In/B） and spermatocytes. TUNEL method and PCNA immunofluorescence were performed. Cimetidine caused a significant reduction in sperm concentration. TUNEL-positive spermatogonia and spermatocytes were correlated to a significant reduction in the number of these cells. In cimetidine-B12 group, sperm concentration was higher than cimetidine group and a significant increase in the number of spermatogonia （stages Ⅱ-Ⅵ） was correlated to a high incidence of PCNA-immunolabeled spermatogonia and spermatocytes. The results show that the supplementation of rats with vitamin B12 during cimetidine treatment increases sperm concentration and exerts a potential effect in the recovery of spermatogonia and spermatocytes.

Effects ofm perioperative cimetidine administration on tumor cell nuclear morphology and DNA content in patients with gastric and colorectal cancer

Objective To explore the effects of perioperative cimetidine administration on tumor cell nuclear morphometric parameters and DNA content in patients with gastric and colorectal adenocarcinoma (GCRA) Past studies have attributed the antitumor effect of cimetidine to its immunomodulatory property, which led to an increase of cellular immunity Whether there are other possible mechanisms by which cimetidine exerts its antitumor function is unknown 49 patients with GCRA were randomized into treatment group (n=25) and control group (n=24) based on whether cimetidine was applied to them during the perioperative periold The treatment group started oral cimetidine intake 400mg, tid, 7-10d before oiperation, followed by curative surgery 'The control group did not receive cimetidine Tumor specimens were paraffin embedded for 4μm thick microsection and stained with (1) hematoxylin and eosin (HE) for the morphometric measurements of tumor cell nuclear area (NA), nuclear perimeter (NP), maximal nuclear diameter (MMND) and minimal nuclea4r diameter (MNND); (2) feulgen stain for tumor nuclear DNA content analysis by IBAS Image Analyzer The percentages (%) of diploidy (2C), tripletetraploidy (3C 4C), quintuple ploidy (5C) and >quintuple ploidy (>5C) tumor cells were calculated, using the mean value of DNA content of 50 lymphocytes as normal 2C control 3C 5C cells were designated as law aneuploid cells and >5C cells as high aneupoid cells Results The clinicopathological variables between the two groups were balanced and comparable There were no statistically significant differences between bthe treatment and control groups in regard of the following parameters: age, gender, tumor location, pathological type, TNM stage, and degree of differentiation The NA (μm 2), NP (μm), MMND (μm) and MNND (μm) for treatm ent group/control group were 23 54±5 08/34 698±10 18 ( P <0 001), 22 06±4 43/24 88±4 05 ( P <0 05),7 84±1 64/8 62±1 24 ( P >0 05), and 4 42±0 61/5 41±0 89 ( P <0 001), respectively The percentages (%) of 2C, 3C 4C, 5C and >5C tumor cells for treatment group/control group were 16 64±2 58/5 35±2 14 ( P <0 002), 39 84±2 28/35 70±3 58 ( P >0 50), 12 42±5 00/14 48±0 74 ( P >0 20), 31 11±6 86/45 97±3 82 ( P <0 005), respectively In the treatment group, there was a tendency tiowards low aneuploid tumor cells from high an euploid tumor cells However, high aneuploid tumor cells predominated in the control group Conclusion Perioperative administration of cimetidine to GCRA patients could decrease the size of tumor cell nuclei, raise the percentage of diploid tumor cells, and partially convery high aneuploid tumor cells into low aneuploid tumor cells All of these effects may in turn help reduce the proliferative potential and invasiveness of tumor cells The direct inhibitory functions on tumor cell nuclei may be a new antitumor mechanism of cimetidine, in addition to its immunomodulatory action

《国际药学文摘》在药学情报源中的地位

《国际药学文摘》(InternationalPharmaceutical Abstract简称IPA),自1964年创刊,到现在已有30年的历史,作为一种新的药学专业检索刊,IPA与EM、IM等医学情报源相比,究竟有什么特色呢?本文拟就IPA的收录期刊、文献量进行分析,并用药学主题词进行文献检索,与EM、IM、《医学中央杂志》、《中国药学文摘》进行比较,从而分析IPA的文献主题侧重。

Thioperamide treats neonatal hypoxic-ischemic encephalopathy by postsynaptic H1 receptors

Thioperamide, a selective histamine H3 receptor antagonist, can increase histamine content in the brain, improve brain edema, and exert a neuroprotective effect. This study aimed to examine the mechanism of action of thioperamide during brain edema in a rat model of neonatal hypoxic ischemic encephalopathy. Our results showed that thioperamide significantly decreased brain water content and malondialdehyde levels, while significantly increased histamine levels and superoxide dismutase activity in the hippocampus. This evidence demonstrates that thioperamide could pre vent oxidative damage and attenuate brain edema following neonatal hypoxicischemic encepha Iopathy. We further observed that changes in the above indexes occurred after combined treatment of thioperamide with the H1 receptor antagonist, pyrilamine, and the H2 receptor antagonist, ci metidine. Experimental findings indicated that pyrilamine reversed the effects of thioperamide; however, cimetidine had no significant influence on the effects of thioperamide. Our present findings suggest that thioperamide can increase brain histamine content and attenuate brain edema and oxidative damage by acting in combination with postsynaptic H1 receptors in a rat model of neo natal hypoxicischemic encephalopathy.

Effect of Lanthanum on Acid Secretion from Isolated Mouse Stomach in Vitro

To explore the effect and the mechanism of La^(3+) on gastric acid secretion (GAS) of isolated mouse stomach with perfused lumen, 12 cm H_2O column intragastric pressure-provided, whole stomach preparations from mice were incubated in buffer at 37 ℃ in vitro, and perfusate was measured for pH with a pHS-3 type pH meter. The results show that La^(3+) (0.41～820×10^(-6) mol·L^(-1)) significantly promotes GAS in a concentration-dependant manner. Proglutamine, a blocker of gastrin receptor, potently inhibits GAS, and it may block the promotive effect of La^(3+) on GAS, and this effect increases with the increase of proglutamin concentration. Cimetidine, a blocker of histamine H_2 receptor, also potently inhibits GAS, and blocks the promotive effect of La^(3+) on GAS in the same manner with proglutamine. These results suggest that La^(3+) promotes GAS in isolated stomach possibly by stimulating the releases of gastrin from G cell and Histamine from ECL cell or by activating the gastrin receptors and Histamine H_2 receptors on the parietal cell, thereby accelerating the acid secretion of parietal cells in stomach.

Efficacy and safety of ecabet sodium on functional dyspepsia:A prospective,double-blinded,randomized,multi-center controlled trial

AIM： To compare ecabet sodium and cimetidine in relieving symptoms of functional dyspepsia. METHODS： We performed a multi-center, prospective, randomized, double-blinded controlled trial to compare the clinical efficacy of ecabet sodium and cimetidine in patients with functional dyspepsia. Two-hundred and seventy-two patients with dyspeptic symptoms fulfilling the Rome-II criteria were enrolled from 7 centers. In the study group （115 patients）, 1.5 g ecabet sodium was given twice a day. In the control group （121 patients）, 400 mg cimetidine was given twice a day. Symptoms and parameters of quality of life were analyzed at baseline, 3, 14, and 28 d after initiating the treatment. RESULTS： Two-hundred and thirty-six patients completed the clinical trial. After 4 wk of treatment, the rates of improvement in patients with dyspeptic symptoms were not different between two groups （77.4% in the ecabet group and 79.3% in the cimetidine group, respectively, P 〉 0.05）. Likewise, the rates of symptomatic improvement were not different at 3 d and 14 d. The parameters of quality of life did not change significantly during the study period in both groups. There was no clinically significant adverse event in both groups.