Ulcerative colitis flair induced by mesalamine suppositories hypersensitivity

Mesalamine suppositories have been used widely for the treatment of distal ulcerative colitis and considered to be safer than systemic administration for its limited systemic absorption.However,previous studies have shown that mesalamine suppository occasionally causes severe hypersensitivity reactions including fever,rashes,colitis exacerbation and acute eosinophilic pneumonia.Here we present a 25-year-old woman with ulcerative colitis with bloody diarrhea accompanied by abdominal pain and fever which were aggravated after introduction of mesalamine suppositories.In light of symptom exacerbation of ulcerative colitis,increased inflammatory injury of colon mucosa shown by colonoscopy and elevated peripheral eosinophil count after mesalamine suppositories administration,and the Naranjo algorithm score of 10,the possibility of hypersensitivity reaction to mesalamine suppositories should be considered,warning us to be aware of this potential reaction after administration of mesalamine formulations even if it is the suppositories.

Application of herbal rectal suppositories beyond intestinal disorders in Persian medicine

Background: Herbal rectal suppositories (RSs) were prescribed not only as a drug delivery system but also as a storing method in Persian medicine. According to the record of ancient references, RSs were clinically administered for diarrhea, constipation, colitis, ascites, dysentery and intestinal parasites, sciatic, lower back pain and joint aches, fever, kidney disease and as an aphrodisiac. Objectives: The aim of this study is to categorize and review different types of RSs, their main herbal components and to find evidence to elucidate their clinical administration. Results: In this study, 7 manuscripts were studied to extract and categorize 11 types of herbal rectal suppositorie (RS) formulations, their ingredients and therapeutic indications. Furthermore, the Persian and scientific names of 43 herbs and their temperaments were mentioned in this study. Hence, ancient therapeutic indications of herbs used in RS formulations as well as their proven effects have been studied, which makes it possible to compare ancient and proven indications of medicinal plants used as ingredients of RSs. Conclusions: In modern medicine, RSs are mostly used for anorectic disorders. However in traditional Persian medicine, they were commonly used not only for anorectic and intestinal diseases, but also as an aphrodisiac, an agent for healing joint, sciatic pain and lumbago, an anti-fever, and an anti-ascites. Other implications of this study could be producing new insights of utilizing herbal RSs in diseases and disorders beyond anorectic and intestinal disorders.

Examination of the Stability of Amoxicillin in Compounded Suppositories and Ointments

We examined the stability of amoxicillin trihydrate from the preparation Augmentin in compounded forms of drugs such as vaginal suppositories and ointments. The quantity of the antibiotic in the preparations studied was determined directly after they had been made and after a lapse of 7 and 14 days. We also carried out comparative examinations of the stability of sodium amoxicillin （Tarommentin） and sodium ampicillin （Ampicillin） in ointments with an addition of a boric acid solution. The examinations confirmed the stability of amoxicillin trihydrate in suppositories and in anhydrous and hydrated ointments. The content of this antibiotic in ointmems with an addition of a boric acid solution decreases slightly. Comparative studies of the stability of sodium amoxicillin and sodium amoxicillin revealed a markedly lower stability of the two antibiotics in comparison to the stability of amoxicillin trihydrate.

Study of Immunomodulating Activity of Rectal Suppositories with an Extract of Licorice Root

The article is devoted to the study of the immunomodulating activity of rectal suppositories with an extract of licorice root and essential oils of chamomile and tea tree. Taking into account that medicine is intended and prescribed for children, all the experiments were performed on immature nonlinear one-month rats with weight of 60.0-80.0 g. As a result, it was found out that rectal insertion of suppositories with an extract of licorice root causes an increase in the phagocytic function of neutrophils and increases the quantity of antibodies in the spleen and titers of hemagglutinins and hemolysins in serum, that indicating on the activation of nonspecific and humoral immunity of immature animals. Moreover, the prospects of possible application of suppositories with an extract of licorice root are showed for prevention and treatment of various immunodependent diseases, viral in particular.

Recombinant streptokinase vs phenylephrine-based suppositories in acute hemorrhoids, randomized, controlled trial(THERESA-3)

AIM: To compare the efficacy and safety of recombinant streptokinase (rSK) and phenylephrine-based suppositories in acute hemorrhoidal disease.

Recombinant streptokinase vs hydrocortisone suppositories in acute hemorrhoids:A randomized controlled trial

AIM: To compare the efficacy and safety of recombinant streptokinase(rSK) vs hydrocortisone acetate-based suppositories in acute hemorrhoidal disease.METHODS: A multicenter(11 sites), randomized(1:1:1), open, controlled trial with parallel groups was performed. All participating patients gave their written,informed consent. After inclusion, patients with acute symptoms of hemorrhoids were centrally randomized to receive, as outpatients, by the rectal route, suppositories of rSK 200000 IU of one unit every 8 h(first 3 units)and afterwards every 12 h until 8 administrations were completed(schedule A), one unit every 8 h until 6 units were completed(schedule B), or 25 mg hydrocortisone acetate once every 8 h up to a maximum of 24 administrations. Evaluations were performed at 3, 5,and 10 d post-inclusion. The main end-point was the 5thday response(disappearance of pain and bleeding, and≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were also evaluated.RESULTS: Groups were homogeneous with regards to demographic and baseline characteristics. Fifth day complete response rates were 156/170(91.8%; 95%CI:87.3-96.2), 155/170(91.2%; 95%CI: 86.6%-95.7%),and 46/170(27.1%; 95%CI: 20.1%-34.0%) with rSK(schedule A and B) and hydrocortisone acetate suppositories, respectively. These 64.6% and 63.9%differences(95%CI: 56.7%-72.2% and 55.7%-72.0%)were highly significant(P < 0.001). This advantage was detected since the early 3rd day evaluation(68.8% and64.1% vs 7.1% for the rSK and active control groups,respectively; P < 0.001) and was maintained even at the late 10 th day assessment(97.1% and 93.5% vs67.1% for rSK and hydrocortisone acetate, respectively;P < 0.001). Time to response was 3 d(95%CI: 2.9-3.1)for both rSK groups and 10 d(95%CI: 9.3-10.7) in the hydrocortisone acetate group. This difference was highly significant(P < 0.001). All subgroup stratified analyses(with or without thrombosis and hemorrhoid classification) showed a statistically significant advantage for the rSK groups. Thrombectomy was necessary in4/251 and 14/133 patients with baseline thrombosis in the rSK and hydrocortisone acetate groups, respectively(P < 0.001). There were no adverse events attributable to the experimental treatment.CONCLUSION: rSK suppositories showed a significant advantage over a widely-used over-the-counter hydrocortisone acetate preparation for the treatment of acute hemorrhoidal illness, as well as having an adequate safety profile.

3D printed tacrolimus suppositories for the treatment of ulcerative colitis

Ulcerative colitis is a global health problem,affecting millions of individuals worldwide.As an inflammatory condition localised in the large intestine,rectal delivery of immunosuppressive therapies such as tacrolimus is a promising strategy to maximise drug concentration at the site of action whilst minimising systemic side effects.Here,for the first time,self-supporting 3D-printed tacrolimus suppositories were prepared without the aid of moulds using a pharmaceutical semi-solid extrusion(SSE)3D printer.The suppositories were printed vertically in three different sizes using combinations of two lipid pharmaceutical excipients(Gelucire 44/14 or Gelucire 48/16)and coconut oil.Although both suppository formulations had the appropriate viscosity characteristics for printing,the Gel 44 formulation required less energy and force for extrusion compared to the Gel 48 system.The Gel 44 disintegrated more rapidly but released tacrolimus more slowly than the Gel 48 suppositories.Although the tacrolimus release profiles were significantly different,both suppository systems released more than 80% drug within 120 min.DSC and XRD analysis was inconclusive in determining the solid-state properties of the drug in the suppositories.In summary,this article reports on the fabrication of 3D printed selfsupporting suppositories to deliver personalised doses of a narrow therapeutic index drug,with potential benefits for patients with ulcerative colitis.

Traditional Chinese Medicine Erhuang Suppository for Treatment of Persistent High-risk Human Papillomavirus Infection and Its Impact on Transcriptome of Uterine Cervix

Objective High-risk human papillomavirus(HR-HPV)infection is the chief cause of cervical intraepithelial neoplasia(CIN)and cervical carcinoma.The Erhuang suppository(EHS)is a traditional Chinese medicine(TCM)prepared from realgar(As2S2),Coptidis rhizoma,alumen,and borneolum syntheticum and has been used for antiviral and antitumor purposes.However,whether EHS can efficiently alleviate HR-HPV infection remains unclear.This study was conducted to evaluate the efficacy of EHS for the treatment of persistent HR-HPV infection in the uterine cervix.Methods In this study,we evaluated the therapeutic efficacy of EHS in a randomized controlled clinical trial with a 3-month follow-up.Totally,70 patients with persistent HR-HPV infection were randomly assigned to receive intravaginal administration of EHS or placebo.HPV DNA,ThinPrep cytologic test(TCT),colposcopy,and safety evaluation were carried out after treatment.Microarray analysis was performed to compare transcriptome profiles before and after EHS treatment.A K14-HPV16 mouse model was generated to confirm the efficiency of EHS.Results After 3 months,74.3%(26/35)of the patients in the treatment group were HPV negative,compared to 6.9%(2/29)in the placebo group.High-throughput microarrays revealed distinct transcriptome profiles after treatment.The differentially expressed genes were significantly enriched in complement activation,immune response,and apoptotic processes.The K14-HPV16 mouse model also validated the remarkable efficacy of EHS.Conclusion This study demonstrated that EHS is effective against HR-HPV infection and cervical lesions.Additionally,no obvious systemic toxicity was observed in patients during the trial.The superior efficacy and safety of EHS demonstrated its considerable value as a potential cost-effective drug for the treatment of HPV infection and HPV-related cervical diseases.

Adjuvant Rectal Diclofenac for Post Operative Analgesia after Caesarean Section—A Randomized Controlled Study

BACKGROUND: Pain management following caesarean section still remains a challenge in our environment. Most potent analgesics are either not readily available or expensive. Diclofenac suppository is an NSAID that can be used for postoperative analgesia. It is available and affordable. OBJECTIVE: To compare the efficacy and safety of combined rectal diclofenac and intramuscular pentazocine with intramuscular pentazocine alone for post operative pain control following lower segment caesarean section. METHODOLOGY: A total of 120 women who met the selection criteria scheduled for caesarean section under spinal anaesthesia with bupivacaine were randomized into two equal groups to receive either 75 mg diclofenac suppository 12 hourly for 24 hours or one anusol suppository (the placebo) 12 hourly for 24 hours. Both groups received pentazocine as primary analgesia. RESULT: The primary outcome measure is the proportion of patients with severe pain at 24 hours using the visual analogue rating scale. Secondary outcome measures are the time from surgery to ambulation, Passage of flatus, maternal satisfaction and presence of complications. Statistical analysis was done using spss version 22 and graph pad statistical package. Student T-test was used for continuous variables whereas chi square was used for categorical variables P CONCLUSION: Adjuvant rectal diclofenac is superior to pentazocine alone in the management of pain after caesarean section. Less number of patients had moderate to severe pain at 24 hours post operation. Maternal satisfaction in relation to pain management is better with diclofenac suppository. The levels of complications were comparable in both groups.

Formulation and evaluation of novel aspirin nanoparticles loaded suppositories

The main objective of the present work is to design aspirin nanoparticles loaded suppositories which will reduce the side effects caused by aspirin suppositories. Aspirin nanoparticles were prepared initially based on ionic-gelation mechanism and lyophilized. The prepared nanoparticles were evaluated, and the results confirmed that Fa9 formulation was the best with greater drug entrapment efficiency. Aspirin suppositories were prepared in order to investigate the best base composition. The prepared suppositories were evaluated and FS1, FS3, FS4, FSS, FS1 l, and FS12 were proved to be the best base compositions based on dissolution performed. The lyophilized aspirin nanoparticles of Fa9 were used to prepare aspirin nanoparticles loaded suppositories. The in vitro results revealed that Fasl 1 was the best formulation.

Activation mechanism of neurotransmitter G protein coupled receptors

G-protein coupled receptors （GPCRs） class C represent a distant group among the large family of GPCRs. This class includes the receptors for the main neurotransmitters, glutamate and gamma-aminobutyric acid （GABA）, and the receptors for Ca2＋, some taste and pheromone molecules, as well as some orphan receptors. Like any other GPCRs, these receptors possess a heptahelical domain （HD） involved in heterotrimeric G-protein activation, but most of them also have a large extracellular domain （VFT） responsible for agonist recognition and binding. These receptors are dimers, either homo or heterodimers. Then whereas have mGluRs is homodimers, GABAB receptor was the first heteromeric G-protein coupled receptor （GPCR） identified. Indeed, both GB1 and GB2 subunits appear necessary to get a functional GABAB receptor. We have demonstrated that the interactions be- tween VFT domain of both GB1 and GB2 were important for receptor activation. We have also shown the dynamic movement of trans-membrane of mGluRs within dimers. Then we have found that the GABAB receptor induced acti- vation of ERK1/2/CREB and protected neurons from apoptosis by trans-activating IGF-1R. We have also demon- strated that GABAB receptor activation has been modulated by the dynamic protein-protein interactions between re- ceptors and its downstream signal proteins such as FAK1 and Rap l. Finally, we have performed the HTS screening and found the first negative allosteric modulator for GABAB receptors.

The Effect of Gankang Suppository on Duck Hepatitis B Virus, Serum Biochemistry and Liver Histology in Ducklings

To examine the effect of Gankang Suppository on duck hepatitis B virus （DHBV）, the serum biochemistry and hepatic histology in an animal model of DHBV infection, a model of DHBV infection was established by infecting 1-day-old Yingtaogu ducklings with DHBV-positive serum. The successful model was confirmed by PCR assay and 48 ducklings infected with DHBV were randomly divided into 3 groups： a Gankang Suppository treatment group, an acyclovir （ACV） group and a DHBV model group （control）, with each group having 16 animals. All the animals were given the medicines for 4 weeks in a row. The serum of the animals was taken 14 and 28 days after the medica- tion and 7 days after drug discontinuation. Real-time PCR was performed to detect the copy numbers of DHBV DNA in the serum. ALT and AST were dynamically monitored. The ducklings were sacrificed on the 7th day after the discontinuation of the treatment and livers were harvested and examined for inflammation and degeneration of liver cells by using HE staining. The results showed that on day 14, 28 after the treatment and day 7 after the withdrawal, the logarithmic values （log） of DHBV DNA copy numbers in ducklings of Gankang Suppository treatment group were significantly lower than that before the treatment （P=0.0092, P=0.0070, P=0.0080, respectively）. Compared with DHBV model control group, the ALT level was significantly decreased （P=0.0020, P=0.0019, respectively） on day 28 after the treatment and on day 7 after the withdrawal. The AST level was also reduced on day 14 after the treatment （P=0.0298）. Compared with the ACV control group, the level of ALT was lower on day 7 after the withdrawal （P=0.0016）. Histologically, the hepatocyte swelling, vacuolous degeneration and acidophilic degeneration in Gankang Suppository treatment group were alleviated 7 days after the withdrawal as compared with model control group （P=0.0282, P=0.0084, P=0.0195, respectively）. It is concluded that Gankang Suppository can effectively suppress DHBV replication, reduce the levels of serum ALT and AST and improve hepatic histology.

Qingchang decoction retention enema may induce clinical and mucosal remission in left-sided ulcerative colitis: A case report

BACKGROUND Ulcerative colitis(UC)is a chronic autoimmune disease characterized by relapsing-remitting abdominal pain,diarrhea,mucopurulent discharge and rectal bleeding.To date,the etiology of the disease remains unknown;therefore,medical therapy is not yet available.Left-sided UC is mainly treated with oral and topical mesalazine.However,due to its modest clinical effect,endoscopic mucosal remission is not achieved in all patients.CASE SUMMARY A 44-year-old man presented to Longhua Hospital with a history of left-sided UC for more than 6 years and slight bloody diarrhea over time.Endoscopy suggested hyperemia,edema,and erosive mucosa involving the rectum and sigmoid colon.The Traditional Chinese medicine Qingchang decoction(QCD)enema treatment was initiated once a day combined with a previous standard dose of mesalazine for 8 wk,and rectal bleeding ceased after 4 wk of treatment.Another QCD enema treatment was provided after symptom relapse due to drug withdrawal for nearly 6 mo.At the 2-mo follow-up,the colonoscopy results indicated mucosal healing with no erosion or ulcers.CONCLUSION The Chinese formula QCD retention enema represents a potential treatment for left-sided UC with predominant rectal bleeding to achieve clinical and mucosal remission.

Effect of Yuchang suppository on PPAR γ/NF-KB signaling pathway in rats with ulcerative colitis

Objective: To investigate the therapeutic effect of Yuchang suppository on experimental ulcerative colitis rats and the effect of PPARγ/NF-KB signaling pathway. Methods: The UC rat model was replicated by 2.4.6-trinitrobenzenesulfonic acid (TNBS)/ethanol method and randomly divided into normal control group, model group, high-dose group of Yuchang suppository, middle dose group , Low-dose group and sulfasalazine group, 8 rats in each group. After 14 days of treatment, the general condition of the rats was observed and the disease activity index was scored. The changes of serum TNF-α, IL-1β and IL-6 levels were detected by ELISA. The colonic mucosal injury index (CMDI) score and colon were observed by colon specimens. Histopathological changes;RT-PCR and Western blot were used to detect the expression of PPARγ and NF-KB genes and proteins in colon tissue. Results: Compared with the normal control group, the DAI and CMDI scores in the model group and the levels of serum TNF-α, IL-1β, IL-6, NF-κB p65 mRNA and protein in colon tissue were significantly increased, PPAR. - γ mRNA and protein expression levels were significantly reduced. The levels of IL-1β, IL-6, TNF-α and the expression of NF-κB p65 mRNA and protein in colon tissue were lower than those in the model group, and the expression levels of PPARγ mRNA and protein were high. In the model group. In the improvement of NF-κBp65 and PPAR-γ gene and protein expression in rat colonic mucosa, the high-dose group and the middle-dose group were significantly better than the low-dose group. Conclusion:Yuchang suppository can significantly improve the symptoms and histopathology of UC model rats. The mechanism may be through activation of PPARγ, blocking the activation of NF-κB signaling pathway, and down-regulating inflammatory factors such as TNF-α and IL-1β. The expression is such that the inflammatory response is alleviated or eliminated, thereby achieving the therapeutic effect of UC.

Treatment of Nonspecific Chronic Prostatitis with Qian Lie Xian Yan Suppository in 104 Cases

Qian Lie Xian Yan Suppository (前列腺炎栓) was rectally applied to treat 104 patients with nonspecific chronic prostatitis ( damp-heat syndrome with blood stasis) in contrast to 30 patients treated with traditional Chinese drug Ye Ju Hua Shuan (野菊花栓Suppository of Flos Chrysanthemi Indici). The results show that chronic prostatitis is markedly improved by using Qian Lie Xian Yan suppository, with a short-term cure rate of 23.1% and a total effective rate of 84.6%, superior to that of the control group. The animal experiment indicates that Qian Lie Xian Yan suppository has better anti-inflammatory and analgesic effects, with an action of promoting blood circulation.

Pharmacodynamics Study in vitro and in vivo of Zijin Huadu Suppository Treating Cervicitis

[Objectives] To observe the pharmaceutical effect of Zijin Huadu suppository on treatment of cervicitis induced by virus,bacteria and phenol in vivo and in vitro,and provide experimental basis for evaluating its therapeutic effects for cervicitis. [Methods]Real-time RT-PCR and CPE methods were used to observe the inhibition of Zijin Huadu suppository on virus,and turbidimetry was used to observe bacteriostatic action; HE pathological section was used to observe cervicitis of rat,and enzyme-linked immunosorbent assay was used to detect virus' s expression in cervical tissue.[Results]In cervicitis rat model infected by HPV16,Zijin Huadu suppositories at the doses of 1. 2,0. 6 and0. 3 g/( kg·d) had significant inhibitory effect on HPV16 expression in cervical tissues,and the doses of 1. 2 and 0. 6 g/( kg·d) had significantly inhibitory effect on pathological changes of cervical tissues. In cervicities rat models infected mixedly by Escherichia coli,Neisseria gonorrhoeae and Staphylococcus aureus,Zijin Huadu suppositories at the doses of 1. 2 and 0. 6 g/( kg·d) had significant inhibitory effect on pathological changes of cervical tissues. In cervicitis rat models induced by chemical substances,Zijin Huadu suppositories at the dose of1. 2 g/( kg·d) had significant inhibitory effect on vagina and cervix lesions in rats. In vitro,Zijin Huadu suppository showed obvious inhibitory effects on HSV-2,HPV16,Staphylococcus aureus,Staphylococcus albus,Staphylococcus epidermidis,group B Streptococcus,E. coli,Pseudomonas aeruginosa,Proteusbacillus vulgaris,Neisseria gonorrhoeae and Candida albicans.[Conclusions] Zijin Huadu suppository has obvious inhibitory effect in vitro on viruses and bacteria,and could obviously improve the phenol-induced cervicitis.

Therapeutical effect of marine lysozyme suppository on bacterial vaginitis caused by S. aureus and E. coli

Aim To research therapeutical effect of marine lysozyme suppository on bacterial vaginitis caused by S. aureus and E. coll. Methods Lysozyme obtained from concha ostreae which were used to preparate marine lyso- zyme suppository. The identification and test of suppository was in line with the standards stated in Chinese pharma- coperia（2010 edition）. After determined its quality control, we studied its therapeutical effect on bacterial vaginitis which caused by S. aureus and E. coli, by vaginitis model in rats infection of S. aureus bacteria and E. coli. Results The preparation technology of marine lysozyme suppository was simple, convenient and clinically effective. The marine lysozyme suppository was delivered by dose 0.5, 0.25, 0. 125 g ~ kg-1, the cure rates of S. aureus infec- tion were 80% , 50% and 30% , respectively, the cure rates of E. coli infection were 90% , 60% and 30% re- spectively, the cure rates of mixed infection were 92.9% , 82. 1% and 92.9% respectively. Marine lysozyme sup- pository had an outstanding therapeutical effect on bacterial vaginitis which caused by S. aureus and E. coll. Con- clusion The preparative process of marine lysozyme suppository was practicable, and it had a good therapeutic effect on bacterial vaginitis caused by S. aureus and E. coll.

Study on pharmacodynamics of recombinant interferon α-2b suppository

Objective To investigate the antiviral activity of recombinant interferonα-2b suppository(IFNα-2b)in vivo and in vitro.Methods The cytopathic-effect inhibition assay was applied in this study to investigate the antiviral activity of this drug as well as yingtelong and axiluowei as positive control.The guinea pig model of vaginitis and skin infection caused by HSV-2 infection were established,treated with IFNα-2b suppository at dosages of 60000、180000、540000 IU,using IFNα-2b injection 180000 IU·kg-1 as controls.Score the pathological changes of appearance and skin,the virus activities of vaginal secretion and tissue sections of viginae were assayed after treatment.Results The TD50 of IFN α-2b and yingtelong for Vero cells was(>100)μg·mL-1 and(>100000)IU·mL-1,respectively.The IC50 of IFN α-2b and yingtelong and axiluowei for Herpes virus type 1 was(0.29±0.08)μg·mL-1 and(185.0±28.8)IU·mL-1 and(0.19±0.03)μg·mL-1,respectively.The mean scores for vaginal and skin lesion of the treated groups were lower than those of untreated group.Among these concentrations,the IFNα-2b suppository of 540000 IU·kg-1 group.Showed highest anti-viral activity.The virus activity in vaginal secretion of treated group was lower than that of untreated group too(P<0.01 or P<0.05).Tissue sections of viginae after treatment with IFNα-2b suppository showed significantly therapeutical effects on the degrees of vaginal lesion.At the same dosage,The anti-HSV activity of IFNα-2b suppository was also compared with IFNα-2b injection,the results showed that the activity of suppository of 540000 IU·kg-1 group was similar to that of the injection.Conclusions The IFNα-2b suppository has anti-viruses function both in vivo and in vitro.

Bioequivalence of Progesterone Sustained Release Suppository in Rabbits

Summary： To study the bioequivalence of a kind of progesterone sustained release suppository, a randomized cross over study was conducted in 12 rabbits. A single rectal dose of 2.75 mg/kg progesterone sustained released suppository （tested formulation, T） and progesterone suppository （reference formulation, R） was administered; a muhiple dose of 2.75 mg/kg was given up to seven times with an interval of 8 h. Concentrations in serum were determined by a competitive enzyme immunoassay. The main parameters of T were： for single and multiple doses, C was 48.8±11.8 ng/mL and 43.5±9.4 ng/mL. Tmax was 0.5±0.3 h and 0. 4±0.3 h, AUC〈（0-21h） was 362. 4±143 ng·h·mL^-1 and 310.6±70. 3 ng·h·mL^-1 , respectively. The relative bioavailability of T to R were （104.2±13.4） % and （111.4±19. 1） %, respectively. Statistical analysis showed that the two formulations were bioequivalent and T had sustained released feature.

Effects of Qianlie'an(前列安)Suppository in Patients with Chronic prostatitis Syndrome:A Randomized Open-Labelled Prospective and Controlled Trial

Objective:To evaluate the clinical efficacy of Qianlie'an (前列安,QLA) suppository via a-nal route administration in treating chronic prostatitis syndrome. Methods:A randomized open-labelled prospective controlled trial was carried out. The total of 120 patients with chronic prostatitis syndrome were randomly divided into 2 groups: 60 patients in the treated group who were treated with QLA suppository combined with ofloxacin, and the other 60 patients in the control group who were given ofloxacin a-lone. The efficacy was evaluated by WBC count in the expressed prostatic secretion (EPS) and the Chronic Prostatitis Symptom Index (CPSI) made by the National Institute of Health (NIH). The clinical effects were also observed in a 4-week follow-up. Results:All but six cases completed the trial and the follow-up. It showed that in the treated group recovery rate was 17. 2%, markedly effective rate 34. 5%, effective rate 32. 8%, total markedly effective rate 51. 7%, and total effective rate 84. 5%, all of which were superior to those in the control group (total markedly effective rate 32.1% and total effective rate 66.1%, respectively), P<0. 01. Conclusion: Administration of QLA suppository via anal route combined with oral antibiotics is an effective therapy for chronic prostatitis syndrome. It can relieve the symptoms of chronic prostatitis syndrome markedly and rapidly. It is a new choice for treatment of the disease.