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.

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.METHODS: A multicenter(14 sites), randomized(1:1), open, parallel groups, active controlled trial was done. After inclusion, subjects with acute symptoms of hemorrhoids, who gave their written, informed consent to participate, were centrally randomized to receive, as outpatients, rSK(200000 IU) or 0.25% phenylephrine suppositories, which had different organoleptic characteristics. Treatment was administered by the rectal route, one unit every 6 h during 48 h for rSK, and up to a maximum of 5 d(20 suppositories) for phenylephrine. Evaluations were performed at 3, 5 and 10 d postinclusion. The main end-point was the 5th-day complete clinical response(disappearance of pain and edema, and ≥ 70% reduction of the lesion size). Time to response and need for thrombectomy were secondary efficacy variables. Adverse events were evaluated too. RESULTS: 5thday complete response rates were 83/110(75.5%) and 36/110(32.7%) with rSK and phenylephrine suppositories, respectively. This 42.7% difference(95%CI: 30.5-54.2) was highly significant(P < 0.001). The advantage was detected since the early 3rdday evaluation(37.3% vs 6.4% for the rSK and active control groups, respectively; P < 0.001) and was kept even at the late 10thday assessment(83.6% vs 58.2% for rSK and phenylephrine, respectively; P < 0.001). Time for complete response was significantly shorter(P = 0.031; log-rank test) in the rSK group(median: 4.9 d; 95%CI: 4.8-5.0) with respect to the active control(median: 9.8 d; 95%CI: 9.8-10.0). Thrombectomy was necessary in 1/59 and 8/57 patients with baseline thrombosis in the rSK and phenylephrine groups, respectively(P = 0.016). There were no adverse events attributable to the experimental treatment. CONCLUSION: rSK suppositories showed a significant advantage over a widely used over-the-counter phen-ylephrine preparation for the treatment of acute hemorrhoidal illness, with an adequate safety profile.

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.

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.

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.

THE CONTRACEPTIVE EFFECT OF MORRHUIC ACID SUPPOSITORY

The morrhuic acid suppository had been used in 1746 women with a total of 16073 women-months cycles. 1354 cases continued to use the suppository for 12 months, 367 cases completed 24 months and 15 cases 25-34 months. The cumulative twelve month life table pregnancy rate was 10.1 per 100 women and the method pergnancy rate was 4.8 per 100 women corresponding to an effective ness rate of 95.2% per 100 women. The gross twelve months cumulative termination rate per 100 women was 27.3 giving a continuation rate of 72.7%. Cervical smears were taken in 499 women showing no carcinomatous changes. It did not interfere with the menstrual cycle and flow. The only adverse side effect was the burning or itching sensation of the vulva which accounts for a 1.2% discontinuation rate. This suppository is sultable for contraception of all women in reproductive age.

The Clinic Analysis of Diclofenac Suppository for Oocyte Retrieval Analgesia in IVF-ET Cycles

Objective: To study the effect of diclofenac suppository in oocyte retrieval of IVF-ET. Study Design: 1176 patients with informed consents were enrolled into this prospective randomized controlled study. The setting was an IVF-ET program at the First Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. According to the analgesic drug use, the patients were randomly divided into pethidine group (573 cases) and diclofenac suppository group (603 cases). The data of vital signs, common adverse reactions, severe adverse events and pain degree in oocyte retrieval were collected. The IVF-ET outcomes were also compared. Results: The post-operation pressure and pulse were lower in pethidine group than in diclofenac suppository group (both P0.001).The rest vital signs were not statistically different (all P>0.05). Common adverse reactions in diclofenac suppository group were relative less (all P0.05). Pain degree between the two groups was not statistically different (P=0.304). IVF-ET outcomes were also not statistically different (all P>0.05). There were 3 cases serious abdominal bleeding with shock in the diclofenac suppository group. Conclusion: Using diclofenac suppository in oocyte retrieval analgesic had a good effect. And there was no adverse effect in the IVF-ET outcome. But we should pay close attention to the probability of serious abdominal bleeding.

Systematic Review and Meta-Analysis of Baofukang Suppository(保妇康栓)Combined with Interferon in the treatment of Cervical High-risk HPV Infection

Objective:This study conducted a systematic review of randomized controlled trials in order to evaluate the efficacy and safety of Baofukang Suppository(保妇康栓)combined with interferon on cervical high-risk human papillomavirus(HR-HPV)infection.Methods:Data comes from China National Knowledge Infrastructure(CNKI),Wanfang database,the VIP information database,Chinese Biomedical Literature Database,PubMed,Cochrane Library,Web of Science and Embase.Primary and secondary outcome measures were extracted from 13 included randomized controlled trials:number of HR-HPV turning negative and effective,time of HPV turning negative,duration of abnormal vaginal secretions and adverse events.Results:Baofukang Suppository combined with interferon were better than interferon alone in improving the negative rate of HR-HPV(RR=1.42,95%CI[1.28,1.58],P<0.00001)and the effective rate of HR-HPV RR=1.3,95%CI[1.24,1.37],P<0.00001),time of HR-HPV turning negative(MD=-8.32,95%CI[-9.17,-7.47],P<0.00001),duration of abnormal vaginal secretions(MD=-8.95,95%CI[-11.34,-6.56],P<0.00001).However,there was no statistical difference in improving inflammatory factor(TNF-α:SMD=-0.49,95%CI[-1.02,0.03],Z=1.83,P=0.07;IL-6:SMD=-13.69,95%CI[-41.98,14.6],Z=0.95,P=0.34)and adverse events(RR=-0.73,95%CI[0.48,1.11,P=0.15)between two groups.Conclusion:The results showed that the efficacy of Baofukang Suppository combined with interferon were better than interferon alone in improving the negative and effective rate of HR-HPV,shortening the time of HR-HPV turning negative and duration of abnormal vaginal secretion and reducing adverse events.

Qingchang suppositry(清肠栓)induced remission in patients with mild-to-moderate ulcerative proctitis:a multicenter,prospective,randomized,parallel-controlled clinical trial

OBJECTIVE:To evaluate the efficacy and safety of Qingchang suppository(清肠栓,QCS),a preparation of Chinese herbal medicine,in the induction of remission in patients with mild-to-moderate ulcerative proctitis(UP).METHODS:We performed a multicenter,prospective,randomized,parallel-controlled trial to evaluate the efficacy of QCS induction therapy in 140 adult patients with mild-to-moderate UP and TCM syndrome of dampness-heat in large intestine.The patients were randomized to receive QCS(study group)or Salicylazosulfapyridine(SASP)suppository(control group)one piece each time,twice a day,per anum for 12 weeks.Mayo score and main symptoms score were evaluated at weeks 0,2,4,8 and 12,rectosigmoidscopy was taken at weeks 0,4,8 and 12,Geboes score,erythrocyte sedimentation rate(ESR),C-reactive protein(CRP)and safety indexes were assessed at weeks 0 and 12.The primary efficacy endpoint is clinical remission rate,the secondary efficacy endpoints are clinical response rate,mucosa healing rate,Geboes score,the remission rates of the main symptoms,the median day to the remission of the symptom,etc.RESULTS:There were no statistical difference in the clinical remission rates,the clinical response rates,the mucosa healing rates,Geboes score,ESR and CRP between the two groups.The remission rates of tenesmus and anal burning sensation of the study group were significantly higher than those of the control group(76.5%vs 25.0%,P=0.009;74.51%vs 29.63%,P=0.003).The median day to the remission of purulent bloody stool of the study group was significantly less than that of control group[11(1,64)vs 19(2,67),P=0.007].The patients receiving QCS had a significantly higher mucosa healing rate at week 4 than the patients receiving SASP suppository(71.42%vs 52.85%,P=0.023).No adverse event occurred in the study group while the adverse events incidence of the control group was 5.7%(P=0.049).CONCLUSIONS:QCS could induce the remission of UP as effectively and safely as SASP suppository,and was superior to SASP suppository in relieving the symptoms of tenesmus,anal burning sensation and purulent bloody stool and the time to reach mucosa healing.